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Wednesday, 25 April 2012

hepatitis b vaccine recombinant Intramuscular

hep-a-TYE-tis B VAX-een re-KOM-bin-ant

Commonly used brand name(s)

In the U.S.

Engerix-B

Engerix-B Pediatric

Recombivax HB

Recombivax HB Pediatric/Adolescent

Available Dosage Forms:

Suspension

Therapeutic Class: Vaccine

Uses For hepatitis b vaccine recombinant

Hepatitis B vaccine recombinant is used to prevent infection by the hepatitis B virus. The vaccine works by causing your body to produce its own protection (antibodies) against the disease.

Hepatitis B vaccine recombinant is made without any human blood or blood products or any other substances of human origin. It cannot give you the hepatitis B virus (HBV) or the human immunodeficiency virus (HIV).

HBV infection is a major cause of serious liver diseases, such as hepatitis and cirrhosis, and a type of liver cancer called primary hepatocellular carcinoma.

Pregnant women who have hepatitis B infection or are carriers of hepatitis B virus can give the disease to their babies when they are born. These babies often suffer serious long-term illnesses from the disease.

Immunization against hepatitis B disease is recommended for all newborn babies, infants, children, and adolescents up to 19 years of age. It is also recommended for adults who live in areas that have a high rate of hepatitis B disease or who may be at increased risk of infection from hepatitis B virus. These adults include:

Sexually active homosexual and bisexual males, including those with HIV infection.

Sexually active heterosexual persons with multiple partners.

Persons who may be exposed to the virus by means of blood, blood products, or human bites, such as health care workers, employees in medical facilities, patients and staff of live-in facilities and daycare programs for the developmentally disabled, morticians and embalmers, police and fire department personnel, and military personnel.

Persons who have kidney disease or who undergo blood dialysis for kidney disease.

Persons with blood clotting disorders who receive transfusions of clotting-factor concentrates.

Household and sexual contacts of HBV carriers.

Persons in areas with high risk of HBV infection [in the population], such as Alaskan Eskimos, Pacific Islanders, Haitian and Indochinese immigrants, and refugees from areas that have a high rate of hepatitis B disease; persons accepting orphans or adoptees from these areas; and travelers to these areas.

Persons who use illegal injection drugs.

Prisoners.

This vaccine is available only from your doctor or other authorized health care professional.

Before Using hepatitis b vaccine recombinant

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

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to hepatitis b vaccine recombinant 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hepatitis B vaccine recombinant in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of hepatitis B vaccine recombinant in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use of hepatitis b vaccine recombinant

A nurse or other trained health professional will give you this vaccine. This vaccine is given as a shot into one of your muscles. If you have bleeding problems such as hemophilia, the vaccine may be given as a shot under your skin.

This vaccine is usually given as 3 doses. After the first dose, two more doses are given 1 month and 6 months after the first dose, unless your doctor tells you otherwise.

Precautions While Using hepatitis b vaccine recombinant

It is very important that you or your child return to your doctor’s office at the right time for the second and third dose. Be sure to notify your doctor of any unwanted effects that occur after you or your child receive this vaccine.

This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, swelling of the tongue and throat, or trouble breathing after you get the injection.

Tell your doctor if you or your child are allergic to latex. The needle cover and the rubber plunger of the prefilled syringe contain dry natural latex rubber, which may cause an allergic reaction in people with a latex allergy.

This vaccine may not protect you against hepatitis B infection if you are already infected with the virus at the time you receive the shot.

hepatitis b vaccine recombinant 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 or nurse immediately if any of the following side effects occur:

More common

Fever of 37.7 degrees C (100 degrees F) or higher

Rare

Aches or pain in the joints, fever, or skin rash or welts (may occur days or weeks after receiving the vaccine)

blurred vision or other vision changes

confusion

difficulty with breathing or swallowing

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

hives

itching, especially of the feet or hands

muscle weakness

numbness or tingling of the arms and legs

reddening of the skin, especially around the ears

sweating

swelling of the eyes, face, or inside of the nose

unusual tiredness or weakness (sudden and severe)

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

Dizziness

headache

soreness at the injection site

Less common

Hard lump, redness, swelling, pain, itching, purple spot, tenderness, or warmth at the injection site

unusual tiredness or weakness

Rare

Aches or pain in the muscles

agitation

back pain or stiffness or pain in neck or shoulder

chills

constipation

diarrhea

difficulty with moving

feeling of warmth

general feeling of discomfort or illness

headache (mild), sore throat, runny nose, or fever (mild)

increased sweating

itching

lack of appetite or decreased appetite

nausea or vomiting

redness of the face, neck, arms, and occasionally, upper chest

sleepiness or unusual drowsiness

sleeplessness

stomach cramps or pain

sudden redness of skin

swelling of glands in the armpit or neck

trouble with sleeping

unable to sleep

welts

weight loss

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: hepatitis b vaccine recombinant Intramuscular side effects (in more detail)

