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: CAPSULE, HUMAN PRESCRIPTION DRUG

Strength: 250 mg/1

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
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  • 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 and other antibacterial drugs, amoxicillin 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 )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, 750-1750 mg/day in divided doses every 8-12 hours. In Pediatric Patients > 3 Months of Age, 20-45 mg/kg/day in divided doses every 8-12 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
  • Capsules:
  • Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side.
  • Tablets: n- .
  • Each film coated tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side.
  • For Oral Suspension:
  • Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate.
  • Capsules: 250 mg, 500 mg (n n n )n n n
  • Tablets: 500 mg, 875 mg (n n n )n n n
  • For Oral Suspension: 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL (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
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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. (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 or oral suspension were diarrhea, rash, vomiting, and nausea. (n n n )n nn
  • www.fda.gov/medwatch
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  • 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
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  • 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.
  • Formulations of amoxicillin contain amoxicillin, 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-[(R)-(-)-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. It may be represented structurally as:n nn
  • The amoxicillin molecular formula is Cn n n Hn n n Nn n n On n n S u2022 3Hn n n O, and the molecular weight is 419.45.n nn
  • Amoxicillin Capsules, USP:
  • Each amoxicillin capsule, with yellow opaque cap and body, contains 250 mg or 500 mg amoxicillin as the trihydrate. The 250 mg capsule is imprinted AMOX 250 on one side and GG 848 on the other side; the 500 mg capsule is imprinted AMOX 500 on one side and GG 849 on the other side. Inactive ingredients: Capsule shells - yellow ferric oxide, titanium dioxide, gelatin, black ferric oxide, shellac, propylene glycol, potassium hydroxide and ammonium hydroxide; Capsule contents - cellulose microcrystalline and magnesium stearate.
  • Meets USP Dissolution Test 2.
  • Amoxicillin Tablets, USP:
  • Each film coated tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. The tablets are oval-shaped and white to yellowish. The 500 mg tablet is unscored, embossed GG-961 on one side and 500 on the other side. The 875 mg tablet is scored and embossed GG-962 on one side and 875 on the other side. In addition each amoxicillin tablet contains these inactive ingredients: colloidal silicon dioxide, crospovidone, ethylcellulose aqueous dispersion, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, triethyl citrate, and titanium dioxide.
  • Amoxicillin for Oral Suspension, USP:
  • Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg, and 400 mg reconstituted suspension contains 0.30 mEq (6.95 mg) of sodium.
  • Amoxicillin trihydrate for oral suspension 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL and 400 mg/5 mL are fruity flavored pink suspensions. Inactive ingredients: anhydrous citric acid, colloidal silicon dioxide, flavorings: raspberry, strawberry, refrachessement, FD&C Red 40, sodium benzoate, sodium citrate, sucrose, and xantham gum.
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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 clavulanate potassium. Amoxicillin and clavulanate potassium was nonmutagenic in the Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin and clavulanate potassium 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 clavulanate potassium 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).n nn
  • 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
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  • Amoxicillin Capsules, USP,
  • 250 mg:
  • NDC 66267-763-04............................................ bottles of 4
  • NDC 66267-763-06............................................ bottles of 6
  • Store capsules, tablets and n- unreconstitutedn- powder for oral suspension at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F).n- [See USP Controlled Room Temperature].
  • Information for Patients
  • CLINITESTu00ae is a registered trademark of Miles, Inc.
  • CLINISTIXu00ae is a registered trademark of Bayer Corporation.
  • CLOtestu00ae is a registered trademark of Kimberly-Clark Corporation.
  • 46176378
  • 12-2015M
  • Manufactured in Austria by Sandoz GmbH for
  • Sandoz Inc., Princeton, NJ 08540
  • Product of Spain
  • 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/1.

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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