Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/70
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Coly-Mycin (Injection)
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Important: Coly-Mycin
M Parenteral is supplied in vials containing colistimethate sodium equivalent
to 150 mg colistin base activity per vial. Reconstitution: The 150 mg vial should be reconstituted with 2.0 mL Sterile Water for Injection, USP. The reconstituted
solution provides colistimethate sodium at a concentration equivalent to 75
mg/mL colistin base activity. During reconstitution
swirl gently to avoid frothing. Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. If these
conditions are observed, the product should not be used.<br/>Dosage: Adults
and pediatric patients���Intravenous or Intramuscular Administration: Coly-Mycin M Parenteral should
be given in 2 to 4 divided doses at dose levels of 2.5 to 5 mg/kg per day
for patients with normal renal function, depending on the severity of the
infection. In obese individuals, dosage should be based
on ideal body weight. The daily dose should be reduced
in the presence of renal impairment. Modifications of dosage in the presence
of renal impairment are presented in Table 1. Note: The suggested
unit dose is 2.5���5 mg/kg; however, the time INTERVAL between injections
should be increased in the presence of impaired renal function. INTRAVENOUS ADMINISTRATION 0.9%
NaCI 5%
dextrose in 0.9% NaCI 5%
dextrose in water 5%
dextrose in 0.45% NaCI 5%
dextrose in 0.225% NaCI lactated
Ringer's solution 10%
invert sugar solution There are not sufficient data
to recommend usage of Coly-Mycin M Parenteral with other drugs or other than
the above listed infusion solutions. Administer the
second half of the total daily dose by slow intravenous infusion, starting
1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the
presence of impaired renal function, reduce the infusion rate depending on
the degree of renal impairment. The choice of intravenous
solution and the volume to be employed are dictated by the requirements of
fluid and electrolyte management. Any
infusion solution containing colistimethate sodium should be freshly prepared
and used for no longer than 24 hours.
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Coly-Mycin M Parenteral (Colistimethate
for Injection, USP) is a sterile parenteral antibiotic product which, when
reconstituted (see Reconstitution), is suitable for intramuscular or intravenous administration. Each
vial contains colistimethate sodium or pentasodium colistinmethanesulfonate
(150 mg colistin base activity). Colistimethate sodium
is a polypeptide antibiotic with an approximate molecular weight of 1750.
The empirical formula is CHNNaOSand
the structural formula is represented below:
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Typical serum and urine levels following a single 150 mg
dose of Coly-Mycin M Parenteral IM or IV in normal adult subjects are shown
in Figure 1. Higher serum levels were obtained
at 10 minutes following IV administration. Serum concentration declined with
a half-life of 2���3 hours following either intravenous or intramuscular
administration in adults and in the pediatric population, including premature
infants. Average urine levels ranged from about 270
mcg/mL at 2 hours to about 15 mcg/mL at 8 hours after intravenous administration
and from 200 to about 25 mcg/mL during a similar period following intramuscular
administration. Microbiology:Colistimethate sodium is a surface active agent which penetrates
into and disrupts the bacterial cell membrane. It has been shown to have bactericidal
activity against most strains of the following microorganisms, both in vitro and in clinical infections as described
in the INDICATIONS
AND USAGE section. Aerobic
gram-negative microorganisms: Enterobacter aerogenes, Escherichia
coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa. Susceptibility Tests: Colistimethate sodium is
no longer listed as an antimicrobial for routine testing and reporting by
clinical microbiology laboratories.
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The use of Coly-Mycin M Parenteral is contraindicated for
patients with a history of sensitivity to the drug or any of its components.
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Coly-Mycin M Parenteral is supplied in vials containing
colistimethate sodium (equivalent to 150 mg colistin base activity per vial)
as a white to slightly yellow Iyophilized cake and is available as one vial
per carton (NDC 61570-414-51). Store
between 20�����25��C (68�����77��F). (See USP controlled
room temperature.) Store
reconstituted solution in refrigerator 2�����8��C (36�����46��F)
or between 20�����25��C (68�����77��F) and use within
7 days. Rx only. Prescribing Information as of February
2005. Distributed by: Monarch Pharmaceuticals, Inc.,
Bristol, TN 37620 (A wholly owned subsidiary of King
Pharmaceuticals, Inc.) Manufactured by: Parkedale Pharmaceuticals,
Inc., Rochester, MI 48307
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INTRAVENOUS ADMINISTRATION 0.9%
NaCI 5%
dextrose in 0.9% NaCI 5%
dextrose in water 5%
dextrose in 0.45% NaCI 5%
dextrose in 0.225% NaCI lactated
Ringer's solution 10%
invert sugar solution There are not sufficient data
to recommend usage of Coly-Mycin M Parenteral with other drugs or other than
the above listed infusion solutions. Administer the
second half of the total daily dose by slow intravenous infusion, starting
1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the
presence of impaired renal function, reduce the infusion rate depending on
the degree of renal impairment. The choice of intravenous
solution and the volume to be employed are dictated by the requirements of
fluid and electrolyte management. Any
infusion solution containing colistimethate sodium should be freshly prepared
and used for no longer than 24 hours.
