LINCOMYCIN- lincomycin hydrochloride injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F)

Available from:

General Injectables and Vaccines, INC.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

This drug is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.

Product summary:

Lincomycin Injection, USP is available in the following strength and package sizes: 300 mg/mL 2 mL Vials — NDC 39822-0350-1 Packaged as 10 vials per carton NDC 39822-0350-2 10 mL Vials — NDC 39822-0353-5 Packaged as 10 vials per carton NDC 39822-0353-6 Each mL of Lincomycin Injection, USP contains lincomycin hydrochloride equivalent to lincomycin 300 mg; also benzyl alcohol, 9.45 mg added as preservative. Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LINCOMYCIN- LINCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
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LINCOMYCIN
SPL UNCLASSIFIED SECTION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Lincomycin and other antibacterial drugs, Lincomycin should be used
only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
BOXED WARNINIG
WARNING
Clostridium difficile associated diarrhea (CDAD) has been reported
with use of
nearly all antibacterial agents, including Lincomycin and may range in
severity from
mild diarrhea to fatal colitis. Treatment with antibacterial agents
alters the normal
flora of the colon leading to overgrowth of C. difficile.
Because lincomycin therapy has been associated with severe colitis
which may end
fatally, it should be reserved for serious infections where less toxic
antimicrobial
agents are inappropriate, as described in the INDICATIONS AND USAGE
section. It
should not be used in patients with nonbacterial infections such as
most upper
respiratory tract infections.
C.diffficile produces toxins A and B which contribute to the
development of CDAD.
Hypertoxin producing strains of C. difficile cause increased morbidity
and mortality,
as these infections can be refractory to antimicrobial therapy and may
require
colectomy. CDAD must be considered in all patients who present with
diarrhea
following antibacterial use. Careful medical history is necessary
since CDAD has
been reported to occur over two months after the administration of
antibacterial
agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not
directed against
C. difficile may need to be discontinued. Appropriate fluid and
electrolyte
management, protein supplementation, antibacterial treatment of C.
difficile, and
surgical evaluation should be instituted as clinically indicated.
DESCRIPTION
Lincomycin Injection is a sterile solution which contains lincomycin
hydrochloride which is
the monohydrated salt of lincomycin, a substance pr