Amoxicillin And Clavulanate Potassium (Amoxicillin And Clavulanate Potassium)

Trade Name : Amoxicillin and Clavulanate Potassium

Sandoz Inc

TABLET, MULTILAYER, EXTENDED RELEASE

Strength 562.5437.562.5 mg/1mg/1mg/1

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

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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 Sandoz Inc. It is available in strength of 562.5; 437.5; 62.5 mg/1; 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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To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release Tablets should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.()

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Extended Release Tablets and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Extended Release 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.
Amoxicillin and Clavulanate Potassium Extended Release Tablets are indicated for the treatment of patients with community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected u03b2-lactamaseu2013producing pathogens (i.e., , , , , or methicillin-susceptible ) and with reduced susceptibility to penicillin (i.e., penicillin MICs = 2 mcg/mL). Amoxicillin and Clavulanate Potassium Extended Release Tablets are not indicated for the treatment of infections due to with penicillin MICs u2265 4 mcg/mL. Data are limited with regard to infections due to with penicillin MICs u2265 4 mcg/n n n
In patients with community-acquired pneumonia in whom penicillin-resistant is suspected, bacteriological studies should be performed to determine the causative organisms and their susceptibility when Amoxicillin and Clavulanate Potassium Extended Release Tablets are prescribed.
Acute bacterial sinusitis or community-acquired pneumonia due to a penicillin- susceptible strain of plus a u03b2-lactamaseu2013producing pathogen can be treated with another Amoxicillin and Clavulanate Potassium product containing lower daily doses of amoxicillin (i.e., 500 mg every 8 hours or 875 mg every 12 hours). Acute bacterial sinusitis or community-acquired pneumonia due to alone can be treated with amoxicillin.
Amoxicillin and Clavulanate Potassium Extended Release Tablets are a combination of a penicillin-class antibacterial drug and a beta-lactamase inhibitor indicated for treatment of community-acquired pneumonia and acute bacterial sinusitis ().

Amoxicillin and Clavulanate Potassium Extended Release Tablets should be taken at the start of a meal to enhance the absorption of amoxicillin and to minimize the potential for gastrointestinal intolerance. Amoxicillin and Clavulanate Potassium Extended Release Tablets are not recommended to be taken with a highu2011fat meal, because clavulanate absorption is decreased. n n n

u2022
2

Amoxicillin and Clavulanate Potassium Extended Release Tablets
Tablets: 1,000 mg of amoxicillin /62.5 mg of clavulanic acid. ()

No data

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Clostridium difficile

The following are discussed in more detail in other sections of the labeling:
The most frequently reported adverse reactions were diarrhea (15%), vaginal mycosis (3%) nausea (2%), and loose stools (2%). ()
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or n

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No data

u2022

Following overdosage, patients have experienced primarily gastrointestinal symptoms including stomach and abdominal pain, vomiting, and diarrhea. Rash, hyperactivity, or drowsiness have also been observed in a small number of patients.
In the case of overdosage, discontinue Amoxicillin and Clavulanate Potassium Extended Release Tablets, treat symptomatically, and institute supportive measures as required. If the overdosage is very recent and there is no contraindication, an attempt at emesis or other means of removal of drug from the stomach may be performed. 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 and do not require gastric emptying5.
Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin.
Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In the case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin 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 both amoxicillin and clavulanate. Both amoxicillin and clavulanate are removed from the circulation by hemodialysis .

