Advair Inhalation Aerosol

Generic Name: fluticasone and salmeterol (Inhalation route)

floo-TIK-a-sone PROE-pee-oh-nate, sal-ME-ter-ol zye-NAF-oh-ate

Inhalation, oral/nebulization route(Disk;Aerosol)

Long-acting beta 2-adrenergic agonists (LABA) increase the risk of asthma-related deaths. In a large trial that compared the safety of salmeterol or placebo added to usual asthma therapy, there was an increase in asthma-related deaths with salmeterol. Available data have not determined whether concurrent inhaled corticosteroid or other long-term asthma control drug use mitigates the increased risk of asthma-related death from LABA. Data from pediatric and adolescent trials suggest that LABA increase the risk of asthma-related hospitalization. Therefore, when treating patients with asthma, fluticasone propionate/salmeterol inhalation powder or aerosol should only be used for patients not adequately controlled on a long-term asthma control medication or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue fluticasone propionate/salmeterol) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication. Do not use fluticasone propionate/salmeterol for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids .

Commonly used brand name(s)

In the U.S.

• Advair Diskus


• Advair Diskus 100/50


• Advair Diskus 250/50


• Advair Diskus 500/50


• Advair HFA

In Canada

• Advair


• Advair Inhalation Aerosol

Available Dosage Forms:

• Aerosol Liquid


• Disk


• Aerosol Powder

Therapeutic Class: Antiasthma, Anti-Inflammatory/Bronchodilator Combination

Pharmacologic Class: Fluticasone

Uses For Advair Inhalation Aerosol

Fluticasone and salmeterol is a combination of two medicines that are used to help control the symptoms of asthma and improve breathing. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines, or when a patient's condition is so severe that more than one medicine is needed every day. This medicine will not relieve an asthma attack that has already started.

This medicine is also used to treat air flow blockage and reduce the worsening of chronic obstructive pulmonary disease (COPD). This includes chronic bronchitis and emphysema.

Inhaled fluticasone belongs to the family of medicines known as corticosteroids or steroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms.

Inhaled salmeterol is a long-acting bronchodilator. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) in the lungs. It relieves cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

This medicine must be used with a short-acting medicine (e.g. albuterol) for an asthma attack or asthma symptoms that need attention right away.

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

Before Using Advair Inhalation Aerosol

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Advair® Diskus® to treat asthma in children older than 4 years of age. Safety and efficacy have not been established in children younger than 4 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of Advair® HFA oral inhalation in children younger than 12 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 fluticasone and salmeterol combination in the elderly. However, elderly people with heart and blood vessel problems may require special caution when receiving fluticasone and salmeterol combination.

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

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while 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


• Dronedarone


• Fluconazole


• Mesoridazine


• Pimozide


• Posaconazole


• Sparfloxacin


• Thioridazine

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.

• Acebutolol


• Alfuzosin


• Alprenolol


• Amiodarone


• Apomorphine


• Arotinolol


• Arsenic Trioxide


• Asenapine


• Astemizole


• Atazanavir


• Atenolol


• Azithromycin


• Befunolol


• Betaxolol


• Bevantolol


• Bisoprolol


• Boceprevir


• Bopindolol


• Brofaromine


• Bucindolol


• Bupranolol


• Bupropion


• Carteolol


• Carvedilol


• Celiprolol


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clorgyline


• Clozapine


• Crizotinib


• Darunavir


• Dasatinib


• Dilevalol


• Disopyramide


• Dofetilide


• Dolasetron


• Droperidol


• Esmolol


• Flecainide


• Fosamprenavir


• Furazolidone


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Indinavir


• Iproniazid


• Isocarboxazid


• Itraconazole


• Ketoconazole


• Labetalol


• Landiolol


• Lapatinib


• Lazabemide


• Levobetaxolol


• Levobunolol


• Levofloxacin


• Linezolid


• Lopinavir


• Lumefantrine


• Mefloquine


• Mepindolol


• Methadone


• Metipranolol


• Metoprolol


• Moclobemide


• Moxifloxacin


• Nadolol


• Nebivolol


• Nefazodone


• Nelfinavir


• Nialamide


• Nilotinib


• Nipradilol


• Norfloxacin


• Octreotide


• Ofloxacin


• Ondansetron


• Oxprenolol


• Paliperidone


• Pargyline


• Pazopanib


• Penbutolol


• Perflutren Lipid Microsphere


• Phenelzine


• Pindolol


• Procainamide


• Procarbazine


• Prochlorperazine


• Promethazine


• Propafenone


• Propranolol


• Protriptyline


• Quetiapine


• Quinidine


• Quinine


• Ranolazine


• Rasagiline


• Ritonavir


• Saquinavir


• Selegiline


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Solifenacin


• Sorafenib


• Sotalol


• Sunitinib


• Talinolol


• Telaprevir


• Telavancin


• Telithromycin


• Terfenadine


• Tertatolol


• Tetrabenazine


• Timolol


• Tipranavir


• Toloxatone


• Toremifene


• Tranylcypromine


• Trazodone


• Trifluoperazine


• 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.

• Erythromycin

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma attack, acute or


• Bronchospasm (difficulty with breathing), acute or


• COPD flare-up or


• Milk protein allergy, severe—Should not be used in patients with these conditions.

• Blood vessel disease (e.g., Churg-Strauss syndrome) or


• Bone problems (e.g., osteoporosis) or


• Cataracts or


• Diabetes or


• Glaucoma or


• Heart disease or


• Heart rhythm problems (e.g., arrhythmia) or


• Hypertension (high blood pressure) or


• Hyperthyroidism (overactive thyroid) or


• Hypokalemia (low potassium in the blood) or


• Ketoacidosis (high ketones in the blood) or


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

• Chickenpox (including recent exposure) or


• Herpes simplex (virus) infection of the eye or


• Infections (virus, bacteria, or fungus) or


• Measles or


• Tuberculosis, active or history of—Inhaled fluticasone can reduce the body's ability to fight off these infections.

• Infection or


• Stress or


• Surgery or


• Trauma—Supplementary oral corticosteroids may be needed. Check with your doctor.

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

Proper Use of fluticasone and salmeterol

This section provides information on the proper use of a number of products that contain fluticasone and salmeterol. It may not be specific to Advair Inhalation Aerosol. Please read with care.

Inhaled fluticasone and salmeterol is used to prevent asthma attacks and to treat chronic obstructive pulmonary disease (COPD). It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your doctor.

Inhaled fluticasone and salmeterol is used with a special inhaler that comes with patient directions or a medication guide. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the Diskus® or inhaler, ask your doctor to show you what to do. Also, ask your doctor to check regularly how you use the Diskus® or inhaler to make sure you are using it properly.