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More hepatitis b vaccine recombinant Intramuscular resources

Hepatitis b vaccine recombinant Intramuscular Side Effects (in more detail)
Hepatitis b vaccine recombinant Intramuscular Use in Pregnancy & Breastfeeding
Hepatitis b vaccine recombinant Intramuscular Drug Interactions
Hepatitis b vaccine recombinant Intramuscular Support Group
0 Reviews for Hepatitis b vaccine recombinant Intramuscular - Add your own review/rating

Compare hepatitis b vaccine recombinant Intramuscular with other medications

Hepatitis B Prevention

meclofenamate

Generic Name: meclofenamate (me kloe fen AM ate)

Brand Names: Meclomen

What is meclofenamate?

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

Meclofenamate is used to treat pain or inflammation caused by arthritis. It is also used to treat menstrual pain.

Meclofenamate may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about meclofenamate?

This medicine 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.

This medicine 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 meclofenamate. Older adults may have an even greater risk of these serious gastrointestinal side effects.

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

What should I discuss with my healthcare provider before taking meclofenamate?

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.

Do not use this medication if you are allergic to meclofenamate, or to aspirin or other NSAIDs.

Before taking meclofenamate, tell your doctor if you are allergic to any drugs, or if you have:

a history of heart attack, stroke, or blood clot;

heart disease, congestive heart failure, high blood pressure;

a history of stomach ulcers or bleeding, bowel problems, diverticulosis;

liver or kidney disease;

asthma;

polyps in your nose; or

if you smoke.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take meclofenamate.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking meclofenamate during the last 3 months of pregnancy may harm the unborn baby. Do not take meclofenamate during pregnancy unless your doctor has told you to. Meclofenamate 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. Do not give this medicine to a child younger than 14 years old without the advice of a doctor.

How should I take meclofenamate?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. The maximum amount of meclofenamate for adults is 400 milligrams (mg) per day. Know the amount of meclofenamate in the specific product you are taking.

If you take meclofenamate for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

Store meclofenamate at room temperature, away from moisture, heat, and light.

What happens if I miss a dose?

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 symptoms may include nausea, vomiting, dizziness, drowsiness, ringing in your ears, numbness or tingling, black or bloody stools, coughing up blood, fever, urinating less than usual or not at all, shallow breathing, fainting, and seizure (convulsions).

What should I avoid while taking meclofenamate?

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain medicines similar to meclofenamate (such as aspirin, ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking meclofenamate. Alcohol can increase the risk of stomach bleeding.

If you take cholestyramine (Prevalite, Questran), avoid taking it within 2 hours before or after you take meclofenamate.

Meclofenamate side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking meclofenamate and call your doctor at once if you have any of these serious side effects:

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

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

urinating less than usual or not at all;

nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;

dizziness, headache, nervousness;

skin itching or rash;

dry mouth;

increased sweating, runny nose;

blurred vision; or

ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect meclofenamate?

Before taking meclofenamate, tell your doctor if you are taking any of the following drugs:

cyclosporine (Gengraf, Neoral, Sandimmune);

a diuretic (water pill) such as furosemide (Lasix);

lithium (Eskalith, Lithobid);

a blood thinner such as warfarin (Coumadin);

steroids (prednisone and others); or

heart or blood pressure medication such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar, Hyzaar), olmesartan (Benicar), telmisartan (Micardis), or valsartan (Diovan);

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

an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik); or

aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others.

This list is not complete and there may be other drugs that can interact with meclofenamate. 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 meclofenamate resources

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

Meclofenamate MedFacts Consumer Leaflet (Wolters Kluwer)

Meclofenamate Prescribing Information (FDA)

Meclofenamate Sodium Monograph (AHFS DI)

Compare meclofenamate with other medications

Premenstrual Dysphoric Disorder
Rheumatoid Arthritis

Where can I get more information?

Your pharmacist can provide more information about meclofenamate.

See also: meclofenamate side effects (in more detail)

Tuesday, 24 April 2012

Pediacare Decongestant Infants

Generic Name: pseudoephedrine (Oral route)

soo-doe-e-FED-rin

Commonly used brand name(s)

In the U.S.

