Uniclor

Uniclor may be available in the countries listed below.

Ingredient matches for Uniclor

Chloramphenicol

Chloramphenicol is reported as an ingredient of Uniclor in the following countries:

• Peru

International Drug Name Search

Eudextran

Eudextran may be available in the countries listed below.

Ingredient matches for Eudextran

Dextran

Dextran average molecular weight about 40000 (a derivative of Dextran) is reported as an ingredient of Eudextran in the following countries:

• Italy

International Drug Name Search

Bovaclox

Bovaclox may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Bovaclox

Ampicillin

Ampicillin trihydrate (a derivative of Ampicillin) is reported as an ingredient of Bovaclox in the following countries:

• Australia


• Finland


• New Zealand


• Poland

Cloxacillin

Cloxacillin benzathine (a derivative of Cloxacillin) is reported as an ingredient of Bovaclox in the following countries:

• Australia


• Finland


• New Zealand


• Poland

International Drug Name Search

Zemplar

Pronunciation: par-i-KAL-si-tol
Generic Name: Paricalcitol
Brand Name: Zemplar

Zemplar is used for:

Preventing and treating high levels of parathyroid hormone in certain patients with chronic kidney disease.

Zemplar is a vitamin D compound. It works by blocking the formation and release of parathyroid hormone (PTH).

Do NOT use Zemplar if:

• you are allergic to any ingredient in Zemplar


• you have high levels of vitamin D or calcium in the blood

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

Before using Zemplar:

Some medical conditions may interact with Zemplar. 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 heart problems (eg, an irregular heartbeat), hardening or narrowing of the arteries (arteriosclerosis), high blood phosphate levels, liver problems, or seizures


• if you are taking a calcium supplement or a calcium-based phosphate binder (eg, calcium acetate)

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

• Thiazide diuretics (eg, hydrochlorothiazide) because the risk of high blood calcium levels may be increased


• Aluminum-containing products (eg, antacids, phosphate binders) because the risk of high blood aluminum levels and aluminum bone toxicity may be increased


• Digitalis medicines (eg, digoxin) because the risk of toxicity may be increased by Zemplar


• Clarithromycin, HIV protease inhibitors (eg, ritonavir, saquinavir), imidazole antifungals (eg, ketoconazole, itraconazole), nefazodone, telithromycin, or voriconazole because side effects of Zemplar may be increased

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

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

• Zemplar is usually given as an injection at your doctor's office, hospital, or clinic. If you are using Zemplar at home, a health care provider will teach you how to use it. Be sure you understand how to use Zemplar. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


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


• 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 Zemplar, contact your doctor for instructions.

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

Important safety information:

• Zemplar may cause dizziness or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Zemplar with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Carefully follow the diet instructions given to you by your health care provider, including instructions on vitamin D and phosphorus restrictions and calcium supplementation.


• Before you begin taking any new prescription or nonprescription medicine, including vitamin or mineral products, read the ingredients to see if it has vitamin D, calcium, or phosphorus in it. If it does or if you are not sure, contact your doctor or pharmacist.


• Avoid excessive use of aluminum-containing products (eg, antacids, phosphate binders) while using Zemplar.


• Lab tests, including blood calcium, phosphorus, and PTH levels, may be performed while you use Zemplar. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Zemplar with extreme caution in CHILDREN; safety and effectiveness in 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 Zemplar while you are pregnant. It is not known if Zemplar is found in breast milk. Do not breast-feed while you are using Zemplar.

Possible side effects of Zemplar:

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:

Diarrhea; dizziness; light-headedness; nausea

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); black, tarry, or bloody stools; chest pain; depression; fainting; fever, chills, or persistent sore throat; irregular heartbeat; muscle cramps or spasms; painful urination; pounding in the chest; seizures; severe or persistent dizziness or headache; stomach pain; swelling of the hands or feet; symptoms of high blood calcium levels (eg, constipation, increased thirst or urination, loss of appetite, nausea, tiredness, trouble thinking, vomiting, weight loss); trouble breathing; unusual or severe dry eyes, mouth, or skin.

