Description
Coly-Mycin M Parenteral (Colistimethate for Injection, USP) is a sterile parenteral antibiotic product which, when reconstituted is suitable for intramuscular or intravenous administration. Each vial contains colistimethate sodium or pentasodium colistin-methanesulfonate (150 mg colistin base activity).
Indications and Usage
Coly-Mycin M Parenteral is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to
Proteus or Neisseria. Coly-Mycin M Parenteral has proven clinically effective in treatment of infections due to the following gram-negative organisms:
Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
Coly-Mycin M Parenteral may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli.
Contraindications
The use of Coly-Mycin M Parenteral is contraindicated for patients with a history of sensitivity to the drug or any of its components.
Warnings
Maximum daily dose should not exceed 5 mg/kg/day (2.3 mg/lb) with
normal renal function.
Transient neurological disturbances may occur. These include
circumoral paresthesia or numbness, tingling or formication of the
extremities, generalized pruritus, vertigo, dizziness, and slurring
of speech. For these reasons, patients should be warned not to drive
vehicles or use hazardous machinery while on therapy. Reduction of
dosage may alleviate symptoms. Therapy need not be discontinued, but
such patients should be observed with particular care.
Nephrotoxicity can occur and is probably a dose-dependent effect of
colistimethate sodium. These manifestations of nephrotoxicity are
reversible following discontinuation of the antibiotic.
Overdosage can result in renal insufficiency, muscle weakness, and
apnea (see OVERDOSAGE section). See PRECAUTIONS Drug Interactions
subsection for use concomitantly with other antibiotics and
curariform drugs.
Respiratory arrest has been reported following intramuscular
administration of colistimethate sodium. Impaired renal function
increases the possibility of apnea and neuromuscular blockade
following administration of colistimethate sodium. Therefore, it is
important to follow recommended dosing guide-lines.
See DOSAGE AND ADMINISTRATION section for use in renal impairment.
Clostridium difficile
associated diarrhea (CDAD) has been reported with nearly all
antimicrobial agents including Coly-Mycin M Parenteral 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. 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
antibiotic 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
antibiotic use not directed against C. difficile may need to
be discontinued. Appropriate fluid and electrolyte management,
protein supplementation, antibiotic treatment of C. difficile,
and surgical evaluation should be instituted as clinically
indicated.
Adverse Reactions
The
following adverse reactions have been reported:
Gastrointestinal:
gastrointestinal upset
Nervous System:
tingling of extremities and tongue, slurred speech, dizziness,
vertigo and paresthesia
Integumentary: generalized itching, urticaria and rash
Body as a Whole:
fever
Laboratory Deviations:
increased blood urea nitrogen (BUN), elevated creatinine and
decreased creatinine clearance
Respiratory System:
respiratory distress and apnea
Renal System:
nephrotoxicity and decreased urine output
