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.
Provides access to the latest drug monographs submitted to the Food and Drug Administration (FDA). Please review the latest applicable package insert for additional information and possible updates. A local search option of this data can be found here.