12 Hour Cold Maximum Strength

Biofed

Cenafed

Chlor-Trimeton Nasal Decongestant

Contac 12-Hour

Dimetapp Decongestant

Efidac 24 Pseudoephedrine

ElixSure Congestion Children's

Genaphed

Pediacare Decongestant Infants

Simply Stuffy

Sudafed

Available Dosage Forms:

Capsule, Extended Release

Tablet, Chewable

Tablet, Extended Release

Solution

Syrup

Liquid

Tablet

Capsule

Capsule, Liquid Filled

Suspension

Therapeutic Class: Decongestant

Pharmacologic Class: Alpha-Adrenergic Agonist

Uses For Pediacare Decongestant Infants

Pseudoephedrine is used to relieve nasal or sinus congestion caused by the common cold, sinusitis, and hay fever and other respiratory allergies. It is also used to relieve ear congestion caused by ear inflammation or infection.

Some of these preparations are available only with your doctor's prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using Pediacare Decongestant Infants

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

Pseudoephedrine may be more likely to cause side effects in infants, especially newborn and premature infants, than in older children and adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of pseudoephedrine in the elderly with use in other age groups.

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.

Clorgyline

Dihydroergotamine

Furazolidone

Iproniazid

Isocarboxazid

Linezolid

Moclobemide

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.

Guanethidine

Methyldopa

Midodrine

Interactions with Food/Tobacco/Alcohol

Proper Use of pseudoephedrine

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

For patients taking pseudoephedrine extended-release capsules:

Swallow the capsule whole. However, if the capsule is too large to swallow, you may mix the contents of the capsule with jam or jelly and swallow without chewing.

Do not crush or chew before swallowing.

For patients taking pseudoephedrine extended-release tablets:

Swallow the tablet whole.

Do not break, crush, or chew before swallowing.

To help prevent trouble in sleeping, take the last dose of pseudoephedrine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.

Take this medicine only as directed. Do not take more of it, do not take it more often, and do not take it for a longer period of time than recommended on the label (usually 7 days), unless otherwise directed by your doctor. To do so may increase the chance of side effects.

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 nasal or sinus congestion:
- For regular (short-acting) oral dosage form (capsules, oral solution, syrup, or tablets):
  - Adults and children 12 years of age and older—60 milligrams (mg) every four to six hours. Do not take more than 240 mg in twenty-four hours.
  - Children 6 to 12 years of age—30 mg every four to six hours. Do not take more than 120 mg in twenty-four hours.
  - Children 4 to 6 years of age—15 mg every four to six hours. Do not take more than 60 mg in twenty-four hours.
  - Children and infants up to 4 years of age—Use is not recommended .
- For long-acting oral dosage form (extended-release capsules or extended-release tablets):
  - Adults and children 12 years of age and older—120 mg every 12 hours, or 240 mg every 24 hours. Do not take more than 240 mg in 24 hours.
  - Infants and children up to 12 years of age—Use is not recommended .

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.

Precautions While Using Pediacare Decongestant Infants

If symptoms do not improve within 7 days or if you also have a high fever, check with your doctor since these signs may mean that you have other medical problems.

Pediacare Decongestant Infants 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:

Rare - more common with high doses

Convulsions (seizures)

hallucinations (seeing, hearing, or feeling things that are not there)

irregular or slow heartbeat

shortness of breath or troubled breathing

Symptoms of overdose

Convulsions (seizures)

fast breathing

hallucinations (seeing, hearing, or feeling things that are not there)

increase in blood pressure

irregular heartbeat (continuing)

shortness of breath or troubled breathing (severe or continuing)

slow or fast heartbeat (severe or continuing)

unusual nervousness, restlessness, or excitement

More common

Nervousness

restlessness

trouble in sleeping

Less common

Difficult or painful urination

dizziness or light-headedness

fast or pounding heartbeat

headache

increased sweating

nausea or vomiting

trembling

unusual paleness

weakness

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: Pediacare Decongestant Infants side effects (in more detail)

More Pediacare Decongestant Infants resources

Pediacare Decongestant Infants Side Effects (in more detail)
Pediacare Decongestant Infants Use in Pregnancy & Breastfeeding
Drug Images
Pediacare Decongestant Infants Drug Interactions
Pediacare Decongestant Infants Support Group
8 Reviews for Pediacare Decongestant Infants - Add your own review/rating

Compare Pediacare Decongestant Infants with other medications

Nasal Congestion

Cetraxal Ear Drops

Pronunciation: SIP-roe-FLOX-a-sin
Generic Name: Ciprofloxacin
Brand Name: Cetraxal

Cetraxal Ear Drops are used for:

Treating ear infections caused by certain bacteria.

Cetraxal Ear Drops are a quinolone antibiotic. It works by killing sensitive bacteria.

Do NOT use Cetraxal Ear Drops if:

you are allergic to any ingredient in Cetraxal Ear Drops

Contact your doctor or health care provider right away if any of these apply to you.

