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M-TRANYLCYPROMINE is a brand name for Tranylcypromine, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: M-TRANYLCYPROMINE (tranylcypromine sulfate) is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. M-TRANYLCYPROMINE is not indicated for the initial treatment of MDD due to the potential for serious adverse reactions and drug…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Dosage should be adjusted to the requirements of the individual patient. If the patient responds to therapy, the response is usually seen within 48 hours to 3 weeks after starting medication. 2 Recommended Dose and Dosage Adjustment Recommended starting dosage is 20 mg per day (10 mg in the morning and 10 mg in the afternoon).
If no signs of a response appear within 2 to 3 weeks, increase dosage to 30 mg daily (20 mg in the morning and 10 mg in the afternoon). Continue this dosage for at least 1 week. If no improvement occurs, continued administration is unlikely to be beneficial.
Although dosages above 30 mg per day have been used, consider that the incidence and severity of side effects may increase as dosage is raised. Dosage increases should be made in increments of 10 mg per day at intervals of 1 to 3 weeks to a maximum daily dose of 60 mg.
M-TRANYLCYPROMINE (tranylcypromine tablets) Page 6 of 26 When a satisfactory response is obtained, dosage may be reduced to a maintenance level. Some patients will be maintained on 20 mg per day; many will need only 10 mg daily. When Electroconvulsive therapy (ECT) is being administered concurrently with M-TRANYLCYPROMINE, 10 mg BID can usually be given during the series, then reduced to 10 mg daily for maintenance therapy.
Switching to or from other Contraindicated Drugs Allow 1 week to elapse between the discontinuance of M-TRANYLCYPROMINE and the administration of any other drug that is contraindicated with M-TRANYLCYPROMINE. The prescribing information for individual products should be consulted.
Because the effect of many antidepressant drugs may persist for 10 to 20 days, do not start M-TRANYLCYPROMINE treatment within less than 1 week of discontinuing treatment with such drugs; then use half the normal dosage for the first week.
Discontinuing Treatment Consider discontinuing M-TRANYLCYPROMINE therapy by slow, gradual dosage reduction. Withdrawal effects, including delirium, have been reported with abrupt discontinuation of tranylcypromine tablets therapy. Higher daily doses and longer duration of use appear to be associated with a higher risk of withdrawal effects.
When tranylcypromine is withdrawn, monoamine oxidase activity is recovered in 3 to 5 days, although the drug is excreted in 24 hours; however, inhibition of MAO activity may persist for up to 1 week.
; however, an intensification of these symptoms and sometimes severe additional manifestations may be seen, depending on the degree of overdosage and on individual susceptibility. Some patients exhibit insomnia, restlessness and anxiety, progressing in severe cases to agitation, mental confusion and incoherence.
Hypotension, dizziness, weakness and drowsiness may occur, progressing in severe cases to extreme dizziness and shock. A few patients have displayed hypertension with severe headache and other symptoms. Rare instances have been reported in which hypertension was accompanied by twitching or myoclonic fibrillation of skeletal muscles with hyperpyrexia, sometimes progressing to generalized rigidity and coma.
Treatment Treatment normally consists of general supportive measures, close observation of vital signs and steps to counteract specific symptoms as they occur. The management of hypertensive crisis is described in 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Hypertensive Crisis.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths, Composition and Packaging M-TRANYLCYPROMINE 10 mg film-coated tablets are red, round, biconvex, and debossed with “10” on one side, plain on the other side.
M-TRANYLCYPROMINE tablets are available in white HDPE bottles of 100 tablets. 7 WARNINGS AND PRECAUTIONS Please see the 3 SERIOUS WARNINGS AND PRECAUTIONS BOX at the beginning of Part I: Health Professional Information.
Cardiovascular Hypertensive crisis:
The most important adverse reaction associated with tranylcypromine tablets is hypertensive crisis, which has sometimes been fatal. This response is not usually dose-related. It is associated with a distinctive reaction characterized by some or all of the Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet / 10 mg tranylcypromine (as tranylcypromine sulfate) Carmine, colloidal silicon dioxide, FD&C Red No.