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop using this medicine without telling your doctor. To do so may increase the chance of side effects.

In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor.

Do not stop using this medicine or other asthma medicines that your doctor has prescribed for you unless you have discussed this with your doctor.

When you use the Advair® HFA inhaler for the first time, or if you have not used it for 7 days or longer, or if the inhaler has been dropped, it may not deliver the right amount of medicine with the first puff. Therefore, before using the inhaler, prime it by spraying the medicine four times into the air away from the face, and shaking it well for 5 seconds before each spray. Avoid spraying it in your eyes.

Rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. However, do not swallow the water after rinsing.

To use the Diskus®:

• Open the foil pouch containing the Diskus®.


• To open the Diskus®, push the thumb grip away from you as far as it will go. You will hear a click and feel a snap. When open, the mouthpiece will appear.


• Slide the mouthpiece lever away from you as far as it will go until it clicks. The Diskus® is now ready to use. If you close the Diskus® or push the lever again, you will lose medicine.


• Turn your head away from the Diskus®, and breathe out to the end of a normal breath. Do not breathe into the Diskus®.


• Holding the Diskus® level, put the mouthpiece between your lips and teeth, and close your lips around the mouthpiece. Do not bite down on the mouthpiece. Do not block the mouthpiece with your teeth or tongue.


• Breathe in through your mouth as deeply as you can until you have taken a full deep breath. Do not breathe through your nose.


• Hold your breath and remove the mouthpiece from your mouth. Continue holding your breath as long as you can up to 10 seconds before breathing out slowly. This gives the medicine time to settle in your airways and lungs.


• Turn your head away from the Diskus®, and breathe out slowly to the end of a normal breath. Do not breathe into the Diskus®.


• If your doctor has told you to inhale more than one puff of medicine at each dose, take the second puff following exactly the same steps you used for the first puff.


• When you are finished, close the Diskus®. Place your thumb on the thumb grip, and slide it back toward you as far as it will go. You will hear it click shut.


• Keep the Diskus® dry. Do not wash the mouthpiece, or any other part of the Diskus®. You may use a dry cloth to wipe it clean.


• The Diskus® has a window that shows the number of doses that are left. This tells you when you are getting low on medicine. When the Diskus® has 5 doses left, the numbers from 5 to 0 will show up in red to remind you to refill your prescription.

To use the Advair® HFA inhaler:

• Take the inhaler out of the pouch before you use it for the first time.


• Do not use the inhaler for this medicine with any other medicine.


• Remove the cap and look at the mouthpiece to make sure it is clean.


• Prime the inhaler before use by shaking the inhaler well and then releasing 4 test sprays.


• To inhale this medicine, breathe out fully, trying to get as much air out of the lungs as possible. Put the mouthpiece fully into your mouth and close your lips around it. Do not block the mouthpiece with your teeth or tongue.


• While pressing down firmly and fully on the purple top of the inhaler, breathe in through your mouth as deeply as you can until you have taken a full deep breath.


• Wait for 30 seconds and repeat these steps for the next puff, starting with shaking the inhaler.


• Gargle and rinse your mouth with water after each dose; this will help prevent hoarseness, throat irritation, and infection in the mouth. Do not swallow the water after rinsing.


• Replace the mouthpiece cover after using the medicine.


• The inhaler has a window that shows the number of doses remaining. This tells you when you are getting low on medicine. The doses counting down from 20 to 0 will show up in red to remind you to refill your prescription. Throw away the inhaler when the count is 000. You may not receive the right amount of medicine.

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 inhalation dosage form (aerosol):
  
  • For preventing an asthma attack:
    
    • Adults, teenagers, and children 12 years of age and older—Two puffs in the morning and another two puffs in the evening. The doses should be at least 12 hours apart.
    
    
    • Children younger than 12 years of age—Use and dose must be determined by your child's doctor.
    
    
  
  


• For inhalation dosage form (powder):
  
  • For preventing an asthma attack:
    
    • Adults, teenagers, and children 4 years of age and older—One inhalation two times per day (morning and evening). The doses should be at least 12 hours apart.
    
    
    • Children younger than 4 years of age—Use and dose must be determined by your doctor.
    
    
  
  
  • For maintenance treatment of COPD:
    
    • Adults—One inhalation (250/50) two times per day (morning and evening). The doses should be at least 12 hours apart.
    
    
    • 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 canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep the medicine in the foil pouch until you are ready to use it. Store at room temperature, away from heat and direct light. Do not freeze.

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.

Precautions While Using Advair Inhalation Aerosol

If you will be using this medicine for a long time, it is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

Tell your doctor if you or your child are also using other medicines for your COPD. Your doctor may want you to stop using the medicine and use it only during a severe COPD attack. Follow your doctor's instructions on how you should take your medicine.

This medicine should not be used if you are having a severe COPD attack, or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.

This medicine should only be used as an additional treatment for patients who cannot be treated with other asthma medicines (such as inhaled corticosteroids) or for asthma patients that require two medicines, including salmeterol. Ask your doctor if you have any questions.

Although this medicine decreases the number of asthma episodes, it may increase the chance of a severe asthma attack when they do occur. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have.

You should not use this medicine if your asthma attack has already started. Your doctor will prescribe another medicine (e.g., a short-acting inhaler) for you to use in case of an acute asthma attack. Make sure you understand how to use the short-acting inhaler. Talk to your doctor if you need instructions.

Talk with your doctor or get medical care right away if:

• Your or your child's symptoms do not improve after using this medicine for 1 week or if they become worse.


• Your short-acting inhaler does not seem to work as well as it used to and you or your child need it more often than normal (e.g., you use 1 whole canister of the short-acting inhaler in 8 weeks time, or you need to use 4 or more inhalations of the short-acting inhaler for 2 or more days in a row).


• You or your child have a big decrease in your peak flow when measured as directed by your doctor.

Do not use this medicine to treat wheezing that is getting worse. Call your doctor right away if wheezing worsens while using this medicine.

Do not use any other asthma medicine or medicine for breathing problems without talking to your doctor. This medicine should not be used with other inhalers that contain budesonide and formoterol combination (Symbicort®), formoterol (Foradil® Aerolizer®, Perforomist™), or arformoterol (Brovona™).

This medicine may cause a fungus infection of the mouth or throat (thrush). Tell your doctor right away if you have white patches in the mouth or throat; or pain when eating or swallowing.

Patients with COPD may be more likely to have pneumonia. Call your doctor if you or your child start having increased sputum (spit) production, change in sputum color, fever, chills, increased cough, or an increase in breathing problems.

Do not change your dose or stop using your medicine without first asking your doctor.