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: Zemplar 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 irregular heartbeat; muscle cramps or spasms; seizures; stomach pain; symptoms of high blood calcium levels (eg, confusion, constipation, increased thirst or urination, loss of appetite, nausea, tiredness, trouble thinking, vomiting, weight loss).

Proper storage of Zemplar:

Zemplar is usually handled and stored by a health care provider. If you are using Zemplar at home, store Zemplar as directed by your pharmacist or health care provider.

General information:

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


• Zemplar 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 Zemplar. 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 Zemplar resources

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

• Zemplar Prescribing Information (FDA)


• Zemplar Consumer Overview


• Zemplar Monograph (AHFS DI)


• Zemplar Advanced Consumer (Micromedex) - Includes Dosage Information


• Paricalcitol Professional Patient Advice (Wolters Kluwer)

Compare Zemplar with other medications

• Secondary Hyperparathyroidism

Abboticin

Abboticin may be available in the countries listed below.

Ingredient matches for Abboticin

Erythromycin

Erythromycin is reported as an ingredient of Abboticin in the following countries:

• Denmark


• Tunisia

Erythromycin ethylsuccinate (a derivative of Erythromycin) is reported as an ingredient of Abboticin in the following countries:

• Denmark


• France


• Iceland


• Norway

Erythromycin lactobionate (a derivative of Erythromycin) is reported as an ingredient of Abboticin in the following countries:

• Denmark


• Finland


• Iceland


• Sweden

Erythromycin stearate (a derivative of Erythromycin) is reported as an ingredient of Abboticin in the following countries:

• Denmark


• Iceland

International Drug Name Search

Neomycin Sulfate

Neomycin Sulfate TABLETS USP, 500 MG

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Neomycin Sulfate Tablets USP and other antibacterial drugs. Neomycin Sulfate Tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

WARNINGS: SYSTEMIC ABSORPTION OF NEOMYCIN OCCURS FOLLOWING ORAL ADMINISTRATION AND TOXIC REACTIONS MAY OCCUR. Patients treated with neomycin should be under close clinical observation because of the potential toxicity associated with their use. NEUOROTOXICITY (INCLUDING OTOTOXICITY AND NEPHROTOXICITY) FOLLOWING THE ORAL USE OF Neomycin Sulfate HAVE BEEN REPORTED, EVEN WHEN USED IN RECOMMENDED DOSES. THE POTENTIAL FOR NEPHROTOXICITY, PERMANENT BILATREAL AUDITORY OTOTOXICITY AND SOMETIMES VESTIBULAR TOXICITY IS PRESENT IN PATIENTS WITH NORMAL RENAL FUNCTION WHEN TREATED WITH HIGHER DOSES OF NEOMYCIN AND/OR FOR LONGER PERIODS THAN RECOMMENDED. Serial, vestibular and audiometric tests, as well as tests of renal function, should be performed (especially in high-risk patients). THE RISK OF NEPHROTOXICITY AND OTOTOXICITY IS GREATER IN PATIENTS WITH IMPAIRED RENAL FUNCTION. Ototoxicity is often delayed in onset and patients developing cochlear damage will not have symptoms during therapy to warn them of developing eighth nerve destruction and total or partial deafness may occur long after neomycin has been discontinued

Neuromuscular blockage and respiratory paralysis have been reported following the oral use of neomycin. The possibility of the occurrence of neuromuscular blockage and respiratory paralysis should be considered if neomycin is administered, especially to patients receiving anesthetics, neuromuscular blocking agents such as tubocurarine, succinylcholine, decamethonium, or in patients receiving massive transfusions of citrate anticoagulated blood. If blockage occurs, calcium salts may reverse these phenomena but mechanical respiratory assistance may be necessary.

