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METHOPRAZINE is a brand name for Methotrimeprazine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 2024-05 1 INDICATIONS, 1.1 Pediatrics 2024-05 1 INDICATIONS, 1.2 Geriatrics 2024-05
Verbatim from this product's HC label. Tap a section to expand.
4 Geriatrics 2024-05 METHOPRAZINE (methotrimeprazine maleate) Page 3 of 40 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of the most recent authorized product monograph are not listed. 9 5 OVERDOSAGE .............................................................................................................
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Hepatic/Biliary/Pancreatic METHOPRAZINE is contraindicated in patients with hepatic impairment. See 2 CONTRAINDICATIONS. Immune METHOPRAZINE is contraindicated in patients with myasthenia gravis. See 2 CONTRAINDICATIONS. Monitoring and Laboratory Tests The following assessments should be done before and periodically during treatment with METHOPRAZINE.
• Blood glucose and body weight • Complete blood count (CBC) • WBC and differential counts and liver function tests • Sore throat, fever and weakness in patients on prolonged therapy may indicate agranulocytosis. If these symptoms appear, discontinue the drug and perform liver function tests • Blood pressure • Renal function METHOPRAZINE (methotrimeprazine maleate) Page 14 of 40 Neurologic METHOPRAZINE is contraindicated in patients with brain damage.
See 2 CONTRAINDICATIONS. METHOPRAZINE is not indicated for the treatment of patients with dementia. 4 Geriatrics.
Seizures:
METHOPRAZINE should be used with caution in epileptic patients, since phenothiazines, including METHOPRAZINE, may lower the seizure threshold. It is advisable to administer an appropriate anticonvulsant medication to epileptic patients receiving METHOPRAZINE therapy.
Neuroleptic Malignant Syndrome:
A potentially fatal symptom complex sometimes referred to as neuroleptic malignant syndrome (NMS) has been reported in association with antipsychotic drugs, including methotrimeprazine maleate tablets. See 3 SERIOUS WARNINGS AND PRECAUSIONS BOX.
Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status (including catatonic signs) and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).
4 Geriatrics 2024-05 METHOPRAZINE (methotrimeprazine maleate) Page 3 of 40 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of the most recent authorized product monograph are not listed. 9 5 OVERDOSAGE .............................................................................................................
10 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 10 7 WARNINGS AND PRECAUTIONS .................................................................................. 11 General .......................................................................................................................
11 Cardiovascular ............................................................................................................ 11 Dependence, Tolerance and/or Abuse Liability .............................................................
12 Driving and Operating Machinery ................................................................................ 12 Endocrine and Metabolism ..........................................................................................
12 Gastrointestinal........................................................................................................... 12 Genitourinary..............................................................................................................
13 Hematologic................................................................................................................ 13 Hepatic/Biliary/Pancreatic ...........................................................................................
13 Immune ...................................................................................................................... 13 Monitoring and Laboratory Tests .................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. If NMS is suspected, immediately discontinue METHOPRAZINE and provide intensive symptomatic treatment and monitoring.
) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.
The management of NMS should include: (1) immediate discontinuation of antipsychotic drugs, including METHOPRAZINE, and other drugs not essential to concurrent therapy; (2) intensive symptomatic treatment and medical monitoring; and (3) treatment of any concomitant serious medical problems for which specific treatments are available.
There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS. If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered.
The patient should be carefully monitored, since recurrences of NMS have been reported. 5 Post-Market Adverse Reactions.
Parkinson’s disease:
Apart from exceptional situations, METHOPRAZINE should not be used in patients with Parkinson’s disease.
METHOPRAZINE (methotrimeprazine maleate) Page 15 of 40 Tardive Dyskinesia:
A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with conventional antipsychotic drugs. Although the prevalence of tardive dyskinesia with conventional antipsychotics appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the beginning of treatment, which patients are likely to develop the syndrome.
2 Clinical Trials Adverse Reactions, Nervous system disorders. Both the risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase.
However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic drug treatment is withdrawn.
Antipsychotic drug treatment itself, however, may suppress (or partially suppress) the signs and symptoms of tardive dyskinesia and thereby may possibly mask the underlying process. The effect that symptom suppression has upon the long-term course of the syndrome is unknown.
METHOPRAZINE 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 METHOPRAZINE should be considered. Ophthalmologic METHOPRAZINE is contraindicated in patients with risks of closed angle glaucoma. See 2 CONTRAINDICAITONS.
Phenothiazines have been associated with retinopathy and lenticular or corneal deposits. Discontinue METHOPRAZINE if retinal changes are observed. Peri-Operative Considerations METHOPRAZINE is contraindicated in patients who will receive spinal or general anesthesia.
See 2 CONTRAINDICATIONS. Psychotic patients on large doses of a phenothiazine drug who are undergoing surgery should be watched carefully for possible hypotensive phenomena. Moreover, it should be remembered that reduced amounts of anesthetics or CNS depressants may be required.
Renal METHOPRAZINE is contraindicated in patients with risks of urinary retention related to urethroprostatic disorders. See 2 CONTRAINDICATIONS. It should be avoided in patients with renal dysfunction or […]
13 METHOPRAZINE (methotrimeprazine maleate) Page 4 of 40 Neurologic .................................................................................................................. 14 Ophthalmologic...........................................................................................................
15 Peri-Operative Considerations ..................................................................................... 15 Renal ..........................................................................................................................
15 Reproductive Health.................................................................................................... 16 Sensitivity/Resistance..................................................................................................
16 Skin............................................................................................................................. 1 Special Populations ..........................................................................................
17 […]