Penicillin G Procaine Injectable Suspension 1 mL and 2 mL Syringe with needle for deep IM injection only, USP

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

PENICILLIN G PROCAINE (UNII: 17R794ESYN) (PENICILLIN G - UNII:Q42T66VG0C)

Disponibil de la:

Pfizer Laboratories Div Pfizer Inc

INN (nume internaţional):

PENICILLIN G PROCAINE

Compoziție:

PENICILLIN G 600000 [iU] in 1 mL

Calea de administrare:

INTRAMUSCULAR

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

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.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

PENICILLIN G PROCAINE- PENICILLIN G PROCAINE INJECTION, SUSPENSION
PFIZER LABORATORIES DIV PFIZER INC
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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