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:

Sagent Pharmaceuticals

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lincomycin injection 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. Lincomycin injection may be administered concomitantly with other antimicrobial agents when indicated. Lincomycin injection 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 lincomycin injection and other antibacterial drugs, lincomycin injection should be used only to treat or prevent infections that are proven

Product summary:

Lincomycin Injection, USP is available as a sterile, clear, and colorless solution in the following strength and package sizes: Each mL of Lincomycin Injection, USP contains 300 mg lincomycin (equivalent to 340 mg lincomycin hydrochloride, USP); also benzyl alcohol, 9.45 mg added as preservative. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LINCOMYCIN- LINCOMYCIN HYDROCHLORIDE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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LINCOMYCIN INJECTION, USP
Sterile Solution for Intramuscular or Intravenous Use
SAGENT
Rx only
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
lincomycin injection and other antibacterial drugs, lincomycin
injection 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 lincomycin injection 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, USP is a sterile solution containing lincomycin
hydrochl