BUFFERED PENICILLIN G POTASSIUM injection, powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PENICILLIN G POTASSIUM (UNII: VL775ZTH4C) (PENICILLIN G - UNII:Q42T66VG0C)

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Therapy Buffered Penicillin G Potassium for Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Buffered Penicillin G Potassium for Injection, USP may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below, however, once these results become available, appropriate therapy should be continued. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin G Potassium and other antibacterial drugs, Penicillin G Potassium 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 in

Product summary:

BUFFERED PENICILLIN G POTASSIUM FOR INJECTION, USP is supplied in the following dosage forms. NDC 51662-1436-1 BUFFERED PENICILLIN G POTASSIUM FOR INJECTION, USP 5,000,000 UNITS (5 MILLION UNITS) HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Buffered Penicillin G Potassium for Injection, USP, is supplied in dry powder form in vials containing 1,000,000 units (1 million units) × 10’s (NDC 0781-6134-95), 5,000,000 units (5 million units) × 10’s (NDC 0781-6135-95), and 20,000,000 units (20 million units) × 1’s (NDC 0781-6136-94) of crystalline penicillin G as the potassium salt; buffered with sodium citrate and citric acid to an optimum pH. STORAGE Store the dry powder at 20° to 25°C (68° to 77°F) [see USP controlled room temperature]. Sterile constituted solution may be kept in refrigerator 2° to 8°C (36° to 46°F) for 7 days without significant loss of potency.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUFFERED PENICILLIN G POTASSIUM- BUFFERED PENICILLIN G POTASSIUM
INJECTION, POWDER,
FOR SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
BUFFERED PENICILLIN G POTASSIUM FOR INJECTION, USP 5,000,000 UNITS (5
MILLION UNITS)
SPL UNCLASSIFIED
BUFFERED
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Penicillin G
Potassium and other antibacterial drugs, Penicillin G Potassium should
be used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Buffered Penicillin G Potassium for Injection, USP is sterile
penicillin G potassium powder for
reconstitution. It is an antibacterial agent intended for intravenous
or intramuscularly use.
Chemically, Penicillin G Potassium is monopotassium
(2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2-
phenylacetamido)-4-thia-1-azabicyclo (3.2.0) heptane-2-carboxylate,
and has the following chemical
structure:
Penicillin G potassium, a water soluble benzylpenicillin, is a white
to almost white crystalline powder
which is almost odorless and/or after reconstitution a colorless
solution. The pH of freshly constituted
solutions usually ranges from 6 to 8.5. Sodium citrate and citric acid
have been added as a buffer.
Buffered Penicillin G Potassium for Injection, USP is supplied in
vials equivalent to 1,000,000 units (1
million units), 5,000,000 units (5 million units), or 20,000,000 units
(20 million units) of penicillin G as
the potassium salt. Each million unit contains approximately 7.9
milligrams of sodium (0.34 mEq) and
65.6 milligrams of potassium (1.68 mEq).
CLINICAL PHARMACOLOGY
After an intravenous infusion of penicillin G, peak serum
concentrations are attained immediately after
completion of the infusion. In a study of ten patients administered a
single 5 million unit dose of
penicillin G intravenously over 3 to 5 minutes, the mean serum
concentrations were 400 mcg/mL, 273
mcg/mL and 3 mcg/mL at 5 to 6 minutes, 10 minutes and 4 hours after
completion of the injection,
respectively. In a separ