Triamcinolone Paste

Pronunciation: trye-am-SIN-oh-lone
Generic Name: Triamcinolone
Brand Name: Generic only. No brands available.

Triamcinolone Paste is used for:

Temporarily relieving symptoms associated with inflammation, ulcers, and lesions in the mouth caused by injury to the skin. It may also be used for other conditions as determined by your doctor.

Triamcinolone Paste is a topical adrenocortical steroid. It works by reducing skin inflammation (redness, swelling, itching, and irritation) in a way that is not clearly understood.

Do NOT use Triamcinolone Paste if:

• you are allergic to any ingredient in Triamcinolone Paste


• you have a fungal, viral, or bacterial infection of the mouth or throat

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

Before using Triamcinolone Paste:

Some medical conditions may interact with Triamcinolone Paste. 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 any kind of skin infection, cuts, scrapes, or lessened blood flow to your skin


• if you have had a recent vaccination; have a herpes eye infection or mouth lesion (cold sore); have measles, tuberculosis, chickenpox, or shingles; or have had a positive tuberculosis test


• if you have diabetes, diarrhea, or an ulcer


• if you are taking prednisone or similar medicines

Some MEDICINES MAY INTERACT with Triamcinolone Paste. Because little, if any, of Triamcinolone Paste is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Triamcinolone Paste 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 Triamcinolone Paste:

Use Triamcinolone Paste as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply Triamcinolone Paste at bedtime unless directed otherwise by your doctor. If you are using Triamcinolone Paste several times per day, apply it after meals unless otherwise directed by your doctor.


• Wash your hands before and after applying Triamcinolone Paste.


• Press a small dab (about ¼ inch) to the affected area of the mouth or gums until a thin film develops. A larger amount may be needed to cover some areas. Do not rub in.


• If you miss a dose of Triamcinolone Paste, apply 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 apply 2 doses at once.

Ask your health care provider any questions you may have about how to use Triamcinolone Paste.

Important safety information:

• Triamcinolone Paste is for topical use in the mouth only. Do not get Triamcinolone Paste in your eyes. If contact is made with the eyes, flush them immediately with tap water.


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


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


• Talk with your doctor before you receive any vaccine while you are using Triamcinolone Paste.


• Do not use Triamcinolone Paste for other conditions at a later time.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Triamcinolone Paste.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Triamcinolone Paste while you are pregnant. It is not known if Triamcinolone Paste is found in breast milk after topical use. If you are or will be breast-feeding while you use Triamcinolone Paste, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Triamcinolone Paste:

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:

Dryness; itching.

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); burning, cracking, irritation, or peeling not present before you began using Triamcinolone Paste; thinning, softening, or discoloration of mouth or gum tissue.

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.

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 increased thirst or urination; muscle weakness; unusual weight gain, especially in the face.

Proper storage of Triamcinolone Paste:

Store Triamcinolone Paste at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Keep Triamcinolone Paste out of the reach of children and away from pets.

General information:

• If you have any questions about Triamcinolone Paste, please talk with your doctor, pharmacist, or other health care provider.


• Triamcinolone Paste is 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 Triamcinolone Paste. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Triamcinolone resources

• Triamcinolone Use in Pregnancy & Breastfeeding
• Triamcinolone Drug Interactions
• Triamcinolone Support Group
• 22 Reviews for Triamcinolone - Add your own review/rating

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Calci-Chew

Generic Name: calcium carbonate (KAL see um KAR boe nate)

Brand Names: Alka-Mints, Cal-Gest, Calcarb, Calci Mix, Calci-Chew, Calci-Mix, Calcium Concentrate, Calcium Liquid Softgel, Calcium Oyster Shell, Caltrate, Chooz, Extra Strength Mylanta Calci Tabs, Icar Prenatal Chewable Calcium, Maalox Antacid Barrier, Maalox Childrens', Maalox Quick Dissolve, Maalox Quick Dissolve Maximum Strength, Maalox Regular Strength, Mylanta Child, Nephro Calci, Os-Cal 500, Oysco 500, Oyst Cal 500, Oyster Cal, Oyster Calcium, Oyster Shell, Pepto Children's, Rolaids Sodium Free, Rolaids Soft Chew, Titralac, Tums, Tums 500, Tums E-X, Tums Kids, Tums QuikPak, Tums Ultra

What is Calci-Chew (calcium carbonate)?

Calcium is a mineral that is found naturally in foods. Calcium is necessary for many normal functions of the body, especially bone formation and maintenance. Calcium can also bind to other minerals (such as phosphate) and aid in their removal from the body.

Calcium carbonate is used to prevent and to treat calcium deficiencies.

Calcium carbonate may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Calci-Chew (calcium carbonate)?

Do not take calcium carbonate or antacids that contain calcium without first asking your doctor if you also take other medicines. Calcium can make it harder for your body to absorb certain medicines. Calcium carbonate works best if you take it with food.

What should I discuss with my healthcare provider before taking Calci-Chew (calcium carbonate)?

To make sure you can safely take calcium carbonate, tell your doctor if you have any of these other conditions:

• 
  

  a history of kidney stones; or

  
  


• 
  

  a parathyroid gland disorder.

  
  

Talk to your doctor before taking calcium carbonate if you are pregnant. Talk to your doctor before taking calcium carbonate if you are breast-feeding a baby.

How should I take Calci-Chew (calcium carbonate)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Calcium carbonate works best if you take it with food. Swallow the calcium carbonate tablet or capsule with a full glass of water.

The chewable tablet should be chewed before you swallow it.

Use the calcium carbonate powder as directed. Allow the powder to dissolve completely, then consume the mixture.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, decreased appetite, constipation, confusion, delirium, stupor, and coma.

What should I avoid while taking Calci-Chew (calcium carbonate)?

Follow your healthcare provider's instructions about any restrictions on food, beverages, or activity.

Calci-Chew (calcium carbonate) 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.

Less serious side effects may include:

• 
  

  nausea or vomiting;

  
  


• 
  

  decreased appetite;

  
  


• 
  

  constipation;

  
  


• 
  

  dry mouth or increased thirst; or

  
  


• 
  

  urinating more than usual.

  
  

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

What other drugs can affect Calci-Chew (calcium carbonate)?

Calcium carbonate can make it harder for your body to absorb other medications you take by mouth. Tell your doctor if you are taking:

• 
  

  digoxin (Lanoxin, Lanoxicaps);

  
  


• 
  

  antacids or other calcium supplements;

  
  


• 
  

  calcitriol (Rocaltrol) or vitamin D supplements; or

  
  


• 
  

  doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap).

