Impavido
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
IMPAVIDO (miltefosine) capsules are indicated in adults and adolescents ≥12 years of age weighing ≥ 30 kg for the treatment of:
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- Visceral leishmaniasis caused by Leishmania donovani [see Clinical Trials (14.1)].
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- Cutaneous leishmaniasis caused by Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis [see Clinical Trials (14.2)].
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- Mucosal leishmaniasis caused by Leishmania braziliensis [see Clinical Trials (14.3)].
Limitations of Use:
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- Leishmania species studied in clinical trials evaluating IMPAVIDO were based on epidemiologic data [see Clinical Trials (14.1, 14.2)].
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- There may be geographic variation in clinical response of the same Leishmania species to IMPAVIDO [see Clinical Trials (14.1, 14.2)].
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- The efficacy of IMPAVIDO in the treatment of other Leishmania species has not been evaluated.
History
There is currently no drug history available for this drug.
Other Information
IMPAVIDO capsules contain the active ingredient miltefosine, an antileishmanial agent. The chemical name of miltefosine is 2-[[(hexadecyloxy)hydroxyphosphenyl]oxy]-N,N,N-trimethylethylammonium 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 and the following structural formula:
The inactive ingredients are colloidal silicon dioxide, microcrystalline cellulose, lactose monohydrate, talc, and magnesium stearate. The capsule shell contains gelatin, titanium dioxide, ferric oxide, and purified water.
Sources
Impavido Manufacturers
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Paladin Therapeutics Inc.
![Impavido (Miltefosine) Capsule [Paladin Therapeutics Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Impavido | Paladin Therapeutics Inc.
The treatment duration is 28 consecutive days. Administer with food to ameliorate gastrointestinal adverse reactions.
Table 1: Miltefosine DosageWeight
Dosage and Administration
30 kg to 44 kg
One 50 mg capsule twice daily with food (breakfast and dinner)
45 kg or greater
One 50 mg capsule three times daily with food (breakfast, lunch, and dinner)
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Profounda, Inc.
Impavido | Profounda, Inc.
The treatment duration is 28 consecutive days. Administer with food to ameliorate gastrointestinal adverse reactions.
Table 1: Miltefosine DosageWeight
Dosage and Administration
30 kg to 44 kg
One 50 mg capsule twice daily with food (breakfast and dinner)
45 kg or greater
One 50 mg capsule three times daily with food (breakfast, lunch, and dinner)
![Impavido (Miltefosine) Capsule [Profounda, Inc.]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
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