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MOCLOBEMIDE is a brand name for Moclobemide, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
4 Drug-Drug Interactions). • Patients with hepatic disease. • Cimetidine doubles the AUC (area under the plasma concentration-time curve) of MOCLOBEMIDE and is expected to approximately double moclobemide steady-state concentrations (see 9.
4 Drug-Drug Interaction). In patients receiving moclobemide concomitantly with cimetidine, a 50% reduction in the dosage of moclobemide may be necessary. 2 Recommended Dose and Dosage Adjustment Usual Adult Dosage The administration of MOCLOBEMIDE should be initiated at 300 mg daily dose (in two divided doses) and increased gradually to a maximum of 600 mg/day if needed, noting carefully the clinical response and any evidence of intolerance.
Individual patient response may allow for a reduction of the daily dose. As with other antidepressants, it should be kept in mind that there may be a lag time in therapeutic response. There is no evidence that increasing the dosage rapidly shortens this latent period and may, in fact, increase the incidence of side-effects.
3 Pharmacokinetics ), the initial daily dose of 300 mg should not be increased until after this first week of therapy. g. cimetidine), the daily dose of MOCLOBEMIDE should be reduced to one third or one half of the standard dose. Renal Impairment Single dose pharmacokinetic data suggest that no dosage adjustment may be required in patients with impaired renal function.
However, multiple dose studies with moclobemide have not been performed in patients with renal dysfunction, therefore, MOCLOBEMIDE should be used with caution in this patient population. In normal volunteers, the absolute bioavailability almost doubles following multiple dosing as compared to a single dose.
Geriatrics No dosage adjustments are necessary in elderly patients.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. The following table lists the adverse events reported during clinical trials in which 1,922 patients were treated with 50 to 600 mg/day moclobemide for depressive illness.
Limited experience in 60 patients treated with 601 to 750 mg/day of moclobemide suggests that the incidence of adverse events may increase at higher doses. 3 Less Common Clinical Trial Adverse Reactions Other clinical adverse events with an incidence of <1% in clinical studies, or reported in post- marketing surveillance, are as follows: • Psychiatric: Difficulty falling asleep, nightmares/dreams, hallucinations, memory disturbances, confusion, disorientation, delusions, increased depression, excitation/irritability, hypomanic symptoms, aggressive behaviour, apathy, tension.
Cases of suicidal ideation and suicidal behaviour have been reported during antidepressant therapy or early after treatment discontinuation (see 7 WARNINGS AND PRECAUTIONS). • Cardiovascular: Hypertension, bradycardia, extrasystoles, angina/chest pain, phlebitic symptoms, flushing.
• Central and Peripheral Nervous System: Migraine, extrapyramidal effects, tinnitus, paresthesia, dysarthria. • Dermatological/Mucocutaneous: Exanthema/rash, allergic skin reaction, itching, gingivitis, stomatitis, dry skin, conjunctivitis, pruritus, urticaria.
• Gastrointestinal: Heartburn, gastritis, meteorism, indigestion. • Genito-Urinary: Disturbances of micturition (dysuria, polyuria, tenesmus) metrorrhagia, PrMOCLOBEMIDE Product Monograph Page 12 of 41 prolonged menstruation. • Miscellaneous: General malaise, skeletal/muscular pain, altered taste sensations, hot flushes/cold sensation, photopsia, dyspnea, visual disturbances.
4 Drug-Drug Interactions). • Concomitantly with dextromethorphan (contained in many proprietary cough medicines). • In combination with trimipramine/maprotiline. • In combination with bupropion. • In combination with triptans. • In combination with tramadol.
4 Drug-Drug Interactions). • Patients with hepatic disease. • Cimetidine doubles the AUC (area under the plasma concentration-time curve) of MOCLOBEMIDE and is expected to approximately double moclobemide steady-state concentrations (see 9.
4 Drug-Drug Interaction). In patients receiving moclobemide concomitantly with cimetidine, a 50% reduction in the dosage of moclobemide may be necessary. 2 Recommended Dose and Dosage Adjustment Usual Adult Dosage The administration of MOCLOBEMIDE should be initiated at 300 mg daily dose (in two divided doses) and increased gradually to a maximum of 600 mg/day if needed, noting carefully the clinical response and any evidence of intolerance.
Individual patient response may allow for a reduction of the daily dose. As with other antidepressants, it should be kept in mind that there may be a lag time in therapeutic response. There is no evidence that increasing the dosage rapidly shortens this latent period and may, in fact, increase the incidence of side-effects.
