Friday, 17 August 2012

Fleet Phospho-soda EZ-Prep


Generic Name: phosphate supplement (Oral route, Parenteral route)


Commonly used brand name(s)

In the U.S.


  • Fleet Phospho-soda EZ-Prep

  • K-Phos Neutral

  • K-Phos Original

  • OsmoPrep

  • Phospha 250 Neutral

  • Phospho-Soda

  • Visicol

Available Dosage Forms:


  • Tablet

  • Tablet, Enteric Coated

  • Liquid

Uses For Fleet Phospho-soda EZ-Prep


Phosphates are used as dietary supplements for patients who are unable to get enough phosphorus in their regular diet, usually because of certain illnesses or diseases. Phosphate is the drug form (salt) of phosphorus. Some phosphates are used to make the urine more acid, which helps treat certain urinary tract infections. Some phosphates are used to prevent the formation of calcium stones in the urinary tract.


Injectable phosphates are to be administered only by or under the supervision of your health care professional. Some of these oral preparations are available only with a prescription. Others are available without a prescription; however, your health care professional may have special instructions on the proper dose of this medicine for your medical condition. You should take phosphates only under the supervision of your health care professional.


Importance of Diet


For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.


The best dietary sources of phosphorus include dairy products, meat, poultry, fish, and cereal products.


The daily amount of phosphorus needed is defined in several different ways.


  • For U.S.—

  • Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).

  • Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

  • For Canada—

  • Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for phosphorus are generally defined as follows:


























PersonsU.S.

(mg)
Canada

(mg)
Infants birth to 3 years of age300–800150–350
Children 4 to 6 years of age800400
Children 7 to 10 years of age800500–800
Adolescent and adult males800–1200700–1000
Adolescent and adult females800–1200800–850
Pregnant females12001050
Breast-feeding females12001050

Before Using Fleet Phospho-soda EZ-Prep


If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Problems in children have not been reported with intake of normal daily recommended amounts. However, use of enemas that contain phosphates in children has resulted in high blood levels of phosphorus.


Geriatric


Problems in older adults have not been reported with intake of normal daily recommended amounts.


Pregnancy


It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.


Breast Feeding


It is especially important that you receive the right amount of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these dietary supplements, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using dietary supplements in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with dietary supplements in this class or change some of the other medicines you take.


  • Amantadine

  • Atropine

  • Belladonna

  • Belladonna Alkaloids

  • Benztropine

  • Biperiden

  • Cisapride

  • Clidinium

  • Darifenacin

  • Dicyclomine

  • Dronedarone

  • Eplerenone

  • Glycopyrrolate

  • Hyoscyamine

  • Mesoridazine

  • Methscopolamine

  • Oxybutynin

  • Pimozide

  • Procyclidine

  • Scopolamine

  • Solifenacin

  • Sparfloxacin

  • Thioridazine

  • Tolterodine

  • Trihexyphenidyl

Using dietary supplements in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Alacepril

  • Alfuzosin

  • Amiloride

  • Amiodarone

  • Amitriptyline

  • Amoxapine

  • Apomorphine

  • Arsenic Trioxide

  • Asenapine

  • Astemizole

  • Azithromycin

  • Benazepril

  • Canrenoate

  • Captopril

  • Chloroquine

  • Chlorpromazine

  • Cilazapril

  • Ciprofloxacin

  • Citalopram

  • Clarithromycin

  • Clomipramine

  • Clozapine

  • Crizotinib

  • Dasatinib

  • Delapril

  • Desipramine

  • Disopyramide

  • Dofetilide

  • Dolasetron

  • Droperidol

  • Enalaprilat

  • Enalapril Maleate

  • Erythromycin

  • Flecainide

  • Fluconazole

  • Fosinopril

  • Gatifloxacin

  • Gemifloxacin

  • Granisetron

  • Halofantrine

  • Haloperidol

  • Ibutilide

  • Iloperidone

  • Imidapril

  • Imipramine

  • Indomethacin

  • Lapatinib

  • Levofloxacin

  • Lisinopril

  • Lopinavir

  • Lumefantrine

  • Mefloquine

  • Methadone

  • Moexipril

  • Moxifloxacin

  • Nilotinib

  • Norfloxacin

  • Nortriptyline

  • Octreotide

  • Ofloxacin

  • Ondansetron

  • Paliperidone

  • Pazopanib

  • Pentopril

  • Perflutren Lipid Microsphere

  • Perindopril

  • Posaconazole

  • Procainamide

  • Prochlorperazine

  • Promethazine

  • Propafenone

  • Protriptyline

  • Quetiapine

  • Quinapril

  • Quinidine

  • Quinine

  • Ramipril

  • Ranolazine

  • Salmeterol

  • Saquinavir

  • Solifenacin

  • Sorafenib

  • Sotalol

  • Spirapril

  • Spironolactone

  • Sunitinib

  • Telavancin

  • Telithromycin

  • Temocapril

  • Terfenadine

  • Tetrabenazine

  • Toremifene

  • Trandolapril

  • Trazodone

  • Triamterene

  • Trifluoperazine

  • Trimipramine

  • Vandetanib

  • Vardenafil

  • Vemurafenib

  • Voriconazole

  • Ziprasidone

  • Zofenopril

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:


  • Burns, severe or

  • Heart disease or

  • Pancreatitis (inflammation of the pancreas) or

  • Rickets or

  • Softening of bones or

  • Underactive parathyroid glands—Sodium- or potassium-containing phosphates may make these conditions worse.

  • Dehydration or

  • Underactive adrenal glands—Potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood).

  • Edema (swelling in feet or lower legs or fluid in lungs) or

  • High blood pressure or

  • Liver disease or

  • Toxemia of pregnancy—Sodium-containing phosphates may make these conditions worse.

  • High blood levels of phosphate (hyperphosphatemia)—Use of phosphates may make this condition worse.

  • Infected kidney stones—Phosphates may make this condition worse.

  • Kidney disease—Sodium-containing phosphates may make this condition worse; potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood).

  • Myotonia congenita—Potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood), and make this condition worse.

Proper Use of phosphate supplement

This section provides information on the proper use of a number of products that contain phosphate supplement. It may not be specific to Fleet Phospho-soda EZ-Prep. Please read with care.


For patients taking the tablet form of this medicine:


  • Do not swallow the tablet. Before taking, dissolve the tablet in ¾ to 1 glass (6 to 8 ounces) of water. Let the tablet soak in water for 2 to 5 minutes and then stir until completely dissolved.

For patients using the capsule form of this medicine:


  • Do not swallow the capsule. Before taking, mix the contents of 1 capsule in one-third glass (about 2½ ounces) of water or juice or the contents of 2 capsules in two-thirds glass (about 5 ounces) of water and stir well until dissolved.

For patients using the powder form of this medicine:


  • Add the entire contents of 1 bottle (2¼ ounces) to enough warm water to make 1 gallon of solution or the contents of one packet to enough warm water to make 1/3 of a glass (about 2.5 ounces) of solution. Shake the container for 2 or 3 minutes or until all the powder is dissolved.

  • Do not dilute solution further.

  • This solution may be chilled to improve the flavor; do not allow it to freeze.

  • Discard unused solution after 60 days.

Take this medicine immediately after meals or with food to lessen possible stomach upset or laxative action.


