A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Coly-Mycin Indications, Dosage, Storage, Stability - Sterile Colistimethate Sodium
Coly-Mycin Indications, Dosage, Storage, Stability - Sterile Colistimethate Sodium
INDICATIONS AND USES
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.
DOSAGE AND ADMINISTRATION
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.
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.
TABLE 1. Suggested Modification of Dosage Schedules
of Coly-Mycin M
Parenteral
for Adults with Impaired Renal Function
|
Renal Function
|
Degree of Impairment |
|
|
Normal |
Mild |
Moderate |
Considerable |
|
Plasma creatinine, mg/100 mL
|
0.7-1.2 |
1.3-1.5 |
1.6-2.5 |
2.6-4.0 |
|
Urea clearance, % of normal
|
80-100 |
40-70 |
25-40 |
10-25 |
|
Dosage
|
|
Unit dose of Coly-Mycin M, mg
|
100-150 |
75-115 |
66-150 |
100-150 |
|
Frequency, times/day
|
4 to 2 |
2 |
2 or 1 |
every 36 hr |
|
Total daily dose, mg
|
300 |
150-230 |
133-150 |
100 |
|
Approximate daily dose, mg/kg/day
|
5.0 |
2.5-3.8 |
2.5 |
1.5 |
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
- Direct Intermittent Administration Slowly inject one-half of the
total daily dose over a period of 3 to 5 minutes every 12 hours.
- Continuous Infusion Slowly inject one-half of the total daily dose
over 3 to 5 minutes. Add the remaining half of the total daily dose
of Coly-Mycin M Parenteral to one of the following:
0.9% NaCl
5% dextrose in 0.9% NaCl
5% dextrose in water
5% dextrose in 0.45% NaCl
5% dextrose in 0.225% NaCl
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.
|
HOW SUPPLIED
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 lyophilized cake and is available as one vial per carton NDC 61570-414-51
Store between 15°-30°C (59°-86°F).
Store reconstituted solution in refrigerator 2°-8°C (36°-46°F) or between
15°-30°C (59°-86°F) and use within 7 days.
Rx only.
Prescribing Information as of February 2004.
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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