Before using Cetraxal Ear Drops:

Some medical conditions may interact with Cetraxal Ear Drops. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you allergic to another quinolone antibiotic (eg, levofloxacin)

Some MEDICINES MAY INTERACT with Cetraxal Ear Drops. Because little, if any, of Cetraxal Ear Drops are absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Cetraxal Ear Drops may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Cetraxal Ear Drops:

Use Cetraxal Ear Drops as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Cetraxal Ear Drops are only for the ear. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse right away with cool water.

Wash hands before and after using Cetraxal Ear Drops.

Before using, hold the ear drop container in your hand for at least 1 minute to avoid dizziness that may result from putting cold drops into the ear.

Lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for at least 1 minute so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out.

To prevent germs from contaminating your medicine, do not touch the applicator to any surface, including the ear.

There is no preservative in Cetraxal Ear Drops; each container is for a one-time use only. Use your dose right away after you open the container. Throw away the container and any medicine left in the container after you use your dose.

Use your doses of Cetraxal Ear Drops about 12 hours apart.

To clear up your infection completely, use Cetraxal Ear Drops for the full course of treatment. Keep using it even if you feel better in a few days.

If you miss a dose of Cetraxal Ear Drops, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Cetraxal Ear Drops.

Important safety information:

If your symptoms do not get better within 7 days or if they get worse, check with your doctor.

Be sure to use Cetraxal Ear Drops for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.

Long-term or repeated use of Cetraxal Ear Drops may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

Talk to your doctor about how to space your doses if you are using other ear drops.

Do not use Cetraxal Ear Drops for other ear infections or conditions without checking with your doctor.

Do not use Cetraxal Ear Drops longer than recommended by your doctor. If you develop 2 or more ear infections in a 6-month period, contact your doctor. You may require further evaluation and a different kind of treatment. Report any discharge from the ear that occurs after the treatment has been completed.

Cetraxal Ear Drops should not be used in CHILDREN younger than 1 year old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Cetraxal Ear Drops while you are pregnant. It is not known if Cetraxal Ear Drops are found in breast milk after use in the ear. Do not breast-feed while taking Cetraxal Ear Drops.

Possible side effects of Cetraxal Ear Drops:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Discomfort, pain, or itching in the ear; headache.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased hearing; severe or persistent ear pain, itching, or irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Cetraxal side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Cetraxal Ear Drops:

Store Cetraxal Ear Drops at room temperature, between 59 and 77 degrees F (15 to 25 degrees C). Store away from heat and light. Avoid freezing. Throw away any unused medicine after your treatment has finished. Keep Cetraxal Ear Drops out of the reach of children and away from pets.

General information:

If you have any questions about Cetraxal Ear Drops, please talk with your doctor, pharmacist, or other health care provider.

Cetraxal Ear Drops are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Cetraxal Ear Drops. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Cetraxal resources

Cetraxal Side Effects (in more detail)
Cetraxal Dosage
Cetraxal Use in Pregnancy & Breastfeeding
Cetraxal Support Group
0 Reviews for Cetraxal - Add your own review/rating

Compare Cetraxal with other medications

Acute Otitis Externa

Thursday, 19 April 2012

Methscopolamine/Phenylephrine Extended-Release Tablets

Pronunciation: METH-skoe-POL-a-meen/FEN-il-EF-rin
Generic Name: Methscopolamine/Phenylephrine
Brand Name: Extendryl PEM

Methscopolamine/Phenylephrine Extended-Release Tablets are used for:

Relieving congestion, sneezing, runny nose, and itchy, watery eyes due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Methscopolamine/Phenylephrine Extended-Release Tablets are an anticholinergic and decongestant combination. It works by blocking histamine, a substance in the body that causes sneezing, runny nose, and watery eyes. It also relieves nasal congestion by shrinking the nasal mucous membranes, which promotes nasal drainage, and dries the chest by decreasing lung secretions.

Do NOT use Methscopolamine/Phenylephrine Extended-Release Tablets if:

you are allergic to any ingredient in Methscopolamine/Phenylephrine Extended-Release Tablets

you are taking sodium oxybate (GHB) or droxidopa, or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) in the last 14 days

you have narrow-angle glaucoma; a blockage of the bladder, stomach, or intestines; peptic ulcer disease; severe bowel problems (eg, ulcerative colitis); inflammation of the esophagus from reflux disease; difficulty swallowing; myasthenia gravis (muscle weakness); or uncontrolled bleeding

you have severe heart disease, severe high blood pressure, severe heart blood vessel problems, or a rapid heartbeat, or you are unable to urinate

you are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Methscopolamine/Phenylephrine Extended-Release Tablets:

Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have an adrenal gland tumor, asthma, bladder or kidney problems, blood clots, blood vessel problems, breathing problems during sleep, an enlarged prostate, heart problems (eg, ischemic heart disease, irregular heartbeat), a hiatal hernia, high blood pressure, increased glaucoma, lung problems (eg, emphysema), a history of diabetes, nerve problems, an overactive thyroid, pressure in the eye, risk factors for glaucoma, seizures, stroke, or trouble urinating

if you have diarrhea

Some MEDICINES MAY INTERACT with Methscopolamine/Phenylephrine Extended-Release Tablets.

