BICILLIN CR- penicillin g benzathine and penicillin g procaine injection, suspension

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Dispensing Solutions, Inc.

INN (International Nazwa):

PENICILLIN G BENZATHINE

Skład:

PENICILLIN G 600000 [iU] in 2 mL

Droga podania:

INTRAMUSCULAR

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin C-R and other antibacterial drugs, Bicillin C-R 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. This drug is indicated in the treatment of moderately severe infections due to penicillin-G-susceptible microorganisms that are susceptible to serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including susceptibility testing) and by clinical response. Bicillin C-R is indicated in the treatment of the following in adults and pediatric patients: Moderately severe to severe infections of the upper-respiratory tract, scarlet fever, erysipelas, and

Podsumowanie produktu:

Bicillin C-R (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 60793-601-10. 2 mL size, containing 1,200,000 units per syringe (21 gauge, thin-wall 1-1/2 inch needle), NDC 60793-600-10. Store in a refrigerator, 2º to 8º (36º to 46ºF). Keep from freezing.

Status autoryzacji:

New Drug Application

Charakterystyka produktu

BICILLIN CR- PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE
INJECTION, SUSPENSION
DISPENSING SOLUTIONS, INC.
----------
BICILLIN C-R
(PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE INJECTABLE
SUSPENSION) DISPOSABLE SYRINGE
FOR DEEP IM INJECTION ONLY
DESCRIPTION
Bicillin C-R (penicillin G benzathine and penicillin G procaine
injectable suspension) contains equal
amounts of the benzathine and procaine salts of penicillin G. 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:
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 of procaine and penicillin G. It
occurs as white crystals or a white,
microcrystalline powder and is slightly soluble in water. Its chemical
structure is as follows:
Each disposable syringe (2 mL size) contains the equivalent of
1,200,000 units of penicillin G
comprising: the equivalent of 600,000 units of penicillin G as the
benzathine salt and the equivalent of
600,000 units of penicillin G as the procaine salt in a stabilized
aqueous suspension with sodium citrate
buffer; and as w/v, approximately 0.5% lecithin, 0.55%
carboxymethylcellulose, 0.55% povidone, 0.1%
methylparaben, and 0.01% propylparaben.
Bicillin C-R injectable suspension in the disposable-syringe
formulation is viscous and opaque. Read
CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DOSAGE AND
ADMINISTRATION
sections prior to use.
CLINICAL PHARMACOLOGY
®
GENERAL
Penicillin G benzathine