Nutropin AQ Vials

Pronunciation: SOE-ma-TROE-pin
Generic Name: Somatropin (rDNA origin - Refrigerated)
Brand Name: Nutropin AQ

Nutropin AQ Vials are used for:

Treating certain children or adults when the body does not produce enough growth hormone. It is also used to treat certain children who are not growing normally due to Turner syndrome or other conditions (eg, chronic kidney problems, idiopathic short stature). It may also be used for other conditions as determined by your doctor.

Nutropin AQ Vials are a growth hormone that produces effects that are identical to the body's naturally occurring growth hormone. It affects the growth of bones, muscles, internal organs, and other tissues of the body.

Do NOT use Nutropin AQ Vials if:

• you are allergic to any ingredient in Nutropin AQ Vials


• you have been or are being treated for cancer or any unusual growths or tumors (especially in the brain) that may still be growing


• you have premature epiphyseal closure (your bone growth is complete) or a serious illness caused by complications from surgery, trauma, or severe breathing problems (eg, respiratory failure)


• you have certain eye problems caused by diabetes (eg, diabetic retinopathy)


• you have Prader-Willi syndrome and are severely overweight or have severe breathing problems

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

Before using Nutropin AQ Vials:

Some medical conditions may interact with Nutropin AQ Vials. 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 endocrine problems including pituitary or adrenal gland problems, diabetes or a family history of diabetes, eye problems caused by diabetes, or an underactive thyroid


• if you have a history of leukemia, unusual growths or tumors (especially in the brain), or cancer


• if you have curvature of the spine (scoliosis), kidney or liver problems, ear or hearing problems (eg, repeated ear infection), Prader-Willi syndrome, are severely overweight, or have had recent major surgery or trauma

Some MEDICINES MAY INTERACT with Nutropin AQ Vials. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Corticosteroids (eg, prednisone) because they may decrease Nutropin AQ Vials's effectiveness


• Anticonvulsants (eg, phenytoin, carbamazepine) or cyclosporine because the risk of their side effects may be increased or their effectiveness may be decreased by Nutropin AQ Vials

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nutropin AQ Vials 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 Nutropin AQ Vials:

Use Nutropin AQ Vials as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Nutropin AQ Vials are given as an injection. A health care provider will teach you how to use it. Be sure you understand how to use Nutropin AQ Vials. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Allow Nutropin AQ Vials to come to room temperature before you use it.


• Wash your hands before and immediately after using Nutropin AQ Vials.


• Use a new needle each time you inject Nutropin AQ Vials. Do not reuse needles.


• Do not use Nutropin AQ Vials if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.


• Always rotate injection sites each time you use Nutropin AQ Vials.


• Do not shake Nutropin AQ Vials. Swirl gently to mix it.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


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

Ask your health care provider any questions you may have about how to use Nutropin AQ Vials.

Important safety information:

• Nutropin AQ Vials may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Nutropin AQ Vials with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Rare, sometimes fatal, lung and breathing problems may be caused by Nutropin AQ Vials in CHILDREN with Prader-Willi syndrome. Those at higher risk include males, severely overweight children, or children with existing serious lung or breathing problems. Children should be checked for certain breathing problems before and during treatment. If your child develops a limp or complains of hip or knee pain during treatment with Nutropin AQ Vials, contact your doctor immediately. Tell your doctor immediately if your child becomes very sick or is hospitalized while using Nutropin AQ Vials. Nutropin AQ Vials may need to be stopped.


• Pancreas inflammation (pancreatitis) has been reported rarely in patients who take Nutropin AQ Vials. The risk may be greater in children, especially in girls who have Turner syndrome. Contact your doctor right away if you develop stomach or back pain.


• Rarely, children using Nutropin AQ Vials have experienced a slipped growth plate in the hip. Contact the doctor right away if the patient develops hip or knee pain or a limp.


• Nutropin AQ Vials may have benzyl alcohol, metacresol, or glycerin in it. Tell your doctor if you have ever had sensitivity or an allergic reaction to benzyl alcohol, metacresol, or glycerin.


• Diabetes patients - Nutropin AQ Vials may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine or your diet.


• Lab tests, including blood sugar levels and thyroid function, may be performed while you use Nutropin AQ Vials. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Nutropin AQ Vials with caution in the ELDERLY; they may be more sensitive to its effects.


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

Possible side effects of Nutropin AQ Vials:

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

Discomfort at the injection site; mild swelling (eg, of the hands or feet); muscle or joint pain.

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); body pain or stiffness; burning, tingling, itching, or numbness in the palm of the hand, fingers, or wrist; change in appearance or size of a mole; chest pain; confusion; constant feeling of need to empty the bowel; curvature of the spine; depression; ear pain, discharge, or discomfort; excessive thirst or hunger; fast heartbeat; fever; frequent urination; hearing problems; increased pressure in the head or eye; infection; nausea; one-sided weakness; severe or persistent stomach or back pain; severe or persistent swelling of the ankles, legs, hands, or feet; slurred speech; sudden, severe, or persistent headache or dizziness; visual changes; vomiting.

Children: Ear discomfort or infection; fatigue or weakness; fever, persistent cough, or trouble breathing; hip or knee pain; leukemia; limp; seizures; snoring or irregular breathing during sleep; worsening of psoriasis.

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: Nutropin AQ 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 excessive thirst or hunger; frequent urination; headache; nausea or vomiting; swelling of the ankles, feet, or hands.

Proper storage of Nutropin AQ Vials:

Before mixing, store Nutropin AQ Vials in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from heat, moisture, and light. Do not use Nutropin AQ Vials past the expiration date on the product label. After mixing, store Nutropin AQ Vials according to the product label. Contact your pharmacist if you have any questions about the proper storage of Nutropin AQ Vials. Keep Nutropin AQ Vials, as well as needles and syringes, out of the reach of children and away from pets.