Sodium oxybate (GHB) because the risk of severe drowsiness or coma may be increased

Furazolidone or MAOIs (eg, phenelzine) because severe high blood pressure, fast or irregular heartbeat, or seizures may occur

Alpha-blockers (eg, prazosin), anesthetics (eg, chloroform, lidocaine), anticholinergics (eg, atropine, benztropine, dicyclomine), beta-blockers (eg, propranolol), carbonic anhydrase inhibitors (eg, acetazolamide), diuretics (eg, furosemide, hydrochlorothiazide), ergotamine, tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of Methscopolamine/Phenylephrine Extended-Release Tablets's side effects

Bromocriptine, catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), certain stimulants (eg, doxapram, pseudoephedrine), cocaine, digoxin, droxidopa, or potassium chloride because the risk of their side effects may be increased by Methscopolamine/Phenylephrine Extended-Release Tablets

Clonidine, guanethidine, guanfacine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Methscopolamine/Phenylephrine Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Methscopolamine/Phenylephrine Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Methscopolamine/Phenylephrine Extended-Release Tablets:

Use Methscopolamine/Phenylephrine Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Methscopolamine/Phenylephrine Extended-Release Tablets by mouth with or without food.

Swallow Methscopolamine/Phenylephrine Extended-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Methscopolamine/Phenylephrine Extended-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.

Do not take Methscopolamine/Phenylephrine Extended-Release Tablets at the same time as antacids, certain medicines for diarrhea (eg, kaolin, pectin, attapulgite, bismuth), or ketoconazole. Take these medicines 2 or 3 hours before or after you take Methscopolamine/Phenylephrine Extended-Release Tablets.

If you miss a dose of Methscopolamine/Phenylephrine Extended-Release Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Methscopolamine/Phenylephrine Extended-Release Tablets.

Important safety information:

Methscopolamine/Phenylephrine Extended-Release Tablets may cause blurred vision, dizziness, or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Methscopolamine/Phenylephrine Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Methscopolamine/Phenylephrine Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

If your symptoms do not get better within 7 days or if you develop a high fever or persistent headache, check with your doctor.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

Methscopolamine/Phenylephrine Extended-Release Tablets may cause dry mouth. To relieve dry mouth, suck on sugarless hard candy or ice chips, chew sugarless gum, drink water, or use a saliva substitute.

Methscopolamine/Phenylephrine Extended-Release Tablets may make your eyes more sensitive to sunlight. It may help to wear sunglasses.

Methscopolamine/Phenylephrine Extended-Release Tablets may reduce sweating. Do not become overheated in hot weather or while you are being active; heatstroke may occur.

Do not take diet or appetite control medicines while you are taking Methscopolamine/Phenylephrine Extended-Release Tablets without checking with your doctor.

Methscopolamine/Phenylephrine Extended-Release Tablets has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

If you have trouble sleeping, ask your doctor or pharmacist about the best time of the day to take Methscopolamine/Phenylephrine Extended-Release Tablets.

Tell your doctor or dentist that you take Methscopolamine/Phenylephrine Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.

Diabetes patients - Methscopolamine/Phenylephrine Extended-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

Methscopolamine/Phenylephrine Extended-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Methscopolamine/Phenylephrine Extended-Release Tablets.

Use Methscopolamine/Phenylephrine Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, hallucinations, and seizures.

Methscopolamine/Phenylephrine Extended-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

Caution is advised when using Methscopolamine/Phenylephrine Extended-Release Tablets in CHILDREN; they may be more sensitive to its effects, especially excitability.

PREGNANCY and BREAST-FEEDING: It is not known if Methscopolamine/Phenylephrine Extended-Release Tablets can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Methscopolamine/Phenylephrine Extended-Release Tablets while you are pregnant. It is not known if Methscopolamine/Phenylephrine Extended-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Methscopolamine/Phenylephrine Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Methscopolamine/Phenylephrine Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth, nose, or throat; excitability or irritability (especially in children); flushing; headache; nausea; nervousness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (difficulty breathing; hives; itching; rash; swelling of the mouth, tightness in the chest; face, lips, or tongue); blurred vision; clumsiness; difficulty swallowing; fast or irregular heartbeat; hallucinations; mental or mood changes; seizures; tremor; trouble sleeping; trouble urinating; unusual bleeding or bruising; vomiting.

