Amoxicillin (Amoxicillin)

Trade Name : Amoxicillin

Teva Pharmaceuticals USA, Inc.

TABLET, FILM COATED

Strength 500 mg/1

Storage and handling for Amoxicillin

AMOXICILLIN Penicillin-class Antibacterial [EPC],Penicillins [CS]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Amoxicillin (Amoxicillin) which is also known as Amoxicillin and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 500 mg/1 per ml. Read more

Amoxicillin (Amoxicillin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

About GNH

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Amoxicillin Tablets are a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin tablets and other antibacterial drugs, amoxicillin tablets should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ()

Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. ( to )
In combination for treatment of infection and duodenal ulcer disease. ()

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In adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours. In Pediatric Patients > 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 hours. Refer to full prescribing information for specific dosing regimens. (, , )
The upper dose for neonates and infants u2264 3 months is 30 mg/kg/day divided every 12 hours. ()
Dosing for Infection: Triple Therapy: 1 gram amoxicillin tablets, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual Therapy: 1 gram amoxicillin tablets and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. ()
Reduce the dose in patients with severe renal impairment (GFR < 30 mL/min). ()

Amoxicillin Tablets USP are available as:
500 mg: Film-coated, capsule-shaped, off-white, unscored tablets, debossed with u201c93u201d on one side and u201c2263u201d on the other side.
875 mg: Film-coated, capsule-shaped, off-white tablets, scored on one side, debossed with u201c93u201d on one side of the score and u201c2264u201d on the other side of the score.

Tablets: 500 mg, 875 mg ()

Amoxicillin tablets are contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other u03b2-lactam antibiotics (e.g., penicillins and cephalosporins).

History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other beta-lactams (e.g., penicillins or cephalosporins) ()

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Anaphylactic reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy. Serious anaphylactic reactions require immediate emergency treatment with supportive measures. ()
Clostridium difficile

The following are discussed in more detail in other sections of the labeling:
The most common adverse reactions (> 1%) observed in clinical trials of amoxicillin were diarrhea, rash, vomiting, and nausea. ()
To report SUSPECTED ADVERSE REACTIONS, contact u00a0at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Probenicid decreases renal tubular secretion of amoxicillin which may result in increased blood levels of amoxicillin. ()
Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. ()
Coadministration with allopurinol increases the risk of rash. ()
Amoxicillin may reduce the efficacy of oral contraceptives. ()

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Pediatric: Modify dose in patients 12 weeks or younger (u2264 3 months). ()

In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms.
Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin.
Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria.
Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin may be removed from circulation by hemodialysis.

Amoxicillin, USP is a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many gram-positive and gram-negative microorganisms. Chemically, it is (2,5,6)-6-[()-(-)-2-amino-2-(-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. The structural formula is:
CHNOSu20223HO M.W. 419.45
Each tablet, for oral administration, contains 500 mg or 875 mg amoxicillin, USP as the trihydrate. Each film-coated tablet also contains colloidal silicon dioxide, crospovidone, D&C Yellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, titanium dioxide, and triacetin.

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Long-term studies in animals have not been performed to evaluate carcinogenic potential. Studies to detect mutagenic potential of amoxicillin alone have not been conducted; however, the following information is available from tests on a 4:1 mixture of amoxicillin and potassium clavulanate. Amoxicillin and potassium clavulanate was non-mutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin and potassium clavulanate was weakly positive in the mouse lymphoma assay, but the trend toward increased mutation frequencies in this assay occurred at doses that were also associated with decreased cell survival. Amoxicillin and potassium clavulanate was negative in the mouse micronucleus test and in the dominant lethal assay in mice. Potassium clavulanate alone was tested in the Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. In a multi-generation reproduction study in rats, no impairment of fertility or other adverse reproductive effects were seen at doses up to 500 mg/kg (approximately 2 times the 3 g human dose based on body surface area).

Randomized, double-blind clinical studies performed in the United States in patients with and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within 1 year) evaluated the efficacy of lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14 day therapy, or in combination with amoxicillin capsules as dual 14 day therapy, for the eradication of . Based on the results of these studies, the safety and efficacy of 2 different eradication regimens were established: Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily (see ). Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily (see ). All treatments were for 14 days. eradication was defined as 2 negative tests (culture and histology) at 4 to 6 weeks following the end of treatment. Triple therapy was shown to be more effective than all possible dual therapy combinations. Dual therapy was shown to be more effective than both monotherapies. Eradication of has been shown to reduce the risk of duodenal ulcer recurrence.

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Amoxicillin Tablets USP are supplied as follows:
500 mg: Film-coated, capsule-shaped, off-white, unscored tablets, debossed with u201c93u201d on one side and u201c2263u201d on the other side. They are available in bottles of 100 (NDC 0093-2263-01) tablets.
875 mg: Film-coated, capsule-shaped, off-white tablets, scored on one side, debossed with u201c93u201d on one side of the score and u201c2264u201d on the other side of the score. They are available in bottles of 100 (NDC 0093-2264-01) tablets.
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
Manufactured In Canada By:n Toronto, Canada M1B 2K9
Manufactured For:n North Wales, PA 19454
Rev. L 7/2018

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