General information:

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


• Nutropin AQ Vials 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 Nutropin AQ Vials. 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 Nutropin AQ resources

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

Compare Nutropin AQ with other medications

• Adult Human Growth Hormone Deficiency
• Growth Retardation, Chronic Renal Failure
• Hypopituitarism
• Idiopathic Short Stature
• Pediatric Growth Hormone Deficiency
• Short Stature for Age
• Turner's Syndrome

Trecator

ethionamide

Dosage Form: tablet, film coated
Trecator®

(ethionamide tablets, USP)

Tablets

Rx only

DESCRIPTION

Trecator® (ethionamide tablets, USP) is used in the treatment of tuberculosis. The chemical name for ethionamide is 2-ethylthioisonicotinamide with the following structural formula:

Ethionamide is a yellow crystalline, nonhygroscopic compound with a faint to moderate sulfide odor and a melting point of 162°C. It is practically insoluble in water and ether, but soluble in methanol and ethanol. It has a partition coefficient (octanol/water) Log P value of 0.3699. Trecator tablets contain 250 mg of ethionamide. The inactive ingredients present are croscarmellose sodium, FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, talc, and titanium dioxide.

CLINICAL PHARMACOLOGY

Absorption

Ethionamide is essentially completely absorbed following oral administration and is not subjected to any appreciable first pass metabolism. Ethionamide tablets may be administered without regard to the timing of meals.

The pharmacokinetic parameters of ethionamide following single oral-dose administration of 250 mg of Trecator film-coated tablets under fasted conditions to 40 healthy adult volunteers are provided in Table 1.

Table 1: Mean (SD) Pharmacokinetic Parameters for Ethionamide Following Single-dose Administration of 250 mg Trecator Film-Coated Tablets to Healthy Adult Volunteers

	Cmax (μg/mL)	Tmax (hrs)	AUC (μg•hr/mL)
Film-Coated Tablet	2.16 (0.61)	1.02 (0.55)	7.67 (1.69)

Trecator tablets have been reformulated from a sugar-coated tablet to a film-coated tablet. The Cmax for the film-coated tablets (2.16 μg/mL) was significantly higher than that of sugar-coated tablets (1.48 μg/mL) (see DOSAGE AND ADMINISTRATION).

Distribution

Ethionamide is rapidly and widely distributed into body tissues and fluids following administration of a sugar-coated tablet, with concentrations in plasma and various organs being approximately equal. Significant concentrations are also present in cerebrospinal fluid following administration of a sugar-coated tablet. Distribution of ethionamide into the same body tissues and fluids, including cerebrospinal fluid following administration of the film-coated tablet, has not been studied, but is not expected to differ significantly from that of the sugar-coated tablet. The drug is approximately 30% bound to proteins. The mean (SD) apparent oral volume of distribution observed in 40 healthy volunteers following a 250 mg oral dose of film-coated tablets was 93.5 (19.2) L.

Metabolism

Ethionamide is extensively metabolized to active and inactive metabolites. Metabolism is presumed to occur in the liver and thus far 6 metabolites have been isolated: 2-ethylisonicotinamide, carbonyl-dihydropyridine, thiocarbonyl-dihydropyridine, S-oxocarbamoyl dihydropyridine, 2-ethylthioiso-nicotinamide, and ethionamide sulphoxide. The sulphoxide metabolite has been demonstrated to have antimicrobial activity against Mycobacterium tuberculosis.

Elimination

The mean (SD) half-life observed in 40 healthy volunteers following a 250 mg oral dose of film-coated tablets was 1.92 (0.27) hours. Less than 1% of the oral dose is excreted as ethionamide in urine.

Mechanism of Action

Ethionamide may be bacteriostatic or bactericidal in action, depending on the concentration of the drug attained at the site of infection and the susceptibility of the infecting organism. The exact mechanism of action of ethionamide has not been fully elucidated, but the drug appears to inhibit peptide synthesis in susceptible organisms.

Microbiology

In Vitro Activity

Ethionamide exhibits bacteriostatic activity against extracellular and intracellular Mycobacterium tuberculosis organisms. The development of ethionamide resistant M. tuberculosis isolates can be obtained by repeated subculturing in liquid or on solid media containing increasing concentrations of ethionamide. Multi-drug resistant strains of M. tuberculosis may have acquired resistance to both isoniazid and ethionamide. However, the majority of M. tuberculosis isolates that are resistant to one are usually susceptible to the other. There is no evidence of cross-resistance between ethionamide and para-aminosalicylic acid (PAS), streptomycin, or cycloserine. However, limited data suggest that cross-resistance may exist between ethionamide and thiosemicarbazones (i.e., thiacetazone) as well as isoniazid.

In Vivo Activity

Ethionamide administered orally initially decreased the number of culturable Mycobacterium tuberculosis organisms from the lungs of H37Rv infected mice. Drug resistance developed with continued ethionamide monotherapy, but did not occur when mice received ethionamide in combination with streptomycin or isoniazid.

SUSCEPTIBILITY TESTING

Ethionamide susceptibility testing should only be performed by qualified or reference laboratories.

Two standardized in vitro susceptibility methods are available for testing ethionamide against M. tuberculosis organisms. The modified proportion method (CDC or NCCLS M24-P) utilizes Middlebrook and Cohn 7H10 agar medium impregnated with ethionamide at a final concentration of 5.0 μg/mL. After 2 to 3 weeks of incubation, MIC99 values are calculated by comparing the quantity of organisms growing in the medium containing drug to the control cultures. Mycobacterial growth in the presence of drug, of at least 1% of the growth in the control culture, indicates resistance.

The radiometric broth method employs the BACTEC 460 machine to compare the growth index from untreated control cultures to cultures grown in the presence of 5.0 μg/mL of ethionamide. Strict adherence to the manufacturer's instructions for sample processing and data interpretation is required for this assay.

Susceptibility test results obtained by these two different methods cannot be compared unless equivalent drug concentrations are evaluated.

The clinical relevance of in vitro susceptibility test results for mycobacterial species other than M. tuberculosis using either the radiometric or the proportion method has not been determined.

