Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
PENICILLIN G PROCAINE (UNII: 17R794ESYN) (PENICILLIN G - UNII:Q42T66VG0C)
Pfizer Laboratories Div Pfizer Inc
PENICILLIN G PROCAINE
PENICILLIN G 600000 [iU] in 1 mL
INTRAMUSCULAR
PRESCRIPTION DRUG
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin G Procaine and other antibacterial drugs, Penicillin G Procaine 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. Penicillin G procaine is indicated in the treatment of moderately severe infections in both adults and pediatric patients due to penicillin-G-susceptible microorganisms that are susceptible to the low and persistent serum levels common to this particular dosage form in the indications listed below. Therapy should be guided by bacteriological studies (including susceptibility tests) and by clinical response. NOTE: When high, sustained serum levels are required, aqueous
Penicillin G Procaine Injectable Suspension is supplied in packages of 10 syringes and ten 21 gauge, thin-wall 1-1/2 inch needles as follows: 1 mL size, containing 600,000 units per syringe (21 gauge, thin-wall 1-1/2 inch needle), NDC 60793-130-10. 2 mL size, containing 1,200,000 units per syringe (21 gauge, thin-wall 1-1/2 inch needle), NDC 60793-131-10. Store in a refrigerator, 2° to 8°C (36° to 46°F). Keep from freezing.
Abbreviated New Drug Application
PENICILLIN G PROCAINE- PENICILLIN G PROCAINE INJECTION, SUSPENSION PFIZER LABORATORIES DIV PFIZER INC ---------- PENICILLIN G PROCAINE INJECTABLE SUSPENSION 1 ML AND 2 ML SYRINGE WITH NEEDLE FOR DEEP IM INJECTION ONLY, USP To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin G Procaine and other antibacterial drugs, Penicillin G Procaine should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Prior to administration of the drug, carefully read the WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the labeling. RX ONLY DESCRIPTION This product is designed to provide a stable aqueous suspension of penicillin G procaine, ready for immediate use. This eliminates the necessity for addition of any diluent, required for the usual dry formulation of injectable penicillin. Penicillin G procaine is chemically designated as (2_S_, 5_R_, 6_R_)-3,3-Dimethyl-7-oxo-6-(2- phenylacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid compound with 2- (diethylamino)ethyl _p_-aminobenzoate (1:1) monohydrate. Its molecular formula is C H N O S∙C H N O ∙H O with a molecular weight of 588.72. Its structural formula is as follows: Each syringe, 1,200,000 units (2 mL size) or 600,000 units (1 mL size), contains penicillin G procaine in a stabilized aqueous suspension with sodium citrate buffer; and as w/v, approximately 0.5% lecithin, 0.5% carboxymethylcellulose, 0.5% povidone, 0.1% methylparaben, and 0.01% propylparaben. Penicillin G Procaine Injectable Suspension is viscous and opaque. Read CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections prior to use. 16 18 2 4 13 20 2 2 2 CLINICAL PHARMACOLOGY Penicillin G procaine is an equimolecular compound of procaine and penicillin G, administered intramuscularly as a suspension. It dissolves (hydrolizes) slowly at the site of injection, giving a plateau type of blood level at about 4 hours which falls slowly over a period of the Aqra d-dokument sħiħ