  
  

This list is not complete and other drugs may interact with calcium carbonate. 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 Calci-Chew resources

• Calci-Chew Side Effects (in more detail)
• Calci-Chew Use in Pregnancy & Breastfeeding
• Calci-Chew Drug Interactions
• Calci-Chew Support Group
• 1 Review for Calci-Chew - Add your own review/rating

• Calcium Carbonate MedFacts Consumer Leaflet (Wolters Kluwer)


• Titralac Consumer Overview


• Titralac MedFacts Consumer Leaflet (Wolters Kluwer)


• Tums Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

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• Indigestion
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• Osteoporosis
• Stomach Ulcer

Where can I get more information?

• Your doctor or pharmacist can provide more information about calcium carbonate.

See also: Calci-Chew side effects (in more detail)

Isuprel

isoproterenol hydrochloride

Dosage Form: injection, solution
Isuprel 1:5000 (Isoproterenol Hydrochloride) 0.2 mg/mL Injection, USP 1mL Single Dose Ampule

Description

Sterile Injection 1:5000

Rx only

Isoproterenol hydrochloride is 3,4-Dihydroxy-a-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a synthetic sympathomimetic amine that is structurally related to epinephrine but acts almost exclusively on beta receptors. The molecular formula is C11H17NO3• HCl. It has a molecular weight of 247.72 and the following structural formula:

Isoproterenol hydrochloride is a racemic compound.

Each milliliter of the sterile 1:5000 solution contains:

Isuprel brand of isoproterenol hydrochloride injection, USP		0.2 mg
Lactic Acid		0.12 mg
Sodium Chloride		7.0 mg
Sodium Lactate		1.8 mg
Sodium Metabisulfite		1.0 mg
Water for Injection	qs ad	1.0 mL

The pH is adjusted between 2.5 and 4.5 with hydrochloric acid. The sterile 1:5000 solution is nonpyrogenic and can be administered by the intravenous, intramuscular, subcutaneous, or intracardiac routes.

Clinical Pharmacology

Isoproterenol is a potent nonselective beta-adrenergic agonist with very low affinity for alpha-adrenergic receptors. Intravenous infusion of isoproterenol in man lowers peripheral vascular resistance, primarily in skeletal muscle but also in renal and mesenteric vascular beds. Diastolic pressure falls. Renal blood flow is decreased in normotensive subjects but is increased markedly in shock. Systolic blood pressure may remain unchanged or rise, although mean arterial pressure typically falls. Cardiac output is increased because of the positive inotropic and chronotropic effects of the drug in the face of diminished peripheral vascular resistance. The cardiac effects of isoproterenol may lead to palpitations, sinus tachycardia, and more serious arrhythmias; large doses of isoproterenol may cause myocardial necrosis in animals. Isoproterenol relaxes almost all varieties of smooth muscle when the tone is high, but this action is most pronounced on bronchial and gastrointestinal smooth muscle. It prevents or relieves bronchoconstriction, but tolerance to this effect develops with overuse of the drug. In man, isoproterenol causes less hyperglycemia than does epinephrine. Isoproterenol and epinephrine are equally effective in stimulating the release of free fatty acids and energy production.

Absorption, Fate, and Excretion. Isoproterenol is readily absorbed when given parenterally or as an aerosol. It is metabolized primarily in the liver and other tissues by COMT. Isoproterenol is a relatively poor substrate for MAO and is not taken up by sympathetic neurons to the same extent as are epinephrine and norepinephrine. The duration of action of isoproterenol may therefore

be longer than that of epinephrine, but is still brief.

Indications and Usage

Isoproterenol hydrochloride injection is indicated:

• For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.


• For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation). (See CONTRAINDICATIONS.)

• For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, is available. (See CONTRAINDICATIONS.)

• For bronchospasm occurring during anesthesia.

• As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure, and cardiogenic shock. (See WARNINGS.)

Contraindications

Use of isoproterenol hydrochloride injection is contraindicated in patients with tachyarrhythmias; tachycardia or heart block caused by digitalis intoxication; ventricular arrhythmias which require inotropic therapy; and angina pectoris.

Warnings

Isoproterenol hydrochloride injection, by increasing myocardial oxygen requirements while decreasing effective coronary perfusion, may have a deleterious effect on the injured or failing heart. Most experts discourage its use as the initial agent in treating cardiogenic shock following myocardial infarction. However, when a low arterial pressure has been elevated by other means, isoproterenol hydrochloride injection may produce beneficial hemodynamic and metabolic effects. In a few patients, presumably with organic disease of the AV node and its branches, isoproterenol hydrochloride injection has paradoxically been reported to worsen heart block or to precipitate Adams-Stokes attacks during normal sinus rhythm or transient heart block. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Precautions

General

Isoproterenol hydrochloride injection should generally be started at the lowest recommended dose. This may be gradually increased if necessary while carefully monitoring the patient. Doses sufficient to increase the heart rate to more than 130 beats per minute may increase the likelihood of inducing ventricular arrhythmias. Such increases in heart rate will also tend to increase cardiac work and oxygen requirements which may adversely affect the failing heart or the heart with a significant degree of arteriosclerosis. Particular caution is necessary in administering isoproterenol hydrochloride injection to patients with coronary artery disease, coronary insufficiency, diabetes, hyperthyroidism, and sensitivity to sympathomimetic amines. Adequate filling of the intravascular compartment by suitable volume expanders is of primary importance in most cases of shock and should precede the administration of vasoactive drugs. In patients with normal cardiac function, determination of central venous pressure is a reliable guide during volume replacement. If evidence of hypoperfusion persists after adequate volume replacement,

isoproterenol hydrochloride injection may be given. In addition to the routine monitoring of systemic blood pressure, heart rate, urine flow, and the electrocardiograph, the response to

therapy should also be monitored by frequent deter ination of the central venous pressure and blood gases. Patients in shock should be closely observed during isoproterenol hydrochloride injection administration. If the heart rate exceeds 110 beats per minute, it may be advisable to decrease the infusion rate or temporarily discontinue the infusion. Determinations of cardiac output and circulation time may also be helpful. Appropriate measures should be taken to ensure adequate ventilation. Careful attention should be paid to acid-base balance and to the correction of electrolyte disturbances. In cases of shock associated with bacteremia, suitable antimicrobial therapy is, of course, imperative.

Drug Interactions

Isoproterenol hydrochloride injection and epinephrine should not be administered simultaneously because both drugs are direct cardiac stimulants and their combined effects may induce serious arrhythmias. The drugs may, however, be administered alternately provided a proper interval has elapsed between doses. Isuprel should be used with caution, if at all, when potent inhalational anesthetics such as halothane are employed because of potential to sensitize the myocardium to effects of sympathomimetic amines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate the carcinogenic potential of isoproterenol hydrochloride have not been done. Mutagenic potential and effect on fertility have not been determined. There is no evidence from human experience that isoproterenol hydrochloride injection may be carcinogenic or mutagenic or that it impairs fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with isoproterenol hydrochloride. It is also not known whether isoproterenol hydrochloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Isoproterenol hydrochloride should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when isoproterenol hydrochloride injection is administered to a nursing woman.

