Serivan(Pimavanserin)
Therapeutic Group: atypical antipsychotic
Presentation
Serivan 17 : Each tablet contains Pimavanserin tartrate INN equivalent to Pimavanserin 17 mg.
Serivan 34 : Each capsule contains Pimavanserin tartrate INN equivalent to Pimavanserin 34 mg
Description
Pimavanserin is an atypical antipsychotic. Pimavanserin acts as an inverse agonist and antagonist at serotonin 5-HT2A receptors.
Indications
Pimavanserin is indicated for the treatment of hallucination and delusion associated with Parkinson’s disease psychosis.
Dosage & Administration
The recommended dose of Pimavanserin is 34 mg, taken orally as two tablets of Serivan 17 mg or one capsule of Serivan 34 once daily, without titration. Pimavanserin can be taken with or without food.
Pediatric Use: Safety and effectiveness of Pimavanserin have not been established in pediatric patients.
Geriatric Use: No dose adjustment is required for elderly patients.
Side Effects
Pimavanserin may increase mortality in elderly patients with Dementia-Related Psychosis. It may cause QT prolongation.
Precautions
Precautions should be taken in case of hepatic and renal impairment, elderly with dementia related psychosis, pregnancy and lactation condition.
Renal Impaired patients: No dosage adjustment for Pimavanserin is needed in patients with CrCL ≥30 mL/min. Use of Pimavanserin is not recommended in patients with CrCL <30 mL/min.
Hepatic Impaired patients: Use of Pimavanserin is not recommended in patients with hepatic impairment.
Use in Pregnancy & Lactation
Pregnancy: There is no adequate or well controlled studies in pregnant women.
Lactation: There are no data regarding the presence of this drug in human milk or its effect on milk production
Drug Interaction
Coadministration with strong CYP3A4 inhibitors (eg, ketoconazole) increases Pimavanserin exposure. Reduce Pimavanserin dose to 17 mg, taken orally as one tablet once daily. Co-administration with strong CYP3A4 inducers may reduce Pimavanserin exposure. No dose adjustment of carbidopa/levodopa is required when administered concominantly with pimavanserin.
Storage
Do not store above 30 C. Keep away from light and out of the reach of children.
Commercial Pack
Serivan 17: Each box contains 3 blister strips of 10 tablets.
Serivan 34: Each box contains 3 blister strips of 6 capsules.