BICILLIN L-A- penicillin g benzathine injection, suspension

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

PENICILLIN G BENZATHINE (UNII: RIT82F58GK) (PENICILLIN G - UNII:Q42T66VG0C)

متاح من:

Pfizer Laboratories Div Pfizer Inc

INN (الاسم الدولي):

PENICILLIN G BENZATHINE

تركيب:

PENICILLIN G 600000 [iU] in 1 mL

طريقة التعاطي:

INTRAMUSCULAR

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Bicillin L-A and other antibacterial drugs, Bicillin L-A 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. Intramuscular penicillin G benzathine is indicated in the treatment of infections due to penicillin-G-sensitive microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form. Therapy should be guided by bacteriological studies (including sensitivity tests) and by clinical response. The following infections will usually respond to adequate dosage of intramuscular penicillin G benzathine: Mild-to-moderate infections of the upper-respiratory tract due to susceptible streptococci. Venereal infections —Syphilis, yaws, bejel, and pinta. Medical Conditions in which Penicillin G Benzathine Therapy is indicated as Prophylaxis: Rheumatic fever and/or chorea —Prophylaxis with penicillin G benzathine has proven effective in preventing recurrence of these conditions. It has also been used as follow-up prophylactic therapy for rheumatic heart disease and acute glomerulonephritis. A history of a previous hypersensitivity reaction to any of the penicillins is a contraindication.

ملخص المنتج:

Bicillin L-A (penicillin G benzathine injectable suspension) is supplied in packages of 10 disposable syringes as follows: 1 mL size, containing 600,000 units per syringe, (21 gauge, thin-wall 1-inch needle for pediatric use), with 0.11 mEq of sodium per 600,000 units of penicillin G (2.59 mg of sodium per 600,000 units of penicillin G), NDC 60793-700-10. 2 mL size, containing 1,200,000 units per syringe, (21 gauge, thin-wall 1-1/2-inch needle), with 0.22 mEq of sodium per 1,200,000 units of penicillin G (5.17 mg of sodium per 1,200,000 units of penicillin G), NDC 60793-701-10. 4 mL size, containing 2,400,000 units per syringe (18 gauge, × 1–1/2-inch needle), with 0.45 mEq of sodium per 2,400,000 units of penicillin G (10.32 mg of sodium per 2,400,000 units of penicillin G), NDC 60793-702-10. Store in a refrigerator, 2° to 8°C (36° to 46°F). Keep from freezing.

الوضع إذن:

New Drug Application

خصائص المنتج

BICILLIN L-A- PENICILLIN G BENZATHINE INJECTION, SUSPENSION
PFIZER LABORATORIES DIV PFIZER INC
----------
BICILLIN L-A
(PENICILLIN G BENZATHINE 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
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 L-A and other antibacterial drugs, Bicillin L-A should be
used only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Bicillin L-A (penicillin G benzathine injectable suspension) 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:
Bicillin L-A contains penicillin G benzathine in aqueous suspension
with sodium citrate
buffer and, as w/v, approximately 0.65% sodium citrate, 0.59%
povidone, 0.54%
carboxymethylcellulose sodium, 0.53% lecithin, 0.12% methylparaben,
and 0.013%
propylparaben.
®
Bicillin L-A contains approximately 0.11 mEq of sodium per 600,000
units of penicillin G
(approximately 2.59 mg of sodium per 600,000 units of penicillin G).
Bicillin L-A suspension in the disposable-syringe formulation is
viscous and opaque. It is
available in a 1 mL, 2 mL, and 4 mL sizes containing the