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

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Pfizer Laboratories Div Pfizer Inc

INN (국제 이름):

PENICILLIN G BENZATHINE

구성:

PENICILLIN G 600000 [iU] in 2 mL

관리 경로:

INTRAMUSCULAR

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 skin and soft-tissue infections due to susceptible streptococci. NOTE: Streptococci in Groups A, C, G, H, L, and M are very sensitive 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.

제품 요약:

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.

승인 상태:

New Drug Application

제품 특성 요약

BICILLIN CR- PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE
INJECTION,
SUSPENSION
PFIZER LABORATORIES DIV PFIZER INC
----------
BICILLIN C-R
(PENICILLIN G BENZATHINE AND PENICILLIN G PROCAINE INJECTABLE
SUSPENSION)
DISPOSABLE 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 THEWARNINGS,ADVERSE REACTIONS, ANDDOSAGE AND
ADMINISTRATIONSECTIONS OF THE LABELING.
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.
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:
MOLECULAR FORMULA
(C
H N O S) ∙
C
H N ∙ 4H O
MOLECULAR WT.
981.19
®
16
18
2
4
2
16
20
2
2
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 i