To help prevent kidney stones, drink at least a full glass (8 ounces) of water every hour during waking hours, unless otherwise directed by your health care professional.


Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your health care professional.


Dosing


The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For potassium phosphates

  • For oral dosage form (solution):
    • To replace phosphorus lost by the body or to make the urine more acid or to prevent the formation of kidney stones in the urinary tract:
      • Adults and teenagers—The equivalent of 228 milligrams (mg) of phosphorus (2 tablets) dissolved in six to eight ounces of water four times a day, with meals and at bedtime.


    • To replace phosphorus lost by the body:
      • Children over 4 years of age—The equivalent of 228 mg of phosphorus (2 tablets) dissolved in six to eight ounces of water four times a day, with meals and at bedtime.

      • Children up to 4 years of age—The dose must be determined by your doctor.



  • For oral dosage forms (capsules or oral solution):
    • To replace phosphorus lost by the body:
      • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (contents of 1 capsule) dissolved in two and one-half ounces of water or juice four times a day, after meals and at bedtime.

      • Children up to 4 years of age—Dose must be determined by your doctor.



  • For oral dosage forms (powder for oral solution):
    • To replace phosphorus lost by the body:
      • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in two and one-half ounces of water four times a day, after meals and at bedtime.

      • Children up to 4 years of age—Dose must be determined by your doctor.



  • For potassium and sodium phosphates

  • For oral dosage form (solution):
    • To replace phosphorus lost by the body or to make the urine more acid or to prevent the formation of kidney stones in the urinary tract:
      • Adults and teenagers—The equivalent of 250 milligrams (mg) of phosphorus dissolved in eight ounces of water four times a day, after meals and at bedtime.


    • To replace phosphorus lost by the body:
      • Children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in eight ounces of water four times a day, after meals and at bedtime.

      • Children up to 4 years of age—Dose must be determined by your doctor.



  • For oral dosage forms (capsules or solution):
    • To replace phosphorus lost by the body:
      • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (the contents of 1 capsule) dissolved in two and one-half ounces of water or juice four times a day, after meals and at bedtime.

      • Children up to 4 years of age—Dose must be determined by your doctor.



  • For oral dosage forms (powder for solution):
    • To replace phosphorus lost by the body:
      • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in two and one-half ounces of water four times a day, after meals and at bedtime.

      • Children up to 4 years of age—Dose must be determined by your doctor.



  • For oral dosage forms (tablets for solution):
    • To replace phosphorus lost by the body:
      • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (1 tablet) dissolved in eight ounces of water four times a day.

      • Children up to 4 years of age—Dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Keep out of the reach of children.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Fleet Phospho-soda EZ-Prep


Your health care professional should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.


Do not take iron supplements within 1 to 2 hours of taking this medicine. To do so may keep the iron from working properly.


For patients taking potassium phosphate-containing medicines:


  • Check with your health care professional before starting any strenuous physical exercise, especially if you are out of condition and are taking other medication. Exercise and certain medicines may increase the amount of potassium in the blood.

For patients on a potassium-restricted diet:


  • This medicine may contain a large amount of potassium. If you have any questions about this, check with your health care professional.

  • Do not use salt substitutes and low-salt milk unless told to do so by your health care professional. They may contain potassium.

For patients on a sodium-restricted diet:


  • This medicine may contain a large amount of sodium. If you have any questions about this, check with your health care professional.

Fleet Phospho-soda EZ-Prep Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


Less common or rare
  • Confusion

  • convulsions (seizures)

  • decrease in amount of urine or in frequency of urination

  • fast, slow, or irregular heartbeat

  • headache or dizziness

  • increased thirst

  • muscle cramps

  • numbness, tingling, pain, or weakness in hands or feet

  • numbness or tingling around lips

  • shortness of breath or troubled breathing

  • swelling of feet or lower legs

  • tremor

  • unexplained anxiety

  • unusual tiredness or weakness

  • weakness or heaviness of legs

  • weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


  • Diarrhea

  • nausea or vomiting

  • stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



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Tuesday, 14 August 2012

MSIR


Generic Name: morphine (Oral route)

MOR-feen

Oral route(Capsule, Extended Release)

Kadian(R): Capsule contains morphine sulfate, an opioid agonist and Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. Kadian(R) is indicated for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. The 100-mg and 200-mg capsules are for use in opioid-tolerant patients only. Kadian(R) capsules should be swallowed whole or the contents sprinkled on applesauce. Do not crush, chew, or dissolve capsule pellets due to the risk of rapid release and absorption of a potentially fatal dose of morphine .


Oral route(Capsule, Extended Release, 24 HR)

Avinza(R): Capsules are a modified-release formulation of morphine sulfate indicated for once daily administration for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time. Avinza(R) capsules should be swallowed whole or the contents sprinkled on applesauce. Do not crush, chew, or dissolve capsule beads due to the risk of rapid release and absorption of a potentially fatal dose of morphine. Avoid alcohol and alcohol-containing medications as consumption of alcohol may result in the rapid release and absorption of a potentially fatal dose of morphine .


Oral route(Solution)

Morphine oral solution is available in 10 mg/5 mL, 20 mg/5 mL and 100 mg/5 mL (20 mg/mL) concentrations. The 100 mg/5 mL (20 mg/mL) concentration is indicated for use in opioid-tolerant patients only. Take care to avoid dosing errors due to confusion between different concentrations and between mg and mL, which could result in accidental overdose and death. Keep morphine oral solution out of the reach of children .


Oral route(Tablet, Extended Release)

MS Contin(R): 100 mg and 200 mg tablets are for use in opioid-tolerant patients only. MS Contin(R) tablets are a controlled-release formulation, should be swallowed whole and are not to be broken, chewed, dissolved, or crushed due to the risk of rapid release and absorption of a potentially fatal dose of morphine . Oramorph(R) SR: This is a sustained-release dosage form. Swallow the tablet whole; the tablet should not be broken in half, nor should it be crushed or chewed .



Commonly used brand name(s)

In the U.S.


  • Avinza

  • Kadian

  • Kadian ER

  • MS Contin

  • MSIR

  • Oramorph SR

  • Roxanol

  • Roxanol-T

Available Dosage Forms:


  • Capsule, Extended Release

  • Capsule, Extended Release, 24 HR

  • Tablet, Extended Release

  • Capsule

  • Tablet

  • Powder for Suspension, Extended Release

  • Solution

  • Capsule, Delayed Release

  • Syrup

Therapeutic Class: Analgesic


Chemical Class: Opioid


Uses For MSIR


Morphine is used to relieve moderate to severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Morphine acts on the central nervous system (CNS) to relieve pain.


When morphine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.


This medicine is available only with your doctor's prescription.


Before Using MSIR


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies have not been performed on the relationship of age to the effects of morphine in the pediatric population. Safety and efficacy have not been established.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of morphine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving morphine.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.