Concurrent and/or sequential systemic, oral or topical use of other aminoglycosides, including paromomycin and other potentially nephrotoxic and/or neurotoxic drugs such as bacitracin, cisplatin, vancomycin, amphotericin B, polymyxin B, colistin and viomycin, should be avoided because the toxicity may be additive.

Other factors which increase the risk of toxicity are advanced age and dehydration. The concurrent use of neomycin with potent diuretics such as ethacrynic acid or furosemide should be avoided, since certain diuretics by themselves may cause ototoxicity. In addition, when administered intravenously, diuretics may enhance neomycin toxicity by altering the antibiotic concentration in serum and tissue.

Neomycin Sulfate Description

Neomycin Sulfate Tablets, USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomyces fradiae. Structurally, Neomycin Sulfate may be represented as follows:

Chemically, it is O-2,6-diamino-2,6-dideoxy-α-D-glucopyranosyl-(1→  3)-O-β-D-ribofuranosyl-(1→5)-O-[2,6-diamino-2, 6-dideoxy-α-D-glucopyranosyl-(1→4)]-2-deoxy-D-streptamine. Neomycin B is identical except that the α-D-glucopyranosyl residue in the neobiosamine moiety is β-L-idopyranosyl.

Each tablet contains 500 mg Neomycin Sulfate (equivalent to 350 mg neomycin base).

Inactive Ingredients: Calcium Stearate, Colloidal Silicon Dioxide, Povidone.

Neomycin Sulfate - Clinical Pharmacology

Neomycin Sulfate is poorly absorbed from the normal gastrointestinal tract. The small absorbed fraction is rapidly distributed in the tissues and is excreted by the kidney in keeping with the degree of kidney function. The unabsorbed portion of the drug (approximately 97%) is eliminated unchanged in the feces.

Growth of most intestinal bacteria is rapidly suppressed following oral administration of Neomycin Sulfate, with the suppression persisting for 48 to 72 hours. Nonpathogenic yeasts and occasionally resistant strains of Enterobacter aerogenes (formerly Aerobacter aerogenes) replace the intestinal bacteria.

As with other aminoglycosides, the amount of systemically absorbed neomycin transferred to the tissues increases cumulatively with each repeated dose administered until a steady state is achieved. The kidney functions as the primary excretory path as well as the tissue binding site, with the highest concentrations found in the renal cortex.  With repeated dosings, progressive accumulation also occurs in the inner ear.  Release of tissue-bound neomycin occurs slowly over a period of several weeks after dosing has been discontinued.

Protein binding studies have shown that the degree of aminoglycoside protein binding is low and, depending upon the methods used for testing, this may be between 0% and 30%.

Microbiology: In vitro tests have demonstrated that neomycin is bactericidal and acts by inhibiting the synthesis of protein in susceptible bacterial cells. It is effective primarily against gram-negative bacilli but does have some activity against gram-positive organisms. Neomycin is active in vitro against Escherichia coli and the Klebsiella-Enterobacter group. Neomycin is not active against anaerobic bowel flora.

If susceptibility testing is needed, using a 30 mcg disc, organisms producing zones of 16 mm or greater are considered susceptible. Resistant organisms produce zones of 13 mm or less. Zones greater than 13 mm and less than 16 mm indicate intermediate susceptibility.

Indications and Usage for Neomycin Sulfate

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Neomycin Sulfate Tablets USP and other antibacterial drugs, Neomycin Sulfate Tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Suppression of Intestinal Bacteria:  Neomycin Sulfate Tablets are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g., preoperative preparation of the bowel. It is given concomitantly with erythromycin enteric-coated base (see DOSAGE AND ADMINISTRATION Section).

Hepatic Coma (Portal-Systemic Encephalopathy):  Neomycin Sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal tract. The subsequent reduction in blood ammonia has resulted in neurologic improvement.

Contraindications

Neomycin Sulfate oral preparations are contraindicated in the presence of intestinal obstruction and in individuals with a history of hypersensitivity to the drug.

