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RX ITEM-Compazine 5Mg Tab 100 By Pbm Pharma

NDC 66213-0115-10 UPC/GTIN No.3-66213-11510-9 Mfg.Part No.11510BRAND: COMPAZINE NDC: 66213-0115-10,66213011510 UPC: 3-66213-11510-9,366213115109 Pbm Pharma IncOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

RX ITEM-Compazine 5Mg Tab 100 By Pbm Pharma

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item No.:RX278130 NDC No.66213011510 UPC No.:366213115109 NDC No. 66213-0115-10 UPC/GTIN No. 3-66213-11510-9 MPN 11510 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No. Rx278130 Compazine 5mg Tab 100 by Pbm Pharma Item No. 3278130 NDC No. 66213011510 UPC No. 366213115109 Other Name Prochlorperazine,C

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COMPAZINE- prochlorperazine maleate tablet, film coated
PBM Pharmaceuticals, Inc.

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. COMPAZINE� (prochlorperazine maleate tablets USP) is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).

DESCRIPTION

Prochlorperazine is a phenothiazine derivative, present in COMPAZINE� as the maleate. Prochlorperazine maleate is designated chemically as 2-chloro-10-[3-(4-methyl-1- piperazinyl)propyl] phenothiazine maleate

C20 H24 ClN3 S�2C4 H4 O4 M.W. 606.10

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 mg of prochlorperazine. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, pregelatinized starch, stearic acid, titanium dioxide, triacetin, and yellow iron oxide.

INDICATIONS AND USAGE

For control of severe nausea and vomiting.

For the treatment of schizophrenia.

COMPAZINE� (prochlorperazine maleate tablets USP) is effective for the short-term treatment of generalized non-psychotic anxiety. However, COMPAZINE� (prochlorperazine maleate tablets USP) 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, COMPAZINE� (prochlorperazine maleate tablets USP) should not be administered at doses of more than 20 mg per day or for longer than 12 weeks, because the use of COMPAZINE� (prochlorperazine maleate tablets USP) at higher doses or for longer intervals may cause persistent tardive dyskinesia that may prove irreversible (see WARNINGS).

The effectiveness of COMPAZINE� (prochlorperazine maleate tablets USP) 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 COMPAZINE� (prochlorperazine maleate tablets USP) will be useful in patients with other non-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).

COMPAZINE� (prochlorperazine maleate tablets USP) has not been shown effective in the management of behavioral complications in patients with mental retardation.
DOSAGE AND ADMINISTRATION

Adults
(For children�s dosage and administration, see below.) Dosage should be increased more gradually in debilitated or emaciated patients.

Elderly Patients
In general, dosages in the lower range are sufficient for most elderly patients. Since they appear to be more susceptible to hypotension and neuromuscular reactions, such patients should be observed closely. Dosage should be tailored to the individual, response carefully monitored and dosage adjusted accordingly. Dosage should be increased more gradually in elderly patients.

1. To Control Severe Nausea and Vomiting
Adjust dosage to the response of the individual. Begin with the lowest recommended dosage.

Oral Dosage � Tablets

Usually one 5 mg or 10 mg tablet 3 or 4 times daily. Daily dosages above 40 mg should be used only in resistant cases.

2. In Adult Psychiatric Disorders
Adjust dosage to the response of the individual and according to the severity of the condition. Begin with the lowest recommended dose. Although response ordinarily is seen within a day or 2, longer treatment is usually required before maximal improvement is seen.

NDC 66213-0115-10 UPC/GTIN No.3-66213-11510-9 Mfg.Part No.11510
RX ITEM-Compazine 5Mg Tab 100 By Pbm Pha
NDC 66213-0115-10 UPC/GTIN No.3-66213-11510-9 Mfg.Part No.11510

BRAND: COMPAZINE NDC: 66213-0115-10,66213011510 UPC: 3-66213-11510-9,366213115109 Pbm Pharma Inc
Compazine 5Mg Tab 100 By Pbm Pharma
BRAND: COMPAZINE NDC: 66213-0115-10,66213011510 UPC: 3-66213-11510-9,366213115109 Pbm Pharma Inc

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
PROCHLORPERAZINE MALEATE
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.