  • Brofaromine

  • Clorgyline

  • Furazolidone

  • Iproniazid

  • Isocarboxazid

  • Lazabemide

  • Linezolid

  • Moclobemide

  • Naltrexone

  • Nialamide

  • Pargyline

  • Phenelzine

  • Procarbazine

  • Rasagiline

  • Selegiline

  • Toloxatone

  • Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Adinazolam

  • Alfentanil

  • Alprazolam

  • Amobarbital

  • Anileridine

  • Aprobarbital

  • Bromazepam

  • Brotizolam

  • Buprenorphine

  • Butabarbital

  • Butalbital

  • Butorphanol

  • Carisoprodol

  • Chloral Hydrate

  • Chlordiazepoxide

  • Chlorpromazine

  • Chlorzoxazone

  • Cimetidine

  • Clobazam

  • Clonazepam

  • Clorazepate

  • Codeine

  • Dantrolene

  • Dezocine

  • Diazepam

  • Estazolam

  • Ethchlorvynol

  • Fentanyl

  • Flunitrazepam

  • Fluphenazine

  • Flurazepam

  • Halazepam

  • Hydrocodone

  • Hydromorphone

  • Ketazolam

  • Levorphanol

  • Lorazepam

  • Lormetazepam

  • Medazepam

  • Meperidine

  • Mephenesin

  • Mephobarbital

  • Meprobamate

  • Metaxalone

  • Methocarbamol

  • Methohexital

  • Midazolam

  • Morphine

  • Morphine Sulfate Liposome

  • Nalbuphine

  • Nitrazepam

  • Nordazepam

  • Opium

  • Oxazepam

  • Oxycodone

  • Oxymorphone

  • Pentazocine

  • Pentobarbital

  • Perphenazine

  • Phenobarbital

  • Prazepam

  • Prochlorperazine

  • Promazine

  • Promethazine

  • Propoxyphene

  • Quazepam

  • Remifentanil

  • Secobarbital

  • Sodium Oxybate

  • Sufentanil

  • Tapentadol

  • Temazepam

  • Thiethylperazine

  • Thiopental

  • Thioridazine

  • Triazolam

  • Trifluoperazine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Cyclosporine

  • Esmolol

  • Gabapentin

  • Rifampin

  • Somatostatin

  • Yohimbine

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Ethanol

Other Medical Problems


The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Addison's disease (adrenal gland problem) or

  • Alcohol abuse, or history of or

  • Chronic obstructive pulmonary disease (COPD) or

  • Cor pulmonale (serious heart condition) or

  • Drug dependence, especially with narcotics, or history of or

  • Enlarged prostate (BPH, prostatic hypertrophy) or

  • Gallbladder disease or gallstones or

  • Head injuries, history of or

  • Heart disease or

  • Hypothyroidism (an underactive thyroid) or

  • Hypovolemia (low blood volume) or

  • Kyphoscoliosis (curvature of the spine with breathing problems) or

  • Pancreatitis (inflammation of the pancreas) or

  • Problems with passing urine or

  • Swallowing problems—Use with caution. May increase risk for more serious side effects.

  • Asthma, severe or

  • Breathing problems, severe (e.g., hypoxia) or

  • Paralytic ileus (intestine stops working and may be blocked) or

  • Respiratory depression (very slow breathing)—Should not be used in patients with these conditions.

  • Hypotension (low blood pressure) or

  • Seizures, history of—Use with caution. May make these conditions worse.

  • Kidney disease or

  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of morphine

This section provides information on the proper use of a number of products that contain morphine. It may not be specific to MSIR. Please read with care.


Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).


You may take this medicine with or without food.


Morphine extended-release capsules and tablets should only be used by patients who have already been taking narcotic pain medicines, also called opioids. These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using this medicine.


Swallow the extended-release capsules and tablets whole. Do not break, crush, dissolve, or chew them. Do not use extended-release tablets that are broken.


If you cannot swallow the extended-release capsule, you may open it and pour the medicine into a small amount of applesauce. Stir this mixture well and swallow it right away without chewing.


While taking the extended-release tablet, part of the tablet may pass into your stool. This is normal and nothing to worry about.


Morphine extended-release capsules or tablets work differently from the regular morphine oral solution or tablets, even at the same dose. Do not switch from one brand or form to the other unless your doctor tells you to.


Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (extended-release capsules):
    • For moderate to severe pain:
      • Patients switching from regular morphine forms:
        • Adults—The capsule is given once a day. The initial dose in milligrams (mg) per day is the same as the total amount of regular morphine that is taken per day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1600 mg per day.

        • Children—Use and dose must be determined by your doctor.


      • Patients who are not taking narcotic medicines:
        • Adults—At first, 30 milligrams (mg) once a day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 1600 mg per day.

        • Children—Use and dose must be determined by your doctor.




  • For oral dosage form (extended-release tablets):
    • For moderate to severe pain:
      • Patients switching from regular morphine forms:
        • Adults—The tablet is given every 8 hours or every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular morphine that is taken per day. The total amount per day will be divided and given as 2 or 3 doses during the day. Your doctor may adjust your dose if needed.

        • Children—Use and dose must be determined by your doctor.




  • For oral dosage form (solution):
    • For moderate to severe pain:
      • Adults—10 to 20 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.

      • Children—Use and dose must be determined by your doctor.



  • For oral dosage form (tablets):
    • For moderate to severe pain:
      • Adults—15 to 30 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose if needed.

      • Children—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Morphine can cause serious unwanted effects if taken by adults who are not used to strong narcotic pain medicines, children, or pets. Make sure you store the medicine in a safe and secure place to prevent others from getting it.


Flush the unused capsules, liquid, and tablets down the toilet.


Precautions While Using MSIR


It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.


This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using this medicine.


This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose.


Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.


This medicine may make you dizzy, drowsy, confused, or disoriented. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.


Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.


This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.


If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble with sleeping.


Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.


Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


MSIR Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Less common
  • Abdominal or stomach pain

  • blurred vision

  • bulging soft spot on the head of an infant

  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

  • change in the ability to see colors, especially blue or yellow

  • chest pain or discomfort

  • chills

  • confusion

  • cough

  • decreased urination

  • difficulty with breathing

  • difficulty with swallowing

  • dizziness

  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

  • fainting

  • fast, pounding, or irregular heartbeat or pulse

  • headache

  • hives

  • increased sweating

  • insomnia

  • itching

  • loss of appetite

  • nausea

  • nervousness

  • noisy breathing

  • pounding in the ears

  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

  • severe constipation

  • severe vomiting

  • shakiness in the legs, arms, hands, or feet

  • shortness of breath

  • skin rash

  • slow or irregular heartbeat

  • sweating

  • swelling

  • tightness in the chest

  • trembling or shaking of the hands or feet

  • trouble with breathing

  • trouble with urinating

  • unusual tiredness or weakness

  • vomiting

  • wheezing

Incidence not known
  • Black, tarry stools

  • bleeding gums

  • blood in the urine or stools

  • bluish lips or skin

  • change in consciousness

  • chest pain or discomfort

  • cold, clammy skin

  • convulsions

  • decrease in the amount of urine

  • decrease in the frequency of urination

  • difficulty in passing urine (dribbling)

  • extremely shallow or slow breathing

  • fast, weak pulse

  • feeling of warmth or heat

  • flushing or redness of the skin, especially on the face and neck

  • irregular, fast or slow, or shallow breathing

  • lightheadedness

  • loss of consciousness

  • low blood pressure or pulse

  • nervousness

  • painful urination

  • pale or blue lips, fingernails, or skin

  • pale skin

  • pinpoint red spots on the skin

  • pounding in the ears

  • shakiness and unsteady walk

  • troubled breathing with exertion

  • unconsciousness

  • unsteadiness, trembling, or other problems with muscle control or coordination

  • unusual bleeding or bruising

  • very slow breathing

  • very slow heartbeat

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of overdose
  • Bloody urine