Your doctor may want you to carry a medical identification (ID) card stating that you or your child are using this medicine. The card will say that you may need additional medicine during an emergency, a severe asthma attack or other illness, or unusual stress.

Using too much of this medicine or using it for a long time may cause may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have more than one of these symptoms while you are using this medicine: darkening of the skin; diarrhea; dizziness; fainting; loss of appetite; mental depression; nausea; skin rash; unusual tiredness or weakness; or vomiting.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Stop using this medicine and check with your doctor right away if you or your child are having a cough, difficulty with breathing, shortness of breath, or wheezing after using this medicine.

If you or your child develop a skin rash, hives, or any allergic reaction to this medicine, stop using the medicine and check with your doctor as soon as possible.

Check with your doctor right away if you or your child have chest pain, a fast heartbeat, nervousness, shaking of the hands or feet, noisy breathing, a feeling of choking, or tightness or irritation of the throat while using this medicine.

This medicine may affect blood sugar and potassium levels. If you have heart disease or are diabetic and notice a change in the results of your blood or urine sugar or potassium tests, check with your doctor.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may decrease bone mineral density when used for a long time. A low bone mineral density can cause weak bones or osteoporosis. If you have any questions about this, ask your doctor.

This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.

This medicine may affect blood sugar levels. If you are diabetic and notice a change in the results of your blood or urine sugar tests, check with your doctor.

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.

Advair Inhalation Aerosol 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

• Black, tarry stools


• blindness


• blurred vision


• burning, tingling, numbness, or pain in the hands, arms, feet, or legs


• chills


• cough


• decreased vision


• difficulty with breathing or swallowing


• eye pain


• fast heartbeat


• fever


• headache


• hives or welts


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


• nausea or vomiting


• noisy breathing


• painful or difficult urination


• sensation of pins and needles


• shortness of breath


• skin itching, rash, or redness


• sore throat


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


• stabbing pain in the arms or legs


• swelling of the face, throat, or tongue


• swollen glands


• tearing


• unusual bleeding or bruising


• wheezing

Incidence not known

• Abdominal or stomach pain


• backache


• bruising


• darkening of the skin


• decrease in height


• diarrhea


• difficulty with moving


• dizziness


• facial hair growth in females


• fainting


• fast, slow, pounding, or irregular heartbeat or pulse


• flushed, dry skin


• fractures


• fruit-like breath odor


• full or round face, neck, or trunk


• heavy bleeding


• increased hunger


• increased thirst or urination


• irritability


• large, flat, blue, or purplish patches in the skin


• loss of sexual desire or ability


• menstrual irregularities


• mental depression


• muscle pain or stiffness


• muscle wasting


• pain in the back, ribs, arms, or legs


• pain in the joints


• sweating


• troubled breathing


• unexplained weight loss


• unusual tiredness or weakness


• weight gain

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

Symptoms of overdose

• Chest pain or tightness


• confusion


• convulsions (seizures)


• decreased urine output


• dry mouth


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


• general feeling of discomfort or illness


• high blood pressure


• loss of appetite


• mood changes


• nervousness


• numbness or tingling in the hands, feet, or lips


• sudden sweating


• tremors


• trouble with sleeping

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

• Body aches or pain


• choking


• congestion


• dryness of the throat


• high-pitched noise when breathing


• hoarseness


• runny nose


• sneezing


• trouble with swallowing


• voice changes

Less common

• Cough-producing mucus


• flu-like symptoms


• irritation or inflammation of the eye


• muscle pain


• pain or tenderness around the eyes and cheekbones


• sleep disorders


• stuffy nose


• white patches in the mouth or throat or on the tongue

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: Advair Inhalation side effects (in more detail)

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More Advair Inhalation Aerosol resources

• Advair Inhalation Aerosol Side Effects (in more detail)
• Advair Inhalation Aerosol Use in Pregnancy & Breastfeeding
• Advair Inhalation Aerosol Drug Interactions
• Advair Inhalation Aerosol Support Group
• 2 Reviews for Advair Inhalation - Add your own review/rating

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• Asthma, Maintenance
• COPD, Maintenance

Effer-K

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

Commonly used brand name(s)

In the U.S.

• Effer-K


• Glu-K


• K+Care ET


• K-Lyte


• K-Lyte Cl


• K-Tab


• Potassimin


• Tri-K


• Urocit-K 10

In Canada

• K-10 Solution


• Kaochlor 10


• Kaochlor 20


• Kaon


• K-Lor


• K-Lyte/Ci


• Potassium Chloride


• Potassium-Rougier


• Roychlor

Available Dosage Forms:

• Tablet, Effervescent


• Solution


• Capsule


• Tablet, Extended Release


• Powder for Suspension, Extended Release


• Tablet


• Powder for Suspension


• Liquid


• Elixir


• Granule


• Capsule, Extended Release


• Powder for Solution

Uses For Effer-K

Potassium is needed to maintain good health. Although a balanced diet usually supplies all the potassium a person needs, potassium supplements may be needed by patients who do not have enough potassium in their regular diet or have lost too much potassium because of illness or treatment with certain medicines.

There is no evidence that potassium supplements are useful in the treatment of high blood pressure.

Lack of potassium may cause muscle weakness, irregular heartbeat, mood changes, or nausea and vomiting.

Injectable potassium is administered only by or under the supervision of your doctor. Some forms of oral potassium may be available in stores without a prescription. Since too much potassium may cause health problems, you should take potassium supplements only if directed by your doctor.

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.

The following table includes some potassium-rich foods.

Food (amount)	Milligrams of potassium	Milliequivalents of potassium
Acorn squash, cooked (1 cup)	896	23
Potato with skin, baked (1 long)	844	22
Spinach, cooked (1 cup)	838	21
Lentils, cooked (1 cup)	731	19
Kidney beans, cooked (1 cup)	713	18
Split peas, cooked (1 cup)	710	18
White navy beans, cooked (1 cup)	669	17
Butternut squash, cooked (1 cup)	583	15
Watermelon (1/16)	560	14
Raisins (½ cup)	553	14
Yogurt, low-fat, plain (1 cup)	531	14
Orange juice, frozen (1 cup)	503	13
Brussel sprouts, cooked (1 cup)	494	13
Zucchini, cooked, sliced (1 cup)	456	12
Banana (medium)	451	12
Collards, frozen, cooked (1 cup)	427	11
Cantaloupe (¼)	412	11
Milk, low-fat 1% (1 cup)	348	9
Broccoli, frozen, cooked (1 cup)	332	9

The daily amount of potassium 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.

Because lack of potassium is rare, there is no RDA or RNI for this mineral. However, it is thought that 1600 to 2000 mg (40 to 50 milliequivalents [mEq]) per day for adults is adequate.

