Amoxicillin (Amoxicillin)

Trade Name

Amoxicillin

Active Ingredient

Power

200 mg/5mL

Type / form

Tablets

Status

Manufacturer

Teva Pharmaceuticals USA, Inc.

Storage and handling for Amoxicillin

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

Disclaimer

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 200 mg/5mL 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

About GNH

GNH India a Global Orphan Drug specialist renowned for its adherence to stringent quality standards. GNH India holds ISO 9001:2015 certification and WHO Good Storage and Distribution Practices (GSDP) compliance, ensuring the highest levels of safety and reliability in our operations.

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  • No data
  • Amoxicillin for Oral Suspension 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 for Oral Suspension and other antibacterial drugs, Amoxicillin for Oral Suspension 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. ()
  • 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. (, , )
  • 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 for Oral Suspension, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram Amoxicillin for Oral Suspension 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). ()
  • Each 5 mL of reconstituted pink, fruit gum flavored suspension contains 200 mg amoxicillin as the trihydrate.
  • Each 5 mL of reconstituted pink, fruit gum flavored suspension contains 400 mg amoxicillin as the trihydrate.
  • Powder for Oral Suspension: 200 mg/5 mL, 400 mg/5 mL, ()
  • Amoxicillin for oral suspension 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) ()
  • 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. ()
  • 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 or oral suspension were diarrhea, rash, vomiting, and nausea. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact TEVA PHARMACEUTICALS USA, Inc. at 1-888-838-2872 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. ()
  • 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. ()
  • No data
  • 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. It may be represented structurally as:
  • CHNOSu20223HO M.W. 419.45
  • Each 5 mL of reconstituted suspension for oral administration contains 200 mg or 400 mg amoxicillin, USP as the trihydrate. Each 5 mL of the 200 mg reconstituted suspension for oral administration contains 0.09 mEq (2.11 mg) of sodium; each 5 mL of the 400 mg reconstituted suspension for oral administration contains 0.12 mEq (2.69 mg) of sodium.
  • Amoxicillin for Oral Suspension USP, 200 mg/5 mL and 400 mg/5 mL are fruit gum flavored suspensions. Inactive ingredients: colloidal silicon dioxide, FD&C Red #40, fruit granulated sugar, natural and artificial fruit gum flavor, sodium benzoate, sodium citrate, spray dried mask flavor, and xanthan gum.
  • 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 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.
  • No data
  • Amoxicillin for Oral Suspension USP is supplied as follows:
  • Each 5 mL of reconstituted pink, fruit gum flavored suspension contains 200 mg amoxicillin as the trihydrate. It is available in bottles of 50 mL (NDC 0093-4160-76), 75 mL (NDC 0093-4160-78), and 100 mL (NDC 0093-4160-73).
  • Each 5 mL of reconstituted pink, fruit gum flavored suspension contains 400 mg amoxicillin as the trihydrate. It is available in bottles of 50 mL (NDC 0093-4161-76), 75 mL (NDC 0093-4161-78), and 100 mL (NDC 0093-4161-73).
  • Store dry powder 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:
  • Teva Canada Limited
  • Toronto, Canada M1B 2K9
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. J 7/2018
  • No data
  • No data

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