  • constricted, pinpoint, or small pupils (black part of the eye)

  • dark-colored urine

  • decreased awareness or responsiveness

  • extreme drowsiness

  • fever

  • increased blood pressure

  • increased thirst

  • lower back or side pain

  • muscle cramps or spasms

  • muscle pain or stiffness

  • no muscle tone or movement

  • severe sleepiness

  • swelling of the face, fingers, or lower legs

  • weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Cramps

  • diarrhea

  • difficulty having a bowel movement (stool)

  • drowsiness

  • false or unusual sense of well-being

  • relaxed and calm feeling

  • sleepiness or unusual drowsiness

  • weight loss

Less common
  • Absent, missed, or irregular menstrual periods

  • acid or sour stomach

  • agitation

  • bad, unusual, or unpleasant (after) taste

  • belching

  • blurred or loss of vision

  • change in taste

  • decreased interest in sexual intercourse

  • depression

  • disturbed color perception

  • double vision

  • dry mouth

  • face is warm or hot to touch

  • fear

  • floating feeling

  • halos around lights

  • heartburn

  • inability to have or keep an erection

  • indigestion

  • loss in sexual ability, desire, drive, or performance

  • muscle stiffness or tightness

  • nervousness

  • night blindness

  • overbright appearance of lights

  • problems with muscle control

  • redness of the skin

  • seeing double

  • skin rash

  • sleeplessness

  • stomach discomfort, upset, or pain

  • stopping of menstrual bleeding

  • trouble sleeping

  • tunnel vision

  • unable to sleep

  • uncontrolled eye movements

  • upper abdominal or stomach pain

  • weakness

Incidence not known
  • Abnormal dreams

  • belching

  • burning while urinating

  • change in vision

  • change in walking and balance

  • change or problem with discharge of semen

  • clumsiness or unsteadiness

  • confusion as to time, place, or person

  • delusions

  • dementia

  • dry skin

  • eye pain

  • feeling of constant movement of self or surroundings

  • general feeling of discomfort or illness

  • hiccup

  • holding false beliefs that cannot be changed by fact

  • impaired vision

  • indigestion

  • loss of memory

  • problems with memory

  • seeing, hearing, or feeling things that are not there

  • sensation of spinning

  • thirst

  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

  • unusual excitement, nervousness, or restlessness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: MSIR side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More MSIR resources


  • MSIR Side Effects (in more detail)
  • MSIR Use in Pregnancy & Breastfeeding
  • Drug Images
  • MSIR Drug Interactions
  • MSIR Support Group
  • 0 Reviews for MSIR - Add your own review/rating


  • Morphine Concentrate MedFacts Consumer Leaflet (Wolters Kluwer)

  • Astramorph PF Prescribing Information (FDA)

  • Astramorph PF Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Avinza Prescribing Information (FDA)

  • Avinza Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Avinza Consumer Overview

  • Infumorph Solution MedFacts Consumer Leaflet (Wolters Kluwer)

  • Kadian Prescribing Information (FDA)

  • Kadian Consumer Overview

  • Kadian Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • MS Contin Prescribing Information (FDA)

  • MS Contin Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • MS Contin Consumer Overview

  • Morphine Sulfate Monograph (AHFS DI)

  • Oramorph SR Prescribing Information (FDA)

  • RMS Suppositories MedFacts Consumer Leaflet (Wolters Kluwer)



Compare MSIR with other medications


  • Pain

Monday, 13 August 2012

Bedranol 80mg SR Capsules





1. Name Of The Medicinal Product



Bedranol*(Propranolol Hydrochloride) SR Capsules 80mg



Rapranol* (Propranolol Hydrochloride) SR Capsules 80mg


2. Qualitative And Quantitative Composition



Each capsule contains propranolol hydrochloride 80mg.



For excipients , see 6.1.



3. Pharmaceutical Form



Modified release capsule, hard.



Hard gelatin capsule with a blue transparent cap and body containing white and whitish/cream pellets.



4. Clinical Particulars



4.1 Therapeutic Indications



a) Control of hypertension.



b) Management of angina.



c) Prophylaxis of migraine.



d) Management of essential tremor.



e) Management of anxiety.



f) Adjunctive management of thyrotoxicosis.



g) Prophylaxis of upper gastro-intestinal bleeding in patients with portal hypertension and oesophageal varices.



4.2 Posology And Method Of Administration



Adults:



(i) Hypertension:



The initial dose is usually 160mg daily taken orally in the morning or evening. An adequate response is seen by most patients at this dosage. If necessary the dose can be increased to 320mg. A further reduction in blood pressure may be achieved by combining Bedranol* SR with other anti-hypertensive agents.



(ii) Angina, essential tremor, thyrotoxicosis, and the prophylaxsis of migraine:



The usual dose is 80 mg daily, taken orally in the morning or evening. The dose may be increased to 160 mg, and then if necessary further increased to 240 mg per day



(iii) Situational and generalised anxiety:



A daily dose of 80 mg propranolol of should be sufficient to provide short-term relief of acute situational anxiety. Generalised anxiety, requiring longer term therapy, usually responds adequately at the same dosage. In some cases the dosage may be increased to 160 mg. Patients should be reviewed after 6 – 12 months of treatment.



(iv) Portal hypertension:



Dosage should be aimed to achieve approximately 25% reduction in resting heart rate. Dosing should initiated at one Bedranol* SR 80 mg Capsule increasing to 160 mg depending on heart rate response. Further 80 mg increments may be added up to a maximum dose of 320 mg once daily.



Elderly patients:



The evidence concerning the relationship between blood level and age is conflicting.



Patients who are already established on 160mg propranolol daily, one capsule of Bedranol* SR Capsules 160mg may be given. It is suggested that elderly patients being started off on propranolol treatment may need smaller initial doses and in these circumstances Bedranol* SR Capsules 80mg or an alternative preparation should be used.



Children:



Bedranol* SR is not suitable for use in children.



Method of administration: Oral.



4.3 Contraindications



Bedranol* SR must not be used if any of the following conditions are present:



• hypersensitivity to propranolol or any of the other ingredients



• a history of bronchospasm or asthma



• bradycardia



• second or third degree heart block



• sick sinus syndrome



• cardiogenic shock



• uncontrolled heart failure



• hypotension



• severe peripheral arterial disease



• Prinzmetal's angina



• untreated phaeochromocytoma



• prolonged fasting, or prone to hypoglycaemia



• metabolic acidosis.



4.4 Special Warnings And Precautions For Use



Patients with a history of wheezing or asthma should not take propranolol unless it is considered essential. The label will carry the following warning: “Do not take this medicine if you have a history of wheezing or asthma.”. The patient information leaflet will state “Do not take this medicine if you have a history of wheezing or asthma. Consult your doctor or pharmacist first.”.



Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.



Intolerance to propranolol, shown as bradycardia and hypotension may occur, in which case propranolol should be withdrawn. If necessary, treatment for overdose should be started.



Beta-blockers may increase both the sensitivity towards allergens and the seriousness of anaphylactic reactions,they also may make patients less responsive to doses of adrenaline used to treat the allergic reactions.



Withdrawal of the drug for any reason should be gradual.



