LINCOCIN- 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:

Pharmacia & Upjohn Company LLC

INN (International Name):

LINCOMYCIN HYDROCHLORIDE

Composition:

LINCOMYCIN 300 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LINCOCIN is indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of CDAD, as described in the BOXED WARNING , before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives. Indicated surgical procedures should be performed in conjunction with antibacterial therapy. LINCOCIN may be administered concomitantly with other antimicrobial agents when indicated. LINCOCIN is not indicated in the treatment of minor bacterial infections or viral infections. To reduce the development of drug-resistant bacteria and maintain the effectiveness of LINCOCIN and other antibacterial drugs, LINCOCIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Product summary:

LINCOCIN (lincomycin injection, USP) is available as a sterile, clear, and colorless solution in the following strength and package sizes: NDC 0009-0555-01 or NDC 0009-0104-04 600 mg/2 mL 2 mL multiple-dose vial (300 mg/mL) NDC 0009-0107-04 3,000 mg/10 mL 10 mL multiple-dose vial (300 mg/mL) Each mL of LINCOCIN contains 300 mg lincomycin (equivalent to 340 mg lincomycin hydrochloride, USP); 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:

New Drug Application

Summary of Product characteristics

LINCOCIN- LINCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION
PHARMACIA & UPJOHN COMPANY LLC
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LINCOCIN
LINCOMYCIN INJECTION, USP
Sterile Solution for Intramuscular and Intravenous Use
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
LINCOCIN and other antibacterial drugs, LINCOCIN should be used only
to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
WARNING
_Clostridioides difficile_ associated diarrhea (CDAD) has been
reported with use of
nearly all antibacterial agents, including LINCOCIN 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. difficile_ 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
LINCOCIN (lincomycin injection, USP) is a sterile solution containing
lincomycin
hydrochloride which is the monohy