Drug Interaction:
Drug interactions-
Micafungin +
Cyclosporine-
cyclosporine whole blood concentration may be elevated increasing the pharmacological
effects.
Itraconazole-
coadministration resulted in itraconazole AUC and Cmax . Monitor intraconazole toxicity
and reduce dosage as necessary
Nifedipine-
Nifedipine AUc and Cmax increased. Monitor for nifedipine toxicity and reduce dosase
as necessary
Sirolimus-
sirolimus AUc was increased in presence of steady state micafungin. Monitor for sirolimus
toxicity and reduce dosage as needed.
Indication:
MYCAMINE (micafungin sodium) For Injection; IV Infusion Only
Initial U.S. Approval: 2005
RECENT MAJOR CHANGES
Indications and Usage,
Treatment of Patients with Candidemia, Acute
Disseminated Candidiasis, Candida Peritonitis and Abscesses (1.1) 1/2008
Dosage and Administration,(2) 1/2008
Micafungin sodium for injection 100mg/vial (Additional Strength)
Indication -
Treatment of patients with candidemia, acute Disseminated Candidiasis,
Candida Peritonitis and abcesses.
Treatment of Esophageal Candidiasis , Prophylaxis of Candida and Asperigillus
Infections in patients undergoing Hemopoetic stem cell transplation .
Treatment of patient with Fungemia , Respiratory nycosis, Gastrointestinal mycosis
caused by Aspergillus sp.
Approved by FDA on 02--05-2014 (Ref- FDA approved List- 2014)
Candida infection
Adverse Reaction:
Adverse reactions-
Cardiovascular - atrial fibrillation 2% bradycardia 2% cardiac disorders 16% hypertension 2%
hypotension 9% tachycardia 2% vascuar disorders 20%
CNS- headache 2% insomnia 5% nervous systen disorders 9%
psychiatric disorders 14%
Dermatologic- skin/subcutaneous tissue disorders 12%
GI- abdominal pain 2% diarrhea 6% GI disorders 38% vomiting 8%
Hematological/lymphatic - anemia 2% blood lymphatic system disorders 17%
thrombocytpenia 3%
Metabolic/nutrional hypokalemia 4% hypernatremia 3% hypoglycemia 12%
hypomagnesiumia 5% metabolism and nutrition disorders 36%
Miscellaneous- bactermia 4% blood alkaline phosphatase increased 4%
edema peripheral 4% general administration disorders 28%
pyrexia 6% sepsis 5% septic shock 6%
Contra-Indications:
Hypersensitivity-
Special precautions-
Hematological effects- closely monitor patients who develop clinical or laboratory evidence
of hemolysisor hemolytic anemia during microfungin therapy
Hepatic effects- monitor patients who develop abnormal liver function tests during micafungin
therapy for evidence of worsening hepatic hepatic function.
Renal effects- monitor patients who develop abnormal renal function tests during mulfungin
therapy for evidence of worsening renal function
Hypersensitivity reactions- isolated cases serious hypersensitivity (anaphylaxis and
anaphylactoid reactions) including shock have been reported
Pregnancy- use micafungin during pregnancy only if required.
Lactation- excecise caution when micafungin is administered to a breast feeding woman.
Children- safety and efficacy in children not established
Elderly- no overal differences insafety or efficacy were observed between elderly
and younger subjects. However excecise caution
Dosages/ Overdosage Etc:
Micafungin sodium for injection 100mg/vial (Additional Strength)
Indication -
Treatment of patients with candidemia, acute Disseminated Candidiasis,
Candida Peritonitis and abcesses.
Treatment of Esophageal Candidiasis , Prophylaxis of Candida and Asperigillus
Infections in patients undergoing Hemopoetic stem cell transplation .
Treatment of patient with Fungemia , Respiratory nycosis, Gastrointestinal mycosis
caused by Aspergillus sp.
Approved by FDA on 02--05-2014 (Ref- FDA approved List- 2014)
Indication
Candida infection
Dosage-
100mg/day administered IV by infusion over 1 hour. The mean duration for treatment was
15 days ( 10 to 47 days )
Patient Information:
PATIENT COUNSELING INFORMATION
Patients should be advised of the potential benefits and risks of Mycamine.
Patients should be informed about the common adverse effects of Mycamine
including hypersensitivity reactions (anaphylaxis and anaphylactoid reactions
including shock), hematological effects (acute intravascular hemolysis,
hemolytic anemia and hemoglobinuria), hepatic effects (abnormal liver function
tests, hepatic dysfunction,hepatitis or worsening hepatic failure) and renal effects
(elevations in BUN and creatinine, renal dysfunction or acute renal failure).
Patients should be instructed to inform their health care provider if they develop
any unusual symptom, or if any known symptom persists or worsens.
Patients should be instructed to inform their health care provider of any other
medications they are currently taking with Mycamine, including over-the-counter
medications
Pharmacology/ Pharmacokinetics:
Pharmacology-
Micafungin a member of echinocandin class of antifungal agents, inhibits the synthesis of
1,3,beta D -glucan an essential component of fungal cell walls which is present in mammalian
cells.
Pregnancy and lactation:
Pregnancy-
Use micafungin during pregnancy only if required.
Lactation-
Excecise caution when micafungin is administered to a breast feeding woman.
Children-
Safety and efficacy in children not established
Elderly-
No overal differences in safety or efficacy were observed between elderly
and younger subjects. However excecise caution
Manufacturer Details