Pediatric Use

Safety and efficacy of isoproterenol in pediatric patients have not been established.Intravenous infusions of isoproterenol in refractory asthmatic children at rates of 0.05-2.7 μg/kg/min have caused clinical deterioration, myocardial necrosis, congestive heart failure and death. The risks of cardiac toxicity appear to be increased by some factors [acidosis, hypoxemia, coadministration of corticosteroids, coadministration of methylxanthines (theophylline, theobromine) or aminophylline] that are especially likely to be present in these patients. If I.V. isoproterenol is used in children with refractory asthma, patient monitoring must include continuous assessment of vital signs, frequent electrocardiography, and daily measurements

of cardiac enzymes, including CPK-MB.

Geriatric Use

Clinical studies of Isuprel did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects in clinical circumstances. There are, however, some data that suggest that elderly healthy or hypertensive patients are less responsive to beta-adrenergic stimulation than are younger subjects. In general, dose selection for

elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function and of concomitant diseases or other drug therapy.

Adverse Reactions

The following reactions to isoproterenol hydrochloride injection have been reported:

CNS: Nervousness, headache, dizziness, nausea, visual blurring.

Cardiovascular: Tachycardia, palpitations, angina, Adams-Stokes attacks, pulmonary edema, hypertension, hypotension, ventricular arrhythmias, tachyarrhythmias.

In a few patients, presumably with organic disease of the AV node and its branches, isoproterenol hydrochloride injection has been reported to precipitate Adams-Stokes seizures during normal sinus rhythm or transient heart block.

Respiratory: Dyspnea.

Other: Flushing of the skin, sweating, mild tremors, weakness, pallor.

Overdosage

The acute toxicity of isoproterenol hydrochloride in animals is much less than that of epinephrine. Excessive doses in animals or man can cause a striking drop in blood pressure, and repeated large doses in animals may result in cardiac enlargement and focal myocarditis. In case of accidental overdosage as evidenced mainly by tachycardia or other arrhythmias, palpitations, angina, hypotension, or hypertension, reduce rate of administration or discontinue isoproterenol hydrochloride injection until patient’s condition stabilizes. Blood pressure, pulse, respiration, and EKG should be monitored. It is not known whether isoproterenol hydrochloride is dialyzable.

The oral LD50 of isoproterenol hydrochloride in mice is 3,850 mg/kg ± 1,190 mg/kg of pure drug in solution.

Dosage and Administration

Isuprel injection 1:5000 should generally be started at the lowest recommended dose and the rate of administration gradually increased if necessary while carefully monitoring the patient. The usual route of administration is by intravenous infusion or bolus intravenous injection. In dire emergencies, the drug may be administered by intracardiac injection. If time is not of the utmost importance, initial therapy by intramuscular or subcutaneous injection is preferred.

Recommended dosage for adults with heart block, Adams-Stroke attacks, and cardiac arrest:

Route of Administration	Preparation of Dilution	Initial Dose	Subsequent Dose Range *
Bolus intravenous injection	Dilute 1 mL (0.2 mg)to 10 mL with Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP	0.02 mg to 0.06 mg (1 mL to 3 mL of diluted solution)	0.01 mg to 0.2 mg (0.5 mL to 10 mL of diluted solution)
Intravenous infusion	Dilute 10 mL (2 mg) in 500 mL of 5% Dextrose Injection, USP	5 mcg/min (1.25 mL of diluted solution per minute)
Intramuscular	Use Solution 1:5000 undiluted	0.2 mg (1 mL)	0.02 mg to 1 mg (0.1 mL to 5 mL)
Subcutaneous	Use Solution 1:5000 undiluted	0.2 mg (1 mL)	0.15 mg to 0.2 mg (0.75 to 1mL)
Intracardiac	Use Solution 1:5000 undiluted	0.02 mg (0.1 mL

*Subsequent dosage and method of administration depend on the ventricular rate and the rapidity with which the cardiac pacemaker can take over when the drug is gradually withdrawn.


There are no well-controlled studies in children to establish appropriate dosing; however, the American Heart Association recommends an initial infusion rate of 0.1 mcg/kg/min, with the usual range being 0.1 mcg/kg/min to 1 mcg/kg/min.

Recommended dosage for adults with shock and hypoperfusion states:

Route of Administration	Preparation of Dilution†	Infusion Rate ††
Intravenous Infusion	Dilute 5 mL (1mg) in 500 mL of 5% Dextrose Injection, USP	0.5 mcg to 5 mcg per minute (0.25 mL to 2.5 mL of diluted solution)

†Concentrations up to 10 times greater have been used when limitation of volume is essential.

††Rates over 30 mcg per minute have been used in advanced states of shock.  The rate of infusion should be adjusted on the basis of heart rate, central venous pressure, systemic blood pressure, and urine flow.  If the heard rate exceeds 110 beats per minute, it may be advisable to decrease or temporarily discontinue the infusion.

Recommended dosage for adults with bronchospasm occurring during anesthesia:

Route of Administration	Preparation of Dilution	Initial Dose	Subsequent Dose
Bolus intravenous injection	Dilute 1 mL (0.2 mg) to 10 mL with Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP	0.01 mg to 0.02 mg (0.5 mL to 1 mL of diluted solution)	The initial dose may be repeated when necessary.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Such solution should not be used.

How Supplied

List	Container	Concentration	Fill	Quantity
1410	Ampule	0.2 mg (0.2 mg/mL)	1 mL	UNI-AMP pak of 25
1410	Ampule	1 mg (0.2 mg/mL)	5 mL	10 ampules per carton

Protect from light. Keep in opaque container until used.

Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP.]

Do not use if the injection is pinkish or darker than slightly yellow or contains a precipitate.


©Hospira 2004

EN-0427

Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

Sample Package Label

Isuprel  Isuprel  injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 52584-021 (0409-1410) Route of Administration INTRACARDIAC, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Isoproterenol Hydrochloride (Isoproterenol) Isoproterenol Hydrochloride 0.2 mg  in 1 mL

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 52584-021-01 1 AMPULE In 1 BAG contains a AMPULE 1 1 mL In 1 AMPULE This package is contained within the BAG (52584-021-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA010515	03/01/2010

Labeler - General Injectables & Vaccines, Inc (108250663)

Revised: 04/2011General Injectables & Vaccines, Inc

More Isuprel resources

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

Compare Isuprel with other medications

• Adams-Stokes Syndrome
• Asthma, acute
• AV Heart Block
• Bronchospasm During Anesthesia
• Cardiac Arrhythmia
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Polibar

1. Name Of The Medicinal Product

Polibar 94 % w/w powder for rectal suspension

2. Qualitative And Quantitative Composition

Active Constituent:

Barium sulfate 94.015% w/w

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Powder for rectal suspension.