See also: Methscopolamine/Phenylephrine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include deep sleep or loss of consciousness; hallucinations; hot or cool skin; irregular heartbeat; irritability, anxiety, or panic; large pupils; numbness or tingling in the arms or legs; seizures; slowed or shallow breathing; vomiting.

Proper storage of Methscopolamine/Phenylephrine Extended-Release Tablets:

Store Methscopolamine/Phenylephrine Extended-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 15 degrees C), in a tightly closed container. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Methscopolamine/Phenylephrine Extended-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Methscopolamine/Phenylephrine Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

Methscopolamine/Phenylephrine Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Methscopolamine/Phenylephrine Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Methscopolamine/Phenylephrine resources

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

Compare Methscopolamine/Phenylephrine with other medications

Hay Fever
Rhinitis

Wednesday, 18 April 2012

Zmax

Generic Name: azithromycin (Oral route)

ay-zith-roe-MYE-sin

Commonly used brand name(s)

In the U.S.

Zithromax

Zithromax Tri-Pak

Zithromax Z-Pak

Zmax

Available Dosage Forms:

Powder for Suspension

Tablet

Powder for Suspension, Extended Release

Capsule

Therapeutic Class: Antibiotic

Chemical Class: Macrolide

Uses For Zmax

Azithromycin is used to treat certain bacterial infections in many different parts of the body. This medicine may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.

Azithromycin belongs to the class of drugs known as macrolide antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

Before Using Zmax

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of azithromycin in children and infants 6 months of age and older. However, safety and efficacy have not been established in infants younger than 6 months of age.

Appropriate studies have not been performed on the relationship of age to the effects of azithromycin oral suspension and tablets to treat pharyngitis or tonsillitis in children younger than 2 years of age. 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 azithromycin in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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.

Cisapride

Dihydroergotamine

Dronedarone

Ergoloid Mesylates

Ergonovine

Ergotamine

Mesoridazine

Methylergonovine

Methysergide

Pimozide

Sparfloxacin

Thioridazine

Acecainide

Alfuzosin

Amiodarone

Amitriptyline

Amoxapine

Apomorphine

Arsenic Trioxide

Asenapine

Astemizole

Azimilide

Bretylium

Chloroquine

Chlorpromazine

Ciprofloxacin

Citalopram

Clarithromycin

Clomipramine

Clozapine

Crizotinib

Dasatinib

Desipramine

Disopyramide

Dofetilide

Dolasetron

Droperidol

Erythromycin

Flecainide

Fluconazole

Gatifloxacin

Gemifloxacin

Granisetron

Halofantrine

Haloperidol

Ibutilide

Iloperidone

Imipramine

Lapatinib

Levofloxacin

Lopinavir

Lumefantrine

Mefloquine

Methadone

Moxifloxacin

Nilotinib

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Ondansetron

Paliperidone

Pazopanib

Perflutren Lipid Microsphere

Posaconazole

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Ranolazine

Salmeterol

Saquinavir

Sematilide

Simvastatin

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Sunitinib

Tedisamil

Telithromycin

Terfenadine

Tetrabenazine

Toremifene

Trazodone

Trifluoperazine

Trimipramine

Vandetanib

Vardenafil

Vemurafenib

Voriconazole

Ziprasidone

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.

Atorvastatin

Digoxin

Fentanyl

Lovastatin

Nelfinavir

Rifabutin

Theophylline

Warfarin

Interactions with Food/Tobacco/Alcohol

Proper Use of azithromycin

This section provides information on the proper use of a number of products that contain azithromycin. It may not be specific to Zmax. 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 medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

You may take Zithromax® oral liquid or tablets with or without food.

Shake well the bottle of Zithromax® oral liquid before each use. Measure your dose correctly with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Measure the extended-release oral liquid with a marked measuring spoon, syringe, or cup. You or your child must take this medicine within 12 hours after it has been mixed with water. It is best to take the extended-release oral liquid on an empty stomach or at least 1 hour before or 2 hours after a meal. If your child does not use all of the medicine in the bottle, throw it away after you give the dose.

Keep using this medicine for the full treatment time, even if you or your child feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

If you are taking aluminum or magnesium-containing antacids, do not take them at the same time that you take this medicine. These medicines may keep azithromycin from working properly.

Dosing

For oral dosage form (extended-release suspension):
- For treatment of infections:
  - Adults—2 grams (g) once a day as a single dose.
  - Children weighing 75 pounds (34 kg) or more—2 g once a day as a single dose.
  - Children and infants 6 months of age and older weighing less than 75 pounds (34 kg)—Dose is based on body weight and must be determined by your doctor. However, the dose is usually 60 milligrams (mg) per kilogram (kg) of body weight once a day as a single dose.
  - Infants younger than 6 months of age—Use and dose must be determined by your doctor.