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General: Since Coly-Mycin M Parenteral 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,
Coly-Mycin M Parenteral 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 Coly-Mycin M Parenteral 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 . Signs indicating the development
of impaired renal function include: diminishing urine output, rising BUN and
serum creatinine and decreased creatinine clearance. Therapy with Coly-Mycin
M Parenteral should be discontinued immediately if signs of impaired renal
function occur. However, if it is necessary to reinstate the drug, dosing
should be adjusted accordingly after drug plasma levels have fallen . Prescribing Coly-Mycin M in absence
of a proven or strongly suspected bacterial infection or prophylactic indication
is unlikely provide benefit to the patient increases the risk of the development
of drug-resistant bacteria.<br/>Drug Interactions: Certain other antibiotics (aminoglycosides and polymyxin)
have also been reported to interfere with the nerve transmission at the neuromuscular
junction. Based on this reported activity, they should not be given concomitantly
with Coly-Mycin M Parenteral except with the greatest caution. Curariform
muscle relaxants (e.g., tubocurarine) and other drugs, including ether, succinylcholine,
gallamine, decamethonium and sodium citrate, potentiate the neuromuscular
blocking effect and should be used with extreme caution in patients being
treated with Coly-Mycin M Parenteral. Sodium cephalothin
may enhance the nephrotoxicity of Coly-Mycin M Parenteral. The concomitant
use of sodium cephalothin and Coly-Mycin M Parenteral should be avoided.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term animal carcinogenicity studies and genetic toxicology
studies have not been performed with colistimethate sodium. There were no
adverse effects on fertility or reproduction in rats at doses of 9.3 mg/kg/day
(0.30 times the maximum daily human dose when based on mg/m).<br/>Pregnancy:<br/>Teratogenic Effects: Pregnancy Category C: Colistimethate sodium given intramuscularly
during organogenesis to rabbits at 4.15 and 9.3 mg/kg resulted in talipes
varus in 2.6% and 2.9% of fetuses, respectively. These doses are 0.25 and
0.55 times the maximum daily human dose based on mg/m. In addition,
increased resorption occurred at 9.3 mg/kg. Colistimethate sodium was not
teratogenic in rats at 4.15 or 9.3 mg/kg. These doses are 0.13 and 0.30 times
the maximum daily human dose based on mg/m. There are no adequate
and well-controlled studies in pregnant women. Since colistimethate sodium
is transferred across the placental barrier in humans, it should be used during
pregnancy only if the potential benefit justifies the potential risk to the
fetus.<br/>Nursing Mothers: It is not known whether colistimethate sodium is excreted
in human breast milk. However, colistin sulphate is excreted in human breast
milk. Therefore, caution should be exercised when colistimethate sodium is
administered to nursing women.<br/>Geriatric Use: Clinical studies of colistemethate sodium did not include
sufficient numbers of subjects aged 65 and over to determine whether they
respond differently from younger subjects. Other reported clinical experience
has not identified differences in responses between the elderly and younger
patients. In general, dose selection for an elderly patient should be cautious,
usually starting at the low end of the dosing range, reflecting the greater
frequency of decreased hepatic, renal, or cardiac function, and of concomitant
disease or other drug therapy. This drug is known to be substantially excreted
by the kidney, and the risk of toxic reactions to this drug may be greater
in patients with impaired renal function. Because elderly patients are more
likely to have decreased renal function, care should be taken in dose selection,
and it may be useful to monitor renal function.<br/>Pediatric Use: In clinical studies, colistimethate sodium was administered
to the pediatric population (neonates, infants, children and adolescents).
Although adverse reactions appear to be similar in the adult and pediatric
populations, subjective symptoms of toxicity may not be reported by pediatric
patients. Close clinical monitoring of pediatric patients is recommended.<br/>Information for Patients: Patients should be counseled that antibacterial drugs including
Coly-Mycin M should only be used to treat bacterial infections. They do not
treat viral infections (e.g., the common cold). When Coly-Mycin M is prescribed
to treat a bacterial infection, patients should be told that although it is
common to feel better early in the course of therapy, the medication should
be taken exactly as directed. Skipping doses or not completing the full courseof therapy may (1) decrease the effectiveness of the immediate treatment and
(2) increase the likelihood that bacteria will develop resistance and will
not be treatable by Coly-Mycin M or other antibacterial drugs in the future.
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Overdosage with colistimethate sodium can cause neuromuscular
blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia,
nystagmus, disorders of speech and apnea. Respiratory muscle paralysis may
lead to apnea, respiratory arrest and death. Overdosage with the drug can
also cause acute renal failure, manifested as decreased urine output and increases
in serum concentrations of BUN and creatinine. As in
any case of overdose, colistimethate sodium therapy should be discontinued
and general supportive measures should be utilized. It
is unknown whether colistimethate sodium can be removed by hemodialysis or
peritoneal dialysis in overdose cases.
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colistimethate
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Coly-Mycin (Injection)
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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
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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 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 guidelines. See DOSAGE AND ADMINISTRATION section for use in renal impairment. Pseudomembranous colitis has been reported with nearly all
antimicrobial agents, and may range in severity from mild to life-threatening.
Therefore, it is important to consider this diagnosis in patients who present
with diarrhea subsequent to the administration of antibacterial agents. Treatment
with antibacterial agents alters the normal flora of the colon and may permit
overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of���antibiotic-associated colitis.��� After
the diagnosis of pseudomembranous colitis has been established, appropriate
therapeutic measures should be initiated. Mild cases of pseudomembranous colitis
usually respond to drug discontinuation alone. In moderate-to-severe cases,
consideration should be given to management with fluids and electrolytes,
protein supplementation, and treatment with an antibacterial drug clinically
effective against Clostridium difficile colitis.
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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 Proteusor 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. To reduce the development
of drug-resistant bacteria and maintain the effectiveness of Coly-Mycin M
and other antibacterial drugs, Coly-Mycin M should be used only to treat or
prevent infections that are proven or strongly suspected to be caused by susceptible
bacteria. When culture and susceptibility information are available, they
should be considered in selecting or modifying antibacterial therapy. In the
absence of such data, local epidemiology and susceptibility patterns may contribute
to the empiric selection of therapy.
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Coly-Mycin
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