ISENTRESS ORAL SUSPENSION Dosage & Rx Info

Isentress Oral Suspension Generic Name & Formulations

Legal Class

General Description

Raltegravir (as potassium) 100mg; per packet; pwd for oral susp; banana flavor.

Pharmacological Class

HIV-1 integrase strand transfer inhibitor (INSTI).

How Supplied

Chew tabs, film-coated tabs—60; Susp (pkts)—1, 60 (w. syringes, mixing cups)

Manufacturer

Merck & Co., Inc.

Isentress Oral Suspension Indications

Indications

HIV-1 infection, in combination with other antiretrovirals.

Isentress Oral Suspension Dosage and Administration

Adult

Use film-coated tabs.

Children

Pre-term neonates or <2kg: not recommended. Give first dose between 24–48hrs post birth if mother received raltegravir 2–24hrs before delivery. Mix susp packet contents with 10mL of water; administer using oral syringe within 30mins. Birth to 1 week (2–<3kg): 4mg (0.4mL) once daily; (3–<4kg): 5mg (0.5mL) once daily; (4–<5kg): 7mg (0.7mL) once daily. 1 to 4 weeks (2–<3kg): 8mg (0.8mL) twice daily; (3–<4kg): 10mg (1mL) twice daily; (4–<5kg): 15mg (1.5mL) twice daily. ≥4 weeks (3–<4kg): 25mg (2.5mL) twice daily; (4–<6kg): 30mg (3mL) twice daily; (6–<8kg): 40mg (4mL) twice daily; (8–<10kg): 60mg (6mL) twice daily; (10–<14kg): 80mg (8mL) twice daily; (14–<20kg): 100mg (10mL) twice daily; (20–<25kg): use chew tabs. Oral susp max dose: 100mg (10mL) twice daily. See full labeling.

Isentress Oral Suspension Contraindications

Not Applicable

Isentress Oral Suspension Boxed Warnings

Not Applicable

Isentress Oral Suspension Warnings/Precautions

Warnings/Precautions

Chew tabs or oral susp are not interchangeable with the film-coated tabs. Monitor liver aminotransferases, myopathy, and rhabdomyolysis. Discontinue if signs/symptoms of severe skin or hypersensitivity reactions develop. Hepatic impairment: Isentress HD not recommended. Pregnancy. Nursing mothers: not recommended.

Isentress Oral Suspension Pharmacokinetics

See Literature

Isentress Oral Suspension Interactions

Interactions

May be antagonized by UGT1A1 inducers (eg, rifampin; see Adult dose) and potentiated by UGT1A1 inhibitors. Concomitant aluminum and/or magnesium-containing antacids, other strong enzyme inducers (eg, carbamazepine, phenobarbital, phenytoin): not recommended. Caution with concomitant drugs known to cause myopathy or rhabdomyolysis (eg, statins). Isentress HD: concomitant calcium carbonate antacid, rifampin, tipranavir/ritonavir, etravirine: not recommended.

Isentress Oral Suspension Adverse Reactions

Adverse Reactions

Insomnia, headache, dizziness, nausea, fatigue, creatinine kinase elevations, myopathy, rhabdomyolysis; severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis), hypersensitivity, immune reconstitution syndrome.

Isentress Oral Suspension

PAGE CONTENTS