"The US Food and Drug Administration (FDA) today approved a drug for children and adults with hemophilia B called albutrepenonacog alfa (Idelvion, CSL Behring), which combines albumin with factor IX to reduce injection frequency."...
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.
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.
DOSAGE AND ADMINISTRATION
Coly-Mycin M Parenteral is supplied in vials containing colistimethate sodium equivalent to 150 mg colistin base activity per vial.
Reconstitution for Intravenous or Intramuscular Administration
The 150 mg vial should be reconstituted with 2 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.
Adults and Pediatric Patients -Intravenous or Intramuscular Administration:
The dose of Coly-Mycin M Parenteral should be 2.5 to 5 mg/kg per day of colistin base in 2 to 4 divided doses 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 and frequency should be reduced for the patients with renal impairment. Suggested modifications of dosage schedule for patients with 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
|Degree of Renal Impairment|
|Creatinine Clearance (mL/min)||≥ 80||50-79||30-49||10-29|
|Dosage Schedule||2.5 – 5 mg/kg, divided into 2 to 4 doses per day||2.5 – 3.8 mg/kg, divided into 2 doses per day||2.5 mg/kg, once daily or divided into 2 doses per day||1.5 mg/kg every 36 hours|
|Note: The suggested total daily dose is calculated from colistin base activity.|
- 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:
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 final intravenous infusion solution containing colistimethate sodium should be freshly prepared and used for no longer than 24 hours.
Store reconstituted solution for intramuscular injection in a refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.
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.
NDC 42023-107-01: one
NDC 42023-107-06: six vials per carton.
Store between 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). [See USP controlled room temperature]
Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C(68° to 77°F) and use within 7 days.
Prescribing information as of January 2013. Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307. Revised: January 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 3/15/2013
Additional Coly-Mycin M Information
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