White powder.

4. Clinical Particulars

4.1 Therapeutic Indications

This medicinal product is for diagnostic use only.

Polibar is a diagnostic reagent for radiological examination of the gastro-intestinal tract.

4.2 Posology And Method Of Administration

Polibar is for rectal (enema) administration.The powder must be reconstituted prior to administration (see section 6.6).

The administered dose of Polibar will depend on the patient in question and the section of the gastrointestinal tract to be viewed.

Adults: Usual Dosage Range 150- 750 g barium sulfate in a suitable suspension.

Double contrast of the large bowel - Give as required between 60 - 115 % w/v.

Single contrast of the large bowel - Give as required between 20 - 40 % w/v.

The actual administered dose should be determined, from experience, by the radiologist.

Children: The dosage will be dependent on the size, age, health state and anatomic region to be imaged of the child. Individual requirements should be determined, from experience, by the radiologist.

Elderly: There are no special dosage recommendations. The dosage should be determined, from experience, by the radiologist.

4.3 Contraindications

Immune System Disorders

Hypersensitivity to barium sulfate or to any of the excipients.

Gastrointestinal Disorders

Patients with any of the following:

– a known or suspected fistula, perforation or obstruction of the lower gastro-intestinal tract

– lower gastrointestinal haemorrhage

– gastrointestinal ischemia

– megacolon or toxic megacolon

– necrotising entercolitis

– colonic ileus

should not receive Polibar.

Surgical and Medical Procedures

Barium sulfate should not be administered immediately before or immediately after gastrointestinal surgery, including snare polypectomy or 'hot' colonic biopsy. If post procedural leakage is expected the product must not be used.

Do not use during and up to four weeks after radiotherapy to the rectum or prostate.

Injury, Poisoning and Procedural Complications

Do not use if there are new injuries or chemical burns of the lower gastrointestinal tract.

4.4 Special Warnings And Precautions For Use

The product should be administered under the supervision of a physician.

Diagnostic procedures which involve the use of radiopaque contrast agents should be carried out under the direction of personnel with the requisite training and with a thorough knowledge of the particular procedure to be performed.

Hypersensitivity

A history of bronchial asthma, atopy, as evidenced by hay fever and eczema, a family history of allergy, or a previous reaction to a contrast agent warrant special attention.

As stated in section 4.8, serious adverse reactions, including death, have been reported with the administration of barium sulfate formulations and are usually associated with the technique of administration, the underlying pathological condition and/or patient hypersensitivities. Anaphylactic and allergic reactions have been reported during double contrast examinations in which glucagon has been used. Rapid recognition, assessment, and diagnosis are crucial to the effective implementation of treatment. Imaging facilities should be staffed with well-trained personnel for the diagnosis and treatment of hypersensitivity reactions.

Barium sulfate preparations used as radiopaque media contain a number of additives to provide diagnostic properties and patient palatability. Allergic responses following the use of barium sulfate suspensions have been reported. Skin irritation, redness, inflammation and hives have been reported for infants and small children following spillage of barium sulfate suspension on their skin.

Known hypersensitivity or allergy to latex is a contraindication for the use of balloon retention enema tips containing latex. The use of a retention cuff enema tip is not necessary or desirable in patients with normal sphincter tone. The presence of adequate sphincter tone can be judged by preliminary rectal digital examination.

Because of reported anaphylactoid reactions to latex, the use of non-latex gloves during the procedure should be considered.

Perforation

In patients with a serious stenosis of the lower gastrointestinal tract, and in the presence of conditions and ailments that increase the risk of perforation such as known gastrointestinal fistulae and carcinomas, inflammatory intestinal disease, diverticulitis and diverticulosis and amoebiasis, careful consideration of the risks and benefits of the administration of a barium sulfate suspension is required.

Care must be taken during insertion of the enema tip into the patient and when using a retention balloon, particularly in the newborn, the elderly and in patients with recto-sigmoidal strictures, inflammatory bowel disease, rectal neoplasm or radiation therapy. Enema tip forceful, too deep insertion or balloon inflation may cause tearing or perforation of the rectum.

Insertion of an enema tip should be performed only after digital examination by qualified medical personnel. When balloon retention tips are used, care should be taken to avoid over inflation of the balloon, since overfilling or asymmetrical filling may cause displacement of the tip. Such a displacement can lead to rectal perforation or barium sulfate granulomas.

Inflation of the balloon should be done under fluoroscopic control by qualified medical personnel. Do not unnecessarily move the enema tip once inserted. A specially designed enema tip is required for a barium sulfate suspension examination of a colostomy patient. Intubation of an enteroclysis catheter should be done by qualified medical personnel.

Fluid Overload

Barium sulfate suspensions have been reported to cause fluid overload due to water absorption.

Children and patients with impaired renal function are the most susceptible to water intoxification, as are children with Hirschsprung's Disease.

It is suggested to not fill the entire colon when evaluating a child with Hirschsprung's Disease; use only the amount of fluid necessary for the diagnosis.

Preparatory enemas in patients with Hirschsprung's Disease should be avoided.

Intravasation

Barium sulfate may also intravasate into the venous drainage of the large bowel and enter the circulation as a "barium embolus". This complication occurs rarely, but can lead to potentially fatal complications, including systemic and pulmonary embolism, disseminated intravascular coagulation, septicaemia and prolonged severe hypotension. It is more likely to occur in elderly patients, due to thinning of the rectal wall and vaginal thinning with age, and in those with colorectal disease, when intraluminal pressure overcomes the resistance of the colonic wall affected by colitis, diverticulitis or intestinal obstruction. It has been associated with inadvertent vaginal placement of the rectal catheter. The diagnosis should be considered in any patient who collapses during or shortly after barium enema, and in those who become suddenly unwell in the hours following the procedure. The diagnosis can be confirmed by simple plain radiography; CT scanning may also be useful to detect dissemination of barium sulfate.

This complication may be prevented by ensuring correct placement of the rectal catheter and by reducing the use of balloon catheters.

Misplacement of the rectal catheter in the vagina can lead to intravasation: correct rectal catheter placement should be confirmed prior to enema administration.