INDICATIONS AND USAGE

Trecator is primarily indicated for the treatment of active tuberculosis in patients with M. tuberculosis resistant to isoniazid or rifampin, or when there is intolerance on the part of the patient to other drugs. Its use alone in the treatment of tuberculosis results in the rapid development of resistance. It is essential, therefore, to give a suitable companion drug or drugs, the choice being based on the results of susceptibility tests. If the susceptibility tests indicate that the patient's organism is resistant to one of the first-line antituberculosis drugs (i.e., isoniazid or rifampin) yet susceptible to ethionamide, ethionamide should be accompanied by at least one drug to which the M. tuberculosis isolate is known to be susceptible.3 If the tuberculosis is resistant to both isoniazid and rifampin, yet susceptible to ethionamide, ethionamide should be accompanied by at least two other drugs to which the M. tuberculosis isolate is known to be susceptible.3

Patient nonadherence to prescribed treatment can result in treatment failure and in the development of drug-resistant tuberculosis, which can be life-threatening and lead to other serious health risks. It is, therefore, essential that patients adhere to the drug regimen for the full duration of treatment. Directly observed therapy is recommended for all patients receiving treatment for tuberculosis. Patients in whom drug-resistant M. tuberculosis organisms are isolated should be managed in consultation with an expert in the treatment of drug-resistant tuberculosis.

CONTRAINDICATIONS

Ethionamide is contraindicated in patients with severe hepatic impairment and in patients who are hypersensitive to the drug.

WARNINGS

The use of Trecator alone in the treatment of tuberculosis results in rapid development of resistance. It is essential, therefore, to give a suitable companion drug or drugs, the choice being based on the results of susceptibility testing. However, therapy may be initiated prior to receiving the results of susceptibility tests as deemed appropriate by the physician. Ethionamide should be administered with at least one, sometimes two, other drugs to which the organism is known to be susceptible (see INDICATIONS AND USAGE). Drugs which have been used as companion agents are rifampin, ethambutol, pyrazinamide, cycloserine, kanamycin, streptomycin, and isoniazid. The usual warnings, precautions, and dosage regimens for these companion drugs should be observed.

Patient compliance is essential to the success of the antituberculosis therapy and to prevent the emergence of drug-resistant organisms. Therefore, patients should adhere to the drug regimen for the full duration of treatment. It is recommended that directly observed therapy be practiced when patients are receiving antituberculous medication. Additional consultation from experts in the treatment of drug-resistant tuberculosis is recommended when patients develop drug-resistant organisms.

PRECAUTIONS

General

Ethionamide may potentiate the adverse effects of the other antituberculous drugs administered concomitantly (see Drug Interactions). Ophthalmologic examinations (including ophthalmoscopy) should be performed before and periodically during therapy with Trecator.

Information For Patients

Patients should be advised to consult their physician should blurred vision or any loss of vision, with or without eye pain, occur during treatment.

Excessive ethanol ingestion should be avoided because a psychotic reaction has been reported.

Laboratory Tests

Determination of serum transaminases (SGOT, SGPT) should be made prior to initiation of therapy and should be monitored monthly. If serum transaminases become elevated during therapy, ethionamide and the companion antituberculosis drug or drugs may be discontinued temporarily until the laboratory abnormalities have resolved. Ethionamide and the companion antituberculosis medication(s) then should be reintroduced sequentially to determine which drug (or drugs) is (are) responsible for the hepatotoxicity.

Blood glucose determinations should be made prior to and periodically throughout therapy with Trecator. Diabetic patients should be particularly alert for episodes of hypoglycemia.

Periodic monitoring of thyroid function tests is recommended as hypothyroidism, with or without goiter, has been reported with ethionamide therapy.

Drug Interactions

Trecator has been found to temporarily raise serum concentrations of isoniazid. Trecator may potentiate the adverse effects of other antituberculous drugs administered concomitantly. In particular, convulsions have been reported when ethionamide is administered with cycloserine and special care should be taken when the treatment regimen includes both of these drugs. Excessive ethanol ingestion should be avoided because a psychotic reaction has been reported.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Teratogenic Effects: Pregnancy Category C

Animal studies conducted with Trecator indicate that the drug has teratogenic potential in rabbits and rats. The doses used in these studies on a mg/kg basis were considerably in excess of those recommended in humans. There are no adequate and well-controlled studies in pregnant women. Because of these animal studies, however, it must be recommended that Trecator be withheld from women who are pregnant, or who are likely to become pregnant while under therapy, unless the prescribing physician considers it to be an essential part of the treatment.

Labor and Delivery

The effect of Trecator on labor and delivery in pregnant women is unknown.

Nursing Mothers

Because no information is available on the excretion of ethionamide in human milk, Trecator should be administered to nursing mothers only if the benefits outweigh the risks. Newborns who are breast-fed by mothers who are taking Trecator should be monitored for adverse effects.

Pediatric Use

Due to the fact that pulmonary tuberculosis resistant to primary therapy is rarely found in neonates, infants, and children, investigations have been limited in these age groups. At present, the drug should not be used in pediatric patients under 12 years of age except when the organisms are definitely resistant to primary therapy and systemic dissemination of the disease, or other life-threatening complications of tuberculosis, is judged to be imminent.

Adverse Reactions

Gastrointestinal: The most common side effects of ethionamide are gastrointestinal disturbances including nausea, vomiting, diarrhea, abdominal pain, excessive salivation, metallic taste, stomatitis, anorexia and weight loss. Adverse gastrointestinal effects appear to be dose related, with approximately 50% of patients unable to tolerate 1 gm as a single dose. Gastrointestinal effects may be minimized by decreasing dosage, by changing the time of drug administration, or by the concurrent administration of an antiemetic agent.

Nervous System: Psychotic disturbances (including mental depression), drowsiness, dizziness, restlessness, headache, and postural hypotension have been reported with ethionamide. Rare reports of peripheral neuritis, optic neuritis, diplopia, blurred vision, and a pellagra-like syndrome also have been reported. Concurrent administration of pyridoxine has been recommended to prevent or relieve neurotoxic effects.

Hepatic: Transient increases in serum bilirubin, SGOT, SGPT; Hepatitis (with or without jaundice).

Other: Hypersensitivity reactions including rash, photosensitivity, thrombocytopenia and purpura have been reported rarely. Hypoglycemia, hypothyroidism, gynecomastia, impotence, and acne also have occurred. The management of patients with diabetes mellitus may become more difficult in those receiving ethionamide.

