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CONTRAINDICATIONS
COLY-MYCIN
M PARENTERAL is contraindicated in patients with a history of sensitivity
to the drug.
PRECAUTIONS
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Maximum daily dose of COLY-MYCIN M
PARENTERAL should not exceed 5 mg/kg/day with normal renal function.
Occupational Hazards: Transient neurological disturbances may occur.
These include circumoral paresthesias 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. Overdosage can result in renal insufficiency, muscle weakness
and apnea.
Pregnancy: The safety of sodium colistimethate during human pregnancy
has not been established.
Since sodium colistimethate is eliminated mainly by renal excretion,
it should be used with caution when the possibility of impaired
renal function exists. The decline in renal function with advanced
age should be considered.
When actual renal impairment is present, sodium colistimethate may
be used, but the greatest caution should be exercised and the dosage
should be reduced in proportion to the extent of the impairment.
Administration of amounts of sodium colistimethate in excess of
renal excretory capacity will lead to high serum levels and can
result in further impairment of renal function, initiating a cycle
which, if not recognized, can lead to acute renal insufficiency,
renal shutdown and further concentration of the antibiotic to toxic
levels in the body. At this point, interference of nerve transmission
at neuromuscular junctions may occur and result in muscle weakness
and apnea.
Easily recognized signs indicating the development of impaired renal
function are diminishing urine output, rising BUN and serum creatinine.
If present, therapy with sodium colistimethate should be discontinued
immediately.
If a life-threatening situation exists, therapy may be reinstated
at a lower dosage after blood levels have fallen.
Certain other antibiotics (kanamycin, streptomycin, dihydrostreptomycin,
polymyxin, neomycin) have also been reported to interfere with the
nerve transmission at the neuromuscular junction and thus should
not be given concomitantly with sodium colistimethate except with
the greatest caution. The antibiotics with a gram positive antimicrobial
spectrum, e.g. penicillin, tetracycline, sodium cephalothin, have
not been reported to interfere with nerve transmission and, accordingly,
would not be expected to potentiate this activity of sodium colistimethate.
Other drugs, including curariform muscle relaxants (ether, tubocurarine,
succinylcholine, gallamine, decamethonium and sodium citrate), potentiate
the neuromuscular blocking effect and should be used with extreme
caution in patients being treated with sodium colistimethate.
If apnea occurs it may be treated with assisted respiration, oxygen,
and calcium chloride injections.
ADVERSE
REACTIONS
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Respiratory arrest has been reported
following IM administration of sodium colistimethate. Impaired renal
function increases the possibility of apnea and neuromuscular blockade
following administration of sodium cholistimethate. This has generally
been due to failure to follow recommended guidelines, usually overdosage,
failure to reduce dose commensurate with degree of renal impairment,
and/or concomitant use of other antibiotics or drugs with neuromuscular
blocking potential.
A decrease in urine output or
increase in BUN or serum creatinine can be interpreted as signs
of nephrotoxicity, which is probably a dose dependent effect of
sodium colistimethate. These manifestations of nephrotoxicity are
reversible following discontinuation of the antibiotic.
Increases of BUN have been reported
for patients receiving sodium colistimethate at dose levels of 1.6
to 5 mg/kg/day. The BUN values returned to normal following cessation
of sodium colistimethate administration.
Paresthesia, tingling of the
extremities or tingling of the tongue and generalized itching or
urticaria have been reported by patients who received sodium colistimethate
by IM or IV injection. In addition, the following adverse reactions
have been reported for sodium colistimethate: drug fever and gastrointestinal
upset, vertigo, and slurring of speech. The subjective symptoms
reported by the adult may not be manifest in infants or young children,
thus requiring close attention to renal function.
OVERDOSE
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Symptoms: Dizziness, ataxia,
speech disturbances, generalized muscular weakness, apnea and elevated
BUN.
Treatment: Usual medical regimen for treatment of oliguria
or anuria. Consider dialysis, particularly if a massive overdosage
is discovered shortly after administration.
| DOSAGE
AND ADMINISTRATION |
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For IV or IM use: Average dose is
2.5 mg/kg/day given in 2 to 4 divided doses. In the presence of
bacteremia, septicemia or other serious infections, greater than
average doses may be required. Maximal dose of 5 mg/kg/day should
not be exceeded in patients with normal renal function.
Aerosol use: Dissolve vial contents
in 1 to 2 mL sterile saline or 5% dextrose in water. May be administered
in a standard nebulizing apparatus or with an IPPB device. Adults:
25 to 50 mg 2 to 3 times daily. Children: 2 to 15 mg 2 to 4 times
daily. Discard unused portions after 24 hours.
Vial Composition
Each COLY-MYCIN M PARENTERAL vial contains: colistin base activity
(as sodium colistimethate) 150 mg as a fluffy, spongy, white to
slightly yellow lyophilized cake which forms a clear, aqueous solution
when reconstituted with 2.0 mL of Sterile Water for Injection USP.
Each mL of reconstituted sterile solution contains: sodium colistimethate
equivalent to 75 mg colistin base. Energy: nil. Sodium: <1 mmol
(16.6 mg)/vial.
Stability and Storage Recommendations
Store COLY-MYCIN M PARENTERAL at controlled room temperature 15
to 30°C.
After reconstitution, COLY-MYCIN M PARENTERAL solution should be
stored refrigerated 2 to 8°C and used within 3 days (or within
24 hours, when stored at controlled room temperature 15 to 30°C).
Any infusion solution containing colistimethate sodium should be
freshly prepared and used for no longer than 24 hours.
AVAILABILITY
OF DOSAGE FORMS
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COLY-MYCIN M PARENTERAL vials are
available in the dosage strength equivalent to 150 mg of colistin
base activity per vial.
PHARMACEUTICAL
INFORMATION
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Drug Substance
Proper Name: Coly-Mycin M Parenteral
Chemical Name: Colistimethate Sodium
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