Remember:

• The total amount of potassium that you get every day includes what you get from food and what you may take as a supplement. Read the labels of processed foods. Many foods now have added potassium.


• Your total intake of potassium should not be greater than the recommended amounts, unless ordered by your doctor. In some cases, too much potassium may cause muscle weakness, confusion, irregular heartbeat, or difficult breathing.

Before Using Effer-K

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

Although there is no specific information comparing use of potassium supplements in children with use in other age groups, they are not expected to cause different side effects or problems in children than they do in 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. Although there is no specific information comparing use of potassium supplements in the elderly with use in other age groups, they are not expected to cause different side effects or problems in older people than they do in younger adults.

Older adults may be at a greater risk of developing high blood levels of potassium (hyperkalemia).

Pregnancy

Potassium supplements have not been shown to cause problems in humans.

Breast Feeding

Potassium supplements pass into breast milk. However, this medicine has not been reported to cause problems in nursing babies.

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


• Clidinium


• Darifenacin


• Dicyclomine


• Eplerenone


• Glycopyrrolate


• Hyoscyamine


• Methscopolamine


• Oxybutynin


• Procyclidine


• Scopolamine


• Solifenacin


• 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


• Amiloride


• Benazepril


• Canrenoate


• Captopril


• Cilazapril


• Delapril


• Enalaprilat


• Enalapril Maleate


• Fosinopril


• Imidapril


• Indomethacin


• Lisinopril


• Moexipril


• Pentopril


• Perindopril


• Quinapril


• Ramipril


• Spirapril


• Spironolactone


• Temocapril


• Trandolapril


• Triamterene


• 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:

• Addison's disease (underactive adrenal glands) or


• Dehydration (excessive loss of body water, continuing or severe)


• Type 2 diabetes mellitus or


• Kidney disease—Potassium supplements may increase the risk of hyperkalemia (high blood levels of potassium), which may worsen or cause heart problems in patients with these conditions.

• Diarrhea (continuing or severe)—The loss of fluid in combination with potassium supplements may cause kidney problems, which may increase the risk of hyperkalemia (high blood levels of potassium).

• Heart disease—Potassium supplements may make this condition worse.

• Intestinal or esophageal blockage—Potassium supplements may damage the intestines.

• Stomach ulcer—Potassium supplements may make this condition worse.

Proper Use of potassium supplement

This section provides information on the proper use of a number of products that contain potassium supplement. It may not be specific to Effer-K. Please read with care.

For patients taking the liquid form of this medicine:

• This medicine must be diluted in at least one-half glass (4 ounces) of cold water or juice to reduce its possible stomach-irritating or laxative effect.


• If you are on a salt (sodium)-restricted diet, check with your doctor before using tomato juice to dilute your medicine. Tomato juice has a high salt content.

For patients taking the soluble granule, soluble powder, or soluble tablet form of this medicine:

• This medicine must be completely dissolved in at least one-half glass (4 ounces) of cold water or juice to reduce its possible stomach-irritating or laxative effect.


• Allow any "fizzing" to stop before taking the dissolved medicine.


• If you are on a salt (sodium)-restricted diet, check with your doctor before using tomato juice to dilute your medicine. Tomato juice has a high salt content.

For patients taking the extended-release tablet form of this medicine:

• Swallow the tablets whole with a full (8-ounce) glass of water. Do not chew or suck on the tablet.


• Some tablets may be broken or crushed and sprinkled on applesauce or other soft food. However, check with your doctor or pharmacist first, since this should not be done for most tablets.


• If you have trouble swallowing tablets or if they seem to stick in your throat, check with your doctor. When this medicine is not properly released, it can cause irritation that may lead to ulcers.

For patients taking the extended-release capsule form of this medicine:

• Do not crush or chew the capsule. Swallow the capsule whole with a full (8-ounce) glass of water.


• Some capsules may be opened and the contents sprinkled on applesauce or other soft food. However, check with your doctor or pharmacist first, since this should not be done for most capsules.

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

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 if you are also taking both diuretics (water pills) and digitalis medicines for your heart.

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 bicarbonate


• For oral dosage forms (tablets for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—25 to 50 milliequivalents (mEq) dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For potassium bicarbonate and potassium chloride


• For oral dosage form (granules for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20 milliequivalents (mEq) dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (tablets for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20, 25, or 50 mEq dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For potassium bicarbonate and potassium citrate


• For oral dosage form (tablets for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—25 or 50 milliequivalents (mEq) dissolved in one-half to one glass of cold water, taken one or two times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For potassium chloride


• For long-acting oral dosage form (extended-release capsules):
  
  • To replace potassium lost by the body:
    
    • Adults and teenagers—40 to 100 milliequivalents (mEq) a day, divided into two or three smaller doses during the day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
  
  
  • To prevent potassium loss:
    
    • Adults and teenagers—16 to 24 mEq a day, divided into two or three smaller doses during the day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For long-acting oral dosage forms (liquid for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20 mEq mixed into one-half glass of cold water or juice, taken one to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mEq of potassium per kilogram (kg) (0.45 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed in water or juice.
    
    
  
  


• For oral dosage form (powder for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—15 to 25 mEq dissolved in four to six ounces of cold water, taken two or four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 1 to 3 mEq per kg (0.45 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be mixed into water or juice.
    
    
  
  


• For oral dosage form (powder for suspension):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20 mEq dissolved in two to six ounces of cold water, taken one to five times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For long-acting oral dosage form (extended-release tablets):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—6.7 to 20 mEq taken three times a day. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  


• For oral dosage form (liquid for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20 milliequivalents (mEq) mixed into one-half glass of cold water or juice, taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kilogram (kg) (0.9 to 1.36 mEq per pound) of body weight a day, taken in smaller doses during the day. The solution should be completely mixed into water or juice.
    
    
  
  


• For oral dosage form (tablets):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—5 to 10 mEq taken two to four times a day. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose must be determined by your doctor.
    
    
  
  

• For potassium gluconate and potassium chloride


• For oral dosage form (liquid for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20 milliequivalents (mEq) diluted in 2 tablespoonfuls or more of cold water or juice, taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kilogram (kg) (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.
    
    
  
  


• For oral dosage form (powder for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20 mEq mixed in 2 tablespoonfuls or more of cold water or juice taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose is base on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kg (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.
    
    
  
  

• For potassium gluconate and potassium citrate


• For oral dosage form (liquid for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—20 milliequivalents (mEq) mixed into one-half glass of cold water or juice, taken two to four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kg (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.
    
