Amoxicillin And Clavulanate Potassium (Amoxicillin And Clavulanate Potassium)

Trade Name : Amoxicillin and Clavulanate Potassium

West-Ward Pharmaceuticals Corp

TABLET

Strength 875125 mg/1mg/1

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

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Amoxicillin And Clavulanate Potassium (Amoxicillin And Clavulanate Potassium) which is also known as Amoxicillin and Clavulanate Potassium and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 875; 125 mg/1; mg/1 per ml. Read more

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.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Tou00a0reduce the development of drug-resistant bacteria and maintain the effectiveness ofu00a0Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0and other antibacterial drugs,u00a0Amoxicillin and Clavulanate Potassiumu00a0Tabletsshould 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 Potassiumu00a0Tabletsu00a0is 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 Potassiumu00a0Tabletsu00a0are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following:
  • Loweru00a0respiratory tract infections ()
  • Acute bacterial otitis media ()
  • Sinusitis ()
  • Skin and skin structure infections ()
  • Urinary tract infections ()
  • Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced whenu00a0Amoxicillin and Clavulanate Potassium Tabletsu00a0is administered at the start of a meal.u00a0Tou00a0minimize the potential for gastrointestinalu00a0intolerance,u00a0Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0should be taken at the start of a meal.
  • Adults and Pediatric Patients > 40 kg: 875 mgu00a0every 12 hoursu00a0()
  • Amoxicillin and Clavulanate Potassium Tablets, USP
  • Formulations and amoxicillin/clavulanate content are:u00a0Tablets: 875 mg/125 mg.u00a0Tablets are scored. ()
  • No data
  • History of a serious hypersensitivity reaction (e.g., anaphylaxis or u00a0Stevens-Johnson syndrome) tou00a0Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0or to other beta-lactamsu00a0(e.g., penicillins or cephalosporins) ()n
  • History of cholestatic jaundice/hepatic dysfunction associated withu00a0Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0()
  • No data
  • Seriousu00a0(includingu00a0fatal)u00a0hypersensitivity reactions:u00a0Discontinueu00a0Amoxicillinu00a0and Clavulanateu00a0Potassiumu00a0Tabletsu00a0ifu00a0au00a0reaction occurs.u00a0()n
  • Hepaticu00a0dysfunctionu00a0andu00a0cholestaticu00a0jaundice: Discontinueu00a0ifu00a0signs/symptomsu00a0ofu00a0hepatitisu00a0occur.u00a0Monitoru00a0liveru00a0functionu00a0testsu00a0inu00a0patientsu00a0with hepaticu00a0impairment.u00a0()
  • Clostridiun- mn- u00a0n- difficile
  • Patientsu00a0withu00a0mononucleosisu00a0whou00a0receive Amoxicillinu00a0andu00a0Clavulanateu00a0Potassiumu00a0Tablets developu00a0skinu00a0rash.u00a0Avoidu00a0Amoxicillinu00a0and Clavulanateu00a0Potassiumu00a0Tabletsu00a0useu00a0inu00a0these patients.u00a0()n
  • Overgrowth:u00a0Theu00a0possibilityu00a0ofu00a0superinfections withu00a0fungalu00a0oru00a0bacterialu00a0pathogensu00a0shouldu00a0be consideredu00a0duringu00a0therapy.u00a0()
  • The following are discussed in more detail in other sections of the labeling:
  • The most frequently reported adverse effects wereu00a0diarrhea/loose stools (9%),u00a0nausea (3%), skin rashes and urticaria (3%),u00a0vomiting (1%)u00a0and vaginitis (1%)u00a0()
  • No data
  • Co-administration with probenecid is not recommended. ()n
  • Concomitant use ofu00a0Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0and oral anticoagulants mayu00a0increase the prolongation of prothrombin time. ()n
  • Co-administration with allopurinol increases the risk of rash. ()n
  • Amoxicillin and Clavulanate Potassiumu00a0Tablets may reduce efficacy of oral contraceptives. ()
  • No data
  • Pediatric Use: Modify dose in patients 12 weeks or younger. ()n
  • Renal impairment; Dosage adjustment is recommended for severe renal impairment (GFR< 30mL/min). (, )
  • In case of overdosage, discontinue medication, treat symptomatically, and institute supportiveu00a0measures as required.u00a0Au00a0prospective study of 51 pediatric patients at a poison-control centeru00a0suggested 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 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 bloodu00a0levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin/clavulanate potassium.u00a0Amoxicillin/clavulanate potassium may be removed from circulation by hemodialysis. n n n n n
  • Amoxicillin and Clavulanate Potassiumu00a0Tablets,u00a0USPu00a0is an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid).u00a0Amoxicillin is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid.u00a0
  • The amoxicillin molecular formula is CHNu00a0Ou00a0Su20223HO, and the molecular weight is 419.46. Chemically, amoxicillin is (256)-6-[()-(-)-2-Amino-2-(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:
  • Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. 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 isu00a0CHKNO , and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)u00a0(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and mayu00a0be represented structurally as:
  • Inactive Ingredients:
  • Colloidal silicon dioxide, ethylcellulose, hypromellose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium starch glycolate, and titanium dioxide.
  • Each tablet of amoxicillin/clavulanate potassium contains 0.63 mEq potassium.
  • No data
  • Long-term studies in animals have not been performed to evaluate carcinogenic potential. Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0(4:1 ratio formulation of amoxicillin:clavulanate) was non-mutagenic in theu00a0Ames bacterial mutation assay, and the yeast gene conversion assay. Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0was weakly positive in the mouse lymphoma assay, but the trend towardu00a0increased mutation frequencies in this assay occurred at doses that wereu00a0also associated with decreased cell survival.
  • Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0was negative in the mouse micronucleus test, andu00a0in the dominant lethal assay in mice. Potassium clavulanate alone was tested in theu00a0Ames bacterial mutation assay and in the mouse micronucleus test, and was negative in each of these assays. Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0(2:1 ratio formulation of amoxicillin:clavulanate)u00a0at 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
  • 1. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin andu00a0cephalosporin ingestions in children less than six years of age.Vet Hum Toxicol. 1988; 30: 66-67.n
  • Amoxicillin and Clavulanate Potassium Tablets, USPu00a0875mg/125mg
  • NDC 0143-9249-20 ........... 20 tablets bottle
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USPu00a0Controlled Roomu00a0Temperature].
  • Dispense in a tight 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.
  • No data
  • Patients should be informed thatu00a0Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0may be taken everyu00a08 hours or every 12 hours, depending on the dose prescribed. Each dose should be taken with au00a0meal or snack to reduce the possibility of gastrointestinal upset.
  • Patients should be counseled that antibacterial drugs, includingu00a0Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0should only be used to treat bacterial infections.u00a0They do not treat viral infections (e.g., the common cold). Whenu00a0Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better earlyu00a0in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1)u00a0decrease the effectiveness of the immediate treatment, and (2)u00a0increase the likelihood that bacteria will develop resistance and will not be treatable byu00a0Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0or other antibacterial drugs in the future.
  • Counsel patients that diarrhea is a common problem caused by antibacterials, and it usually ends whenu00a0the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (withu00a0or 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 awareu00a0thatu00a0Amoxicillin and Clavulanate Potassiumu00a0Tabletsu00a0contain a penicillin class drug product that can cause allergic reactions in some individuals.
  • Distributed by:n n Eatontown, NJ 07724 U.S.A.
  • Manufactured by: n n n P.O.Box 182400Amman 11118 - JordanRevisedu00a0September 2018
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