Trade Name: Amoxicillin and Clavulanate Potassium

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: TABLET, FILM COATED, HUMAN PRESCRIPTION DRUG

Strength: 500; 125 mg/1; mg/1

Storage and handling

AMOXICILLIN; CLAVULANATE POTASSIUM Penicillin-class Antibacterial [EPC],Penicillins [CS],beta Lactamase Inhibitor [EPC],beta Lactamase Inhibitors [MoA]

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.
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  • No data
  • To reduce the development of drugu2011resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium should be used only to treat 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.
  • Amoxicillin and clavulanate potassium is a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
  • Amoxicillin and clavulanate potassium is a combination penicillin-class antibacterial and betau2011lactamase inhibitor indicated for treatment of the following:
  • Lower respiratory tract infections n n n (n n n )n nn
  • Acute bacterial otitis media n n n (n n n )n nn
  • Sinusitis n n n n
  • Skin and skin structure infections n n n n
  • Urinary tract infectionsn n n n
  • Amoxicillin and clavulanate potassium may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium is administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium should be taken at the start of a meal.
  • Adults and Pediatric Patients > 40 kg: 500 or 875 mg every 12 hours or 250 or 500 mg every 8 hours. (n n n )n n n
  • Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. n n n n
  • Neonates and infants < 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Use of the 125 mg/5 mL oral suspension is recommended. n n n n
  • Tablets
  • Oral Suspension:
  • The 250 mg /125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet should NOT be substituted for each other, as they are not interchangeable and the 250 mg/125 mg tablet should not be used in children weighing less than 40 kg. The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid. The 250 mg/125 mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.
  • Two 250 mg/125 mg tablets of amoxicillin and clavulanate potassium should NOT be substituted for one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium. Since both the 250 mg/125 mg and 500 mg/125 mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg tablets of amoxicillin and clavulanate potassium are not equivalent to one 500 mg/125 mg tablet of amoxicillin and clavulanate potassium.
  • Formulations and amoxicillin and clavulanate content are:
  • Tablets: 500 mg/125 mg, 875 mg/125 mg. n n n n
  • Oral Suspension:u00a0 200 mg/28.5 mg per 5 mL, 400 mg/57 mg per 5 mL n n n n
  • No data
  • History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium or to other betau2011lactams (e.g., penicillins or cephalosporins) n n n n
  • History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium.n n n n
  • No data
  • Serious (including fatal) hypersensitivity reactions: Discontinue amoxicillin and clavulanate potassium if a reaction occurs. n n n n
  • Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur.u00a0 Monitor liver function tests in patients with hepatic impairment. n n n n
  • Clostridium difficilen- Array
  • Patients with mononucleosis who receive amoxicillin and clavulanate potassium develop skin rash. Avoid amoxicillin and clavulanate potassium use in these patients. n n n n
  • Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. n n n n
  • The following are discussed in more detail in other sections of the labeling:
  • The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%)n n n )n nn
  • To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • No data
  • Cou2011administration with probenecid is not recommended. n n n n
  • Concomitant use of amoxicillin and clavulanate potassium 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
  • Amoxicillin and clavulanate potassium may reduce efficacy of oral contraceptives. n n n n
  • No data
  • Pediatric Use: Modify dose in patients 12 weeks or younger. n n n n
  • Renal impairment; Dosage adjustment is recommended for severe renal impairment (GFR< 30mL/min). (n n n , n n n )n n n
  • In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures as required.u00a0 A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250u00a0mg/kg of amoxicillin are not associated with significant clinical symptomsn n n .n nn
  • Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin and clavulanate potassium.
  • Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin and clavulanate potassium overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin and clavulanate potassium 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 and clavulanate potassium. Amoxicillin and clavulanate potassium may be removed from circulation by hemodialysisn n n [see n n n n )].n nn
  • Amoxicillin and clavulanate potassium is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid).
  • Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is Cn n n Hn n n Nn n n On n n Su20223Hn n n O, and the molecular weight is 419.46. Chemically, amoxicillin is (2n n 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 and may be represented structurally as:n nn
  • Clavulanic acid is produced by the fermentation of n n n n . It is a beta-lactam structurally related to the penicillins and possesses the ability to inactivate some beta-lactamases by blocking the active sites of these enzymes. The clavulanate potassium molecular formula is Cn n n Hn n n KNOn n n , and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (n n n )(n n n )-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:n nn
  • Inactive Ingredients:
  • Tabletsn- -
  • Oral Suspension -
  • Each 5 mL of reconstituted suspension contains:
  • amoxicillin, 200 mg, as the trihydrate and clavulanic acid, 28.5 mg, as clavulanate potassium or
  • amoxicillin, 400 mg, as the trihydrate and clavulanic acid, 57 mg, as clavulanate potassium.
  • No data
  • Longu2011term studies in animals have not been performed to evaluate carcinogenic potential.
  • Amoxicillin and clavulanate potassium (4:1 ratio formulation of amoxicillin:clavulanate) was non-mutagenic 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.
  • Amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses of up to 1,200 mg/kg/day was found to have no effect on fertility and reproductive performance in rats. Based on body surface area, this dose of amoxicillin is approximately 4 times the maximum recommended adult human oral dose (875 mg every 12 hours). For clavulanate, the dose multiple is approximately 9 times higher than the maximum recommended adult human oral dose (125 mg every 8 hours), also based on body surface area.
  • No data
  • No data
  • Tablets
  • Amoxicillin and clavulanate potassium tablets, USP 500 mg/125 mg are white to off-white oblong film coated tablets with beveled edges, debossed with 500/125 on one side and AMC on the other side. They are supplied in plastic bottles of 3 and 4.
  • NDC 66267-857-03 bottles of 3 tablets
  • NDC 66267-857-04 bottles of 4 tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers.
  • Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep out of the reach of children.
  • Patients should be informed that amoxicillin and clavulanate potassium may be taken every 8 hours or every 12 hours, depending on the dose prescribed. Each dose should be taken with a meal or snack to reduce the possibility of gastrointestinal upset.
  • Patients should be counseled that antibacterial drugs, including amoxicillin and clavulanate potassium, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin and clavulanate potassium is 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 amoxicillin and clavulanate potassium or other antibacterial drugs in the future.
  • Counsel patients that diarrhea is a common problem caused by antibacterials, and it usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, patients should contact their physician.
  • Patients should be advised to keep suspension refrigerated. Shake well before using. When dosing a child with the suspension (liquid) of amoxicillin and clavulanate potassium, use a dosing spoon or medicine dropper. Be sure to rinse the spoon or dropper after each use. Bottles of suspension of amoxicillin and clavulanate potassium may contain more liquid than required. Follow your doctoru2019s instructions about the amount to use and the days of treatment your child requires. Discard any unused medicine.
  • Patients should be aware that amoxicillin and clavulanate potassium contains a penicillin class drug product that can cause allergic reactions in some individuals.
  • CLINITEST is a registered trademark of Miles, Inc.
  • Manufactured in Slovenia by
  • Lek Pharmaceuticals d.d. for
  • Sandoz Inc., Princeton, NJ 08540
  • Rev. October 2014
  • No data

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of amoxicillin and clavulanate potassium (Amoxicillin and Clavulanate Potassium) which is also known as Amoxicillin and Clavulanate Potassium and Manufactured by NuCare Pharmaceuticals, Inc.. It is available in strength of 500; 125 mg/1; mg/1.

amoxicillin and clavulanate potassium (Amoxicillin and Clavulanate Potassium) 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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