Prochlorperazine maleate (PROCHLORPERAZINE MALEATE)

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Trade Name: PROCHLORPERAZINE MALEATE

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: NuCare Pharmaceuticals,Inc.

Presentation: TABLET, HUMAN PRESCRIPTION DRUG

Strength: 10 mg/1

Storage and handling

PROCHLORPERAZINE MALEATE Phenothiazine [EPC],Phenothiazines [CS]

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These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
Trademark shown are property of their respective owners and GNH India does not lay any claim on them.

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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.n n n n 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: D&C yellow no. 10 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, pregelatinized starch, stearic acid and titanium dioxide.n nn

For control of severe nausea and vomiting. n n n n For the treatment of schizophrenia.n n n n 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).n n n n 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 n n n ).n n n n 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-psychotic conditions in which anxiety, or signs that mimic anxiety, are found (e.g., physical illness, organic mental conditions, agitated depression, character pathologies, etc.).n n n n Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation.n nn

Do not use in patients with known hypersensitivity to phenothiazines.n n n n Do not use in comatose states or in the presence of large amounts of central nervous system depressants (alcohol, barbiturates, narcotics, etc.).n n n n Do not use in pediatric surgery.n n n n Do not use in pediatric patients under 2 years of age or under 20 lbs. Do not use in children for conditions for which dosage has not been established.n nn

Increased Mortality in Elderly Patients with Dementia-Related Psychosisn n n n n- Arrayn- The extrapyramidal symptoms which can occur secondary to prochlorperazine may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g., Reyeu2019s syndrome or other encephalopathy. The use of prochlorperazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reyeu2019s syndrome.
Tardive Dyskinesia: n- Arrayn- Array
Neuroleptic Malignant Syndrome (NMS):
Falls:
Usage in Pregnancy:
Non-teratogenic Effectsn n n n
Prochlorperazine Maleate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers:

Leukopenia, Neutropenia and Agranulocytosis:n n n n n- Arrayn- in vitro,
Long-Term Therapy: n- Arrayn- u00a0n n n n
Geriatric Use: n- see n n n and n n n n n- see n n n n

Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur. Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs (see n n n ).n n n n Cholestatic jaundice has occurred. If fever with grippe-like symptoms occurs, appropriate liver studies should be conducted. If tests indicate an abnormality, stop treatment. There have been a few observations of fatty changes in the livers of patients who have died while receiving the drug. No causal relationship has been established.n n n n Leukopenia and agranulocytosis have occurred. Warn patients to report the sudden appearance of sore throat or other signs of infection. If white blood cell and differential counts indicate leukocyte depression, stop treatment and start antibiotic and other suitable therapy.n nn
Neuromuscular (Extrapyramidal) Reactionsn n n n
Dystonia n n n Class effect:n n n
Motor Restlessness:
Pseudo-Parkinsonism:
Tardive Dyskinesia:
Adverse Reactions Reported with Prochlorperazine or Other Phenothiazine Derivatives:n n n n

(See also n n n )n n n n n --Primarily involvement of the extrapyramidal mechanism producing some of the dystonic reactions described above.n n n n Symptoms of central nervous system depression to the point of somnolence or coma. Agitation and restlessness may also occur. Other possible manifestations include convulsions, EKG changes and cardiac arrhythmias, fever and autonomic reactions such as hypotension, dry mouth and ileus.n n n n TREATMENT--It is important to determine other medications taken by the patient since multiple-dose therapy is common in overdosage situations. Treatment is essentially symptomatic and supportive. Early gastric lavage is helpful. Keep patient under observation and maintain an open airway, since involvement of the extrapyramidal mechanism may produce dysphagia and respiratory difficulty in severe overdosage. n n n n Extrapyramidal symptoms may be treated with antiparkinsonism drugs, barbiturates or Benadryl. See prescribing information for these products. Care should be taken to avoid increasing respiratory depression.n n n n If administration of a stimulant is desirable, amphetamine, dextroamphetamine or caffeine with sodium benzoate is recommended.n n n n Stimulants that may cause convulsions (e.g., picrotoxin or pentylenetetrazol) should be avoided.n n n n If hypotension occurs, the standard measures for managing circulatory shock should be initiated. If it is desirable to administer a vasoconstrictor, Levophed and Neo-Synephrine are most suitable. Other pressor agents, including epinephrine, are not recommended because phenothiazine derivatives may reverse the usual elevating action of these agents and cause further lowering of blood pressure.n n n n Limited experience indicates that phenothiazines are not dialyzable.n nn

(For childrenu2019s dosage and administration, see below.) Dosage should be increased more gradually in debilitated or emaciated patients.
Elderly Patients:
1.To Control Severe Nausea and Vomiting:n n n n n- Oral Dosage-Tablets:
2.In Adult Psychiatric Disorders: n- Oral Dosage:
Psychotic Disorders including Schizophrenian- Inrelatively mild conditions
In moderate to severe conditions,
In more severe disu00adturbances,
DOSAGE AND ADMINISTRATION--CHILDREN
Do not use in pediatric surgery.n n n n
1. Severe Nausea and Vomiting in Children:n n n n
Oral Dosage:
2. Children with schizophrenia:n n n n n- Oral Dosage:

10mg Charteruse, round, film coated tablets debossed with TL 115 scored on one side and plain on the other side.n n nNDC 66267-318-04 BOTTLES OF 04n
NDC 66267-318-10 BOTTLES OF 10
NDC 66267-318-12 BOTTLES OF 12
NDC 66267-318-15 BOTTLES OF 15
NDC 66267-318-20 BOTTLES OF 20
NDC 66267-318-30 BOTTLES OF 30
NDC 66267-318-60 BOTTLES OF 60

Store at 20 - 25n n n C (68 - 77n n n F) [See USP Controlled Room Temperature]. n n n Protect from light. Dispense in a tight, light-resistant container. n nn
* norepinephrine bitartrate, Abbott Laboratories. n n n ** phenylephrine hydrochloride, Abbott Laboratories. n n n *** phenytoin, Parke Davis.n n n u00a7 metrizamide, Sanofi Pharmaceuticals.n n n llu00a0diphenhydramine hydrochloride, Parke Davis. n nn
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Revised: 05/2017

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler, Supplier, Exporters from India of Prochlorperazine maleate (PROCHLORPERAZINE MALEATE) which is also known as PROCHLORPERAZINE MALEATE and Manufactured by NuCare Pharmaceuticals,Inc.. It is available in strength of 10 mg/1.

Prochlorperazine maleate (PROCHLORPERAZINE MALEATE) is supplied for Tenders, Emergency imports, Un - licensed, Specials, Orphan drug, Name patient line, RLD supplies, Reference listed drugs, Comparator Drug, Bio-Similar, Innovator samples, For Clinical trials. Click to know price.