Amoxicillin and Clavulanate Potassium Tablet for GMP Medicine

Composition:

Amoxi and Clavulanate Potassium 1g Film Coated Tablet: Each film coated tablet contacines Amoxi Trihydrate USP equivalent to Amoxi 875mg and Clavulanate Potassium USP equivalent to Clavalanic acid 125mg.

Properties:

Amoxiand Clavulanate Potassium is an oral antibacterial combination consiating of the semi synthetic broad-spectrum antibiotic Amoxi and the beta-lactamase enzyme inhibitor clavulanic acid, which protects amoxi from destruction and subsequent loss of antibacterial activity by the beta-lactamase enzyme produced by many gram-negative and gram-positive vacteria.

This conbination extends the spectrum of amoxi to include a wider range of organisms, including many resistant to other beta-lactam antibiotics. Amoxi and clavulanic acid are well absorbed from the gastrointestinal tract following oral administration of Amoxi and Clavulanate Potassium.

Amoxi and Clavulanate Potassium is bacterial against a wide range of beta-lactamase and non-beta-lactamase producing organisms including:

Gram-positive: and Gram-negative

Indications:

Amoxi and Clavulanate Potassium is indicated for treatment of the following bacterial inlections due to susceptible organisms:

-Upper respiratory tract infection (including ENT) , e.g. tonsillitis, sinusitis, otitis media;

-Lower respiratory tract infections, e.g. actue and chronic bronchitis, lobar and bronchopneumonia.

-Gentio-urinary tract infection, e.g. cystitis, urethritis, pyelonephritis, pelvic infection, chancroid, gonorrhoea.

-Skin and soft tissue infection, e.g. boils, abscesses, cellulitis, animal bites, wound infections.

-Bone and joint infections, e.g. osteomyelitis

Dosage and Administration:

Amoxi and Clavulanate Potassiummay be administrated without regards to meals. However, to munimize potential pastrointestinal intolerance, administer at the start of a meal.

Adults and Children over 12 years:
 

Contraindications:

Amoxi and Clavulanate Potassium should not be administrated to patients hypersensitive to penicillins, cephalosporins and other beta-lactams, It is also contraindicated in patients with a previous history of Amoxi and Clavulanate acid or penicillin-associated jaundice or hepatic dysfunction.

Use in Pregnancy and lactation:

As with all mediciens, use should be avoided in pregnancy, especially during the first trimester, unless considered essential by the physician.

Amoxi and Clavulanate Potassium may be administrated during the period of lactation.

With the exception of the risk of sensitization, associated with excretion of trace amounts in the breast milk, there are no significant effects to the infants.

Side effects:

Amoxi and Clavulanate Potassium is well tolerated. Side effects, as with amoxi, are uncommon and mainly of mild and transitory nature. The reported adverse effects include diarrhoea, nausea, vomiting, antibiotic-associated colitis, and candidiasis have been reported. Hepatitis and cholestatic jaundice have been reported rarely.

Drug interaction:

Prolongation of bleeding time and prothrombin time have been reported in some patients receving amoxi clavulanic acid. Amoxi and Clavulanate Potassium should be used with care in patients on anti-coagulant therapy,in common with other broad-spectrum antibiotics, Amoxi and Clavulanate Potassium may reduce the efficacy of oral contraceptives and patients should be wamed accordingly.

Storage:

Store at room temperature below 30c, in a dry place, protected from light.