Etravirine dosage and administration

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Etravirine
INTELENCE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ahmed Zaghw, M.D. [2]

Dosage and Administration

Adult Patients

The recommended oral dose of INTELENCE® tablets is 200 mg (one 200 mg tablet or two 100 mg tablets) taken twice daily following a meal seeClinical Pharmacology. The type of food does not affect the exposure to etravirine.

Pediatric Patients (6 years to less than 18 years of age)

The recommended dose of INTELENCE® for pediatric patients 6 years to less than 18 years of age and weighing at least 16 kg is based on body weight (see table below) not exceeding the recommended adult dose. INTELENCE tablet(s) should be taken orally, following a meal see Clinical Pharmacology. The type of food does not affect the exposure to etravirine.

The safety and efficacy of INTELENCE® have not been established in children less than 6 years of age [see Clinical Pharmacology (12.3)].

Healthcare professionals should pay special attention to the accurate dose selection of INTELENCE®, the transcription of the medication order, the dispensing information and the dosing instructions to minimize the risk of medication errors, overdosing, and underdosing.

Method of Administration

Patients should be instructed to swallow the INTELENCE® tablet(s) whole with a liquid such as water. Patients who are unable to swallow the INTELENCE® tablet(s) whole may disperse the tablet(s) in a glass of water.

The patient should be instructed to do the following:

  • Place the tablet(s) in 5 mL (1 teaspoon) of water, or at least enough liquid to cover the medication.
  • Stir well until the water looks milky.
  • If desired, add more water or alternatively orange juice or milk (patients should not place the tablets in orange juice or milk without first adding water). The use of grapefruit uice or warm (greater than 40°C) or carbonated beverages should be avoided.
  • Drink it immediately, rinse the glass several times with water, orange juice, or milk and completely swallow the rinse each time to make sure the patient takes the entire dose.[1]

References

  1. "INTELENCE (ETRAVIRINE) TABLET [JANSSEN PRODUCTS LP]".

Adapted from the FDA Package Insert.