    
  
  

• For trikates


• For oral dosage form (liquid for solution):
  
  • To prevent potassium loss or replace potassium lost by the body:
    
    • Adults and teenagers—15 milliequivalents (mEq) mixed into one-half glass of cold water or juice, taken three or four times a day. Your doctor may change the dose if needed. However, most people will not take more than 100 mEq a day.
    
    
    • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mEq per kilogram (kg) (0.9 to 1.36 mEq per pound) of body weight taken in smaller doses during the day. The solution should be well mixed into water or juice.
    
    
  
  

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 Effer-K

Your doctor should check your progress at regular visits to make sure the medicine is working properly and that possible side effects are avoided. Laboratory tests may be necessary.

Do not use salt substitutes, eat low-sodium foods, especially some breads and canned foods, or drink low-sodium milk unless you are told to do so by your doctor, since these products may contain potassium. It is important to read the labels carefully on all low-sodium food products.

Check with your doctor before starting any physical exercise program, especially if you are out of condition and are taking any other medicine. Exercise and certain medicines may increase the amount of potassium in the blood.

Check with your doctor at once if you notice blackish stools or other signs of stomach or intestinal bleeding. This medicine may cause such a condition to become worse, especially when taken in tablet form.

Effer-K 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.

Stop taking this medicine and check with your doctor immediately if any of the following side effects occur:

Less common

• Confusion


• irregular or slow heartbeat


• numbness or tingling in hands, feet, or lips


• shortness of breath or difficult breathing


• unexplained anxiety


• unusual tiredness or weakness


• weakness or heaviness of legs

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

Rare

• Abdominal or stomach pain, cramping, or soreness (continuing)


• chest or throat pain, especially when swallowing


• stools with signs of blood (red or black color)

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

• Diarrhea


• nausea


• stomach pain, discomfort, or gas (mild)


• vomiting

Sometimes you may see what appears to be a whole tablet in the stool after taking certain extended-release potassium chloride tablets. This is to be expected. Your body has absorbed the potassium from the tablet and the shell is then expelled.

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.

Clinalog injection

Generic Name: triamcinolone (injection) (trye am SIN oh lone)

Brand Names: Aristospan Injection, Clinacort, Ken-Jec 40, Kenalog-10, Kenalog-40, TAC 3, Triamonide 40, U-Tri-Lone

What is Clinalog (triamcinolone (injection))?

Triamcinolone injection is a steroid. It prevents the release of substances in the body that cause inflammation.

Triamcinolone injection is injected into the joint space to treat inflammation of the joints or tendons to treat arthritis, bursitis, or epicondylitis (tennis elbow). It is usually given in these conditions only as a short-term treatment of a severe or aggravated episode.

Triamcinolone injection is injected into soft tissues of the body to treat certain skin disorders caused by autoimmune conditions such as lupus, psoriasis, lichen planus, and others.

Triamcinolone injection may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Clinalog (triamcinolone (injection))?

You should not receive this medication if you are allergic to triamcinolone, or if you have a condition called idiopathic thrombocytopenic purpura (ITP).

Before receiving triamcinolone injection, tell your doctor if you are allergic to any drugs, or if you have any type of infection (including tuberculosis), a thyroid disorder, a muscle disorder, stomach or intestinal problems, or if you have recently had a heart attack.

Long-term use of steroids can also cause harmful effects on your eyes. Your doctor may want you to have regular eye exams while you are receiving triamcinolone injection.

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

Steroids can lower the blood cells that help your body fight infections, making it easier for you to get sick from being around others who are ill, or from bacteria in a skin wound. Use caution to prevent illness, infection, or injury.

Do not receive a "live" vaccine while you are being treated with triamcinolone injection. The live vaccine may not work as well during this time, and may not fully protect you from disease.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroids.

What should I discuss with my health care provider before receiving Clinalog (triamcinolone (injection))?

You should not receive this medication if you are allergic to triamcinolone, or if you have a condition called idiopathic thrombocytopenic purpura (ITP).

If you have any of these other conditions, you may need a dose adjustment or special tests:

• 
  

  any type of bacterial, fungal, or viral infection (including tuberculosis);

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  a muscle disorder such as myasthenia gravis;

  
  


• 
  

  diverticulitis, stomach or intestinal ulcer, or recent stomach surgery; or

  
  


• 
  

  if you have recently had a heart attack.

  
  

FDA pregnancy category C. It is not known whether triamcinolone injection will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Triamcinolone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using triamcinolone injection.

This medication can decrease bone formation, which could lead to osteoporosis, especially with long-term use. Talk with your doctor about your specific risk of bone loss while receiving triamcinolone injection.

Steroids can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How is triamcinolone injection given?

This medication is injected into a joint or soft tissue (such as a psoriasis lesion). You will receive this injection in a clinic or hospital setting.

Steroids can lower the blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill, or from bacteria in a skin wound. Steroids can also slow the healing of skin wounds. Use caution to prevent illness, infection, or injury.

If you need surgery, tell the surgeon ahead of time if you have recently received a triamcinolone injection.

Long-term use of steroids can cause harmful effects on the eyes, such as glaucoma or cataracts. If you receive triamcinolone injection for longer than 6 weeks, your doctor may want you to have regular eye exams.

Steroid medications should not be stopped suddenly. You may need to receive less and less before you are taken off the medication completely.

Your doctor may instruct you to limit your salt intake while you are receiving triamcinolone injection. You may also need to take potassium supplements. Follow your doctor's instructions.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are being treated with triamcinolone injection.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving Clinalog (triamcinolone (injection))?

Do not receive a "live" vaccine while using triamcinolone injection. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroids.

Clinalog (triamcinolone (injection)) 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  fast, slow, or uneven heart rate;

  
  


• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling, rapid weight gain;

  
  


• 
  

  dangerously high blood pressure (severe headache, buzzing in your ears, anxiety, confusion, chest pain);

  
  


• 
  

  problems with your vision;

  
  


• 
  

  eye swelling, redness, discomfort, or drainage (may be signs of infection);

  
  


• 
  

  severe depression, changes in mood or behavior;

  
  


• 
  

  seizure (convulsions); or

  
  


• 
  

  muscle pain, tenderness, or weakness.

  
  

Less serious side effects may include:

• 
  

  nausea, bloating, appetite changes;

  
  


• 
  

  stomach or side pain;

  
  


• 
  

  headache, sleep problems (insomnia);

  
  


• 
  

  acne, scaling, or other skin changes;

  
  


• 
  

  a wound that is slow to heal;

  
  


• 
  

  thinning hair;

  
  


• 
  

  bruising or swelling;

  
  


• 
  

  sweating more than usual; or

  
  


• 
  

  irregular menstrual periods.

