IMPAVIDO capsules contain the active ingredient miltefosine, an antileishmanial agent. The chemical name of miltefosine is 2-[[(hexadecyloxy)hydroxyphosphenyl]oxy]-N,N,Ntrimethylethylammonium inner salt. Miltefosine is a white powder that is freely soluble in water, 0.1 N HCl or NaOH, methanol, and ethanol. It has the empirical formula of C21H46NO4P with a molecular weight of 407.6
INDICATIONS AND USAGE:
Limitations of Use
Hypersensitivity to miltefosine or any of its excipients
| WARNINGS AND PRECAUTIONS:
| ADVERSE REACTIONS:
Adverse reactions occurring in ≥2% of patients include nausea,
See PACKAGE INSERT for PATIENT COUNSELING INFORMATION and Medication Guide.
| DOSAGE AND ADMINISTRATION:
The treatment duration is 28 consecutive days. Administer with food to ameliorate gastrointestinal adverse reactions.
| DOSAGE FORMS AND STRENGTHS:
IMPAVIDO® (miltefosine) oral capsules are opaque, red, hard gelatin capsules with “PLB” imprinted on the capsule body and “MILT 50” imprinted on the cap using a white ink. Each capsule contains 50 mg miltefosine [see DESCRIPTION, Storage and Handling].
Storage And Handling
Store at 20-25°C (68–77 °F); excursions permitted to 15-30°C (59 – 86°F). [See USP Controlled Room Temperature]. Protect from moisture.
Dispense only in the original carton.
National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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