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: 875; 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.
  3. Read more
  • No data
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) 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 Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) are combination penicillin-class antibacterials and beta-lactamase inhibitors indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*:
  • Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) are combination penicillin-class antibacterials and beta-lactamase inhibitors indicated for treatment of the following:
  • Lower respiratory tract infections (n n n ) n n n
  • Acute bacterial otitis media (n n n ) n n n
  • Sinusitis (n n n ) n n n
  • Skin and skin structure infections (n n n ) n n n Urinary tract infections (n n n )n n n
  • Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) should be taken at the start of a meal.
  • Adults and Pediatric Patients > 40 kg: 500 mg/125 mg or 875 mg/125 mg every 12 hours or 250 mg/125 mg or 500 mg/125 mg every 8 hours. (n n n , 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 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/31.25 mg per 5 mL oral suspension is recommended. (n n n ) n n n
  • Tablets
  • 500 mg/125 mg Tablets: White, oblong-shaped, biconvex, film-coated, unscored tablets, debossed 93 on one side and 2274 on the other side. Each tablet contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.
  • 875 mg/125 mg Tablets: White, capsule-shaped, biconvex, film-coated, scored tablets, debossed 93 on one side and 22 score line 75 on the other side. Each tablet contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt.
  • Powder for Oral Suspension
  • 200 mg/28.5 mg per 5 mL: White to off-white, orange-raspberry flavored powder for oral suspension (each 5 mL of reconstituted suspension, when reconstituted according to directions on the container label, contains 200 mg amoxicillin and 28.5 mg of clavulanic acid as the potassium salt).
  • 400 mg/57 mg per 5 mL: White to off-white, orange-raspberry flavored powder for oral suspension (each 5 mL of reconstituted suspension, when reconstituted according to directions on the container label, contains 400 mg amoxicillin and 57 mg of clavulanic acid as the potassium salt).
  • Chewable Tablets
  • 200 mg/28.5 mg Chewable Tablets: Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2270 on the other.
  • 400 mg/57 mg Chewable Tablets: Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2272 on the other.
  • The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet 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 Amoxicillin and Clavulanate Potassium Tablet and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid. The 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet 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 Amoxicillin and Clavulanate Potassium Tablets should NOT be substituted for one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet. Since both the 250 mg/125 mg and 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg/125 mg Amoxicillin and Clavulanate Potassium Tablets are not equivalent to one 500 mg/125 mg Amoxicillin and Clavulanate Potassium Tablet.
  • Formulations and amoxicillin/clavulanate content are:
  • Tablets: 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg tablets are scored. (n n n )n nn
  • Powder for Oral Suspension: 200 mg/28.5 mg per 5 mL, 400 mg/57 mg per 5 mL (n n n )n nn
  • Chewable Tablets: 200 mg/28.5 mg, 400 mg/57 mg (n n n )n nn
  • No data
  • History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin/clavulanate potassium or to other beta-lactams (e.g., penicillins or cephalosporins) (n n n ) n n n
  • History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin/clavulanate potassium. (n n n )n n n
  • No data
  • Serious (including fatal) hypersensitivity reactions: Discontinue amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) if a reaction occurs. (n n n ) n n n
  • Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. (n n n ) n n n
  • Clostridium difficile
  • Patients with mononucleosis who receive amoxicillin/clavulanate potassium develop skin rash. Avoid amoxicillin/clavulanate potassium use in these patients. (n n n ) n n n
  • Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. (n n 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 TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com; or FDA at 1-800-FDA-1088 or n n n n
  • No data
  • Coadministration with probenecid is not recommended. (n n n )n n n
  • Concomitant use of amoxicillin/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 n n
  • Amoxicillin/clavulanate potassium may reduce efficacy of oral contraceptives. (n n n )n n n
  • No data
  • Pediatric Use: Modify dose in patients 12 weeks or younger. (n n n ) n n n
  • Renal Impairment; Dosage adjustment is recommended for severe renal impairment (GFR< 30 mL/min). (n n n , 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 symptomsn n n . n nn
  • Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin/clavulanate potassium.
  • Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin/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/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/clavulanate potassium. Amoxicillin/clavulanate potassium may be removed from circulation by hemodialysis. [see n n n ]n nn
  • Amoxicillin and Clavulanate Potassium Tablets, Amoxicillin and Clavulanate Potassium for Oral Suspension, and Amoxicillin and Clavulanate Potassium Tablets (Chewable) are oral antibacterial combinations consisting of the semisynthetic antibiotic amoxicillin, USP and the beta-lactamase inhibitor, clavulanate potassium, USP (the potassium salt of clavulanic acid). Amoxicillin, USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. Chemically, amoxicillin, USP is (n n n ,n n n ,n 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 has the following structural formula:n nn
  • Cn n n Hn n n Nn n n On n n Su20223Hn n n O M.W. 419.45n nn
  • Clavulanic acid is produced by the fermentation of 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. Chemically, clavulanate potassium, USP is potassium (n n n )-(2n n n ,5n n n )-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and has the following structural formula:n nn
  • Cn n n Hn n n KNOn n n M.W. 237.25n nn
  • Amoxicillin and Clavulanate Potassium Tablets USP
  • Each tablet contains 500 mg or 875 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. Each Amoxicillin and Clavulanate Potassium Tablet USP contains 0.63 mEq potassium.
  • Inactive Ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, and triacetin.
  • Amoxicillin and Clavulanate Potassium for Oral Suspension USP
  • After reconstitution each teaspoonful (5 mL) of suspension will contain 200 mg amoxicillin, USP as the trihydrate and 28.5 mg clavulanic acid as the potassium salt or 400 mg amoxicillin, USP as the trihydrate and 57 mg clavulanic acid as the potassium salt. Each 5 mL of reconstituted Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5 mL contains 0.14 mEq potassium. Each 5 mL of reconstituted Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 400 mg/57 mg per 5 mL contains 0.29 mEq of potassium.
  • Inactive Ingredients: Powder for oral suspension: artificial raspberry powder, aspartame*, citric acid, colloidal silicon dioxide, mannitol, hypromellose, natural orange flavor, sodium citrate, sodium saccharin and xanthan gum.
  • * See n n n .n nn
  • Amoxicillin and Clavulanate Potassium Tablets USP (Chewable)
  • Each chewable tablet contains 200 mg amoxicillin, USP as the trihydrate and 28.5 mg clavulanic acid as the potassium salt or contains 400 mg amoxicillin, USP as the trihydrate and 57 mg clavulanic acid as the potassium salt. Each Amoxicillin and Clavulanate Potassium Tablet USP, (Chewable) 200 mg/28.5 mg contains 0.14 mEq potassium. Each Amoxicillin and Clavulanate Potassium Tablet USP, (Chewable) 400 mg/57 mg contains 0.29 mEq potassium.
  • Inactive Ingredients: aspartame*, colloidal silicon dioxide, FD&C Red #40 lake, magnesium stearate, mannitol, microcrystalline cellulose, SA84 artificial ripe banana flavor, and artificial cherry flavor powder.
  • * See n n n .n nn
  • No data
  • Long-term studies in animals have not been performed to evaluate carcinogenic potential.
  • Amoxicillin/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/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/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 tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) (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
  • Amoxicillin and Clavulanate Potassium Tablets USP
  • Amoxicillin and Clavulanate Potassium Tablets USP are supplied as follows:
  • 875 mg/125 mg: White, capsule-shaped, biconvex, film-coated, scored tablets, debossed 93 on one side and 22 score line 75 on the other side. Each tablet contains 875 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available in bottles:
  • NDC 66267-859-03 Bottles of 3
  • NDC 66267-859-04 Bottles of 4
  • 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). Advise patients to keep in a closed container.
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • Patients should be informed that amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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 tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable), should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are 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 tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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/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/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 tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) contain a penicillin class drug product that can cause allergic reactions in some individuals.
  • 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. B 10/2014
  • No data

