STEMETIL TAB 5MG 5 MG

What is STEMETIL TAB 5MG?

STEMETIL TAB 5MG 5 MG contains PROCHLORPERAZINE (PROCHLORPERAZINE MALEATE) : 5 MG. It is listed in the Health Canada Drug Product Database under DIN 01927752, held by AVENTIS PHARMA INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as cancelled post market, status dated 01-Aug-2005. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is STEMETIL TAB 5MG used for?

Stemetil (prochlorperazine) is indicated in the management of manifestations of psychotic disorders such as agitation, confusion, delusion, tension and anxiety. It is also effective in controlling nausea and vomiting due to stimulation of the chemoreceptor trigger zone. In selected patients, Stemetil may be of value for the relief of excessive anxiety, accompanied by severe tension and agitation, associated with psychoneurotic or somatic conditions.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

Begin with the lowest recommended dosage. Adjust to response of the individual. ADULTS Oral or rectal route: To control nausea, vomiting or excessive anxiety: usually 5 to 10 mg, 3 or 4 times daily; in mild cases, a single dose of 5 to 10 mg is often adequate. In psychiatry for moderate to severe conditions, the usual starting dosage is 10 mg 3 or 4 times a day; increase dosage gradually by 5 to 10 mg every 2 or 3 days until symptoms are controlled or adverse reactions intervene. Some patients respond satisfactorily on 50 to 75 mg per day. In more severe disturbances it may reach 100 to 150 mg a day. For maintenance therapy, the dosage should be reduced to the minimum effective dose. Parenteral route - I.M. Dosage: The drug is given by deep intramuscular injection. Total daily dosage rarely exceeds 40 mg, except in severe psychiatric cases. When control is achieved, the oral route should be substituted. To control nausea, vomiting or excessive anxiety: 5 to 10 mg, 2 or 3 times a day. In psychiatry for the immediate control of severely disturbed patients: 10 to 20 mg initially, repeated every 2 to 4 hours until control is obtained. More than 3 or 4 doses are seldom necessary. The patients should be kept in bed and under medical supervision. In surgery: 5 to 10 mg I.M., 1 to 2 hours before anesthesia. Repeat once during surgery if necessary. Post-operatively, the same dose of 5 to 10 mg I.M. may be given to control acute symptoms and repeated, if necessary, every 3 to 4 hours (maximum, 40 mg daily). I.V. Infusion: During and after surgery, Stemetil may be given I.V. in the infusion solution at a concentration of 20 mg per litre. Total daily dose rarely exceeds 30 mg.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Stemetil (prochlorperazine) suppositories, Stemetil (prochlorperazine mesylate) syrup, injectable and Stemetil (prochlorperazine maleate) tablets should be stored at 15° to 25°C, protect from light.

How is it supplied?

Stemetil (prochlorperazine base) 5 mg/mL (as mesylate) injectable is available in amber glass ampoules of 2 mL in boxes of 10 ampoules. Stemetil (prochlorperazine base) 5 mg/mL (as mesylate) syrup is available in amber glass bottles of 100 mL. Stemetil (prochlorperazine base) 10 mg suppositories are available in boxes of 10 suppositories. Stemetil (prochlorperazine base) 5 mg (as maleate) tablets are available in amber plastic bottles of 100 and 500 tablets.

Contraindications

Stemetil (prochlorperazine) should not be administered in the presence of circulatory collapse, altered states of consciousness or comatose states, particularly when these are due to intoxication with central depressant drugs (alcohol, hypnotics, narcotics, etc...). It is contraindicated in severely depressed patients, in the presence of blood dyscrasias, liver disease, renal insufficiency, pheochromocytoma, or in patients with severe cardiovascular disorders or a history of hypersensitivity to phenothiazine derivatives. As with other phenothiazines, Stemetil is contraindicated in patients with suspected or established subcortical brain damage, with or without hypothalamic damage, since a hyperthermic reaction with temperatures above 40°C may occur, sometimes not until 14 to 16 hours after drug administration. Phenothiazine compounds should not be used in patients receiving large doses of hypnotics, due to the possibility of potentiation. Stemetil is contraindicated in children undergoing surgery.

Warnings and precautions

The antiemetic action of Stemetil (prochlorperazine) may mask the signs and symptoms of overdosage of other drugs and may obscure the diagnosis and treatment of other conditions such as brain tumor or intestinal obstruction. Therefore the etiology of nausea and vomiting should be established before using the drug. The use of this drug may impair the mental and physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. Potentiation of the effects of alcohol may also occur. As with other neuroleptics, very rare cases of QT interval prolongation have been reported with Stemetil. Tardive Dyskinesia: As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or after drug discontinuation. The syndrome is mainly characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw. The manifestations may be permanent in some patients. The syndrome may be masked when treatment is reinstituted, when the dosage is increased or when a switch is made to a different antipsychotic drug. STEMETIL should be prescribed in a manner that is most likely to minimize the risk of tardive dyskinesia. The lowest effective dose and the shortest duration of treatment should be used, and treatment should be discontinued at the earliest opportunity, or if a satisfactory response cannot be obtained. If the signs and symptoms of tardive dyskinesia appear during treatment, discontinuation of STEMETIL should be considered. Neuroleptic Malignant Syndrome: Neuroleptic malignant syndrome (NMS) may occur in patients receiving antipsychotic drugs. NMS is characterized by hyperthermia, muscle rigidity, altered consciousness, and signs of autonomic instability including irregular blood pressure, tachycardia, cardiac arrhythmias and diaphoresis. Additional signs may include elevated serum creatine kinase, myoglobinuria (rhabdomyolysis), acute renal failure and leukocytosis. Hyperthermia is often an early sign of this syndrome. Antipsychotic treatment should be withdrawn immediately and appropriate supportive therapy and careful monitoring instituted. Hypotension and electrocardiographic changes, particularly non-specific and usually reversible Q and T wave distortions, have been associated with the administration of phenothiazines. Therefore, prochlorperazine should be used with caution in patients with compensated cardiovascular and cerebrovascular disorders. Unexpected, sudden deaths have occurred in hospitalized patients treated with phenothiazines. Previous brain damage or seizures may predispose. High doses should be avoided in known seizure patients. Sudden exacerbations of psychotic behavior patterns occurred in several patients shortly before death. Acute fulminating pneumonia or pneumonitis and aspiration of gastric contents also were observed. Therefore, the physician also should keep in mind the possible development of "silent pneumonias". Neuroleptic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of neuroleptic drugs. Neither clinical studies, nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorogenesis; the available evidence is considered too limited to be conclusive at this time. Withdrawal Emergent Neurological Signs: Abrupt withdrawal after short-term administration

What can be used instead?

Other Canadian products sharing ATC code N05AB04 PROCHLORPERAZINE. 3 of 15 DINs in this group are currently marketed — marketed products are listed first, because that is what can actually be bought. These tables describe supply, not clinical equivalence: substitution rests with the prescriber or pharmacist, and interchangeability is determined provincially.

Who else supplies PROCHLORPERAZINE worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. PROCHLORPERAZINE appears in 82 registered pack listings across 2 markets, published on 2 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.