Trade Name: Amoxicillin

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals,Inc.

Presentation: POWDER, FOR SUSPENSION, HUMAN PRESCRIPTION DRUG

Strength: 250 mg/5mL

Storage and handling

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

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
  • No data
  • Indications and Usage, Gonorrhea (n n n ) Removed 9/2015 n nn
  • Dosage and Administration, Gonorrhea (n n n ) Removed 9/2015n nn
  • Amoxicillin is 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 capsules, amoxicillin for oral suspension, amoxicillin tablets (chewable) and other antibacterial drugs, amoxicillin capsules, amoxicillin for oral suspension, and amoxicillin tablets (chewable) should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. (n n n )n nn
  • Infections of the ear, nose, throat, genitourinary tract, skin and skin structure, and lower respiratory tract. (n n n to n n n )n n n
  • In combination for treatment of n n n infection and duodenal ulcer disease. (n n n )n n n
  • No data
  • 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. (n n n , n n n , n n n )n n n
  • The upper dose for neonates and infants u2264 3 months is 30 mg/kg/day divided every 12 hours. (n n n )n n n
  • Dosing for n n n Infection: Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. (n n n )n n n
  • Reduce the dose in patients with severe renal impairment (GFR < 30 mL/min). (n n n )n n n
  • Amoxicillin Capsules USP
  • 250 mg: Opaque caramel cap and opaque buff body, hard gelatin capsule. Printed black u201cTEVAu201d on cap and u201c3107u201d on body portions of the capsule and contain 250 mg amoxicillin as the trihydrate.
  • 500 mg: Opaque buff cap and opaque buff body, hard gelatin capsules. Printed black u201cTEVAu201d on cap and u201c3109u201d on body portions of the capsules and contain 500 mg amoxicillin as the trihydrate.
  • Amoxicillin for Oral Suspension USP
  • 125 mg/5 mL: Each 5 mL of reconstituted mixed berry flavored suspension contains 125 mg amoxicillin as the trihydrate.
  • 250 mg/5 mL: Each 5 mL of reconstituted mixed berry flavored suspension contains 250 mg amoxicillin as the trihydrate.
  • Amoxicillin Tablets USP (Chewable)
  • 125 mg: White to off-white, capsule-shaped tablet, debossed 93 on one side and 2267 on the other side and contain 125 mg amoxicillin as the trihydrate.
  • 250 mg: White to off-white, capsule-shaped tablet, debossed 93 (partial bisect between 9 and 3) on one side and 2268 on the other side and contain 250 mg amoxicillin as the trihydrate.
  • Capsules: 250 mg, 500 mg (n n n )n n n
  • Powder for Oral Suspension: 125 mg/5 mL, 250 mg/5 mL (n n n )n n n
  • Tablets (Chewable): 125 mg, 250 mg (n n n )n n n
  • Amoxicillin is 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) (n n n )n n n
  • No data
  • 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. (n n n )n n n
  • 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 capsules, tablets (chewable) or oral suspension were diarrhea, rash, vomiting, and nausea. (n n n )n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Probenicid decreases renal tubular secretion of amoxicillin which may result in increased blood levels of amoxicillin. (n n n )n n n
  • Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. (n n n )n n n
  • Coadministration with allopurinol increases the risk of rash. (n n n )n n n
  • Amoxicillin may reduce the efficacy of oral contraceptives. (n n n )n n n
  • No data
  • Pediatric: Modify dose in patients 12 weeks or younger (u2264 3 months). (n n n )n n n
  • 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 amoxicillinn n n .n nn
  • 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 (2n n n ,5n n n ,6n n n )-6-[(n n n )-(-)-2-amino-2-(n n n -hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. The structural formula is:n nn
  • Cn n n Hn n n Nn n n On n n Su20223Hn n n O M.W. 419.45n nn
  • Amoxicillin Capsules USP
  • Each capsule, for oral administration, contains 250 mg or 500 mg amoxicillin, USP as the trihydrate.
  • Inactive Ingredients: CAPSULES-DRUG PRODUCT: magnesium stearate, talc.
  • CAPSULE SHELL AND PRINT CONSTITUENTS: black iron oxide, D&C Yellow #10, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40, FD&C Red #40 Aluminum Lake, gelatin, propylene glycol, shellac, titanium dioxide. In addition, the 500 mg capsule shell may also contain methylparaben, potassium hydroxide, propylparaben, and sodium lauryl sulfate; and the 250 mg capsule shell contains D&C Red #28 and FD&C Blue #1.
  • Amoxicillin for Oral Suspension USP
  • Each 5 mL of reconstituted suspension contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate.
  • Inactive Ingredients: SUSPENSION: FD&C Red #40, mixed berry flavoring, silicon dioxide, sodium benzoate, sodium citrate, sucrose, and xanthan gum.
  • Amoxicillin Tablets USP (Chewable)
  • Each chewable tablet, for oral administration, contains 125 mg or 250 mg of amoxicillin, USP as the trihydrate.
  • Inactive Ingredients: CHEWABLE TABLETS: cherry flavor, lactose anhydrous, magnesium stearate, mannitol, microcrystalline cellulose, sodium citrate, and sucrose.
  • No data
  • 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 n n n 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 n n n . Based on the results of these studies, the safety and efficacy of 2 different eradication regimens were established: n n n Amoxicillin 1 gram twice daily/clarithromycin 500 mg twice daily/lansoprazole 30 mg twice daily (see Table 6). n n n Amoxicillin 1 gram three times daily/lansoprazole 30 mg three times daily (see Table 7). All treatments were for 14 days. n n n 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 n n n has been shown to reduce the risk of duodenal ulcer recurrence.n nn
  • No data
  • 250 mg: Opaque caramel cap and opaque buff body, hard gelatin capsule. Printed black u201cTEVAu201d on cap and u201c3107u201d on body portions of the capsule and contain 250 mg amoxicillin as the trihydrate. They are available in bottles of 100 (NDC 66267-994-00)
  • 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.
  • Information for Patients
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
  • Manufactured In Canada By:
  • TEVA CANADA LIMITED
  • Toronto, Canada M1B 2K9
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • No data

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Amoxicillin (Amoxicillin) which is also known as Amoxicillin and Manufactured by NuCare Pharmaceuticals,Inc.. It is available in strength of 250 mg/5mL.

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.

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