Pivmecillinam

FDA Drug Profile — PIVYA

Drug Details

Generic Name
Pivmecillinam
Brand Names
PIVYA
Application Number
NDA216483
Sponsor
Alembic Pharmaceuticals Inc.
NDC Codes
1
Dosage Forms
TABLET, COATED
Routes
ORAL
Active Ingredients
PIVMECILLINAM HYDROCHLORIDE

Indications and Usage

1. INDICATIONS AND USAGE PIVYA is a penicillin class antibacterial indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus . ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of PIVYA and other antibacterial drugs, PIVYA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Uncomplicated Urinary Tract Infections PIVYA is indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli (E. coli) , Proteus mirabilis, and Staphylococcus saprophyticus. 1.2 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of PIVYA and other antibacterial drugs, PIVYA should be used only to treat or prevent 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.