FDA approval Ampicillin - Omnipen clinical trails
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FDA Approval for Ampicillin - Omnipen

Ampicillin is the semi-synthetic beta-lactam antibiotic generic drug used to formulate its branded version called Omnipen made by Wyeth Laboratories Inc of the United States. It works by inhibiting the bacterial cell wall synthesis. This drug was developed in 1961 and offered the boarder range of activity than either of the novel penicillin. Ampicillin was officially cleared by the Food and Drug Administration-FDA in 1963. It is closely related to another penicillin drug-amoxicillin. Omnipen is brand name for generic version of Ampicillin given by its producer Wyeth Laboratories Inc.

Omnipen is indicated for treating infections like middle ear, sinuses, bladder, kidney and uncomplicated gonorrhea. It is also used intravenously for treating meningitis and other serious types of bacterial infections. It is directed to be taken with full glass of water either on empty stomach at least before one hour or after two hours of taking meals. Unlike penicillin, Ampicillin-Omnipen and amoxicillin can penetrate and prevent the growth of specific kinds of bacteria known as gram-negative bacteria.

This is the prescription class of medication with approved dose size ranging from 100mg to 500mg precisely for oral dose: Tablet of 250mg and 500mg, Oral suspension: 100mg/ml, 125mg/ml, 250mg/ml and Injections: 10g, 125mg, 125mg/vial, 1g, 1gm/vial, 250mg/vial, 2g, 2gm/vial, 500mg, 500mg/vial. The FDA recommends conditions for its storing like the tablet should be stored at temperatures between 15 and 30 degrees C while the suspension form should be stored refrigerated and may be used for only up to 14 days after it is reconstituted by the pharmacist.
 

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