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Amoxicillin And Clavulanate Potassium (Amoxicillin And Clavulanate Potassium)

Trade Name : Amoxicillin and Clavulanate Potassium

NorthStar Rx LLC

TABLET, FILM COATED

Strength 250125 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 NorthStar Rx LLC. It is available in strength of 250; 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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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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  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium u00a0tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets 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.n Amoxicillin and clavulanate potassium tablets are 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 tablets are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following: Lower respiratory tract infections n Acute bacterial otitis media n Sinusitis n Skin and skin structure infections n Urinary tract infections n
  • Amoxicillin and clavulanate potassium tablets may be taken without regard to meals; however, absorption of clavulanate potassium is enhanced when amoxicillin and clavulanate potassium tablets are administered at the start of a meal. To minimize the potential for gastrointestinal intolerance, amoxicillin and clavulanate potassium tablets 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.u00a0u00a0n
  • 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.u00a0n
  • 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.u00a0n
  • The amoxicillin and clavulanate potassium tablet 250 mg/125 mg 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 amoxicillin and clavulanate potassium tablet 250 mg/125 mg and the 250 mg/62.5 mg chewable tablet do not contain the same amount of clavulanic acid. The amoxicillin and clavulanate potassium tablet 250 mg/125 mg contains 125 mg of clavulanic acid whereas the 250 mg/62.5 mg chewable tablet contains 62.5 mg of clavulanic acid.n Two amoxicillin and clavulanate potassium tablets 250 mg/125 mg should NOT be substituted for one amoxicillin and clavulanate potassium tablet 500 mg/125 mg. Since both the amoxicillin and clavulanate potassium tablets 250 mg/125 mg and 500 mg/125 mg contain the same amount of clavulanic acid (125 mg, as the potassium salt), two amoxicillin and clavulanate potassium tablets 250 mg/125 mg are not equivalent to one amoxicillin and clavulanate potassium tablet 500 mg/125 mg.
  • Tablets: 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg tablets are scored n
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  • History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens Johnson syndrome) to amoxicillin and clavulanate potassium tablets or to other beta-lactams (e.g., penicillins or cephalosporins).u00a0n
  • History of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium tablets.u00a0n
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  • Serious (including fatal) hypersensitivity reactions: Discontinue amoxicillin and clavulanate potassium if a reaction occurs.u00a0n
  • Hepatic dysfunction and cholestatic jaundice: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests in patients with hepatic impairment. n
  • Clostridium difficile
  • Patients with mononucleosis who receive amoxicillin and clavulanate potassium develop skin rash. Avoid amoxicillin and clavulanate potassium use in these patients. n
  • Overgrowth: The possibility of superinfections with fungal or bacterial pathogens should be considered during therapy. n
  • 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
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  • Co-administration with probenecid is not recommended.u00a0n
  • Concomitant use of amoxicillin and clavulanate potassium and oral anticoagulants may increase the prolongation of prothrombin time.u00a0n
  • Coadministration with allopurinol increases the risk of rash.u00a0n
  • Amoxicillin and clavulanate potassium may reduce efficacy of oral contraceptives. n
  • No data
  • Pediatric Use: Modify dose in patients 12 weeks or younger.u00a0n
  • u00a0Renal Impairment: Dosage adjustment is recommended for severe renal impairment (GFR< 30 mL/min).u00a0u00a0n
  • 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.n Interstitial nephritis resulting in oliguric renal failure has been reported in patients after overdosage with amoxicillin and clavulanate potassium.n 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.n 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 hemodialysis .
  • Amoxicillin and clavulanate potassium tablets, USP are an oral antibacterial combination consisting of amoxicillin and the beta-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid).n Amoxicillin USP is an analog of ampicillin, derived from the basic penicillin nucleus, 6-aminopenicillanic acid. The amoxicillin molecular formula is CHNOSu20223HO, 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:u00a0
  • Clavulanic acid is produced by the fermentation of . 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 CHKNO, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium ()()-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate and may be represented structurally as:
  • Each film coated tablet for oral administration contains 250 mg, 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 250 mg/125 mg, 500 mg/125 mg or 875 mg/125 mg contains 0.63 mEq potassium.n n Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, surelease clear (aqueous ethyl cellulose dispersion), and titanium dioxide.
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  • 1. Swanson-Biearman B, Dean BS, Lopez G, Krenzelok EP. The effects of penicillin and cephalosporin ingestions in childrenu00a0less than six years of age. Vet Hum Toxicol. 1988; 30: 66-67.
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  • 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.n 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.n 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.n Patients should be aware that amoxicillin and clavulanate potassium contains a penicillin class drug product that can cause allergic reactions in some individuals.n CLINITEST is a registered trademark of Miles, Inc.
  • Manufactured for:u00a0u00a0u00a0u00a0Northstar Rx LLC u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Memphis, TN 38141 u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Manufactured by:u00a0u00a0u00a0u00a0Aurobindo Pharma Limited u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0Hyderabad-500 090, India.n M.L.No.: 57/RR/AP/2003/F/Rn Revised: 07/2018
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