3 Pharmacokinetics ), the initial daily dose of 300 mg should not be increased until after this first week of therapy. g. cimetidine), the daily dose of MOCLOBEMIDE should be reduced to one third or one half of the standard dose. Renal Impairment Single dose pharmacokinetic data suggest that no dosage adjustment may be required in patients with impaired renal function.
However, multiple dose studies with moclobemide have not been performed in patients with renal dysfunction, therefore, MOCLOBEMIDE should be used with caution in this patient population. In normal volunteers, the absolute bioavailability almost doubles following multiple dosing as compared to a single dose.
MOCLOBEMIDE (moclobemide) is contraindicated: • In patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or the component of the container . For a complete listing see 6 DOSAGE FORMAS, STRENGTHS, COMPOSITION AND PACKAGING.
• In patients in an acute confusional state. 4 Drug-Drug Interaction). 4 Drug-Drug Interactions). 4 Drug-Drug Interactions) • In combination with meperidine. Although there is limited experience with the concomitant use of moclobemide and narcotics, death has occurred in patients receiving a conventional MAO inhibitor and meperidine (pethidine) given concomitantly.
• Concomitantly with thioridazine. 4 Drug-Drug Interactions). • Concomitantly with dextromethorphan (contained in many proprietary cough medicines). • In combination with trimipramine/maprotiline. • In combination with bupropion. • In combination with triptans.
• In combination with tramadol. PrMOCLOBEMIDE Product Monograph Page 5 of 41
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data Clinical Trial Findings Laboratory examinations were performed in a total of 1,401 patients during clinical trials with moclobemide. Reductions were observed in leucocyte, SGOT and SGPT values, however, these reductions were attributed to raised baseline values returning to normal and were not considered clinically relevant.
No other laboratory abnormalities were noted during clinical trials. 5 Post-Market Findings In post-market surveillance, there appeared to be a low incidence of raised liver enzymes, without associated clinical sequelae.
Geriatrics No dosage adjustments are necessary in elderly patients. 5 OVERDOSAGE PrMOCLOBEMIDE Product Monograph Page 6 of 41 Symptoms Signs and symptoms of overdosage with moclobemide include nausea, vomiting, drowsiness, disorientation, slurred speech, amnesia, reduced reflexes, agitation, hypertension and convulsions.
One patient remained stuporous for 36 hours following an overdose with 1,550 m g moclobemide. All abnormal laboratory values and vital signs returned to within normal range one to five days after overdosage. No organ toxicity was reported.
Treatment The treatment of overdosage should consist of general supportive measures. Gastric lavage or induction of emesis activated charcoal and fluid control may be of benefit. , agents active on the CNS), could be life-threatening.
Serotonin syndrome and death have been reported after combined overdose of moclobemide and other antidepressants. Therefore, such patients should be closely monitored so that appropriate care and treatment may be given. For management of a suspected drug overdose, contact your regional poison control centre.
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table – Dosage Forms, Strengths, Composition and Packaging Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablets 100 mg, 150 mg and 300 mg 100 mg and 150 mg tablet: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dextrates, hydroxypropyl cellulose, hydroxypropyl methylcellulose, iron oxide yellow, magnesium stearate, methylcellulose, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide.
The 100 mg tablet also contains iron oxide red. 300 mg tablet: colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, methylcellulose, microcrystalline cellulose, polyethylene glycol and titanium dioxide.
Physical Characteristics PrMOCLOBEMIDE Product Monograph Page 7 of 41 MOCLOBEMIDE 100 mg: Each orange, oval, biconvex, film-coated tablet, scored on one side and engraved “100” on the other, contains moclobemide 100 mg. Available in bottles of 100.
MOCLOBEMIDE 150 mg:
Each pale yellow, oval, biconvex, film-coated tablet, scored on one side and engraved “150” on the other, contains moclobemide 150 mg. Available in bottles of 100.
MOCLOBEMIDE 300 mg:
Each white, oval, biconvex, film-coated tablet, scored on one side and engraved “300” on the other, contains moclobemide 300 mg. Available in bottles of 100. 7 WARNINGS AND PRECAUTIONS Potential Association with the Occurrence of Behavioural and Emotional Changes, Including Self-Harm It is unknown whether increased risk of suicidal ideation and behaviour is associated with the use of older antidepressants (e g moclobemide) in pediatric patients and/ or adults.
However, recent analyses of placebo-controlled clinical trial safety databases from SSRIs and other newer antidepressants suggest that use of these drugs may be associated with behavioural and emotional changes, including an increased risk of suicidal ideation and behaviour over that of placebo.
Thus, rigorous clinical monitoring for suicidal ideation or other indicators of potential for suicidal behaviour is advised in patients of all ages given any antidepressant drug. This includes monitoring for emotional and behavioural changes.
Clinical Worsening and Suicide risk in […]