Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
Prochlorperazine Maleate (UNII: I1T8O1JTL6) (Prochlorperazine - UNII:YHP6YLT61T)
Proficient Rx LP
Prochlorperazine Maleate
Prochlorperazine 5 mg
ORAL
PRESCRIPTION DRUG
For control of severe nausea and vomiting. For the treatment of schizophrenia. Prochlorperazine is effective for the short-term treatment of generalized non-psychotic anxiety. However, prochlorperazine is not the first drug to be used in therapy for most patients with non-psychotic anxiety, because certain risks associated with its use are not shared by common alternative treatments (e.g., benzodiazepines). When used in the treatment of non-psychotic anxiety, prochlorperazine should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of prochlorperazine at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS ). The effectiveness of prochlorperazine as treatment for non-psychotic anxiety was established in 4-week clinical studies of outpatients with generalized anxiety disorder. This evidence does not predict that prochlorperazine will be useful in patients with other non-psychoti
Prochlorperazine Maleate Tablets USP are available in the following strengths and package sizes: 5mg Chartreuse, round, film-coated tablet debossed with "TL" on the top and "113" on the bottom of the score line on one side and plain on the other side. Bottles of 15 NDC 63187-502-15 Bottles of 30 NDC 63187-502-30 Bottles of 60 NDC 63187-502-60 Bottles of 90 NDC 63187-502-90 10mg Chartreuse, round, film-coated tablet debossed with "TL" on the top and "115" on the bottom of the score line on one side and plain on the other side. Bottles of 15 NDC 63187-251-15 Bottles of 30 NDC 63187-251-30 Bottles of 60 NDC 63187-251-60 Bottles of 90 NDC 63187-251-90
Abbreviated New Drug Application
PROCHLORPERAZINE MALEATE- PROCHLORPERAZINE MALEATE TABLET PROFICIENT RX LP ---------- PROCHLORPERAZINE MALEATE TABLETS USP RX ONLY WARNING INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5% compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Prochlorperazine maleate is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS). DESCRIPTION Prochlorperazine is a phenothiazine derivative, present in prochlorperazine tablets as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4- methyl- 1 -piperazinyl)propyl] phenothiazine maleate [molecular weight 606.10] and has the following structure Prochlorperazine Maleate is classified as an anti-emetic and antipsychotic agent. Prochlorperazine maleate is white or pale yellow, practically odorless crystalline powder. It is practically insoluble in water and in alcohol; slightly soluble in warm chloroform. Each tablet, for oral administration contains prochlorperazine maleate equivalent to 5 mg or 10 m Perskaitykite visą dokumentą