COLY-MYCIN M Solution for injection (2018)

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Par Pharmaceutical, Inc.

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1. Description

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. ...

2. Clinical Pharmacology

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 ...

3. 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 ...

4. 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.

5. Warnings

Maximum daily dose calculated from colistin base activity should not exceed 5 mg/kg/day with normal renal function. Transient neurological disturbances may occur. These include circumoral paresthesia or ...

6.1. 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 ...

6.2. 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 ...

6.4. 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 ...

6.6. 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 ...

6.7. Pregnancy

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. ...

6.9. 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 ...

6.10. 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 ...

6.11. Geriatric Use

Clinical studies of colistimethate 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 ...

7. Adverse Reactions

The following adverse reactions have been reported: Gastrointestinal: gastrointestinal upset Nervous System: tingling of extremities and tongue, slurred speech, dizziness, vertigo, paresthesia, ...

9. Overdosage

Overdosage with colistimethate sodium can cause neuromuscular blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, disorders of speech and apnea. Respiratory muscle ...

10. 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 for Intravenous or Intramuscular Administration ...

11. 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. NDC 42023-107-01: one ...

12. Storage and Handling

Store unreconstituted product between 20° to 25°C (68° to 77°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° ...