OVERDOSAGE

No specific information is available on the treatment of overdosage with Trecator. If it should occur, standard procedures to evacuate gastric contents and to support vital functions should be employed.

DOSAGE AND ADMINISTRATION

In the treatment of tuberculosis, a major cause of the emergence of drug-resistant organisms, and thus treatment failure, is patient nonadherence to prescribed treatment. Treatment failure and drug-resistant organisms can be life-threatening and may result in other serious health risks. It is, therefore, important that patients adhere to the drug regimen for the full duration of treatment. Directly observed therapy is recommended when patients are receiving treatment for tuberculosis. Consultation with an expert in the treatment of drug-resistant tuberculosis is advised for patients in whom drug-resistant tuberculosis is suspected or likely. Ethionamide should be administered with at least one, sometimes two, other drugs to which the organism is known to be susceptible (see INDICATIONS AND USAGE).

Trecator is administered orally. The usual adult dose is 15 to 20 mg/kg/day, administered once daily or, if patient exhibits poor gastrointestinal tolerance, in divided doses, with a maximum daily dosage of 1 gram.

Trecator tablets have been reformulated from a sugar-coated tablet to a film-coated tablet. Patients should be monitored and have their dosage retitrated when switching from the sugar-coated tablet to the film-coated tablet (see CLINICAL PHARMACOLOGY).

Therapy should be initiated at a dose of 250 mg daily, with gradual titration to optimal doses as tolerated by the patient. A regimen of 250 mg daily for 1 or 2 days, followed by 250 mg twice daily for 1 or 2 days with a subsequent increase to 1 gm in 3 or 4 divided doses has been reported.4,5 Thus far, there is insufficient evidence to indicate the lowest effective dosage levels. Therefore, in order to minimize the risk of resistance developing to the drug or to the companion drug, the principle of giving the highest tolerated dose (based on gastrointestinal intolerance) has been followed. In the adult this would seem to be between 0.5 and 1.0 gm daily, with an average of 0.75 gm daily.

The optimum dosage for pediatric patients has not been established. However, pediatric dosages of 10 to 20 mg/kg p.o. daily in 2 or 3 divided doses given after meals or 15 mg/kg/24 hrs as a single daily dose have been recommended.1,2 As with adults, ethionamide may be administered to pediatric patients once daily. It should be noted that in patients with concomitant tuberculosis and HIV infection, malabsorption syndrome may be present. Drug malabsorption should be suspected in patients who adhere to therapy, but who fail to respond appropriately. In such cases, consideration should be given to therapeutic drug monitoring (see CLINICAL PHARMACOLOGY).

The best times of administration are those which the individual patient finds most suitable in order to avoid or minimize gastrointestinal intolerance, which is usually at mealtimes. Every effort should be made to encourage patients to persevere with treatment when gastrointestinal side effects appear, since they may diminish in severity as treatment proceeds.

Concomitant administration of pyridoxine is recommended.

Duration of treatment should be based on individual clinical response. In general, continue therapy until bacteriological conversion has become permanent and maximal clinical improvement has occurred.

HOW SUPPLIED

Trecator® (ethionamide tablets, USP) are supplied in bottles of 100 tablets as follows:

250 mg, orange film-coated tablet marked “W” on one side and “4117” on reverse side, NDC 0008-4117-01.

Store at controlled room temperature 20° to 25°C (68° to 77°F). Dispense in a tight container.

REFERENCES

1. Feigin, R.D., and Cherry, J.D.: Textbook of Pediatric Infectious Diseases, 2nd Edition. Philadelphia, W.B. Saunders Co., 1987, pp. 1371-1372.


2. Nelson, W.E., Behrman, R.E., Vaughan, V.C. (eds.): Nelson Textbook of Pediatrics, 13th edition. Philadelphia, W.B. Saunders Co., 1987, p.636.


3. Treatment of Tuberculosis and Tuberculosis Infection in Adults and Children, Am J Respiratory and Critical Care Medicine, 149:1359-1374, 1994.


4. Peloquin, CA: Pharmacology of the Antimycobacterial Drugs, Med Clin North Am 77(6): 1230-1262, 1993.


5. American Thoracic Society. Am J Respir Crit Care Med 1997;156:S1-S25.

This product’s label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556.

Wyeth®

Manufactured for

Wyeth Pharmaceuticals Inc.

Philadelphia, PA 19101

By Norwich Pharmaceuticals, Inc.

North Norwich, New York 13814

W10479C006

ET02

Rev 11/07

PRINCIPAL DISPLAY PANEL – 250 mg TABLETS - LABEL

NDC 0008-4117-01

100 Tablets

Trecator®

(ethionamide tablets, USP)

250 mg

Tablets

SEALED FOR YOUR PROTECTION

Rx only

Wyeth®

Trecator  ethionamide  tablet, film coated

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0008-4117 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ETHIONAMIDE (ETHIONAMIDE) ETHIONAMIDE 250 mg

Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM   FD&C YELLOW NO. 6   MAGNESIUM STEARATE   CELLULOSE, MICROCRYSTALLINE   POLYETHYLENE GLYCOL   POLYVINYL ALCOHOL   POVIDONE   SILICON DIOXIDE   TALC   TITANIUM DIOXIDE

Product Characteristics Color ORANGE (ORANGE ) Score no score Shape ROUND (ROUND ) Size 12mm Flavor Imprint Code W;4117 Contains

Packaging # NDC Package Description Multilevel Packaging 1 0008-4117-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA013026	11/08/2004

Labeler - Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc. (071170729)

Establishment
Name	Address	ID/FEI	Operations
Norwich Pharmaceuticals Inc.		132218731	MANUFACTURE, ANALYSIS

Revised: 04/2011Wyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.

More Trecator resources

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

• Trecator Concise Consumer Information (Cerner Multum)


• Trecator MedFacts Consumer Leaflet (Wolters Kluwer)


• Trecator Monograph (AHFS DI)


• Trecator Advanced Consumer (Micromedex) - Includes Dosage Information


• Ethionamide Professional Patient Advice (Wolters Kluwer)

Compare Trecator with other medications

• Tuberculosis, Active

Symbyax

Generic Name: fluoxetine and olanzapine (floo OX eh teen and oh LAN za peen)

Brand Names: Symbyax

What is fluoxetine and olanzapine?

Fluoxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs).

Olanzapine is an antipsychotic medication. These drugs affect chemicals in the brain.

The combination of fluoxetine and olanzapine is used to treat depression caused by bipolar disorder (manic depression). Fluoxetine and olanzapine is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

Fluoxetine and olanzapine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about fluoxetine and olanzapine?

This medication is not for use in psychotic conditions related to dementia. Olanzapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Do not use this medication together with pimozide (Orap) or thioridazine (Mellaril), or if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you become pregnant while taking fluoxetine and olanzapine, do not stop taking it without your doctor's advice.

What should I discuss with my healthcare provider before taking fluoxetine and olanzapine?

This medication is not for use in psychotic conditions related to dementia. Olanzapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Do not use this medication together with pimozide (Orap) or thioridazine (Mellaril), or if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

You must wait at least 14 days after stopping an MAOI before you can take fluoxetine and olanzapine. After you stop taking fluoxetine and olanzapine, you must wait at least 5 weeks before you start taking thioridazine (Mellaril) or an MAOI.

Video: Treatment for Depression

Treatments for depression are getting better everyday and there are things you can start doing right away.

To make sure you can safely take fluoxetine and olanzapine, tell your doctor if you have any of these other conditions:

• liver disease;


• 
  

  heart disease, high or low blood pressure, or a history of heart attack or stroke;

  
  


• 
  

  diabetes, high cholesterol or triglycerides;

  
  


• 
  

  seizures or epilepsy;

  
  


• 
  

  narrow-angle glaucoma;

  
  


• 
  

  paralytic ileus (a stomach disorder);

  
  


• 
  

  breast cancer;

  
  


• 
  

  enlarged prostate; or

  
  


• 
  

  a history of drug abuse or suicidal thoughts.

  
  

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking fluoxetine and olanzapine, do not stop taking it without your doctor's advice.

FDA pregnancy category C. An SSRI antidepressant may cause serious lung problems in a newborn if you take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. Fluoxetine and olanzapine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking this medication. Do not give this medication to anyone under 18 years old without medical advice.

How should I take fluoxetine and olanzapine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Fluoxetine and olanzapine can be taken with or without food. Try to take the medicine at the same time each day.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Olanzapine can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are taking olanzapine.

Store at room temperature away from moisture and heat.

See also: Symbyax dosage (in more detail)

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 some of the serious side effects listed in this medication guide.

What should I avoid while taking fluoxetine and olanzapine?

Drinking alcohol can increase certain side effects of fluoxetine and olanzapine. Fluoxetine and olanzapine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Fluoxetine and olanzapine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have a serious side effect such as:

• 
  

  sudden and severe headache, chest pain, numbness, and problems with vision, speech, or balance;

  
  


• 
  

  increased thirst, frequent urination, excessive hunger, or weakness;

  
  


• 
  

  agitation, hallucinations, fever, fast heart rate, overactive reflexes, vomiting, diarrhea, loss of coordination;

  
  


• 
  

  very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

  
  


• 
  

  jerky muscle movements you cannot control, seizure (convulsions);

  
  


• 
  

  feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

  
  


• 
  

  flu symptoms, easy bruising, sores in your mouth and throat; or

  
  


• 
  

  seizure (convulsions);

  
  


• 
  

  nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

  
  

Less serious side effects may include:

• 
  

  dry mouth, increased appetite, weight gain;

  
  


• 
  

  feeling drowsy or tired;

  
  


• 
  

  blurred vision; or

  
  


• 
  

  swelling in your hands or feet.

  
  

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

What other drugs will affect fluoxetine and olanzapine?

Ask your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with fluoxetine and olanzapine may cause you to bruise or bleed easily.

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

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

• 
  

  vinblastine (Velban);

  
  


• 
  

  heart rhythm or blood pressure medication;

  
  


• 
  

  tryptophan (sometimes called L-tryptophan);

  
  


• 
  

  lithium, clozapine (Clozaril, Fazaclo), haloperidol (Haldol);

  
  


• 
  

  phenytoin (Dilantin), carbamazepine (Carbatrol, Tegretol);

  
  


• 
  

  a blood thinner such as warfarin (Coumadin, Jantoven);

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl, and others);

  
  


• 
  

  medicine to treat Parkinson's disease, such as bromocriptine (Parlodel), pergolide (Permax), pramipexole (Mirapex), ropinorole (Requip), or cabergoline (Cabaser);

  
  


• 
  

  almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex, Treximet), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or

  
  


• 
  

  any other antidepressants, especially another form of fluoxetine or olanzapine such as Prozac, Prozac Weekly, Sarafem, or Zyprexa.

  
  

This list is not complete and other drugs may interact with fluoxetine and olanzapine. 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 Symbyax resources

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

• Symbyax Prescribing Information (FDA)


• Symbyax Advanced Consumer (Micromedex) - Includes Dosage Information


• Symbyax MedFacts Consumer Leaflet (Wolters Kluwer)


• Symbyax Consumer Overview

Compare Symbyax with other medications

• Bipolar Disorder
• Depression

Where can I get more information?

• Your pharmacist can provide more information about fluoxetine and olanzapine.

See also: Symbyax side effects (in more detail)

Tears Renew

Generic Name: ocular lubricant (OK yoo lar LOO bri kant)

Brand Names: Artificial Tears, Celluvisc, Clear Eyes CLR, Comfort Tears, Dry Eye Relief, GenTeal, Isopto Tears, Lacri-Lube S.O.P., Lacrisert, Lubricant Eye Drops, Moisture Drops, Oasis Tears, Opti-Free Rewetting Drops, optive, Refresh, Soothe, Sterilube, Systane, Systane Balance, Tears Again, Tears Naturale, Tears Renew, TheraTears, Ultra Fresh, Visine Tears

What is Tears Renew (ocular lubricant)?

There are many brands and forms of ocular lubricant available and not all are listed on this leaflet.

Ocular lubricant is a solution specially formulated to moisten the eyes.

Ocular lubricant is used to relieve burning, irritation, and discomfort caused by dry eyes.

Ocular lubricant may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Tears Renew (ocular lubricant)?

