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New Drug Indications - September 2023


tapentadol hydrochloride

Nucynta

Pharmaceutical company: Collegium Pharmaceutical, Inc.

NEW INDICATION & DOSAGE

Acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate (immediate-release)

Children age 6 and older weighing 80 kg or more: 50 mg PO every 4 hours. May increase dosage to 75 mg every 4 hours, then 100 mg every 4 hours to maintain adequate analgesia, as tolerated. Maximum single dose, 100 mg.

Children age 6 and older weighing 60 to 79 kg: 50 mg PO every 4 hours. May increase dosage to 75 mg every 4 hours to maintain adequate analgesia, as tolerated. Maximum single dose, 75 mg.

Children age 6 and older weighing 40 to 59 kg: 50 mg PO every 4 hours. Maximum single dose, 50 mg.

Adjust-a-dose: Maximum daily dose is 7.5 mg/kg/day (six 1.25-mg/kg doses over 24 hours). In children with a high BMI, maximum daily dose must not exceed the maximum dose for a body weight at the 97th percentile for a given age. Reduce dosage over time as acute pain decreases. Duration of treatment for children shouldn't exceed 3 days. Use in children with liver or kidney impairment isn't recommended.

Released: September 2023

Nursing Drug Handbook

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