For oral dosage forms (suspension or tablets):
- For treatment of infections:
  - Adults—500 to 2000 milligrams (mg) once a day, taken as a single dose. Depending on the type of infection, this may be followed with doses of 250 to 500 mg once a day for several days.
  - Children and infants 6 months of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 10 to 30 milligrams (mg) per kilogram (kg) of body weight once a day, taken as a single dose. Depending on the type of infection, this may be followed with doses of 5 to 10 mg/kg of body weight once a day for several days.
  - Infants younger than 6 months of age—Use and dose must be determined by your doctor.
- For treatment of pharyngitis or tonsillitis:
  - Adults—500 milligrams (mg) on Day1 (the first day), taken as a single dose. Then, 250 mg on Day 2 through Day 5.
  - Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is usually 12 milligrams (mg) per kilogram (kg) of body weight once a day for 5 days.
  - Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

Storage

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.

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

Do not refrigerate or freeze the extended-release oral liquid. Throw away any unused liquid after your dose.

You may store the oral liquid at room temperature or in the refrigerator. Do not freeze the bottle. Do not keep the oral liquid for more than 10 days. Throw away any unused liquid after all doses are completed.

Precautions While Using Zmax

It is very important that your doctor check the progress of you or your child at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

If you or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have a rash; itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you take this medicine.

Serious skin reactions can occur with this medicine. Stop using this medicine and check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.

Stop using this medicine and check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Azithromycin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you or your child have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

If you or your child vomits within one hour of taking the extended-release oral liquid, call your doctor right away to see if more medicine is needed.

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.

Zmax 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:

More common

Diarrhea

loose stools

Less common

Blistering, crusting, irritation, itching, or reddening of the skin

cracked, dry, or scaly skin

fever

swelling

Rare

Abdominal or stomach pain

blistering, peeling, or loosening of the skin

bloody or cloudy urine

bloody, black, or tarry stools

body aches or pain

burning while urinating

chest pain

chills

congestion

cough increased

cough producing mucus

dark urine

difficult or labored breathing

difficult or painful urination

dizziness

drowsiness

dryness or soreness of the throat

earache

fainting

fast, irregular, pounding, or racing heartbeat or pulse

general feeling of discomfort or illness

general feeling of tiredness or weakness

headache

indigestion

irregular or slow heart rate

itching

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

loss of appetite

muscle aches and pains

nausea or vomiting

noisy breathing

passing of gas

rash

red skin lesions, often with a purple center

red, irritated eyes

redness or swelling in the ear

runny nose

shivering

shortness of breath

sneezing

sores, ulcers, or white spots on the lips or in the mouth

stomach pain, continuing

stomach pain, fullness, or discomfort

stuffy nose

sweating

swelling of the face, ankles, hands, feet, or lower legs

tender, swollen glands in the neck

tightness in the chest

trouble with sleeping

trouble with swallowing

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

upper right abdominal or stomach pain

voice changes

vomiting of blood

wheezing

yellow eyes or skin

Incidence not known

Abdominal or stomach cramps

abdominal or stomach tenderness

bleeding gums

bloating

blood in the urine or stools

blurred vision

change in hearing

clay-colored stools

coma

confusion

constipation

continuing ringing or buzzing or other unexplained noise in the ears

decreased urine output

depression

diarrhea, watery and severe, which may also be bloody

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

fainting

greatly decreased frequency of urination or amount of urine

hives

hostility

increased thirst

irritability

lethargy

loss of hearing

lower back or side pain

muscle twitching

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

pinpoint red spots on the skin

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

rapid weight gain

seizures

stupor

unusual weight loss

Rare

Acid or sour stomach

aggressive, angry

bad, unusual, or unpleasant (after) taste

belching

burning feeling in the chest or stomach

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

change in taste

changes in the color of the tongue

crying

depersonalization

dry mouth

dysphoria

euphoria

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

full feeling

heartburn

hyperventilation

increase in body movements

itching of the vagina or genital area

lack or loss of strength

mental depression

nervousness

pain during sexual intercourse

paranoia

quick to react or overreact emotionally

rapidly changing moods

rash with flat lesions or small raised lesions on the skin

redness of the skin

restlessness

sensation of spinning

shaking

shortness of breath

sleepiness or unusual drowsiness

sleeplessness

sore mouth or tongue

stomach upset

thick, white vaginal discharge with no odor or with a mild odor

unable to sleep

white patches in the mouth, tongue, or throat

Incidence not known

Difficulty with moving

fear or nervousness

increased sensitivity of the skin to sunlight

muscle pain or stiffness

pain in the joints

redness or other discoloration of the skin

severe sunburn

trouble sitting still

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: Zmax side effects (in more detail)

More Zmax resources

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

Zmax Extended-Release Oral Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Zmax Prescribing Information (FDA)