There are many brands and forms of ocular lubricant available and not all are listed on this leaflet.

You should not use an ocular lubricant if you are allergic to it. Ocular lubricant will not treat or prevent an eye infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have any type of infection in your eye.

Do not allow the dropper or tube tip to touch any surface, including the eyes or hands. If the dropper or tube becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Stop using ocular lubricant and call your doctor if you have severe burning, stinging, irritation, eye pain, or vision changes.

This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Talk with your doctor if your symptoms do not improve or if they get worse while you are using ocular lubricant.

What should I discuss with my healthcare provider before using Tears Renew (ocular lubricant)?

You should not use an ocular lubricant if you are allergic to it. Ocular lubricant will not treat or prevent an eye infection.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have any type of infection in your eye.

Ocular lubricant is not expected to harm an unborn baby. Ask a doctor or pharmacist about using ocular lubricant if you are pregnant. It is not known whether ocular lubricant passes into breast milk or if it could harm a nursing baby. Ask a doctor or pharmacist about using ocular lubricant if you are pregnant.

How should I use Tears Renew (ocular lubricant)?

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.

Do not use this medication while wearing contact lenses. Eye medication may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medication before putting your contact lenses in. Wash your hands before using ocular lubricant.

To apply the eye drops:

• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

  
  


• 
  

  Use only the number of drops your doctor has prescribed.

  
  


• 
  

  Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

  
  


• 
  

  Do not use the eye drops if the liquid has changed colors or has particles in it.

  
  

To apply the ointment:

• 
  

  Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the ointment tube with the tip pointing toward this pocket. Look up and away from the tip.

  
  


• 
  

  Squeeze out a ribbon of ointment 1/2-inch long into the lower eyelid pocket without touching the tip of the tube to your eye. Look down and close your eyes for a few minutes. Rolling your eyes around gently will help spread the ointment evenly.

  
  


• 
  

  After opening your eyes, you may have blurred vision for a short time. Avoid driving or doing anything that requires you to be able to see clearly.

  
  

Do not allow the dropper or tube tip to touch any surface, including the eyes or hands. If the dropper or tube becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Talk with your doctor if your symptoms do not improve or if they get worse while you are using ocular lubricant. Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle or tube tightly closed when not in use.

What happens if I miss a dose?

Since ocular lubricant is used on an as needed basis, you are not likely to miss a dose.

What happens if I overdose?

An overdose of ocular lubricant is not expected to be dangerous.

What should I avoid while using Tears Renew (ocular lubricant)?

This medication may cause blurred vision. Be careful if you drive or do anything that requires you to be able to see clearly.

Avoid using other medications in your eyes during treatment with ocular lubricant unless your doctor tells you to.

Tears Renew (ocular lubricant) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using ocular lubricant and call your doctor if you have a serious side effect such as:

• 
  

  severe burning, stinging, or eye irritation after using the medication;

  
  


• 
  

  eye pain; or

  
  


• 
  

  vision changes.

  
  

Less serious side effects may include:

• 
  

  mild eye burning or irritation;

  
  


• 
  

  itching or redness of your eyes;

  
  


• 
  

  watery eyes;

  
  


• 
  

  blurred vision; or

  
  


• 
  

  unpleasant taste in your mouth.

  
  

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

What other drugs will affect Tears Renew (ocular lubricant)?

It is not likely that other drugs you take orally or inject will have an effect on ocular lubricant used in the eyes. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More Tears Renew resources

• Tears Renew Use in Pregnancy & Breastfeeding
• Tears Renew Support Group
• 0 Reviews for Tears Renew - Add your own review/rating

• FreshKote Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Genteal Advanced Consumer (Micromedex) - Includes Dosage Information


• Lacri-Lube S.O.P. Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• Lacrisert Prescribing Information (FDA)


• Lacrisert Insert MedFacts Consumer Leaflet (Wolters Kluwer)


• Lacrisert Advanced Consumer (Micromedex) - Includes Dosage Information


• Murine Tears Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Murocel Eye Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Refresh Redness Relief Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Refresh liquigel

Compare Tears Renew with other medications

• Eye Dryness/Redness

Where can I get more information?

• Your pharmacist can provide more information about ocular lubricant.

Tylenol Children's Plus Cold and Allergy Suspension

Pronunciation: a-SEET-a-MIN-oh-fen/DYE-fen-HYE-dra-meen/FEN-il-EF-rin
Generic Name: Acetaminophen/Diphenhydramine/Phenylephrine
Brand Name: Tylenol Children's Plus Cold and Allergy

Tylenol Children's Plus Cold and Allergy Suspension is used for:

Relieving symptoms such as pain, sinus congestion, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also used for other conditions as determined by your doctor.

Tylenol Children's Plus Cold and Allergy Suspension is an analgesic, antihistamine, and decongestant combination. The analgesic works in the brain to help decrease pain. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages, which decreases stuffiness.

Do NOT use Tylenol Children's Plus Cold and Allergy Suspension if:

• you are allergic to any ingredient in Tylenol Children's Plus Cold and Allergy Suspension


• you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems


• you are unable to urinate or are having an asthma attack


• you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

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

Before using Tylenol Children's Plus Cold and Allergy Suspension:

Some medical conditions may interact with Tylenol Children's Plus Cold and Allergy Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, plan 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 a fast, slow, or irregular heartbeat


• if you have a history of asthma; lung problems (eg, chronic bronchitis, emphysema); trouble breathing when you sleep (apnea): adrenal gland problems (eg, adrenal gland tumor); heart problems; high blood pressure; diabetes; blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; ulcers; trouble urinating; an enlarged prostate or other prostate problems; seizures; the blood disease porphyria; an overactive thyroid; severe kidney problems; or liver problems; or if you consume more than 3 alcohol-containing drinks per day

Some MEDICINES MAY INTERACT with Tylenol Children's Plus Cold and Allergy Suspension. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), catechol-o-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, isoniazid, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Tylenol Children's Plus Cold and Allergy Suspension's side effects


• Anticoagulants (eg, warfarin), digoxin, or droxidopa because the risk of bleeding, irregular heartbeat, or heart attack may be increased


• Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Tylenol Children's Plus Cold and Allergy Suspension


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Tylenol Children's Plus Cold and Allergy Suspension

This may not be a complete list of all interactions that may occur. Ask your health care provider if Tylenol Children's Plus Cold and Allergy Suspension 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 Tylenol Children's Plus Cold and Allergy Suspension:

Use Tylenol Children's Plus Cold and Allergy Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tylenol Children's Plus Cold and Allergy Suspension by mouth with or without food.


