Revision Year: 2015 Publisher: Megapharm Ltd, P.O. Box 514, Hod Hasharon, 4510501, Israel Manufacturer: Paesel + Lorei GmbH & Co. KG, Rheinberg, Germany
Treatment of visceral Leishmaniasis caused by Leishmania donovani, indicated in adults and adolescents ≥12 years of age weighing ≥30 kg (66 lbs).
Treatment of cutaneous Leishmaniasis caused by Leishmania brasiliensis complex or Leishmania mexicana complex, indicated in adults and adolescents ≥12 years of age weighing ≥30 kg (66 lbs).
Impavido hard capsules are for oral use.
The dosage of Impavido hard capsules depends on body weight.
| Body weight | Daily Dosage | Number of Hard capsules |
|---|---|---|
| 30-31 kg | 60 mg | 6 hard capsules Impavido 10 mg |
| 32-39 kg | 80 mg | 8 hard capsules Impavido 10 mg |
| 40 kg and above | 100 mg | 2 hard capsules Impavido 50 mg |
No data from clinicalstudies are available for patients with a bodyweight higher than 67 kg. An increase of the daily dosage to 150 mg (3 hard capsulesImpavido 50 mg) could be considered in patients with a bodyweight above 67 kg under monitoring of the tolerability.
The daily dosage for children aged 12 years and older with a body weight of at least 30 kg, adolescents and adults with a body weight of lower than 45 kg is 100 mg miltefosine (2 hard capsulesImpavido 50 mg). Patients with a bodyweight higher than 45 kg receive 150 mg miltefosine daily (3 hard capsulesImpavido 50 mg).
No data from clinicalstudies are available for patients with a bodyweight lower than 30 kg.
The hard capsules should be taken with meals. Dosages of 2-8 hard capsules per day should be divided into 2-3 individual doses to be taken either in the morning and in the evening or in the morning, at noon and in the evening.
The duration of treatmentis 28 days. Immunocompromised patients may require prolonged treatment (see section 4.4.)
A specific antidote against miltefosine is not known.
Gastrointestinalsymptoms(nausea, vomiting, loss of appetite) are to be expected in case of acute overdose. Adverse effects on liver, kidney, and retinal function cannot be excluded in case of substantial overdose.
Institute adequate hydration to prevent the risk of impaired renal function, and replace electrolytes as necessary. Because Miltefosine is only slightly excreted in the urine, forced diuresis will not increase Miltefosine excretion. Gastrointestinal lavage is of unknown value.
Shelf life: 5 years.
Store below 30°C.
Store in the original package in order to protect from moisture.
Impavido 10 mg: Pack with 56 hard capsulessealed in 8 aluminium/aluminium blisterstrips, each containing 7 hard capsules.
Impavido 50 mg: Packs with 28 and 56 hard capsulessealed in 4 and 8 aluminium/aluminium blister strips,respectively, each containing 7 hard capsules.
Any unused product or waste materialshould be disposed in accordance with localrequirements.
The hard capsule should not be break, crush, dissolve, or chew Impavido before swallowing.
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