Ask for Quote

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 875; 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.

Browse Our Services And Processes

Name Patient Supply

Name Patient Supply

Validated Cold Chain Shipment

Validated Cold Chain Shipment

Comparator Sourcing for Clinical Trials

Comparator Sourcing for Clinical Trials

Our Process - The Gnh Way

Our Process - The Gnh Way

Other Pharmaceutical Products

BENZALKONIUM CHLORIDE - 1 (nickelodeon bright bubble gum scented hand sanitizer)

BENZALKONIUM CHLORIDE - 1 (nickelodeon bright bubble gum scented hand sanitizer)

Liposomal Amphotericin - B for Injection IP (AmBisome)

Liposomal Amphotericin - B for Injection IP (AmBisome)

Edatate Calcium Disodium Injection USP 200mg/ml (Cal-Rsodate)

Edatate Calcium Disodium Injection USP 200mg/ml (Cal-Rsodate)

Melphalan Injection IP 50mg (Alkacel)

Melphalan Injection IP 50mg (Alkacel)

Monobenzone Cream USP 20% (Albaquin)

Monobenzone Cream USP 20% (Albaquin)

Beclomethasone Dipropionate and Levosalbutamol Inhaler (Aerocort)

Beclomethasone Dipropionate and Levosalbutamol Inhaler (Aerocort)

Are you an existing customer or a vendor of GNH India? Log in here to