In patients with ischaemic heart disease treatment must not be discontinued abruptly. Either the equivalent dose of another beta-blocker may be substituted, or the withdrawal of Bedranol* SR should be gradual. This can be carried out by substituting the equivalent dose in propranolol 40mg tablets and then reducing the dose.



Bedranol* SR should be used with caution in patients whose cardiac reserve is poor.



Bedranol* SR may aggravate peripheral arterial circulatory disturbances.



As propranolol has a negative effect on conduction time, care must be taken when giving it to patients with first degree heart block.



Care must be taken in patients with renal or hepatic dysfunction when beginning treatment and choosing the initial dose.



Bedranol* SR should be used with care in patients with decompensated cirrhosis.



In patients with portal hypertension, liver function may deteriorate. There have been reports that treatment with propranolol may increase the risk of developing hepatic encephalopathy.



Propranolol, as with other beta-blocking drugs may block the symptoms of hypoglycaemia (especially tachycardia). It may even cause hypoglycaemia in non-diabetic patients e.g. neonates, infants, children, elderly patients, patients on haemodialysis or patients suffering from chronic liver disease and patients suffering from overdose. It has rarely caused seizures and/or coma in isolated patients. Caution should be exercised in the concurrent use of propranolol therapy in diabetic patients as it may prolong the hypoglycaemic response to insulin.



4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction



Care should be taken when prescribing beta-adrenoceptor blocking drugs with Class 1 antidysrhythmic agents there is an increased risk of myocardial depression and bradycardia, there is also an increased risk of lidocane toxicity. The antidysrhythmic propafenone increases plasma concentration of propranolol.



Beta-adrenoceptor blocking drugs should be used with caution in combination with calcium channel blockers such as verapamil or diltiazem in patients with impaired ventricular function. These should not be given to patients with conduction abnormalities. Beta-blockers or calcium channel blockers should not be given intravenously within 48 hours of discontinuing either one or the other.



Use with nifedipine or other dihydropyridines may cause an increased risk of hypotension, and heart failure may occur in patients with undiscovered cardiac insufficiency.



Propranolol modifies the tachycardia of hypoglycaemia and care should be taken when treating diabetic patients with Bedranol* SR whether or not they are also taking hypoglycaemic agents. Propranolol may prolong the hypoglycaemic response to insulin.



Use of adrenaline or other sympathomimetics with propranolol may counteract the effect of propranolol. Care should be taken in giving parenteral administration of adrenaline to patients taking beta-blocking drugs as, rarely, vasoconstriction, hypertension and bradycardia may result.



Rebound hypertension which can follow after withdrawal of clonidine may be exacerbated by beta-blockers. Therefore, if the patient is transferring from clonidine to propranolol, the latter treatment should be started several days after clonidine has been stopped. If Bedranol* SR and clonidine are given together, clonidine should be discontinued several days after stopping treatment with Bedranol* SR.



Digitoxin or digoxin taken at the same time as beta-blockers can increase atrioventricular conduction time.



Ergotamine, dihydroergotamine or related compounds given with propranolol have resulted in reports of vasospastic reactions in some patients.



The hypotensive effects of propranolol may be decreased if the patient also takes prostaglandin synthetase inhibitors, eg ibuprofen or indometacin.



If propranolol is taken with chlorpromazine, plasma levels of both agents may be increased, leading to enhanced antipsychotic and elevated antihypertensive effects.



Concomitant administration of rifampicin with propranolol may result in reduced plasma concentrations of propranolol. Thyroxine taken at the same time as propranolol also has this effect.



Cimetidine taken at the same time as propranolol will increase propranolol plasma levels. Fluvoxamine taken with propranolol also has this effect.



Alcohol enhances hypotensive effect.



It may be necessary to withdraw Bedranol* SR before surgery (24 hours should be allowed to elapse between the last dose and anaesthesia). If Bedranol* SR is continued throughout surgery the anaesthetist should be told and care should be taken in selecting and using suitable anaesthetic agents (note bupivacaine toxicity with propranolol). An anaesthetic agent with as little myocardial depression as possible should be used. Beta-blockers used with anaesthesic agents may result in attenuation of reflex tachycardia and the risk of hypotension may increase.



Propranolol may affect lignocaine infusion by increasing the plasma concentration of lignocaine by approximately a third and therefore this should be avoided.



ACE inhibitors and Angiotensin-II Antagonists taken at the same time as propranolol may result in enhanced hypotensive effects. Aldesleukin and Alprostadil also has this effect.



Concomitant administration of corticosteroid may result in antagonism of hypotensive effect.



Propranolol may increase plasma concentration of rizatriptan when taken concomitantly.



Beta blockers including propranolol when taken with moxisylyte may result in severe postural hypotension



Concomitant administration of muscle relaxants may result in enhanced hypotensive effect.



Oestrogen and progestrogens, as used in the contraceptive pill, when taken with propranolol may antagonise the hypotensive effect.



The manufacturer of tropisetron advises caution for the co-administration with propranolol.



The concomitant administration of xamoterol with propranolol may result in a reduction in the beta-blockade.



Parasympathomimetics when used with propranolol increase the possibility of arrhythmias.



Interference with laboratory tests: Propranolol has been reported to interfere with the estimation of serum bilirubin by the diazo method and with the determination of catecholamines by methods using fluorescence.



4.6 Pregnancy And Lactation



Although there is no evidence that propranolol is teratogenic Bedranol* SR should not be used in pregnancy unless absolutely necessary. Beta-blockers reduce placental perfusion which may result in intra-uterine foetal death, immature or premature deliveries. Bradycardia may occur in the foetus and there may be an increased risk of cardiac and pulmonary problems in the post-natal period. Hypoglycaemia or bradycardia may occur in the neonate.



Breast-feeding is not recommended as beta-blockers taken by the mother will pass into the breast-milk.



4.7 Effects On Ability To Drive And Use Machines



Bedranol* SR should not impair ability to drive and use machines. However, sometimes dizziness or tiredness may occur. If so, the patient should not drive or operate machines.



4.8 Undesirable Effects



The following undesirable effects may occur.



Cardiovascular: deterioration of heart failure, bradycardia, postural hypotension with or without syncope may occur. Heart block, intermittent claudication or Raynaud's phenomenon may be precipitated or exacerbated. Cold extremities may occur.



Central nervous system: dizziness, confusion, mood changes, depression or psychosis and hallucinations, sleep disturbances or nightmares may occur.



Special senses: reports of visual disturbances, conjunctivitis or dry eyes have been made.



Peripheral nervous system: peripheral neuropathy or myopathies or paraesthesia may occur.



Gastrointestinal: GI disturbance including nausea, vomiting, diarrhoea, constipation or abdominal cramps have been reported.



Haematological: thrombocytopenia, purpura and rarely agranulocytosis. Eosinophilia may occur which passes quickly.



Hepatic: propranolol treatment may increase the risk of developing hepatic encephalopathy.



Respiratory: bronchospasm may occur in patients with bronchial asthma or a history of asthma. Fatalities have been reported.



Skin and hair: exacerbation of psoriasis, psoriasiform skin reactions, skin rashes, pruritus, or alopecia may occur.



Endocrine: hypoglycaemia in neonates, infants, children, elderly patients, patients on haemodialysis, patients on concomitant anti-diabetic therapy, patients with prolonged fasting and patients with chronic liver disease has been reported (see section 4.3, 4.4, 4.5).



