cy of PERSERIS [see Clinical Pharmacology (12.3)].
Intervention: Changes in efficacy and safety should be carefully monitored with any dose adjustment of PERSERIS. At the initiation of therapy with a strong CYP3A4 inducer, patients should be closely monitored during the first 4 to 8 weeks. In patients receiving PERSERIS 90 mg, consider increasing the dose to 120 mg. In patients receiving PERSERIS 120 mg, additional oral risperidone therapy may need to be considered. On discontinuation of a strong CYP3A4 inducer, the dosage of PERSERIS or any additional oral risperidone therapy should be re-eva luated and, if necessary, decreased to adjust for the expected increase in plasma concentration of risperidone and 9-hydroxyrisperidone. For patients treated with PERSERIS 90 mg and discontinuing from a strong CYP3A4 inducer, it is recommended to continue treatment with the 90 mg dose unless clinical judgment necessitates interruption of PERSERIS treatment [see Dosage and Administration (2.3)].
Examples: rifampin, carbamazepine, phenytoin, phenobarbital
Centrally-Acting Drugs and Alcohol
Clinical Impact: Due to additive pharmacologic effects, the concomitant use of centrally-acting drugs, including alcohol, may increase nervous system disorders.
Intervention: Caution should be used when PERSERIS is administered in combination with other centrally-acting drugs or alcohol.
Examples: Antipsychotics, alcohol
Hypotensive Agents
Clinical Impact: Because of its potential for inducing hypotension, PERSERIS may enhance the hypotensive effects of other therapeutic agents with this potential.
Intervention: Caution should be used when PERSERIS is administered in combination with other therapeutic agents with hypotensive effects.
Examples: Antihypertensive Drugs
Dopamine Agonists
Clinical Impact: Agents with central antidopaminergic activity such as PERSERIS may antagonize the pharmacologic effects of dopamine agonists.
Intervention: Caution should be used when PERSERIS is administered in combination with levodopa and dopamine agonists.
Examples: carbidopa, levodopa
7.2 Drugs Having No Clinically Important Interactions with PERSERIS
Based on pharmacokinetic studies with oral risperidone, no dosage adjustment of PERSERIS is required when administered concomitantly with amitriptyline, cimetidine, ranitidine, clozapine, topiramate and moderate CYP3A4 inhibitors (erythromycin). Additionally, no dosage adjustment is necessary for lithium, valproate, topiramate, digoxin and CYP2D6 substrates (donepezil and galantamine) when co-administered with PERSERIS [see Clinical Pharmacology (12.3)].
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including PERSERIS, during pregnancy. Healthcare professionals are encouraged to register patients by contacting the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
Risk Summary
Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery (see CLINICAL CONSIDERATIONS). Overall av |