Constipation

Polibar should be used with care if the patient is dehydrated, suffers from any condition or is on any other treatment that can cause constipation, or if the patient has history of constipation. In this situation a mild bulk laxative should be administered following completion of the X-ray examination. Increased intake of liquids is recommended after oral or rectal administration of barium sulfate to prevent severe constipation and the risk of impaction.

Other Possible Complications

Care must be taken during an enema procedure as vasovagal reactions, syncopal episodes, cardiac dysrhythmia and other cardiovascular side effects can occur during barium enemas.

All plastic/rubber accessories are disposable, single-use devices that must not be reused or left in the body cavity for an extended period of time.

Apprehensive patients may develop weakness, pallor, tinnitus, diaphoresis and bradycardia following the administration of any diagnostic agent. Such reactions are usually unpredictable and are best treated by having the patient lie flat for an additional 10 - 30 minutes under observation.

Patient preparation for diagnostic gastrointestinal examinations frequently requires cathartics and a liquid diet. The various preparations can result in water loss for the patient. Patients should be rehydrated quickly following a barium sulfate suspension examination of the gastrointestinal tract. In patients with reduced colon motility, saline cathartics may be required after the barium sulfate suspension enema. Saline cathartics are recommended on a routine basis in patients with a history of constipation unless clinically contraindicated.

Baroliths

Baroliths consist of inspissated barium associated with faeces. They are often asymptomatic, but may be associated with abdominal pain, appendicitis, bowel obstruction, or perforation. Patients who are elderly, with impaired gastrointestinal motility, colon obstruction, electrolyte imbalance, dehydration or on a low residue diet may be at risk of developing baroliths. To reduce this risk, adequate hydration should be maintained during and in the days following barium sulfate procedure. The use of laxatives (especially in case of constipation) should be considered.

Children, Elderly and Debilitated Patients

As with any barium sulfate preparation, care should be taken when administering Polibar to children, the elderly or the debilitated. It should be used cautiously in patients with pre-existing heart disease. As bacteraemia may occur during a barium enema, IV antibiotic cover is recommended for patients with prosthetic heart valves.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed.

Barium sulfate is biologically inert and there are no known interactions with other medicinal products. However, the presence of barium sulfate formulations in the gastrointestinal tract may alter the absorption of therapeutic agents taken concomitantly. In order to minimise any potential change in absorption, the separate administration of barium sulfate from that of other medicines should be considered.

Other examinations of the same area of the gastrointestinal tract with another contrast agent may be complicated by the presence of barium sulfate (residue) in the gastrointestinal tract up to several days following the examination with barium contrast media.

4.6 Pregnancy And Lactation

Following oral or rectal administration, barium sulfate is absorbed systemically in negligible amounts. Though barium sulfate is pharmacologically inert, no studies of its mutagenic or teratogenic potential are available.

Although this product is not contraindicated in pregnancy, we would like to point out that radiographic procedures may damage the foetus, particularly during the first trimester of pregnancy. Any examination should only be carried out after careful consideration of the benefit/risk of the procedure.

Since the absorption of barium sulfate is negligible, its use is not contraindicated during breastfeeding.

4.7 Effects On Ability To Drive And Use Machines

Polibar has negligible influence on the ability to drive and use machines.

4.8 Undesirable Effects

Undesirable effects may occur during or after a procedure with barium sulfate.

Skin and subcutaneous disorders together with immune system disorders, reflecting allergic reactions either to barium sulfate or the product excipients, are among the most commonly reported effects; for example urticaria, erythema and rash.

Gastrointestinal disorders are also one of the most frequently reported class of undesirable effects; for example diarrhoea, nausea, abdominal pain/distention, constipation.

Within the table below, clinically significant adverse reactions are listed if they have been reported during post approval use of all barium sulfate formulations. Their frequency is not known, therefore relative reporting rate (for example, less commonly) compared to overall reporting for barium sulfate is used.

MedDRA System Organ Class	MedDRA Preferred Term
Infections and infestations	Appendicitis, Bacteraemia. Less commonly other infections have been reported including rare cases of Abscess intestinal, Liver abscess, Peritoneal infection and Pneumonia
Blood and the lymphatic system disorders	Lymphadenopathy
Immune system disorders	Hypersensitivity presenting with a wide range of signs and symptoms including skin and subcutaneous reactions such as urticaria, pruritus, rash, erythema and facial swelling. Potential hypersensitivity associated respiratory signs and symptoms including dyspnoea, pharyngeal oedema and throat tightness have been reported. Anaphylactic reaction and anaphylactic shock have been reported less commonly.
Metabolism and nutrition disorders	Infrequent cases of Hyperglycaemia have been reported in diabetic patients
Psychiatric disorders	Agitation, Confusional state, Nervousness and related symptoms have been reported during the administration of barium sulfate
Nervous system disorders	Loss of consciousness, Syncope, Syncope vasovagal, Dizziness, Burning sensation, Headache, Dysarthria, Hypotonia
Eye disorders	Eye disorders, including Eye swelling, usually associated with allergic reactions have been reported
Ear and labyrinth disorders	Tinnitus
Cardiac disorders	Bradycardia, Cyanosis, Tachycardia
Vascular disorders	Hypotension, Pallor, Vasodilatation
Respiratory, thoracic and mediastinal disorders	Bronchospasm, Dyspnoea, Laryngeal oedema, Pharyngeal oedema and pain, Throat irritation or tightness, Cough. When administered orally, Aspiration, Pneumonia aspiration.
Gastrointestinal disorders	Gastrointestinal signs and symptoms are widely reported, it is not always possible to differentiate between pre-existing medical conditions and procedural complications. Events reported include: Constipation and in severe cases gastrointestinal blockage; Gastrointestinal inflammation, ulceration or perforation; Abdominal discomfort, Abdominal pain and distension; Diarrhoea; Colitis ulcerative may be aggravated; Nausea; Vomiting and Retching; Flatulence; Swollen tongue
Skin and subcutaneous tissue disorders	Skin reactions are varied and most likely to be associated with allergic reactions. Reports include: Erythema, Dermatitis Contact, Excessive granulation tissue, Hyperhidrosis, Periorbital oedema, Pruritus, Rash, Swelling face, Urticaria
Renal and urinary disorders	Dysuria
General disorders and administration site conditions	Malaise, Pain, Swelling, Asthenia, Pyrexia, Face oedema
Investigations	Electrocardiogram abnormal
Injury and poisoning	Intravasation by barium sulfate, associated with pre

More rarely and depending on the route of administration, i.e. oral or rectal, the following procedural complications have been reported:

Infections (e.g. peritonitis) subsequent to existing or new gastrointestinal perforation. Complications include adhesions and granuloma.

Subsequent to existing or procedural gastrointestinal trauma, intravasation of barium sulfate with rare subsequent venous emboli formation, including the hepatic portal vein, vena cava and pulmonary embolism that may be fatal in approx 50% of cases.

