Antidepressant
Antidepressant
Action And Clinical Pharmacology: Moclobemide is a short-acting, reversible inhibitor of monoamine oxidase (MAO).
Indications And Clinical Uses: For the symptomatic relief of depressive illness.
Precautions: General: The possibility of suicide in depressed patients is inherent in their illness and may persist until remission occurs. Therefore, patients must be carefully supervised during all phases of treatment with moclobemide. Prescriptions in potentially suicidal patients should be written for a limited supply only.
Occupational Hazards: Patients should be cautioned against driving an automobile or performing hazardous tasks until they are certain of the effect that moclobemide has on them.
Pregnancy: Safety of use in pregnancy has not been established. Therefore, moclobemide is not recommended in women who may be pregnant, unless, in the opinion of the physician, the expected benefits to the patient markedly outweigh the possible risk to the fetus.
Drug Interactions: Cimetidine is expected to approximately double moclobemide steady-state concentrations.
Other Antidepressants: Concomitant Use: Clinical interaction studies between moclobemide and a tricyclic antidepressant (clomipramine) resulted in severe adverse reactions; the concomitant use of moclobemide and tricyclic antidepressants is contraindicated.
Fluoxetine: An exception is fluoxetine; at least 5 weeks should elapse between its discontinuation and initiation of treatment with moclobemide.
Buspirone: To date, there is no experience regarding the co-administration of moclobemide and buspirone. Therefore, patients should be carefully monitored should concomitant administration be implemented.
Antipsychotics: In depressed patients with schizophrenic or schizoaffective disorder, psychotic symptoms may be exacerbated during treatment with moclobemide. There is little experience regarding the concomitant use of moclobemide and antipsychotic drugs. Therefore, patients should be carefully monitored should concomitant treatment be undertaken.
Alcohol: Excessive alcohol consumption should be avoided. Alcohol interaction studies were performed at blood alcohol concentrations of 0.05%. However, no studies were conducted at blood alcohol concentrations recognized as legally intoxicating.
Antihypertensives: Clinical trials with moclobemide have shown inconsistent effects on the blood pressure of hypertensive patients. Therefore, careful monitoring is recommended during initial treatment.
Adverse Reactions: The incidence of adverse reactions may increase at higher doses.
Psychiatric: difficulties falling asleep, nightmares/dreams, hallucinations, memory disturbances, confusion, disorientation, delusions, increased depression, excitation/irritability, hypomanic symptoms, aggressive behavior, apathy, tension.
Central and Peripheral Nervous System: migraine, extrapyramidal effects, tinnitus, paresthesia, dysarthria.
Gastrointestinal: heartburn, gastritis, meteorism, indigestion.
Cardiovascular: hypertension, bradycardia, extrasystoles, angina/chest pain, phlebitic symptoms, flushing.
Symptoms And Treatment Of Overdose: Symptoms: Signs and symptoms of overdosage with moclobemide include nausea, vomiting, drowsiness, disorientation, slurred speech, amnesia, reduced reflexes, agitation, hypertension and convulsions.
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.
Dosage And Administration: Note: Moclobemide should always be taken after meals.
Usual Adult Dosage: The administration of moclobemide should be initiated at 300 mg daily dose (in 2 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. Furthermore, because bioavailability of moclobemide has been shown to increase over the first week of dosing (see Pharmacology, Pharmacokinetics), the initial daily dose of 300 mg should not be increased until after this first week of therapy.
Liver Dysfunction: When hepatic metabolism is severely impaired by hepatic disease or inhibited by a drug that affects microsomal mixed function oxidase activity (e.g., cimetidine), the daily dose of moclobemide should be reduced to one-third or one-half of the standard dose.
Availability And Storage: 150 mg: Each pale yellow, single-scored, biconvex, film-coated tablet imprinted ¾ on one side, single scored on the other, contains: moclobemide 150 mg. Nonmedicinal ingredients: cornstarch, ethylcellulose, iron oxide, lactose, magnesium stearate, methylhydroxypropyl cellulose, polyethylene glycol, povidone, sodium starch glycolate, talc and titanium dioxide. Gluten-, parabens-, sucrose-, sulfites- and tartrazine-free. Bottles of 100.
300 mg: Each white, single scored, biconvex, film-coated tablet imprinted on one side and single scored on the other, contains: moclobemide 300 mg. Nonmedicinal ingredients: cornstarch, ethylcellulose, lactose, magnesium stearate, methylhydroxypropyl cellulose, polyethylene glycol, povidone, sodium starch glycolate, talc and titanium dioxide. Bottles of 100.