Patients with a history of hypersensitivity or serious toxic reaction other aminoglycosides may have a cross-sensitivity to neomycin.

Neomycin Sulfate oral preparations are contraindicated in patients with inflammatory or ulcerative gastrointestinal disease because of the potential for enhanced gastrointestinal absorption of neomycin.

Warnings

(see boxed WARNINGS)

Additional manifestations of neurotoxicity may include numbness, skin tingling, muscle twitching and convulsions.The risk of hearing loss continues after drug withdrawal.

Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycoside antibiotics cross the placenta and there have been several reports of total irreversible bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to fetus or newborn have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Animal reproduction studies of neomycin have not been conducted. If neomycin is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Precautions

General

Prescribing Neomycin Sulfate Tablets USP in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide beneï¬t to the patient and increases the risk of the development of drug-resistant bacteria.

As with other antibiotics, use of oral neomycin may result in overgrowth of non-susceptible organisms, particularly fungi.  If this occurs, appropriate therapy should be instituted.

Neomycin is quickly and almost totally absorbed from body surfaces (except the urinary bladder) after local irrigation and when applied topically in association with surgical procedures. Delayed-onset irreversible deafness, renal failure and death due to neuromuscular blockade (regardless of the status of renal function) have been reported following irrigation of both small and large surgical ï¬elds with minute quantities of neomycin.

Cross-allergenicity among aminoglycosides has been demonstrated.

Aminoglycosides should be used with caution in patients with muscular disorders such as myasthenia gravis or parkinsonism since these drugs may aggravate muscle weakness because of their potential curare-like effect on the neuromuscular junction.

Small amounts of orally administered neomycin are absorbed through intact intestinal mucosa.

There have been many reports in the literature of nephrotoxicity and/or ototoxicity with the oral use of neomycin. If renal insufï¬ciency develops during oral therapy, consideration should be given to reducing the drug dosage or discontinuing therapy.

An oral neomycin dose of 12 grams per day produces a malabsorption syndrome for a variety of substances, including fat, nitrogen, cholesterol, carotene, glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.

Orally administered neomycin increases fecal bile acid excretion and reduces intestinal lactase activity.

Information for the patient

Patients should be counseled that antibacterial drugs including Neomycin Sulfate Tablets USP should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Neomycin Sulfate Tablets USP are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.  Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Neomycin Sulfate Tablets USP or other antibacterial drugs in the future.

Before administering the drug, patients or members of their families should be informed of possible toxic effects on the eighth nerve. The possibility of acute toxicity increases in premature infants and neonates.

Laboratory tests

Patients with renal insufï¬ciency may develop toxic neomycin blood levels unless doses are properly regulated. If renal insufï¬ciency develops during treatment, the dosage should be reduced or the antibiotic discontinued. To avoid nephrotoxicity and eighth nerve damage associated with high doses and prolonged treatment, the following should be performed prior to and periodically during therapy: urinalysis for increased excretion of protein, decreased speciï¬c gravity, casts and cells; renal function tests such as serum creatinine, BUN or creatinine clearance; tests of the vestibulocochlearis nerve (eighth cranial nerve) function.

Serial, vestibular and audiometric tests should be performed (especially in high-risk patients). Since elderly patients may have reduced renal function which may not be evident in the results of routine screening tests such as BUN or serum creatinine, a creatinine clearance determination may be more useful.

Drug interactions

Caution should be taken in concurrent or serial use of other neurotoxic and/or nephrotoxic drugs because of possible enhancement of the nephrotoxicity and/or ototoxicity and neomycin (see boxed WARNINGS).

Caution should also be taken in concurrent or serial use of other aminoglycosides and polymyxins because they may enhance neomycin’s nephrotoxicity and/or ototoxicity and potentiate Neomycin Sulfate’s neuromuscular blocking effects.