Please see section 4.4 for measures to be taken to avoid these adverse reactions, and actions to take if such adverse reactions occur.

Very rare cases of death associated with barium sulfate administration have been reported in the literature. The majority of the deaths relate to procedural complications usually caused by failure to follow generally accepted radiological practice. Some cases had a history indicating that barium sulfate administration was highly unlikely to be a primary or even secondary causative factor in patient fatality.

4.9 Overdose

Barium sulfate is non-toxic and absorbed systemically in negligible amounts.

Repeated use within a very short period of time has led to abdominal cramps, nausea, vomiting, diarrhoea, and constipation. These symptoms are transitory in nature and may be allowed to resolve without medical intervention or may be treated according to currently accepted standards of care.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: X-ray contrast media, barium sulfate with suspending agents, ATC code: V08BA01

The active constituent of Polibar, barium sulfate, is inert and has no pharmacodynamic properties. It serves only as a radiopaque substance to opacify the gastro-intestinal track during X-ray examinations.

5.2 Pharmacokinetic Properties

Under physiological conditions, barium sulfate passes through the gastrointestinal tract in an unchanged form and is absorbed only in small, pharmacologically insignificant amounts.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included elsewhere in the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Gum ghatti

Sorbitol (E420)

Sodium citrate (E331)

Sodium carrageenan (E407)

Simeticone

Polyoxyethylene glyceryl mono-oleate

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

Three years.

This pack is for single-use only. Polibar should be administered immediately following reconstitution and must not be stored.

6.4 Special Precautions For Storage

Store below 25 °C. Store in the original package.

6.5 Nature And Contents Of Container

Unit dose prefilled enema bag composed of polyvinylchloride containing 397 g, 567 g or 680 g of product. Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

Adults: Polibar should be suspended over the density range of 20 - 115 % w/v (20 - 60 % w/w).

Reconstitution information for use of Polibar is provided below.

Attach clamp to tubing and close. Study the appropriate graph below. This shows the density range and how much water to use for each density. Measure the indicated quantity of warm (40 ^oC) water and add this to the bag through the red snap-cap seal. Hold the bag by the finger holes and shake vigorously for 10-20 seconds. When ready to use shake again, 10-20 seconds. Then with the thumb and forefinger pop the red ball at the bag tube junction into the bag. Run barium through the tubing - attach rectal tube. The kit is now ready.

Water to be added (mL)

397 g enema bag

567 g enema bag

680 g enema bag

Any unused, opened product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Bracco UK Limited,

Wooburn Green

Bucks, HP10 0HH, UK

8. Marketing Authorisation Number(S)

PL 18920/0014

9. Date Of First Authorisation/Renewal Of The Authorisation

7th May 1993 / 15th January 2004

10. Date Of Revision Of The Text

November 2009

emtricitabine, rilpivirine, and tenofovir

em-trye-SYE-ta-been, ril-pi-VIR-een hye-droe-KLOR-ide, ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate

Oral route(Tablet)

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues, including tenofovir disoproxil fumarate, a component of emtricitabine/rilpivirine hydrochloride/tenofovir disoproxil fumarate. Not indicated for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy have not been established in patients co-infected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with HBV and HIV-1 and have discontinued emtricitabine/rilpivirine hydrochloride/tenofovir; monitor hepatic function upon discontinuation of therapy .

Commonly used brand name(s)

In the U.S.

• Complera

Available Dosage Forms:

• Tablet

Pharmacologic Class: Nucleoside Reverse Transcriptase Inhibitor

Uses For emtricitabine, rilpivirine, and tenofovir

Emtricitabine, rilpivirine, and tenofovir combination is used to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). emtricitabine, rilpivirine, and tenofovir is usually given to patients who have not received any HIV treatment in the past.

emtricitabine, rilpivirine, and tenofovir will not cure HIV infection or AIDS. It works by lowering the amount of HIV in the blood. The medicine will also help your immune system. This may help delay problems that usually result from AIDS or HIV disease. It will not keep you from spreading HIV to other people. People who receive emtricitabine, rilpivirine, and tenofovir may continue to have some of the problems usually related to AIDS or HIV disease.

emtricitabine, rilpivirine, and tenofovir is available only with your doctor's prescription.

Before Using emtricitabine, rilpivirine, and tenofovir

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 emtricitabine, rilpivirine, and tenofovir, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to emtricitabine, rilpivirine, and tenofovir 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

Emtricitabine, rilpivirine, and tenofovir combination is not recommended for children. 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 emtricitabine, rilpivirine, and tenofovir combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving emtricitabine, rilpivirine, and tenofovir combination.

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

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 emtricitabine, rilpivirine, and tenofovir, 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 emtricitabine, rilpivirine, and tenofovir 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.

• Carbamazepine


• Dexamethasone


• Esomeprazole


• Lansoprazole


• Omeprazole


• Oxcarbazepine


• Pantoprazole


• Phenobarbital


• Phenytoin


• Rabeprazole


• Rifabutin


• Rifampin


• Rifapentine


• St John's Wort

Using emtricitabine, rilpivirine, and tenofovir 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.

• Adefovir Dipivoxil


• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Atazanavir


• Calcium Carbonate


• Cimetidine


• Delavirdine


• Didanosine


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Efavirenz


• Etravirine


• Famotidine


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Nevirapine


• Nizatidine


• Ranitidine


• Telaprevir

Using emtricitabine, rilpivirine, and tenofovir 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.

• Ketoconazole


• Lopinavir


• Methadone


• Ritonavir


• Tipranavir

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 emtricitabine, rilpivirine, and tenofovir. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone problems, history of or


• Depression, or history of or


• Fanconi syndrome (type of kidney disease) or


• Hepatitis B infection or


• Liver disease or


• Osteomalacia (soft bones) or


• Osteoporosis (weak or brittle bones)—Use with caution. May make these conditions worse.

• Kidney disease—Should not be used in patients with this condition.

Proper Use of emtricitabine, rilpivirine, and tenofovir

Take emtricitabine, rilpivirine, and tenofovir exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

Keep taking emtricitabine, rilpivirine, and tenofovir for the full time of treatment, even if you begin to feel better. Do not stop taking it without checking first with your doctor. When your supply of the medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of the medicine.

emtricitabine, rilpivirine, and tenofovir comes with a patient information leaflet. Read and follow the instructions in the leaflet carefully. Ask your doctor if you have any questions.

It is best to take emtricitabine, rilpivirine, and tenofovir with food.

If you are taking antacids that contain aluminum, magnesium, or calcium, take the antacid at least 2 hours before or 4 hours after emtricitabine, rilpivirine, and tenofovir.

