BICILLIN C-R 900/300- penicillin g benzathine and penicillin g procaine injection, suspension

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

PENICILLIN G BENZATHINE (UNII: RIT82F58GK) (PENICILLIN G - UNII:Q42T66VG0C), PENICILLIN G PROCAINE (UNII: 17R794ESYN) (PENICILLIN G - UNII:Q42T66VG0C)

Disponibil de la:

Pfizer Laboratories Div Pfizer Inc

INN (nume internaţional):

PENICILLIN G BENZATHINE

Compoziție:

PENICILLIN G 900000 [iU] in 2 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 Bicillin C-R 900/300 and other antibacterial drugs, Bicillin C-R 900/300 should be used only to treat or prevent infections that are proven or strongly suspected to be caused by 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. Bicillin C-R 900/300 is indicated in the treatment of infections as described below that are susceptible to serum levels characteristic of this particular dosage form. Therapy should be guided by bacteriological studies (including susceptibility testing) and by clinical response. Bicillin C-R 900/300 is indicated in the treatment of the following in pediatric patients: Moderately severe to severe infections of the upper-respiratory tract, scarlet fever, erysipelas, and skin and soft-tissue infections due to susceptible streptococci. NOTE: Streptococci in Groups A, C, G, H, L, and M are very susceptible to penicillin G. Other groups, including Group D (enterococci), are resistant. Penicillin G sodium or potassium is recommended for streptococcal infections with bacteremia. Moderately severe pneumonia and otitis media due to susceptible Streptococcus pneumoniae . NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, peritonitis, and arthritis of pneumococcal etiology are better treated with penicillin G sodium or potassium during the acute stage. When high, sustained serum levels are required, penicillin G sodium or potassium, either IM or IV, should be used. This drug should not be used in the treatment of venereal diseases, including syphilis, gonorrhea, yaws, bejel, and pinta. A previous hypersensitivity reaction to any penicillin or to procaine is a contraindication.

Rezumat produs:

Bicillin® C-R 900/300 (penicillin G benzathine and penicillin G procaine injectable suspension) is supplied in packages of 10 disposable syringes as follows: 2 mL size, containing 1,200,000 units per syringe (21 gauge, thin-wall 1-inch needle for pediatric use), NDC 60793-602-10. Store in a refrigerator, 2° to 8°C (36° to 46°F). Keep from freezing.

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

BICILLIN C-R 900/300- PENICILLIN G BENZATHINE AND PENICILLIN G
PROCAINE INJECTION, SUSPENSION
PFIZER LABORATORIES DIV PFIZER INC
----------
BICILLIN C-R 900/300
(PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE INJECTABLE
SUSPENSION)
2 ML SYRINGE
For deep IM injection only.
WARNING: NOT FOR INTRAVENOUS USE. DO NOT INJECT INTRAVENOUSLY
OR ADMIX WITH OTHER INTRAVENOUS SOLUTIONS. THERE HAVE BEEN
REPORTS OF INADVERTENT INTRAVENOUS ADMINISTRATION OF
PENICILLIN G BENZATHINE WHICH HAS BEEN ASSOCIATED WITH
CARDIORESPIRATORY ARREST AND DEATH. PRIOR TO ADMINISTRATION OF THIS
DRUG, CAREFULLY READ THE WARNINGS, ADVERSE REACTIONS, AND DOSAGE AND
ADMINISTRATION SECTIONS OF THE LABELING.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Bicillin C-R 900/300 and other antibacterial drugs, Bicillin C-R
900/300 should be used
only to treat or prevent infections that are proven or strongly
suspected to be caused
by bacteria.
DESCRIPTION
Bicillin C-R 900/300 (penicillin G benzathine and penicillin G
procaine injectable
suspension) contains the equivalent of 900,000 units of penicillin G
as the benzathine
and 300,000 units of penicillin G as the procaine salts. It is
available for deep
intramuscular injection.
Penicillin G benzathine is prepared by the reaction of
dibenzylethylene diamine with two
molecules of penicillin G. It 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
_N,N'_-dibenzylethylenediamine (2:1), tetrahydrate. It occurs as a
white, crystalline powder
and is very slightly soluble in water and sparingly soluble in
alcohol. Its chemical
structure is as follows:
MOLECULAR FORMULA
(C
H N O S) ∙
MOLECULAR WT.
981.19
®
(C
H N O S) ∙
C
H N ∙ 4H O
981.19
Penicillin G procaine, (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, is an equimolar salt