• Shake well before each use.


• Use the dosing cup that comes with Tylenol Children's Plus Cold and Allergy Suspension to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If you miss a dose of Tylenol Children's Plus Cold and Allergy Suspension and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tylenol Children's Plus Cold and Allergy Suspension.

Important safety information:

• Tylenol Children's Plus Cold and Allergy Suspension may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Tylenol Children's Plus Cold and Allergy Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Tylenol Children's Plus Cold and Allergy Suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Do not take diet or appetite control medicines while you are taking Tylenol Children's Plus Cold and Allergy Suspension without checking with you doctor.


• Tylenol Children's Plus Cold and Allergy Suspension has acetaminophen, diphenhydramine, and phenylephrine in it. Before you start any new medicine, check the label to see if it has these or similar medicines in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do NOT take more than the recommended dose without checking with your doctor.


• If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.


• If you have a fever that becomes worse or lasts for more than 3 days, contact your doctor.


• Contact your doctor if you have a sore throat that becomes severe, last for more than 2 days, or occurs with fever, headache, rash, nausea, or vomiting.


• Tylenol Children's Plus Cold and Allergy Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Tylenol Children's Plus Cold and Allergy Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.


• Tylenol Children's Plus Cold and Allergy Suspension may harm your liver. Your risk may be greater if you drink alcohol while you are using Tylenol Children's Plus Cold and Allergy Suspension. Talk to your doctor before you take Tylenol Children's Plus Cold and Allergy Suspension or other fever reducers if you drink more than 3 drinks with alcohol per day.


• Tylenol Children's Plus Cold and Allergy Suspension may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Tylenol Children's Plus Cold and Allergy Suspension for a few days before the tests.


• Tell your doctor or dentist that you take Tylenol Children's Plus Cold and Allergy Suspension before you receive any medical or dental care, emergency care, or surgery.


• Use Tylenol Children's Plus Cold and Allergy Suspension with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Tylenol Children's Plus Cold and Allergy Suspension in CHILDREN; they may be more sensitive to its effects, especially excitability.


• Tylenol Children's Plus Cold and Allergy Suspension should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tylenol Children's Plus Cold and Allergy Suspension while you are pregnant. Tylenol Children's Plus Cold and Allergy Suspension is found in breast milk. Do not breast-feed while taking Tylenol Children's Plus Cold and Allergy Suspension.

Possible side effects of Tylenol Children's Plus Cold and Allergy Suspension:

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; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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); dark urine; difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; mood or mental changes; pale stools; seizures; severe drowsiness; severe or persistent dizziness, nervousness, lightheadedness, or headache; severe or persistent trouble sleeping; stomach pain; tremor; vision changes; yellowing of skin or eyes.

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: Tylenol Children's Plus Cold and Allergy 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Tylenol Children's Plus Cold and Allergy Suspension:

Store Tylenol Children's Plus Cold and Allergy Suspension at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Tylenol Children's Plus Cold and Allergy Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Tylenol Children's Plus Cold and Allergy Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Tylenol Children's Plus Cold and Allergy Suspension 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 Tylenol Children's Plus Cold and Allergy Suspension. 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 Tylenol Children's Plus Cold and Allergy resources

• Tylenol Children's Plus Cold and Allergy Side Effects (in more detail)
• Tylenol Children's Plus Cold and Allergy Use in Pregnancy & Breastfeeding
• Tylenol Children's Plus Cold and Allergy Drug Interactions
• 0 Reviews for Tylenol Children's Plus Cold and Allergy - Add your own review/rating

Compare Tylenol Children's Plus Cold and Allergy with other medications

• Cold Symptoms

Telavancin

Generic Name: telavancin (TEL a VAN sin)

Brand Names: Vibativ

What is telavancin?

Telavancin is an antibiotic that treats infection caused by bacteria.

Telavancin is used to treat severe skin infections.

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

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

Before using this medication, tell your doctor if you are pregnant. You may need a pregnancy test to determine whether you are pregnant before you start using telavancin. If you are not pregnant before you start using telavancin, use effective birth control to prevent pregnancy during treatment. Any woman who could possibly become pregnant should use birth control during treatment with telavancin. If you are a woman using telavancin, you are considered able to become pregnant unless you have ovarian failure, have had a tubal ligation or hysterectomy, or have been in menopause or not had a menstrual period in 2 years.

Telavancin can be harmful to the kidneys, and this effect is increased when telavancin is used together with other medicines that can harm the kidneys. Before using telavancin, tell your doctor if you are receiving chemotherapy, or using medicines to treat a bowel disorder, medication to prevent organ transplant rejection, antiviral medications, pain or arthritis medicines, a diuretic (water pill), or any other injected antibiotics.

If you have kidney disease, you may need a dose adjustment or special tests to safely use telavancin.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Telavancin will not treat a viral infection such as the common cold or flu.

Call your doctor right away if you have a serious side effect such as watery or bloody diarrhea, confusion, thirst, swelling, feeling short of breath, or urinating less than usual or not at all

What should I discuss with my health care provider before using telavancin?

You should not use this medication if you are allergic to it.

If you have kidney disease, you may need a dose adjustment or special tests to safely use telavancin.

FDA pregnancy category C. It is not known whether telavancin is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant. You may need a pregnancy test to determine whether you are pregnant before you start using telavancin.

Your name may need to be listed on a pregnancy registry if you use telavancin while you are pregnant. The purpose of this registry is to track the outcome of the pregnancy and delivery to evaluate whether telavancin had any effect on the baby.

If you are not pregnant before you start using telavancin, use effective birth control to prevent pregnancy during treatment. Any woman who could possibly become pregnant should use birth control during treatment with telavancin. If you are a woman using telavancin, you are considered able to become pregnant unless you have ovarian failure, have had a tubal ligation or hysterectomy, or have been in menopause or not had a menstrual period in 2 years. It is not known whether telavancin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is telavancin given?