Amoxicillin and Clavulanate Potassium Extended Release Tablets for oral use is an antibacterial combination consisting of the semisynthetic antibacterial amoxicillin (present as amoxicillin trihydrate and amoxicillin sodium) and the u03b2-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 trihydrate molecular formula is C16H19N3O5Su20223H2O, and the molecular weight is 419.45. Chemically, amoxicillin trihydrate is (2,5,6)-6-[()-(-)-2-Amino-2-(p-hydroxyphenyl)acetamido]-3,3u2011 dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate and may be represented structurally as:
The amoxicillin sodium molecular formula is C16H18N3NaO5S, and the molecular weight is 387.39. Chemically, amoxicillin sodium is [2 -[2u03b1,5u03b1,6u03b2(S*)]]-6-[[Amino(4u2011 hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1- azabicyclo[3.2.0]heptane-2u2011 carboxylic acid monosodium salt and may be represented structurally as:
Clavulanic acid is produced by the fermentation of . It is a u03b2u2011 lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of u03b2-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated u03b2-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins. The clavulanate potassium molecular formula is C8H8KNO5, and the molecular weight is 237.25. Chemically, clavulanate potassium is potassium (Z)-(2,5)-3-(2-hydroxy ethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate, and may be represented structurally as:
Inactive Ingredients:
Each film coated tablet contains amoxicillin trihydrate and amoxicillin sodium equivalent to 1000 mg of amoxicillin and clavulanate potassium equivalent to 62.5 mg of clavulanic acid.
Each tablet of Amoxicillin and Clavulanate Potassium Extended Release Tablets contains approximately 12 mg of potassium and 29 mg of sodium.
Meets USP Dissolution Test 2.

No data

Longu2011term studies in animals have not been performed to evaluate carcinogenic potential. The mutagenic potential of Amoxicillin and Clavulanate Potassium was investigated with an Ames test, a human lymphocyte cytogenetic assay, a yeast test, and a mouse lymphoma forward mutation assay, and with mouse micronucleus tests and a dominant lethal test. All were negative apart from the mouse lymphoma assay, where weak activity was found at very high, cytotoxic concentrations. Amoxicillin and Clavulanate Potassium at oral doses of up to 1,200 mg/kg/day (1.9 times the maximum human dose of amoxicillin and 15 times the maximum human dose of clavulanate based on body surface area) was found to have no effect on fertility and reproductive performance in rats dosed with a 2:1 ratio formulation of amoxicillin:clavulanate.

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Amoxicillin and Clavulanate Potassium Extended Release Tablets
NDC 0781-1943-82 Bottles of 28 (7 day Extended Release Tablets pack)
NDC 0781-1943-39 Bottles of 40 (10 day Extended Release Tablets pack)
Storage
Store tablets at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Dispense in original container.
Keep out of reach of children.

Advise the patient to read the FDA-approved patient labeling (Patient Information)
Counsel patients to take Amoxicillin and Clavulanate Potassium Extended Release Tablets every 12 hours with a low fat meal or snack to reduce the possibility of gastrointestinal upset. If diarrhea develops and is severe or lasts more than 2 or 3 days, call your doctor.
Patients should be counseled that antibacterial drugs, including Amoxicillin and Clavulanate Potassium Extended Release Tablets, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Amoxicillin and Clavulanate Potassium Extended Release Tablets 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 Extended Release Tablets 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. Discard any unused medicine.
Patients should be aware that Amoxicillin and Clavulanate Potassium contain a penicillin class drug product that can cause allergic reactions in some individuals.
MAALOX is a registered trademark of Novartis Consumer Health, Inc. CLINITEST is a registered trademark of Miles, Inc.
46172787
10-2015M
Manufactured in Austria by Sandoz GmbH
for Sandoz Inc., Princeton, NJ 08540

NDC 0781-1943-82
Amoxicillin
and Clavulanate
Potassium
Extended
Release Tablets
1000 mg */62.5 mg
Rx Only
AMOXICILLIN, 1000 mg,
CLAVULANIC ACID, 62.5 mg,
as clavulanate potassium
7 day Extended Release Pack
28 Scored Tablets
SANDOZ

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Amoxicillin And Clavulanate Potassium (Amoxicillin And Clavulanate Potassium)

Trade Name : Amoxicillin and Clavulanate Potassium

TABLET, MULTILAYER, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Amoxicillin And Clavulanate Potassium (Amoxicillin And Clavulanate Potassium)

Trade Name : Amoxicillin and Clavulanate Potassium

TABLET, MULTILAYER, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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