  
  

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 Clinalog (triamcinolone (injection))?

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

• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  cyclosporine (Neoral, Gengraf, Sandimmune);

  
  


• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  insulin or diabetes medications you take by mouth;

  
  


• 
  

  isoniazid (used to treat tuberculosis);

  
  


• 
  

  rifampin (Rifadin, Rimactane);

  
  


• 
  

  seizure medication such as phenobarbital (Luminal, Solfoton), phenytoin (Dilantin), carbamazepine (Carbatrol, Tegretol), and others,

  
  


• 
  

  antibiotics such as azithromycin (Zithromax), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Ery-Tab, Erythrocin), and others; or

  
  


• 
  

  aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others.

  
  

This list is not complete and other drugs may interact with triamcinolone injection. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Clinalog resources

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

Compare Clinalog with other medications

• Adrenocortical Insufficiency
• Allergic Reactions
• Alopecia
• Ankylosing Spondylitis
• Asthma
• Berylliosis
• Bursitis
• Chorioditis
• Chorioretinitis
• Conjunctivitis
• Dermal Necrosis, Prophylaxis
• Dermatitis
• Erythroblastopenia
• Frozen Shoulder
• Gouty Arthritis
• Hay Fever
• Heart Failure
• Hemolytic Anemia
• Idiopathic Thrombocytopenic Purpura
• Iridocyclitis
• Iritis
• Keloids
• Keratitis
• Leukemia
• Lichen Planus
• Lichen Sclerosus
• Lichen Simplex Chronicus
• Loeffler's Syndrome
• Meningitis
• Nephrotic Syndrome
• Neuritis
• Osteoarthritis
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis
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See also: Clinalog side effects (in more detail)

Duphalac

1. Name Of The Medicinal Product

Lactulose Solution BP /Duphalac®.

2. Qualitative And Quantitative Composition

Lactulose 3.35 g/5 ml.

For excipients, see 6.1

3. Pharmaceutical Form

A colourless to brownish yellow, clear or not more than slightly opalescent liquid.

4. Clinical Particulars

4.1 Therapeutic Indications

1. For the treatment of constipation.

2. For the treatment of hepatic encephalopathy (portal systemic encephalopathy); hepatic coma.

4.2 Posology And Method Of Administration

Constipation:

Adults (including the elderly):	initially 15 ml twice daily
Children 5 to 10 years:	10 ml twice daily
Children under 5 years:	5 ml twice daily
Babies under 1 year:	2.5 ml twice daily

All dosages should subsequently be adjusted to the needs of the individual. Each dose may if necessary be taken with water or fruit juices, etc.

Hepatic encephalopathy:

Adults (including the elderly): Initially 30 - 50 ml (6-10 x 5 ml spoonfuls) three times a day. Subsequently adjust the dose to produce two or three soft stools each day.

Children: no dosage recommendations for this indication.

4.3 Contraindications

Contraindicated in patients with galactosaemia and in cases of gastro-intestinal obstruction.

4.4 Special Warnings And Precautions For Use

Lactulose should be administered with care to patients who are intolerant to lactose (see 6.1).

The dose normally used in constipation should not pose a problem for diabetics. The dose used in the treatment of (pre)coma hepaticum is usually much higher and may need to be taken into consideration for diabetics.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

It should be taken into account that the exoneration reflex could be disturbed during the treatment.

In case of insufficient therapeutic effect after several days, consultation of a physician is advised.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Limited data on pregnant patients indicate neither malformative nor foeto/neonatal toxicity.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).

The use of lactulose may be considered during pregnancy if necessary.

Lactation

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to lactulose is negligible.

Duphalac can be used during breast-feeding.

4.7 Effects On Ability To Drive And Use Machines

Not known.

4.8 Undesirable Effects

Flatulence may occur during the first few days of treatment. As a rule it disappears after a couple of days. When dosages higher than instructed are used, abdominal pain and diarrhoea may occur. In such a case the dosage should be decreased. See also overdose section 4.9.

If high doses (normally only associated with portosystemic encephalopathy, PSE) are used for an extended period of time, the patient may experience an electrolyte imbalance due to diarrhoea. Dosage should then be adjusted to obtain two or three formed stools per day.

Gastrointestinal disorders

Flatulence, abdominal pain, nausea and vomiting. If dosed too high, diarrhoea.

Investigations

Electrolyte imbalance due to diarrhoea.

4.9 Overdose

If the dose is too high, the following may occur:

Symptom: diarrhoea and abdominal pain.

Treatment: cessation of treatment or dose reduction. Extensive fluid loss by diarrhoea or vomiting may require correction of electrolyte disturbances.

No specific antidote. Symptomatic treatment should be given.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

The active ingredient, lactulose, is metabolised in the colon by the sacchrolytic bacteria, producing low molecular weight organic acids, mainly lactic acid, which lower the pH of the colon contents, promote the retention of water by an osmotic effect, thus increasing peristaltic activity.

5.2 Pharmacokinetic Properties

Lactulose is minimally absorbed; therefore, the kinetics of the absorbed material are not relevant to the principal therapeutic action.

5.3 Preclinical Safety Data

The results of acute, sub-chronic and chronic toxicity studies in various species indicate that the compound has very low toxicity. The effects observed, appear to be more related to the effect of bulk in the gastrointestinal tract than to a more specific toxic activity. In reproduction and teratology experiments in rabbits, rats or mice no adverse effects were found.

6. Pharmaceutical Particulars

6.1 List Of Excipients

None.

6.2 Incompatibilities

None known.

6.3 Shelf Life

HDPE: 2 years. Other containers: 3 years.

6.4 Special Precautions For Storage

Do not store above 25°C. Do not refrigerate or freeze.

6.5 Nature And Contents Of Container

Brown glass and white HDPE bottles containing 200, 300, 500 and 1000 ml; polyethylene bottles containing 5 litres; 15 ml foil sachets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Solvay Healthcare Limited/Solvay Healthcare Ltd trading as Mansbridge Pharmaceuticals

Mansbridge Road

West End

Southampton

SO18 3JD

8. Marketing Authorisation Number(S)

PL 00512/5001R

9. Date Of First Authorisation/Renewal Of The Authorisation

14.03.88 / 23.07.99

10. Date Of Revision Of The Text

19/08/2010

Dovobet Ointment

1. Name Of The Medicinal Product

Dovobet 50 microgram/g + 0.5 mg/g ointment

2. Qualitative And Quantitative Composition

One gram of ointment contains 50 micrograms of calcipotriol (as monohydrate) and 0.5 mg of betamethasone (as dipropionate).

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Ointment.

Off-white to yellow.

