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Amoxicillin And Clavulanate Potassium (Amoxicillin And Clavulanate Potassium)

Trade Name : Amoxicillin and Clavulanate Potassium

Northstar RxLLC

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 RxLLC. 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

Packaging and Delivery

Validated Cold Chain Shipment

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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  • No data
  • To reduce the development of drug-resistant 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 tablets, USP 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, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated for treatment of the following:
  • 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.
  • 2.1n- 2.2
  • Tablets
  • Amoxicillin and Clavulanate Potassium Tablets, USP, 250 mg/125 mg:
  • Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg:
  • The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet should NOT be substituted for each other, as they are not interchangeable and the 250-mg tablet should not be used in children weighing less than 40 kg. The 250-mg tablet of amoxicillin and clavulanate potassium and the 250-mg chewable tablet do not contain the same amount of clavulanic acid. The 250-mg tablet of amoxicillin and clavulanate potassium contains 125 mg of clavulanic acid whereas the 250-mg chewable tablet contains 62.5 mg of clavulanic acid.
  • Two 250 mg tablets of amoxicillin and clavulanate potassium should NOT be substituted for one 500 mg tablet of amoxicillin and clavulanate potassium. Since both the 250 mg and 500 mg tablets of amoxicillin and clavulanate potassium contain the same amount of clavulanic acid (125 mg, as the potassium salt), two 250 mg tablets of amoxicillin and clavulanate potassium are not equivalent to one 500 mg tablet of amoxicillin and clavulanate potassium.
  • Formulations and amoxicillin/clavulanate content are:
  • u2022
  • 3
  • No data
  • No data
  • Clostridium difficile
  • 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%) ()
  • www.fda.gov/medwatch
  • No data
  • No data
  • 2.3n- 8.6
  • 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 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. n
  • 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). Amoxicillin 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:
  • 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:
  • Inactive Ingredients
  • No data
  • Long-term 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, 250 mg/125 mg:
  • NDC 16714-476-01 bottles of 30
  • Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg:
  • NDC 16714-477-01 bottles of 20
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature]. Dispense in original container; advise patient to keep in closed container.
  • Keep out of reach of children.
  • No data
  • NDC 16714-476-01
  • Rx only
  • Amoxicillin
  • and Clavulanate
  • Potassium
  • Tablets, USP
  • 250 mg/125 mg*
  • 30 Tablets
  • NORTHSTAR
  • NDC 16714-477-01
  • Rx only
  • Amoxicillin
  • and Clavulanate
  • Potassium
  • Tablets, USP
  • 500 mg/125 mg*
  • 20 Tablets
  • NORTHSTAR

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