Miscellaneous: headache, sexual dysfunction, fatigue (commonly), lassitude (often passing quickly), and an increase in antinuclear antibodies have been observed. There have been isolated reports of a myasthenia gravis-like syndrome or aggravation of myasthenia gravis.



Intolerance to propranolol, shown as bradycardia and hypotension may occur, in which case propranolol should be withdrawn. If necessary, treatment for overdose should be started.



Propranolol should be discontinued gradually if the patient's well-being is adversely affected by any undesirable effects.



4.9 Overdose



Symptoms of overdose: bradycardia, hypotension, bronchospasm and acute cardiac insufficiency.



General supportive measures should be employed such as gastric lavage, activated charcoal and a laxative to stop any remaining drug being absorbed. Shock treatment, if required should be given. Excessive bradycardia may be countered with 1-2mg IV atropine, followed if necessary by glucagon 10mg IV. This may be repeated, or followed by an intravenous infusion of glucagon 1-10mg/hour according to response. Alternatively, a beta-receptor stimulant such as isoprenaline 25mcg IV, orciprenaline 500mcg (0.5mg) IV or dobutamine 2.5-10mcg/kg/minute IV may be given.



5. Pharmacological Properties



5.1 Pharmacodynamic Properties



Propranolol is a competitive blocker of beta-adrenergic receptor sites.



5.2 Pharmacokinetic Properties



Following oral administration Bedranol* SR peak plasma levels occur approximately 7 to 8.5 hours after an oral dose. Individual plasma concentrations vary. The plasma half-life of propranolol is about 3 to 6 hours. Propranolol binds well to plasma proteins. It has high lipid solubility, and crosses the blood-brain barrier, placenta and enters breast milk.



Propranolol is absorbed almost completely from the gastrointestinal tract, but binds to hepatic tissue where it is subject to first-pass metabolism.



Propranolol is metabolised in the liver, and excreted in the urine as metabolites and unchanged drug.



5.3 Preclinical Safety Data



There are no preclinical safety data of relevance to the prescriber.



6. Pharmaceutical Particulars



6.1 List Of Excipients



Capsule contents:



Sucrose



Corn starch



Shellac



Talc



Capsule shells:



Gelatin,



Indigotine (E132)



Printing Ink:



Shellac



Black iron oxide (E172)



Propylene glycol



6.2 Incompatibilities



Not applicable.



6.3 Shelf Life



36 months.



6.4 Special Precautions For Storage



No special temperature precautions for storage.



6.5 Nature And Contents Of Container



Blister strips composed of: White opaque PVC/PVdC laminate (PVC 250m coated with PVdC 40gsm), Aluminium foil (20m). Blister strips will be packed into cartons.



Pack sizes: 28, 30, 56, 60 and 100. Not all pack sizes are marketed.



6.6 Special Precautions For Disposal And Other Handling



Not applicable.



7. Marketing Authorisation Holder



Sandoz Ltd



Frimley Business Park,



Frimley,



Camberley,



Surrey,



GU16 7SR.



United Kingdom



8. Marketing Authorisation Number(S)



PL 4416/0320



9. Date Of First Authorisation/Renewal Of The Authorisation



4 September 2001



10. Date Of Revision Of The Text



11/2010



* trade mark




Phospha 250 Neutral Oral, Parenteral


Generic Name: phosphate supplement (Oral route, Parenteral route)


Commonly used brand name(s)

In the U.S.


  • Fleet Phospho-soda EZ-Prep

  • K-Phos Neutral

  • K-Phos Original

  • OsmoPrep

  • Phospha 250 Neutral

  • Phospho-Soda

  • Visicol

Available Dosage Forms:


  • Tablet

  • Tablet, Enteric Coated

  • Liquid

Uses For Phospha 250 Neutral


Phosphates are used as dietary supplements for patients who are unable to get enough phosphorus in their regular diet, usually because of certain illnesses or diseases. Phosphate is the drug form (salt) of phosphorus. Some phosphates are used to make the urine more acid, which helps treat certain urinary tract infections. Some phosphates are used to prevent the formation of calcium stones in the urinary tract.


Injectable phosphates are to be administered only by or under the supervision of your health care professional. Some of these oral preparations are available only with a prescription. Others are available without a prescription; however, your health care professional may have special instructions on the proper dose of this medicine for your medical condition. You should take phosphates only under the supervision of your health care professional.


Importance of Diet


For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.


The best dietary sources of phosphorus include dairy products, meat, poultry, fish, and cereal products.


The daily amount of phosphorus needed is defined in several different ways.


  • For U.S.—

  • Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).

  • Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

  • For Canada—

  • Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Normal daily recommended intakes for phosphorus are generally defined as follows:


























PersonsU.S.

(mg)
Canada

(mg)
Infants birth to 3 years of age300–800150–350
Children 4 to 6 years of age800400
Children 7 to 10 years of age800500–800
Adolescent and adult males800–1200700–1000
Adolescent and adult females800–1200800–850
Pregnant females12001050
Breast-feeding females12001050

Before Using Phospha 250 Neutral


If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Problems in children have not been reported with intake of normal daily recommended amounts. However, use of enemas that contain phosphates in children has resulted in high blood levels of phosphorus.


Geriatric


Problems in older adults have not been reported with intake of normal daily recommended amounts.


Pregnancy


It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. However, taking large amounts of a dietary supplement in pregnancy may be harmful to the mother and/or fetus and should be avoided.


Breast Feeding


It is especially important that you receive the right amount of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these dietary supplements, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using dietary supplements in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with dietary supplements in this class or change some of the other medicines you take.


  • Amantadine

  • Atropine

  • Belladonna

  • Belladonna Alkaloids

  • Benztropine

  • Biperiden

  • Cisapride

  • Clidinium

  • Darifenacin

  • Dicyclomine

  • Dronedarone

  • Eplerenone

  • Glycopyrrolate

  • Hyoscyamine

  • Mesoridazine

  • Methscopolamine

  • Oxybutynin

  • Pimozide

  • Procyclidine

  • Scopolamine

  • Solifenacin

  • Sparfloxacin

  • Thioridazine

  • Tolterodine

  • Trihexyphenidyl

Using dietary supplements in this class with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Alacepril

