Orap (pimozide)

When pimozide is used for suppression of motor and vocal tics in patients with Tourette's syndrome, the initial dosage of the drug should be low and dosage adjustments should be made gradually. Dosage of pimozide must be carefully adjusted to balance symptomatic relief and the suppression of tics against the adverse effects of the drug. Patients receiving pimozide should have an ECG performed before therapy with the drug is initiated and periodically thereafter, particularly during the period of dosage adjustment. (See Cautions: Precautions and Contraindications.)

Pimozide is administered orally. The drug may usually be administered once daily but also may be given in divided doses, particularly if once-daily dosing is not well tolerated. Some clinicians recommend administration of the drug as a single dose at bedtime to minimize adverse effects.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Reproduction studies in rats and rabbits using oral pimozide dosages up to 2.5 mg/kg daily (up to about 8 times the maximum recommended human dosage) have not revealed evidence of fetal malformation; however, in rats receiving oral pimozide dosages of 2.5 mg/kg daily or higher, a decreased pregnancy rate, increased fetal resorption, and retarded development of fetuses occurred. The observed effects may have resulted from delay or inhibition of implantation. In rabbits, dose-related maternotoxicity, mortality, decreased weight gain, and embryotoxicity, including increased fetal resorption, occurred.

Neonates exposed to antipsychotic agents during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tardive dyskinetic-like symptoms, tremor, somnolence, respiratory distress, and feeding disorder in these neonates. The majority of cases were also confounded by other factors, including concomitant use of other drugs known to be associated with withdrawal symptoms, prematurity, congenital malformations, and obstetrical and perinatal complications; however, some cases suggested that neonatal extrapyramidal symptoms and withdrawal may occur with exposure to antipsychotic agents alone. Some of the cases described time of symptom onset, which ranged from birth to one month after birth. Any neonate exhibiting extrapyramidal or withdrawal symptoms following in utero exposure to antipsychotic agents should be monitored. Symptoms were self-limiting in some neonates but varied in severity; some infants required intensive care unit support and prolonged hospitalization. For further information on extrapyramidal and withdrawal symptoms in neonates, see Cautions: Pregnancy, Fertility, and Lactation, in the Phenothiazines General Statement 28:16.08.24.

Pimozide should be used during pregnancy only when the potential benefits justify the potential risks to the fetus. Women should be advised to notify their clinician if they become pregnant or plan to become pregnant during therapy with the drug. In addition, clinicians should advise women of childbearing potential about the benefits and risks of using antipsychotic agents during pregnancy. Patients should also be advised not to stop taking their antipsychotic agent if they become pregnant without first consulting with their clinician, since abruptly discontinuing the drugs can cause clinically important complications.

It is not known whether pimozide is distributed into milk. Because of the potential for serious adverse reactions (e.g., tumorigenicity, unknown cardiovascular effects) to pimozide in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced messaging available.