The decision to inform patients and/or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand the information provided.To lessen the likelihood of adverse reactions related to cumulative drug effect, patients with a history of long-term therapy with prochlorperazine and/or other antipsychotics should be evaluated periodically to decide whether the maintenance dosage could be lowered or drug therapy discontinued.Drugs which lower the seizure threshold, including phenothiazine derivatives, should not be used with AmipaqueIn clinical trial and postmarketing experience, events of leukopenia/neutropenia and agranulocytosis have been reported temporally related to antipsychotic agents.Possible risk factors for leukopenia/neutropenia include preexisting low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia.

While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. After this time patients should be evaluated to determine their need for continued treatment. This calendar tracks upcoming PDUFA drug approval dates and FDA advisory committee meetings. ).Do not use in pediatric patients under 2 years of age or under 20 lbs. The use of prochlorperazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye’s syndrome.Children with acute illnesses (e.g., chicken-pox, CNS infections, measles, gastroenteritis) or dehydration seem to be much more susceptible to neuromuscular reactions, particularly dystonias, than are adults. If hypotension occurs after parenteral or oral dosing, place patient in head-low position with legs raised. Should these symptoms occur in children or pregnant patients, the drug should be stopped and not reinstituted. For example, CDER classifies biological products submitted in an application under section 351(a) of the Public Health Service Act as NMEs for purposes of FDA review, regardless of whether the Agency previously has approved a related active moiety in a different product. Dosage should not be increased until these side effects have subsided.If these symptoms become too troublesome, they can usually be controlled by a reduction of dosage or change of drug. These adverse events include hypotension, anticholinergic effects (such as urinary retention, constipation, and confusion), and neuromuscular reactions (such as parkinsonism and tardive dyskinesia) (see Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur.
Daily dosages above 40 mg should be used only in resistant cases.Adjust dosage to the response of the individual and according to the severity of the condition. Begin with the lowest recommended dose.


Tissue culture experiments indicate that approximately 1/3 of human breast cancers are prolactin-dependent Chromosomal aberrations in spermatocytes and abnormal sperm have been demonstrated in rodents treated with certain antipsychotics.As with all drugs which exert an anticholinergic effect, and/or cause mydriasis, prochlorperazine should be used with caution in patients with glaucoma.Because phenothiazines may interfere with thermoregulatory mechanisms, use with caution in persons who will be exposed to extreme heat.Phenothiazines can diminish the effect of oral anticoagulants.Phenothiazines can produce alpha-adrenergic blockade.Thiazide diuretics may accentuate the orthostatic hypotension that may occur with phenothiazines.Antihypertensive effects of guanethidine and related compounds may be counteracted when phenothiazines are used concomitantly.Concomitant administration of propranolol with phenothiazines results in increased plasma levels of both drugs.Phenothiazines may lower the convulsive threshold; dosage adjustments of anticonvulsants may be necessary. Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url; 09/02/2020: ORIG-1: Approval Not Applicable Label is not available on this site. Available for Android and iOS devices.

If generic versions of this product have been approved by the FDA, there may be Prochlorperazine is a phenothiazine derivative, present in CompazineProchlorperazine maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless, crystalline powder. In some instances, the syndrome was followed by irreversible brain damage. Do not give more than 10 mg the first day.