If you are taking a stomach medicine for heartburn or ulcers (such as cimetidine, famotidine, nizatidine, ranitidine, Axid®, Pepcid®, Tagamet®, or Zantac®), take the heartburn medicine at least 12 hours before or 4 hours after emtricitabine, rilpivirine, and tenofovir.

Dosing

The dose of emtricitabine, rilpivirine, and tenofovir 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 emtricitabine, rilpivirine, and tenofovir. If your dose is different, do not change it unless your doctor tells you to do so.

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

• For oral dosage form (tablets):
  
  • For treatment of HIV infection:
    
    • Adults—One tablet once a day.
    
    
    • Children—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of emtricitabine, rilpivirine, and tenofovir, 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.

If you miss a dose or forget to use your medicine and it is less than 12 hours since your last dose, take it as soon as you can and take your next dose at the normal time. If you miss a dose or forget to use it, and it is more than 12 hours since your last dose, wait and take your next dose at the normal time. Do not use extra medicine to make up for a missed dose.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using emtricitabine, rilpivirine, and tenofovir

It is very important that your doctor check your progress at regular visits to make sure that emtricitabine, rilpivirine, and tenofovir is working properly. Blood and urine tests may be needed to check for unwanted effects.

emtricitabine, rilpivirine, and tenofovir does not decrease the risk of transmitting HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not share needles or equipment with anyone or use dirty needles. If you have any questions about this, check with your doctor.

emtricitabine, rilpivirine, and tenofovir may cause a rare, but serious, unwanted effect called lactic acidosis. This is a condition where the blood has too much acid. Stop using emtricitabine, rilpivirine, and tenofovir and call your doctor right away if you have more than one of these symptoms: abdominal or stomach discomfort; a decreased appetite; diarrhea; fast, shallow breathing; a general feeling of discomfort; muscle pain or cramping; nausea; shortness of breath; sleepiness; or unusual tiredness or weakness.

emtricitabine, rilpivirine, and tenofovir may cause rare, but serious, liver problems. This may occur in patients with a history of hepatitis B infection. Stop using emtricitabine, rilpivirine, and tenofovir and check with your doctor right away if you have more than one of these symptoms: clay-colored stools; dark urine; a decreased appetite; fever; headache; itching; nausea and vomiting; skin rash; stomach pain or tenderness; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Tell your doctor right away if you start to feel depressed and have thoughts about hurting yourself. Report any unusual thoughts or behavior that troubles you, especially if they are new or get worse quickly.

emtricitabine, rilpivirine, and tenofovir may cause your bones to get thin. This could increase your risk for broken bones (fractures). Ask your doctor about this if you have any concerns.

emtricitabine, rilpivirine, and tenofovir may cause you to have extra body fat. Tell your doctor if you notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from your legs, arms, or face.

When you start taking HIV medicines, your immune system may get stronger. If you already have pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight the infections. If this occurs, be sure to tell your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are taking emtricitabine, rilpivirine, and tenofovir. The results of some tests may be affected by emtricitabine, rilpivirine, and tenofovir.

emtricitabine, rilpivirine, and tenofovir should not be used together with adefovir (Hepsera®), dexamethasone (Decadron®), lamivudine (Combivir®, Epivir®, Epivir-HBV®, Epzicom™, Trizivir®), or certain seizure medicines (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, or Trileptal®).

Do not use emtricitabine, rilpivirine, and tenofovir together with medicines for tuberculosis (such as rifabutin, rifampin, rifapentine, Mycobutin®, Priftin®, Rifadin®, or Rimactane®), certain stomach medicines (such as esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Aciphex®, Nexium®, Prevacid®, Prilosec®, or Protonix®). or St. John's wort.

The medicines in this combination tablet are also available as Atripla®, Emtriva®, Edurant®, Truvada®, and Viread®. Do not take the emtricitabine, rilpivirine, and tenofovir combination with any of these medicines.

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.

emtricitabine, rilpivirine, and tenofovir 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

• Discouragement


• feeling sad or empty


• irritability


• lack of appetite


• loss of interest or pleasure


• mental depression


• thoughts of killing oneself


• tiredness


• trouble concentrating


• trouble sleeping

Less common

• Body aches or pain


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


• chest pain


• cough


• difficulty with breathing


• ear congestion


• fever or chills


• headache


• loss of voice


• runny or stuffy nose


• shortness of breath


• sneezing


• sore throat


• tightness in the chest


• troubled breathing


• unsteadiness or awkwardness


• unusual tiredness or weakness


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


• wheezing

Incidence not known

• Abdominal or stomach discomfort


• agitation


• bloating


• bloody or cloudy urine


• bone pain


• broken bones, especially the thigh bone


• changes in behavior


• confusion


• constipation


• dark urine


• decreased appetite


• decrease in amount of urine


• diarrhea


• difficulty with swallowing


• dizziness


• dry mouth


• fast heartbeat


• fast, shallow breathing


• frequent urination


• general tiredness and weakness


• headache


• hives


• hostility


• increased thirst


• indigestion


• irritability


• itching


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


• lethargy


• light-colored stools


• loss of appetite


• muscle pain or cramps


• muscle tenderness, wasting, or weakness


• nausea or vomiting


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


• pain in the stomach, side, or abdomen, possibly radiating to the back


• rapid weight gain


• seizures


• skin rash


• sleepiness


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


• upper right stomach pain


• vomiting


• yellow eyes or skin

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

• Abnormal dreams


• sleeplessness


• trouble sleeping


• unable to sleep

Less common

• Acid or sour stomach


• back pain


• belching


• difficulty with moving


• heartburn


• pain in the joints


• pain or tenderness around the eyes and cheekbones


• sneezing


• stomach discomfort or upset

Incidence not known

• Lack or loss of strength

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.

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Tapentadol Extended-Release Tablets

Pronunciation: ta-PEN-ta-dol
Generic Name: Tapentadol
Brand Name: Nucynta ER

Tapentadol Extended-Release Tablets are a narcotic pain reliever used for around-the-clock treatment of moderate or severe pain. It should not be used to treat occasional pain or pain after injury or surgery.

Swallow Tapentadol Extended-Release Tablets whole. Do NOT break, crush, chew, dissolve, or split Tapentadol Extended-Release Tablets. Doing so may cause the release of too much medicine into the bloodstream, which could be fatal.

Do not drink alcohol or use medicines (prescription or nonprescription) that contain alcohol while you are taking Tapentadol Extended-Release Tablets. Using alcohol with Tapentadol Extended-Release Tablets may cause the release of too much medicine into the bloodstream, which could be fatal.

Tapentadol Extended-Release Tablets are used for:

Treating moderate to severe long-term pain when around-the-clock pain medicine is needed for more than a few days.