Azithromycin Professional Patient Advice (Wolters Kluwer)

Azithromycin Monograph (AHFS DI)

Azithromycin MedFacts Consumer Leaflet (Wolters Kluwer)

Zithromax Prescribing Information (FDA)

Zithromax Consumer Overview

Compare Zmax with other medications

Babesiosis
Bacterial Endocarditis Prevention
Bacterial Infection
Bartonellosis
Bronchitis
Cervicitis
Chancroid
COPD, Acute
Cystic Fibrosis
Gonococcal Infection, Uncomplicated
Granuloma Inguinale
Legionella Pneumonia
Lyme Disease, Erythema Chronicum Migrans
Mycobacterium avium-intracellulare, Prophylaxis
Mycobacterium avium-intracellulare, Treatment
Mycoplasma Pneumonia
Nongonococcal Urethritis
Otitis Media
Pelvic Inflammatory Disease
Pharyngitis
Pneumonia
Sinusitis
Skin Infection
Tonsillitis/Pharyngitis
Toxoplasmosis
Typhoid Fever
Upper Respiratory Tract Infection

Thursday, 12 April 2012

Amprol 128

Dosage Form: FOR ANIMAL USE ONLY
AMPROL SOLUBLE POWDER

INDICATIONS

Amprol 128 (amprolium) 20% Soluble Powder is intended for the treatment of

coccidiosis in growing chickens, turkeys and laying hens.

USE DIRECTIONS

USE DIRECTIONS: Give amprolium at the 0.012% level (10 oz Amprol 128 20%

Soluble Powder per 128 Gallons) as soon as coccidiosis is diagnosed and continue for

three to five days. (in severe outbreaks, give amprolium at the 0.024% level.)

Continue with 0.006% amprolium medicated water for an additional 1 to 2 weeks. No

other source of drinking water should be available to the birds during this time.

Use as the sole source of amprolium.

CAUTION

CAUTION: If no improvement is noted within 3 days, have the diagnosis confirmed

and follow the instructions of your veterinarian or poultry pathologist. Losses may

result from intercurrent disease or other conditions affecting drug intake which can

contribute to the virulence of cocidiosis under field conditions.

NOT FOR HUMAN USE.

Restricted Drug - Use Only as Directed (California)

Keep this and all drugs out f the reach of children.

MIXING AND DOSAGE ADMINISTRATION

PREMEASURED FOR AUTOMATIC

WATER PRDPORTIONERS

For Automatic Water Proportioners

For use in automatic water proportioners that meter

1 fluid ounce of stock solution per gallon of drinking

water.

                                     Dissolve Amprol 128

                                   (amprolium) 20% Soluble Powder

To prepare                           In one gallon of water

dosage levels of:               (Makes 1 gallon of stock solution)

0.024%                                        2 bags (20 oz) in 1 gallon

0.012%                                        1 bag (20 oz) in 1 gallon

0.006%                                       1/2 bag (20 oz) in 1 gallon

To Prepare 50 Gallons of Medicated Water

DOSAGE LEVEL               MIXING DIRECTIONS

0.024%                        Dissolve 8 ounces of Amprol 128

                                   20% SOLUBLE POWDER in about 5

                                   gallons of water in a 50-gallon

                                   medicated barrel. Stir, then add

                                   water to the 50-gallon mark.

                                   Stir thoroughly.

0.012%                        Follow same directions as above but

                                   use 4 ounces of Amprol 128 20%

                                   SOLUBLE POWDER.

0.006%                        Follow same directions as above but

                                   use 2 ounces of Amprol 128 20%

                                   SOLUBLE POWDER.

Note: Make drinking water fresh daily. Stock

solutions for proportioners may be stored in a

clean, closed labeled container for up to 3 days.

AMPROl® is a registered trademark of Huvepharma.lnc.

STORAGE

STORAGE: Store between 5o - 25oC (41o - 77oF) with brief excursions to 40oC (104oF)

Amprol 128 Label Image

AMPROL 128
amprolium powder

Product Information
Product Type	OTC ANIMAL DRUG	NDC Product Code (Source)	23243-9709
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMPROLIUM (AMPROLIUM)	AMPROLIUM	0.2 g in 1 g

Inactive Ingredients
Ingredient Name	Strength
No Inactive Ingredients Found

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	23243-9709-3	24 POUCH In 1 PAIL	contains a POUCH
1		283.5 g In 1 POUCH	This package is contained within the PAIL (23243-9709-3)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA033165	06/29/2009

Labeler - Huvepharma, Inc. (619153559)

Establishment
Name	Address	ID/FEI	Operations
Huvepharma, Inc.		619153559	pack, label, manufacture, analysis

Revised: 04/2010Huvepharma, Inc.

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