  • Alfuzosin

  • Amiloride

  • Amiodarone

  • Amitriptyline

  • Amoxapine

  • Apomorphine

  • Arsenic Trioxide

  • Asenapine

  • Astemizole

  • Azithromycin

  • Benazepril

  • Canrenoate

  • Captopril

  • Chloroquine

  • Chlorpromazine

  • Cilazapril

  • Ciprofloxacin

  • Citalopram

  • Clarithromycin

  • Clomipramine

  • Clozapine

  • Crizotinib

  • Dasatinib

  • Delapril

  • Desipramine

  • Disopyramide

  • Dofetilide

  • Dolasetron

  • Droperidol

  • Enalaprilat

  • Enalapril Maleate

  • Erythromycin

  • Flecainide

  • Fluconazole

  • Fosinopril

  • Gatifloxacin

  • Gemifloxacin

  • Granisetron

  • Halofantrine

  • Haloperidol

  • Ibutilide

  • Iloperidone

  • Imidapril

  • Imipramine

  • Indomethacin

  • Lapatinib

  • Levofloxacin

  • Lisinopril

  • Lopinavir

  • Lumefantrine

  • Mefloquine

  • Methadone

  • Moexipril

  • Moxifloxacin

  • Nilotinib

  • Norfloxacin

  • Nortriptyline

  • Octreotide

  • Ofloxacin

  • Ondansetron

  • Paliperidone

  • Pazopanib

  • Pentopril

  • Perflutren Lipid Microsphere

  • Perindopril

  • Posaconazole

  • Procainamide

  • Prochlorperazine

  • Promethazine

  • Propafenone

  • Protriptyline

  • Quetiapine

  • Quinapril

  • Quinidine

  • Quinine

  • Ramipril

  • Ranolazine

  • Salmeterol

  • Saquinavir

  • Solifenacin

  • Sorafenib

  • Sotalol

  • Spirapril

  • Spironolactone

  • Sunitinib

  • Telavancin

  • Telithromycin

  • Temocapril

  • Terfenadine

  • Tetrabenazine

  • Toremifene

  • Trandolapril

  • Trazodone

  • Triamterene

  • Trifluoperazine

  • Trimipramine

  • Vandetanib

  • Vardenafil

  • Vemurafenib

  • Voriconazole

  • Ziprasidone

  • Zofenopril

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:


  • Burns, severe or

  • Heart disease or

  • Pancreatitis (inflammation of the pancreas) or

  • Rickets or

  • Softening of bones or

  • Underactive parathyroid glands—Sodium- or potassium-containing phosphates may make these conditions worse.

  • Dehydration or

  • Underactive adrenal glands—Potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood).

  • Edema (swelling in feet or lower legs or fluid in lungs) or

  • High blood pressure or

  • Liver disease or

  • Toxemia of pregnancy—Sodium-containing phosphates may make these conditions worse.

  • High blood levels of phosphate (hyperphosphatemia)—Use of phosphates may make this condition worse.

  • Infected kidney stones—Phosphates may make this condition worse.

  • Kidney disease—Sodium-containing phosphates may make this condition worse; potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood).

  • Myotonia congenita—Potassium-containing phosphates may increase the risk of hyperkalemia (too much potassium in the blood), and make this condition worse.

Proper Use of phosphate supplement

This section provides information on the proper use of a number of products that contain phosphate supplement. It may not be specific to Phospha 250 Neutral. Please read with care.


For patients taking the tablet form of this medicine:


  • Do not swallow the tablet. Before taking, dissolve the tablet in ¾ to 1 glass (6 to 8 ounces) of water. Let the tablet soak in water for 2 to 5 minutes and then stir until completely dissolved.

For patients using the capsule form of this medicine:


  • Do not swallow the capsule. Before taking, mix the contents of 1 capsule in one-third glass (about 2½ ounces) of water or juice or the contents of 2 capsules in two-thirds glass (about 5 ounces) of water and stir well until dissolved.

For patients using the powder form of this medicine:


  • Add the entire contents of 1 bottle (2¼ ounces) to enough warm water to make 1 gallon of solution or the contents of one packet to enough warm water to make 1/3 of a glass (about 2.5 ounces) of solution. Shake the container for 2 or 3 minutes or until all the powder is dissolved.

  • Do not dilute solution further.

  • This solution may be chilled to improve the flavor; do not allow it to freeze.

  • Discard unused solution after 60 days.

Take this medicine immediately after meals or with food to lessen possible stomach upset or laxative action.


To help prevent kidney stones, drink at least a full glass (8 ounces) of water every hour during waking hours, unless otherwise directed by your health care professional.


Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your health care professional.


Dosing


The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For potassium phosphates

  • For oral dosage form (solution):
    • To replace phosphorus lost by the body or to make the urine more acid or to prevent the formation of kidney stones in the urinary tract:
      • Adults and teenagers—The equivalent of 228 milligrams (mg) of phosphorus (2 tablets) dissolved in six to eight ounces of water four times a day, with meals and at bedtime.


    • To replace phosphorus lost by the body:
      • Children over 4 years of age—The equivalent of 228 mg of phosphorus (2 tablets) dissolved in six to eight ounces of water four times a day, with meals and at bedtime.

      • Children up to 4 years of age—The dose must be determined by your doctor.



  • For oral dosage forms (capsules or oral solution):
    • To replace phosphorus lost by the body:
      • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (contents of 1 capsule) dissolved in two and one-half ounces of water or juice four times a day, after meals and at bedtime.

      • Children up to 4 years of age—Dose must be determined by your doctor.



  • For oral dosage forms (powder for oral solution):
    • To replace phosphorus lost by the body:
      • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in two and one-half ounces of water four times a day, after meals and at bedtime.

      • Children up to 4 years of age—Dose must be determined by your doctor.



  • For potassium and sodium phosphates

  • For oral dosage form (solution):
    • To replace phosphorus lost by the body or to make the urine more acid or to prevent the formation of kidney stones in the urinary tract:
      • Adults and teenagers—The equivalent of 250 milligrams (mg) of phosphorus dissolved in eight ounces of water four times a day, after meals and at bedtime.


    • To replace phosphorus lost by the body:
      • Children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in eight ounces of water four times a day, after meals and at bedtime.

      • Children up to 4 years of age—Dose must be determined by your doctor.



  • For oral dosage forms (capsules or solution):
    • To replace phosphorus lost by the body:
      • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (the contents of 1 capsule) dissolved in two and one-half ounces of water or juice four times a day, after meals and at bedtime.

      • Children up to 4 years of age—Dose must be determined by your doctor.



  • For oral dosage forms (powder for solution):
    • To replace phosphorus lost by the body:
      • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus dissolved in two and one-half ounces of water four times a day, after meals and at bedtime.

      • Children up to 4 years of age—Dose must be determined by your doctor.



  • For oral dosage forms (tablets for solution):
    • To replace phosphorus lost by the body:
      • Adults, teenagers, and children over 4 years of age—The equivalent of 250 mg of phosphorus (1 tablet) dissolved in eight ounces of water four times a day.

      • Children up to 4 years of age—Dose must be determined by your doctor.



Missed Dose


If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Keep out of the reach of children.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Phospha 250 Neutral


Your health care professional should check your progress at regular visits to make sure that this medicine does not cause unwanted effects.


Do not take iron supplements within 1 to 2 hours of taking this medicine. To do so may keep the iron from working properly.


For patients taking potassium phosphate-containing medicines:


  • Check with your health care professional before starting any strenuous physical exercise, especially if you are out of condition and are taking other medication. Exercise and certain medicines may increase the amount of potassium in the blood.

For patients on a potassium-restricted diet:


  • This medicine may contain a large amount of potassium. If you have any questions about this, check with your health care professional.

  • Do not use salt substitutes and low-salt milk unless told to do so by your health care professional. They may contain potassium.

For patients on a sodium-restricted diet:


  • This medicine may contain a large amount of sodium. If you have any questions about this, check with your health care professional.