Tapentadol Extended-Release Tablets are a narcotic pain reliever. It works in certain areas of the brain and nervous system to decrease pain.

Do NOT use Tapentadol Extended-Release Tablets if:

• you are allergic to any ingredient in Tapentadol Extended-Release Tablets


• you have very slow, shallow, or difficult breathing; severe lung problems (eg, severe asthma, wheezing, shortness of breath); severe hypercapnia (high blood carbon dioxide levels); or you are having an asthma attack


• you have or may have paralytic ileus (bowel paralysis)


• you have severe kidney or liver problems


• you are taking tramadol or another medicine that contains tapentadol


• you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

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

Before using Tapentadol Extended-Release Tablets:

Some medical conditions may interact with Tapentadol 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 (especially depression medicines) or nonprescription medicine, herbal preparation, or dietary supplement


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


• if you have a history of liver or kidney problems; stomach or bowel problems, blockage, or surgery; gallbladder problems; thyroid problems; metabolism problems; adrenal problems (eg, Addison disease); enlarged prostate; trouble urinating; curvature of the spine (scoliosis); or pancreas problems (eg, pancreatitis)


• if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, or infection of the brain or nervous system


• if you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD], sleep apnea), a heart problem called cor pulmonale, low blood pressure, or a seizure disorder (eg, epilepsy)


• if you have severe drowsiness, constipation, hypercapnia, hypoxia (low blood oxygen levels), dehydration or low blood volume, poor health, or are severely overweight


• if you have a history of mental or mood problems (eg, depression, anxiety, hallucinations), if you are going through withdrawal from alcohol or other substances, or if you or a family member have a history of alcohol or other substance abuse


• if you have recently had or will be having surgery

Some MEDICINES MAY INTERACT with Tapentadol Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticholinergics (eg, scopolamine, oxybutynin) because the risk of constipation or difficulty urinating may be increased


• MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), St. John's wort, tricyclic antidepressants (eg, amitriptyline), or triptans (eg, sumatriptan) because a severe side effect called serotonin syndrome may occur. Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea


• Buprenorphine, butorphanol, nalbuphine, naltrexone, or pentazocine because they may decrease Tapentadol Extended-Release Tablets's effectiveness


• Other opioid pain medicines (eg, codeine, hydrocodone), muscle relaxers (eg, cyclobenzaprine), phenothiazines (eg, chlorpromazine), or medicines used for allergies, mental or mood disorders, nausea, or sleep disorders because the risk of side effects, including severe drowsiness, trouble breathing, or low blood pressure, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tapentadol 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 Tapentadol Extended-Release Tablets:

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

• Tapentadol Extended-Release Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Tapentadol Extended-Release Tablets refilled.


• Take Tapentadol Extended-Release Tablets by mouth with or without food. If your dose requires more than 1 tablet, take only 1 tablet at a time.


• Swallow Tapentadol Extended-Release Tablets whole. Do not break, crush, chew, dissolve, or split before swallowing. Do not soak, lick, or wet the tablet before you put it in your mouth. Do not inject Tapentadol Extended-Release Tablets. Contact your doctor if you cannot swallow Tapentadol Extended-Release Tablets whole.


• Take each tablet with enough water to be sure that it can be completely swallowed immediately after you place it in your mouth.


• Do not suddenly stop taking Tapentadol Extended-Release Tablets. You may have an increased risk of withdrawal symptoms. If you need to stop Tapentadol Extended-Release Tablets, your doctor will gradually lower your dose.


• Keep Tapentadol Extended-Release Tablets out of the reach of children and away from pets. If Tapentadol Extended-Release Tablets are no longer needed, discard it immediately by flushing down the toilet.


• If you miss a dose of Tapentadol Extended-Release Tablets, 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 Tapentadol Extended-Release Tablets.

Important safety information:

• Tapentadol Extended-Release Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Tapentadol 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 (prescription or nonprescription) that contain alcohol while you are taking Tapentadol Extended-Release Tablets. Check with your pharmacist if you have questions about whether any of your medicines contain alcohol.


• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tapentadol Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Tapentadol Extended-Release Tablets may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.


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


• Tapentadol Extended-Release Tablets may cause constipation. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Talk to your doctor about using fiber laxatives or stool softeners to prevent or treat constipation while you use Tapentadol Extended-Release Tablets.


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


• Tapentadol Extended-Release Tablets may increase the risk of seizures in certain patients, including patients who have a history of seizures. Talk to your doctor to see if you may have a greater risk of seizures while taking Tapentadol Extended-Release Tablets and seek immediate medical attention if you have a seizure.


• Serotonin syndrome is a possibly fatal syndrome that can be caused by Tapentadol Extended-Release Tablets. Your risk may be greater if you take Tapentadol Extended-Release Tablets with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.


• Accidental ingestion or overdose of Tapentadol Extended-Release Tablets may be fatal in children or adults. Keep Tapentadol Extended-Release Tablets out of the reach of children. In case of accidental ingestion or an overdose, call a doctor or poison control center right away.


• Use Tapentadol Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, constipation, weakness or tiredness, and severe light-headedness.


• Tapentadol Extended-Release Tablets should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: Tapentadol Extended-Release Tablets may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tapentadol Extended-Release Tablets while you are pregnant. It is not known if Tapentadol Extended-Release Tablets are found in breast milk. Do not breast-feed while taking Tapentadol Extended-Release Tablets.

When used for long periods of time or at high doses, Tapentadol Extended-Release Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Tapentadol Extended-Release Tablets stops working well. Do not take more than prescribed.

Some people who use Tapentadol Extended-Release Tablets for a long time without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE. If you suddenly stop taking Tapentadol Extended-Release Tablets, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Tapentadol 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; headache; nausea; tiredness; vomiting.

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; unusual hoarseness); agitation; burning, numbness, or tingling; chest pain; cold, clammy skin; confusion; difficult or increased urination; difficult, slow, or shallow breathing; disorientation; fainting; fast, slow, or irregular heartbeat; hallucinations; loss of coordination; memory problems; mood or mental changes; seizures; severe or persistent dizziness, drowsiness, or light-headedness; trouble talking, thinking, or walking.

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: Tapentadol 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 bluish skin; cold, clammy skin; difficult, slow, or shallow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; limp muscles; pinpoint pupils; seizures; slow or irregular heartbeat; vomiting.

Proper storage of Tapentadol Extended-Release Tablets:

Store Tapentadol Extended-Release Tablets at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tapentadol Extended-Release Tablets out of the reach of children and away from pets.

General information:

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


• Tapentadol 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 Tapentadol 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

Copyright © 2012 Wolters Kluwer Health, Inc.

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