Oral neomycin inhibits the gastrointestinal absorption of penicillin V, oral vitamin B-12, methotrexate and 5-fluorouracil. The gastrointestinal absorption of digoxin also appears to be inhibited. Therefore, digoxin serum levels should be monitored.

Oral Neomycin Sulfate may enhance the effect of coumarin in anticoagulants by decreasing vitamin K availability.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed with Neomycin Sulfate to evaluate carcinogenic or mutagenic potential or impairment of fertility.

Pregnancy Category D

(see WARNINGS section).

Nursing Mothers

It is not known whether neomycin is excreted in human milk, but it has been shown to be excreted in cow milk following a single intramuscular injection. Other aminoglycosides have been shown to be excreted in human milk. Because of the potential for serious adverse reactions from the aminoglycosides in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and efï¬cacy of oral Neomycin Sulfate in patients less than 18 years of age have not been established. If treatment of a patient less than 18 years of age is necessary, neomycin should be used with caution and the period of treatment should not exceed two weeks because of absorption from the gastrointestinal tract.

Adverse Reactions

The most common adverse reactions to oral Neomycin Sulfate are nausea, vomiting and diarrhea.  The "Malabsorption Syndrome" characterized by increased fecal fat, decreased serum carotene and fall in xylose absorption has been reported with prolonged therapy. Nephrotoxicity, ototoxicity and neuromuscular blockage have been reported (see boxed WARNINGS and PRECAUTIONS sections).

Overdosage

Because of low absorption, it is unlikely that acute overdosage would occur with oral Neomycin Sulfate. However, prolonged administration could result in sufï¬cient systemic drug levels to produce neurotoxicity, ototoxicity and/or nephrotoxicity.

Hemodialysis will remove Neomycin Sulfate from the blood.

Neomycin Sulfate Dosage and Administration

To minimize the risk of toxicity, use the lowest possible dose and the shortest possible treatment period to control the condition. Treatment for periods longer than two weeks is not recommended.

Hepatic Coma

For use as an adjunct in the management of hepatic coma, the recommended dose is 4 to 12 grams per day given in the following regimen:

1. Withdraw protein from diet. Avoid use of diuretic agents.


2. Give supportive therapy, including blood products, as indicated.


3. Give Neomycin Sulfate Tablets USP in doses of 4 to 12 grams of Neomycin Sulfate per day (eight to 24 tablets) in divided doses.  Treatment should be continued over a period of ï¬ve to six days, during which time protein should be returned incrementally to the diet.


4. If less potentially toxic drugs cannot be used for chronic hepatic insufï¬ciency, neomycin in doses of up to four grams daily (eight tablets per day) may be necessary. The risk for the development of neomycin-induced toxicity progressively increases when treatment must be extended to preserve the life of a patient with hepatic encephalopathy who has failed to fully respond. Frequent periodic monitoring of these patients to ascertain the presence of drug toxicity is mandatory (see PRECAUTIONS). Also, neomycin serum concentrations should be monitored to avoid potentially toxic levels. The beneï¬ts to the patient should be weighed against the risks of nephrotoxicity, permanent ototoxicity and neuromuscular blockade following the accumulation of neomycin in the tissues.

Preoperative Prophylaxis for Elective Colorectal Surgery

Listed below is an example of a recommended bowel preparation regimen. A proposed surgery time of 8:00 a.m. has been used.

Pre-op day 3: Minimum residue or clear liquid diet. Bisacodyl, 1 tablet orally at 6:00 p.m.

Pre-op day 2: Minimum residue or clear liquid diet. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., 2:00 p.m., and 6:00 p.m. Enema at 7:00 p.m. and 8:00 p.m.

Pre-op day 1: Clear liquid diet. Supplemental (IV) fluids as needed. Magnesium sulfate, 30 mL, 50% solution (15 g) orally at 10:00 a.m., and 2:00 p.m. Neomycin Sulfate (1 g) and erythromycin base (1 g) orally at 1:00 p.m., 2:00 p.m., and 11:00 p.m. No enema.