Phospha 250 Neutral Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


Less common or rare
  • Confusion

  • convulsions (seizures)

  • decrease in amount of urine or in frequency of urination

  • fast, slow, or irregular heartbeat

  • headache or dizziness

  • increased thirst

  • muscle cramps

  • numbness, tingling, pain, or weakness in hands or feet

  • numbness or tingling around lips

  • shortness of breath or troubled breathing

  • swelling of feet or lower legs

  • tremor

  • unexplained anxiety

  • unusual tiredness or weakness

  • weakness or heaviness of legs

  • weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


  • Diarrhea

  • nausea or vomiting

  • stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Sunday, 12 August 2012

Advil Childrens Allergy Sinus


Generic Name: chlorpheniramine, ibuprofen, and pseudoephedrine (KLOR fen EER a meen, EYE bue pro fen, SOO doe ee FED rin)

Brand Names: Advil Allergy Sinus, Advil Childrens Allergy Sinus, Advil Multi-Symptom Cold


What is Advil Childrens Allergy Sinus (chlorpheniramine, ibuprofen, and pseudoephedrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.


Ibuprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen works by reducing hormones that cause inflammation and pain in the body.


Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).


The combination of chlorpheniramine, ibuprofen, and pseudoephedrine is used to treat sneezing, itching, watery eyes, runny nose, stuffy nose, sinus congestion, headache, and pain or fever caused by allergies or the common cold.


Chlorpheniramine, ibuprofen, and pseudoephedrine may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about Advil Childrens Allergy Sinus (chlorpheniramine, ibuprofen, and pseudoephedrine)?


Do not give this medication to a child younger than 12 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use chlorpheniramine, ibuprofen, and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

Ibuprofen can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).


Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.


Ibuprofen can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning at any time while you are taking ibuprofen. Ibuprofen may be more likely to cause stomach bleeding in adults who are 60 or older.


Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes worsening stomach pain, black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.


You should not use this medication if you are allergic to ibuprofen or pseudoephedrine, or if you have a stomach ulcer or active bleeding in your stomach or intestines, polyps in your nose, or a history of allergic reaction to aspirin or other NSAIDs.

What should I discuss with my doctor before taking Advil Childrens Allergy Sinus (chlorpheniramine, ibuprofen, and pseudoephedrine)?


Do not use chlorpheniramine, ibuprofen, and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take chlorpheniramine, ibuprofen, and pseudoephedrine before the MAO inhibitor has cleared from your body. Do not use this medication if you are allergic to ibuprofen or pseudoephedrine, or if you have:

  • a stomach ulcer or active bleeding in your stomach or intestines;




  • polyps in your nose; or




  • a history of allergic reaction to aspirin or other NSAIDs.



If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take this medication, tell your doctor if you have:



  • asthma, emphysema, bronchitis, or if you smoke;




  • a history of stomach problems, including heartburn, indigestion, stomach pain, and ulcers or bleeding;




  • heart disease, congestive heart failure, high blood pressure;




  • systemic lupus erythematosus (SLE);



  • liver or kidney disease;


  • a thyroid disorder;




  • a bleeding or blood clotting disorder;




  • glaucoma;




  • diabetes;




  • enlarged prostate or problems with urination; or




  • if you smoke.



Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).


NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.


This medication may be harmful to an unborn baby. Taking ibuprofen during the last 3 months of pregnancy may result in birth defects and prolonged labor and delivery. Do not take chlorpheniramine, ibuprofen, and pseudoephedrine during the last 3 months of pregnancy unless your doctor has told you to. Chlorpheniramine, ibuprofen, and pseudoephedrine passes into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Ibuprofen may be more likely to cause stomach bleeding in adults who are 60 or older. Do not give this medication to a child younger than 12 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

How should I take Advil Childrens Allergy Sinus (chlorpheniramine, ibuprofen, and pseudoephedrine)?


Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.


Take this medicine with food or milk if it upsets your stomach. Do not take more of this medication than is recommended. An overdose of ibuprofen can cause damage to your stomach or intestines. The maximum amount of ibuprofen for adults is 800 milligrams per dose or 3200 mg per day (4 maximum doses). Use only the smallest amount of chlorpheniramine, ibuprofen, and pseudoephedrine needed to get relief from your cold or allergy symptoms. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Call your doctor if you have any new symptoms, or if you have a fever lasting longer than 3 days, stuffy nose lasting longer than 7 days, or pain lasting longer than 10 days. Do not take this medication for longer than 10 days without your doctor's advice.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.


This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.


Store this medication at room temperature away from moisture and heat.

What happens if I miss a dose?


Since cold medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention if you think you have used too much of this medicine. Overdose may cause nausea, vomiting, stomach pain, dizziness, feeling restless or nervous, blurred vision, sweating, breathing problems, or seizure (convulsions).

What should I avoid while taking Advil Childrens Allergy Sinus (chlorpheniramine, ibuprofen, and pseudoephedrine)?


This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol while taking this medication. If you drink more than 3 alcoholic beverages a day, ibuprofen may increase your risk of stomach bleeding.

Avoid becoming overheated or dehydrated during exercise and in hot weather.


Avoid taking this medication with diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.


Do not use any other over-the-counter cough, cold, or pain medication without first asking your doctor or pharmacist. Chlorpheniramine, ibuprofen, and pseudoephedrine are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of either medication. Read the label of any other medicine you are using to see if it contains an antihistamine, decongestant, or pain reliever.

Advil Childrens Allergy Sinus (chlorpheniramine, ibuprofen, and pseudoephedrine) side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives or blistering skin rash; wheezing or trouble breathing; faint; or swelling of your face, lips, tongue, or throat. Stop taking this medication seek medical attention or call your doctor at once if you have a serious side effect such as:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;




  • worsening stomach pain, black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;




  • fast, pounding, or uneven heartbeat;




  • redness or swelling;




  • severe dizziness, trouble sleeping, or nervousness;




  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;




  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure);




  • urinating less than usual or not at all;




  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or




  • fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).



Less serious side effects may include:



  • upset stomach, nausea, heartburn, diarrhea, constipation;




  • bloating, gas, loss of appetite;




  • warmth, tingling, or redness under your skin;




  • dizziness, headache, feeling excited or restless;




  • skin itching or rash; or




  • ringing in your ears.



This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


What other drugs will affect Advil Childrens Allergy Sinus (chlorpheniramine, ibuprofen, and pseudoephedrine)?


Before taking this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine.

Tell your doctor about all other medications you use, especially:



  • a blood thinner such as warfarin (Coumadin);




  • steroids (prednisone and others);




  • a diuretic (water pill), or medicine to treat high blood pressure;




  • aspirin to prevent stroke or heart attack (ibuprofen can make aspirin less effective in protecting your heart and blood vessels);




  • a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;




  • antidepressants such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), and others; or




  • other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Voltaren), etodolac (Lodine), indomethacin (Indocin), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.



This list is not complete and there may be other drugs that can interact with chlorpheniramine, ibuprofen, and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More Advil Childrens Allergy Sinus resources


  • Advil Childrens Allergy Sinus Use in Pregnancy & Breastfeeding
  • Advil Childrens Allergy Sinus Drug Interactions
  • 0 Reviews for Advil Childrens Allergy Sinus - Add your own review/rating


  • Advil Allergy Sinus Prescribing Information (FDA)

  • Advil Allergy Sinus Consumer Overview



Compare Advil Childrens Allergy Sinus with other medications


  • Cold Symptoms
  • Hay Fever


Where can I get more information?


  • Your pharmacist can provide more information about chlorpheniramine, ibuprofen, and pseudoephedrine.