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.

Candida infection

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%

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

Micafungin sodium for injection 100mg/vial (Additional Strength)

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 )

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-
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