Drug Detail:Lampit (Nifurtimox [ nye-fure-ti-mox ])
Generic Name: NIFURTIMOX 30mg
Dosage Form: tablet, film coated
Drug Class: Miscellaneous antibiotics
Important Administration Instructions
- •
- LAMPIT (30 mg and 120 mg) tablets are for oral use and must be taken with food.
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- LAMPIT tablets are dosed by body weight of the patient [see Dosage and Administration (2.2)].
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- LAMPIT (30 mg and 120 mg) tablets are functionally scored tablets which can be split into one-half (15 mg and 60 mg respectively) at the scored lines by hand. Do not break LAMPIT tablets mechanically with a tablet splitting device [see Dosage and Administration (2.4) and Instructions for Use].
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- LAMPIT 30 mg and 120 mg tablets can be made into a slurry as an alternative method of administration for patients who cannot swallow the tablets [see Dosage and Administration (2.5)].
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- Discontinue consumption of alcohol during treatment with LAMPIT [see Contraindications (4) and Drug Interactions (7)].
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- Complete the full course of treatment to prevent recurrence of the infection.
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- If a dose is missed, take the missed dose as soon as possible together with food. However, if it is within 3 hours of the next scheduled dose, skip the missed dose and continue treatment as prescribed. Do not take a double dose to make up for a missed dose.
Recommended Dosage in Pediatric Patients
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- Administer LAMPIT (30 mg and 120 mg) tablets orally three times a day with food.
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- Total daily recommended dosages of LAMPIT are based on the body weight of the patient (see Table 1).
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- Adjust LAMPIT dosage accordingly if body weight decreases during treatment [see Warnings and Precautions (5.4)].
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- The recommended duration of treatment with LAMPIT is 60 days.
Table 1: Total Daily Recommended Dosages of LAMPIT Based on Body Weight
|
Age |
Body weight group |
Total daily dose of nifurtimox (mg/kg) |
|
Birtha to less than 18 years |
41 kg or greater |
8 to 10 |
|
Less than 41 kg |
10 to 20 |
aTerm newborn with body weight of greater than or equal to 2.5 kg
Table 2: Individual Dosages Based on Body Weight in Pediatric Patients (Birtha to Less than 18 years of age)
|
Body weight (kg) |
Dose (mg) |
Number of LAMPIT 30 mg tablets per dose |
Number of LAMPIT |
|
2.5 kg to 4.5 kg |
15 mg |
½ tablet |
— |
|
4.6 kg to less than 9 kg |
30 mg |
1 tablet |
— |
|
9 kg to less than 13 kg |
45 mg |
1 ½ tablets |
— |
|
13 kg to less than 18 kg |
60 mg |
2 tablets |
½ tablet |
|
18 kg to less than 22 kg |
75 mg |
2 ½ tablets |
— |
|
22 kg to less than 27 kg |
90 mg |
3 tablets |
— |
|
27 kg to less than 35 kg |
120 mg |
4 tablets |
1 tablet |
|
35 kg to less than 41 kg |
180 mg |
— |
1 ½ tablets |
|
41 kg to less than 51 kg |
120 mg |
— |
1 tablet |
|
51 kg to less than 71 kg |
180 mg |
— |
1 ½ tablets |
|
71 kg to less than 91 kg |
240 mg |
— |
2 tablets |
|
91 kg or greater |
300 mg |
— |
2 ½ tablets |
aTerm newborn with body weight of greater than or equal to 2.5 kg
Pregnancy Testing Prior to Initiating LAMPIT
Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with LAMPIT [see Warnings and Precautions (5.2) and Use in Specific Populations (8.3)].
Instructions for Splitting LAMPIT Tablets
Do not break LAMPIT tablets mechanically with a tablet splitting device. A functional score line is used to divide the tablet by hand as follows:
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- To split LAMPIT tablet, place the tablet on a flat surface with the score line facing up.
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- With the tablet resting on the flat surface, apply enough downward pressure with the index finger centered on the top of the tablet to break it along the score line.
Preparation of a Slurry of LAMPIT as an Alternate Method of Administration
For patients who are unable to swallow whole or half tablets, LAMPIT tablet can be dispersed in water and administered as outlined below.
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- Place approximately 2.5 mL of water into a spoon.
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- Place the prescribed dose into the water.
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- Allow the tablet(s) to disintegrate (typically less than 30 seconds).
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- A slurry (liquid suspension) is formed.
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- Take the slurry immediately with food.