4. Clinical Particulars

4.1 Therapeutic Indications

Topical treatment of stable plaque psoriasis vulgaris amenable to topical therapy in adults.

4.2 Posology And Method Of Administration

Posology

Dovobet ointment should be applied to the affected area once daily.

The recommended treatment period is 4 weeks. There is experience with repeated courses of Dovobet up to 52 weeks. If it is necessary to continue or restart treatment after 4 weeks, treatment should be continued after medical review and under regular medical supervision.

When using calcipotriol containing medicinal products, the maximum daily dose should not exceed 15 g. The body surface area treated with calcipotriol containing medicinal products should not exceed 30 % (see section 4.4).

Special populations

Renal and hepatic impairment

The safety and efficacy of Dovobet ointment in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated.

Paediatric population

The safety and efficacy of Dovobet ointment in children below 18 years have not been established. No data are available.

Method of administration

Dovobet ointment should be applied to the affected area. In order to achieve optimal effect, it is not recommended to take a shower or bath immediately after application of Dovobet ointment.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients.

Dovobet ointment is contraindicated in erythrodermic, exfoliative and pustular psoriasis.

Due to the content of calcipotriol Dovobet ointment is contra-indicated in patients with known disorders of calcium metabolism.

Due to the content of corticosteroid Dovobet ointment is contraindicated in the following conditions: Viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to tuberculosis or syphilis, perioral dermatitis, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne vulgaris, acne rosacea, rosacea, ulcers, wounds, perianal and genital pruritus.

4.4 Special Warnings And Precautions For Use

Effects on endocrine system

Dovobet ointment contains a potent group III steroid and concurrent treatment with other steroids must be avoided. Adverse reactions found in connection with systemic corticosteroid treatment, such as adrenocortical suppression or impact on the metabolic control of diabetes mellitus may occur also during topical corticosteroid treatment due to systemic absorption. Application under occlusive dressings should be avoided since it increases the systemic absorption of corticosteroids. Application on large areas of damaged skin and under occlusive dressings or on mucous membranes or in skin folds should be avoided since it increases the systemic absorption of corticosteroids (see section 4.8).

In a study in patients with both extensive scalp and extensive body psoriasis using a combination of high doses of Dovobet gel (scalp application) and high doses of Dovobet ointment (body application), 5 of 32 patients showed a borderline decrease in cortisol response to adrenocorticotropic hormone (ACTH) challenge after 4 weeks of treatment (see section 5.1).

Effects on calcium metabolism

Due to the content of calcipotriol, hypercalcaemia may occur if the maximum daily dose (15 g) is exceeded. Serum calcium is, however, quickly normalised when treatment is discontinued. The risk of hypercalcaemia is minimal when the recommendations relevant to calcipotriol are followed. Treatment of more than 30 % of the body surface should be avoided (see section 4.2).

Local adverse reactions

Skin of the face and genitals are very sensitive to corticosteroids. The medicinal product should not be used in these areas. The patient must be instructed in correct use of the medicinal product to avoid application and accidental transfer to the face, mouth and eyes. Hands must be washed after each application to avoid accidental transfer to these areas.

Concomitant skin infections

When lesions become secondarily infected, they should be treated with antimicrobiological therapy. However, if infection worsens, treatment with corticosteroids should be stopped.

Discontinuation of treatment

When treating psoriasis with topical corticosteroids there may be a risk of generalised pustular psoriasis or of rebound effects when discontinuing treatment. Medical supervision should therefore continue in the post-treatment period.

Long-term use

With long-term use there is an increased risk of local and systemic corticosteroid adverse reactions. The treatment should be discontinued in case of adverse reactions related to long-term use of corticosteroid (see section 4.8).

Unevaluated uses

There is no experience for the use of Dovobet ointment in guttate psoriasis.

Concurrent treatment and UV exposure

There is no experience for the use of this medicinal product on the scalp. Dovobet ointment for body psoriasis lesions has been used in combination with Dovobet gel for scalp psoriasis lesions, but there is no experience of combination of Dovobet with other topical anti-psoriatic products at the same treatment area, other anti-psoriatic medicinal products administered systemically or with phototherapy.

During Dovobet ointment treatment, physicians are recommended to advise patients to limit or avoid excessive exposure to either natural or artificial sunlight. Topical calcipotriol should be used with UVR only if the physician and patient consider that the potential benefits outweigh the potential risks (see section 5.3).

Dovobet ointment contains butylhydroxytoluene (E321). This may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed.

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate data from the use of Dovobet ointment in pregnant women. Studies in animals with glucocorticoids have shown reproductive toxicity (see section 5.3), but a number of epidemiological studies have not revealed congenital anomalies among infants born to women treated with corticosteroids during pregnancy. The potential risk for humans is uncertain. Therefore, during pregnancy, Dovobet ointment should only be used when the potential benefit justifies the potential risk.

Breastfeeding

Betamethasone passes into breast milk but risk of an adverse effect on the infant seems unlikely with therapeutic doses. There are no data on the excretion of calcipotriol in breast milk. Caution should be exercised when prescribing Dovobet ointment to women who breast feed. The patient should be instructed not to use Dovobet ointment on the breast when breast feeding.

Fertility

Studies in rats with oral doses of calcipotriol or betamethasone dipropionate demonstrated no impairment of male and female fertility.

4.7 Effects On Ability To Drive And Use Machines

Dovobet has no or negligible influence on the ability to drive and to use machines.

4.8 Undesirable Effects

The trial programme for Dovobet ointment has so far included more than 2,500 patients and has shown that approximately 10 % of patients can be expected to experience a non-serious undesirable effect.

These reactions are usually mild and cover mainly various skin reactions like rash, pruritus and burning sensation. Pustular psoriasis has been reported rarely. Rebound effect after end of treatment has been reported but the frequency of this is not known.

Based on data from clinical trials and postmarket use the following adverse reactions are listed for Dovobet ointment.

The adverse reactions are listed by MedDRA System Organ Class, and the individual adverse reactions are listed starting with the most frequently reported. Within each frequency grouping, the adverse reactions are listed in order of decreasing seriousness.

The following terminologies have been used in order to classify the frequencies of adverse reactions:

Very common
Common
Uncommon
Rare
Very rare	<1/10,000
Not known (cannot be estimated from the available data)

Skin and subcutaneous tissue disorders
Common	Pruritus Rash Burning sensation of skin
Uncommon	Exacerbation of psoriasis Skin pain or irritation Dermatitis Erythema Folliculitis Application site pigmentation changes
Rare	Pustular psoriasis
General disorders and administration site conditions
Not known	Rebound effect - included in section 4.4

The following adverse reactions are considered to be related to the pharmacological classes of calcipotriol and betamethasone, respectively:

Calcipotriol

Adverse reactions include application site reactions, pruritus, skin irritation, burning and stinging sensation, dry skin, erythema, rash, dermatitis, eczema, psoriasis aggravated, photosensitivity and hypersensitivity reactions including very rare cases of angioedema and facial oedema.