Telavancin is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Telavancin must be given slowly through an IV infusion, and can take at least 1 hour to complete.

This medication is usually given once every 24 hours for 7 to 14 days. Follow your doctor's instructions.

Telavancin powder must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Each single-use vial (bottle) of this medicine is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Telavancin will not treat a viral infection such as the common cold or flu.

To be sure this medication is not causing harmful effects, your kidney function will need to be checked with blood tests on a regular basis. Do not miss any follow-up visits to your doctor.

Telavancin can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using telavancin.

Store telavancin powder in the refrigerator. Do not freeze. After mixing telavancin with a diluent, you may store the mixture in the refrigerator and use it within 72 hours. Do not freeze. Mixed medicine may also be stored at room temperature, but you must then use it within 4 hours after mixing.

Do not use the mixed medication if it has changed colors or has any particles in it. Mix a new dose.

What happens if I miss a dose?

Contact your doctor for instructions if you miss a dose of this medication.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include confusion, increased thirst, vomiting, swelling, and urinating less than usual or not at all.

What should I avoid while using telavancin?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, stop taking this medication and call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Telavancin side effects

Some people receiving a telavancin injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your doctor right away if you feel itchy or tingly, or have a red rash on your upper body during the injection. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

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  diarrhea that is watery or bloody;

  
  


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  drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

  
  


• 
  

  swelling, weight gain, feeling short of breath; or

  
  


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  urinating less than usual or not at all.

  
  

Less serious side effects may include:

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  nausea, vomiting, diarrhea, stomach pain, loss of appetite;

  
  


• 
  

  chills or shivering;

  
  


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  headache, dizziness;

  
  


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  foamy appearance in your urine;

  
  


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  unusual or unpleasant taste in your mouth;

  
  


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  vaginal itching or discharge;

  
  


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  mild skin rash or itching; or

  
  


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  redness or pain around the IV needle.

  
  

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.

Telavancin Dosing Information

Usual Adult Dose for Skin and Structure Infection:

Complicated infections: 10 mg/kg IV, infused over 60 minutes, once every 24 hours for 7 to 14 days

Therapy duration should be guided by severity and site of infection and by patient's clinical and bacteriological progress.

What other drugs will affect telavancin?

Telavancin can be harmful to the kidneys, and this effect is increased when telavancin is used together with other medicines that can harm the kidneys. Before using telavancin, tell your doctor if you are receiving chemotherapy, or using medicines to treat a bowel disorder, medication to prevent organ transplant rejection, antiviral medications, pain or arthritis medicines, a diuretic (water pill), or any other injected antibiotics.

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

• 
  

  arsenic trioxide (Trisenox);

  
  


• 
  

  droperidol (Inapsine);

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);

  
  


• 
  

  an antidepressant such as amitriptylline (Elavil, Vanatrip), clomipramine (Anafranil), or desipramine (Norpramin);

  
  


• 
  

  anti-malaria medications such as chloroquine (Arelan), or mefloquine (Lariam);

  
  


• 
  

  heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quinidex, Quin-Release Quin-G), or sotalol (Betapace);

  
  


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  medicine to prevent or treat nausea and vomiting, such as dolasetron (Anzemet) or ondansetron (Zofran);

  
  


• 
  

  medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);

  
  


• 
  

  migraine headache medicine such as sumatriptan (Imitrex) or zolmitriptan (Zomig); or

  
  


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  narcotic medication such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose).

  
  

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

More telavancin resources

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

• telavancin Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information


• Telavancin Professional Patient Advice (Wolters Kluwer)


• Telavancin MedFacts Consumer Leaflet (Wolters Kluwer)


• Telavancin Hydrochloride Monograph (AHFS DI)


• Vibativ Prescribing Information (FDA)


• Vibativ Consumer Overview

Compare telavancin with other medications

• Skin and Structure Infection

Where can I get more information?

• Your pharmacist can provide more information about telavancin.

See also: telavancin side effects (in more detail)

Nicomide-T Gel

Pronunciation: NYE-a-sin-a-mide
Generic Name: Niacinamide
Brand Name: Nicomide-T

Nicomide-T Gel is used for:

Treating acne.

Nicomide-T Gel is a vitamin B supplement. Exactly how Nicomide-T Gel works is unknown.

Do NOT use Nicomide-T Gel if:

• you are allergic to any ingredient in Nicomide-T Gel

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

Before using Nicomide-T Gel:

Some medical conditions may interact with Nicomide-T Gel. 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

Some MEDICINES MAY INTERACT with Nicomide-T Gel. However, no specific interactions with Nicomide-T Gel are known at this time.

Ask your health care provider if Nicomide-T Gel 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 Nicomide-T Gel:

Use Nicomide-T Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Wash the affected area with a mild cleanser or other cleansing product prescribed by your doctor and completely dry.


• Apply a thin layer of the medicine to the affected area twice daily or as directed by your doctor. Gently rub the medicine in until it is evenly distributed.


• Wash your hands immediately after using Nicomide-T Gel.


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

Ask your health care provider any questions you may have about how to use Nicomide-T Gel.

Important safety information:

• Nicomide-T Gel is for external use only. Avoid getting Nicomide-T Gel in your eyes. If you get Nicomide-T Gel in your eyes, rinse thoroughly with cool tap water.


• Follow up with your doctor after 8 to 12 weeks to monitor your progress.


• Do not use any other medicines or special cleansers on your skin unless your doctor instructs you otherwise. Makeup and other acne medicines may be applied over Nicomide-T Gel as directed by your doctor.


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

Possible side effects of Nicomide-T Gel:

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:

Dry skin.

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); irritation.

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

See also: Nicomide-T side effects (in more detail)

If OVERDOSE is suspected:

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

Proper storage of Nicomide-T Gel:

Store Nicomide-T Gel at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep Nicomide-T Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Nicomide-T Gel, please talk with your doctor, pharmacist, or other health care provider.


• Nicomide-T Gel 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 Nicomide-T Gel. 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 Nicomide-T resources

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

Compare Nicomide-T with other medications

• Rosacea