Day of Operation: Patient evacuates rectum at 6:30 a.m. for scheduled operation at 8:00 a.m.

How is Neomycin Sulfate Supplied

Neomycin Sulfate Tablets USP, 500 mg (equivalent in activity to 350 mg of neomycin base per tablet) are available as round, off-white, unscored tablets, debossed "ZYNOVA" and "01", in bottles of 100 tablets (NDC-51991-738-01).

Store at controlled room temperature between 20º and 25ºC (68º and 77ºF) (see USP).

Dispense in tight containers as deï¬ned in the USP/NF.

Address medical inquiries to Breckenridge Pharmaceutical: (800) 367-3395

Manufactured by:

OMAN PHARMACEUTICAL PRODUCTS CO. L.L.C.

Salalah, Sultanate of Oman

Distributed by:

Breckenridge Pharmaceutical, Inc. Boca Raton, FL 33487

Iss. D 08/2010

PRINCIPAL DISPLAY PANEL

Neomycin Sulfate TABLETS USP, 500 MG

NDC 51991-738-01

Neomycin Sulfate  Neomycin Sulfate  tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51991-738 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Neomycin Sulfate (NEOMYCIN) Neomycin Sulfate 500 mg

Inactive Ingredients Ingredient Name Strength CALCIUM STEARATE   SILICON DIOXIDE   POVIDONE

Product Characteristics Color WHITE (OFF WHITE) Score no score Shape ROUND Size 12mm Flavor Imprint Code ZYNOVA;01 Contains

Packaging # NDC Package Description Multilevel Packaging 1 51991-738-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA065468	01/03/2011

Labeler - Breckenridge Pharmaceutical, Inc. (150554335)

Establishment
Name	Address	ID/FEI	Operations
Oman Pharmaceutical Products Co. LLC		534770578	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Nutra Med		022004902	PACK

Revised: 12/2010Breckenridge Pharmaceutical, Inc.

More Neomycin Sulfate resources

• Neomycin Sulfate Dosage
• Neomycin Sulfate Use in Pregnancy & Breastfeeding
• Drug Images
• Neomycin Sulfate Drug Interactions
• Neomycin Sulfate Support Group
• 0 Reviews for Neomycin Sulfate - Add your own review/rating

• Neomycin Sulfate Monograph (AHFS DI)


• Neomycin MedFacts Consumer Leaflet (Wolters Kluwer)


• Mycifradin Concise Consumer Information (Cerner Multum)


• Neo-Fradin Advanced Consumer (Micromedex) - Includes Dosage Information


• Neo-Fradin Solution MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Neomycin Sulfate with other medications

• Bowel Preparation
• Diarrhea
• Hepatic Coma
• Hepatic Encephalopathy

neomycin Ophthalmic

nee-oh-MYE-sin

Chemical Class: Aminoglycoside

Uses For neomycin

Neomycin belongs to the family of medicines called antibiotics. Neomycin ophthalmic preparations are used to treat infections of the eye.

Neomycin is available only with your doctor's prescription.

Before Using neomycin

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 neomycin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to neomycin 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

Studies on neomycin have been done only in adult patients, and there is no specific information comparing use of neomycin in children with use in other age groups.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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

Proper Use of neomycin

To use:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1-cm (approximately ⅓-inch) strip of ointment is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using neomycin eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

To help clear up your infection completely, keep using neomycin for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

The dose of neomycin 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 neomycin. 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 eye infection:
  
  • For eye ointment dosage form:
    
    • Adults and children—Use in the eye every eight to twenty-four hours.
    
    
  
  

Missed Dose

If you miss a dose of neomycin, apply 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.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using neomycin

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

neomycin 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

• Itching, rash, redness, swelling, or other sign of irritation not present before use of neomycin

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:

Less common

• Burning or stinging

After application, eye ointments may be expected to cause your vision to blur for a few minutes.

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

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

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