Systemic effects after topical use may appear very rarely causing hypercalcaemia or hypercalciuria (see section 4.4).

Betamethasone (as dipropionate)

Local reactions can occur after topical use, especially during prolonged application, including skin atrophy, telangiectasia, striae, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and colloid milia. When treating psoriasis there may be a risk of generalised pustular psoriasis.

Systemic reactions due to topical use of corticosteroids are rare in adults, however they can be severe. Adrenocortical suppression, cataract, infections, impact on the metabolic control of diabetes mellitus and increase of intra-ocular pressure can occur, especially after long term treatment. Systemic reactions occur more frequently when applied under occlusion (plastic, skin folds), when applied on large areas and during long term treatment (see section 4.4).

4.9 Overdose

Use above the recommended dose may cause elevated serum calcium which should rapidly subside when treatment is discontinued.

Excessive prolonged use of topical corticosteroids may suppress the pituitary-adrenal functions resulting in secondary adrenal insufficiency which is usually reversible. In such cases symptomatic treatment is indicated.

In case of chronic toxicity the corticosteroid treatment must be discontinued gradually.

It has been reported that due to misuse one patient with extensive erythrodermic psoriasis treated with 240 g of Dovobet ointment weekly (corresponding to a daily dose of approximately 34 g) for 5 months (maximum recommended dose 15 g daily) developed Cushing's syndrome and pustular psoriasis after abruptly stopping treatment.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Antipsoriatics. Other antipsoriatics for topical use, Calcipotriol, combinations. ATC Code: D05AX52

Calcipotriol is a vitamin D analogue. In vitro data suggests that calcipotriol induces differentiation and suppresses proliferation of keratinocytes. This is the proposed basis for its effect in psoriasis.

Like other topical corticosteroids, betamethasone dipropionate has anti-inflammatory, antipruritic, vasoconstrictive and immunosuppresive properties, however, without curing the underlying condition. Through occlusion the effect can be enhanced due to increased penetration of the stratum corneum. The incidence of adverse events will increase because of this. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear.

A safety study in 634 psoriasis patients has investigated repeated courses of Dovobet ointment used once daily as required, either alone or alternating with Dovonex, for up to 52 weeks, compared with Dovonex used alone for 48 weeks after an initial course of Dovobet ointment. Adverse drug reactions were reported by 21.7 % of the patients in the Dovobet ointment group, 29.6 % in the Dovobet ointment/Dovonex alternating group and 37.9 % in the Dovonex group. The adverse drug reactions that were reported by more than 2 % of the patients in the Dovobet ointment group were pruritus (5.8 %) and psoriasis (5.3 %). Adverse events of concern possibly related to long-term corticosteroid use (e.g. skin atrophy, folliculitis, depigmentation, furuncle and purpura) were reported by 4.8 % of the patients in the Dovobet ointment group, 2.8 % in the Dovobet ointment/Dovonex alternating group and 2.9 % in the Dovonex group.

Adrenal response to ACTH was determined by measuring serum cortisol levels in patients with both extensive scalp and body psoriasis, using up to 106 g per week combined Dovobet gel and Dovobet ointment. A borderline decrease in cortisol response at 30 minutes post ACTH challenge was seen in 5 of 32 patients (15.6 %) after 4 weeks of treatment and in 2 of 11 patients (18.2 %) who continued treatment until 8 weeks. In all cases, the serum cortisol levels were normal at 60 minutes post ACTH challenge. There was no evidence of change of calcium metabolism observed in these patients. With regard to HPA suppression, therefore, this study shows some evidence that very high doses of Dovobet gel and ointment may have a weak effect on the HPA axis.

5.2 Pharmacokinetic Properties

Clinical studies with radiolabelled ointment indicate that the systemic absorption of calcipotriol and betamethasone from Dovobet ointment is less than 1 % of the dose (2.5 g) when applied to normal skin (625 cm²) for 12 hours. Application to psoriasis plaques and under occlusive dressings may increase the absorption of topical corticosteroids. Absorption through damaged skin is approx. 24 %.

Following systemic exposure, both active ingredients – calcipotriol and betamethasone dipropionate – are rapidly and extensively metabolised. Protein binding is approx. 64 %. Plasma elimination half-life after intravenous application is 5-6 hours. Due to the formation of a depot in the skin elimination after dermal application is in order of days. Betamethasone is metabolised especially in the liver, but also in the kidneys to glucuronide and sulphate esters. The main route of excretion of calcipotriol is via faeces (rats and minipigs) and for betamethasone dipropionate it is via urine (rats and mice). In rats, tissue distribution studies with radiolabelled calcipotriol and betamethasone dipropionate, respectively, showed that the kidney and liver had the highest level of radioactivity.

Calcipotriol and betamethasone dipropionate were below the lower limit of quantification in all blood samples of 34 patients treated for 4 or 8 weeks with both Dovobet gel and Dovobet ointment for extensive psoriasis involving the body and scalp. One metabolite of calcipotriol and one metabolite of betamethasone dipropionate were quantifiable in some of the patients.

5.3 Preclinical Safety Data

Studies of corticosteroids in animals have shown reproductive toxicity (cleft palate, skeletal malformations). In reproduction toxicity studies with long-term oral administration of corticosteroids to rats, prolonged gestation and prolonged and difficult labour were detected. Moreover, reduction in offspring survival, body weight and body weight gain was observed. There was no impairment of fertility. The relevance for humans is unknown.

A dermal carcinogenicity study with calcipotriol in mice revealed no special hazard to humans.

Photo(co)carcinogenicity studies in mice suggest that calcipotriol may enhance the effect of UVR to induce skin tumours.

No carcinogenicity or photocarcinogenicity studies have been performed with betamethasone dipropionate.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Liquid paraffin

Polyoxypropylene-15 stearyl ether

All-rac-α-tocopherol

White soft paraffin

Butylhydroxytoluene (E321)

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

2 years.

After first opening: 1 year.

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

Aluminium/epoxyphenol tubes with polyethylene screw cap.

Tube sizes: 3 (sample), 15, 30, 60, 100 and 120 g.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

LEO Pharmaceutical Products Ltd. A/S

Industriparken 55

DK-2750 Ballerup

Denmark

8. Marketing Authorisation Number(S)

PL 05293/0003

9. Date Of First Authorisation/Renewal Of The Authorisation

15 March 2006

10. Date Of Revision Of The Text

April 2011