, arteriosclerosis, hypertension). • History of recurrent or frequent headaches. • Liver damage or blood dyscrasias. • Phaeochromocytoma and catecholamine-releasing paragangliomas. M-TRANYLCYPROMINE is contraindicated in combination with the following medications (before, during or shortly after).
g. g. g. g. g. g. g. pseudoephedrine, phenylephedine, ephedrine, methyldopa, dopamine, and levodopa and tryptophan), including those contained in cold, hay fever or weight-reducing products, herbal products, and diet supplements • Other individual drugs in the following list: buspirone, carbamazepine, cyclobenzaprine, dextromethorphan, dopamine, hydroxytryptophan, levodopa, meperidine, methyldopa, milnacipran, rasagiline, reserpine, s-adenosyl-L-methionine (SAM-e), tapentadol, tetrabenazine, tryptophan • Foods and beverages with a high tyramine content 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.
Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors (see 7 WARNINGS AND PRECAUTIONS). M-TRANYLCYPROMINE is not approved for use in pediatric patient. • Hypertensive crisis: When excessive amounts of tyramine are consumed in conjunction with M-TRANYLCYPROMINE, or within 2 weeks of stopping treatment, a serious and sometimes fatal hypertensive reaction may occur (see 7 WARNINGS AND PRECAUTIONS, Cardiovascular, Hypertensive crisis).
1 Dosing Considerations Dosage should be adjusted to the requirements of the individual patient. If the patient responds to therapy, the response is usually seen within 48 hours to 3 weeks after starting medication. 2 Recommended Dose and Dosage Adjustment Recommended starting dosage is 20 mg per day (10 mg in the morning and 10 mg in the afternoon).
M-TRANYLCYPROMINE is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
, arteriosclerosis, hypertension). • History of recurrent or frequent headaches. • Liver damage or blood dyscrasias. • Phaeochromocytoma and catecholamine-releasing paragangliomas. M-TRANYLCYPROMINE is contraindicated in combination with the following medications (before, during or shortly after).
g. g. g. g. g. g. g. pseudoephedrine, phenylephedine, ephedrine, methyldopa, dopamine, and levodopa and tryptophan), including those contained in cold, hay fever or weight-reducing products, herbal products, and diet supplements • Other individual drugs in the following list: buspirone, carbamazepine, cyclobenzaprine, dextromethorphan, dopamine, hydroxytryptophan, levodopa, meperidine, methyldopa, milnacipran, rasagiline, reserpine, s-adenosyl-L-methionine (SAM-e), tapentadol, tetrabenazine, tryptophan • Foods and beverages with a high tyramine content
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tranylcypromine in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Geriatrics (>60 years of age):
Use with caution. Consider more gradual dosage increases as this population may have an increased risk for hypotension (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics).
Pediatrics (<18 years of age):
M-TRANYLCYPROMINE is not indicated for use in children or adolescents less than 18 years of age. 4 Administration Instruct patients to: • avoid foods and beverages with high tyramine content while being treated with M-TRANYLCYPROMINE and for 2 weeks after stopping M-TRANYLCYPROMINE (see 2 CONTRAINDICATIONS) • avoid use of all alcoholic beverages while taking M-TRANYLCYPROMINE • take their dose of M-TRANYLCYPROMINE at approximately the same time each day.
m. may be a potential method for managing insomnia. 5 Missed Dose In the case of a missed dose of M-TRANYLCYPROMINE, instruct patients to take their next dose at its regularly scheduled time. M-TRANYLCYPROMINE (tranylcypromine tablets) Page 7 of 26
40 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide M-TRANYLCYPROMINE (tranylcypromine tablets) Page 8 of 26 following symptoms: occipital headache which may radiate frontally, palpitation, neck stiffness or soreness, nausea or vomiting, sweating (sometimes with fever and sometimes with cold, clammy skin) with early pallor followed later by flushing, and photophobia.
Either tachycardia or bradycardia may be present, sometimes associated with constricting chest pain. Mydriasis may occur. The occipital headache, together with pain and stiffness in the cervical muscles, may mimic subarachnoid hemorrhage, but can equally be associated with actual intracranial bleeding, as in other conditions where a sudden rise in blood pressure occurs.
Cases of such bleeding have been reported, some of which have been fatal. Blood pressure should be followed closely in patients taking M-TRANYLCYPROMINE to detect evidence of any pressor response. It is emphasized that full reliance should not be placed on blood pressure readings, but that the patient should also be observed frequently.
If a hypertensive reaction occurs, M-TRANYLCYPROMINE should be discontinued. Patients should be managed according to standard of care.
Hypotension:
Hypotension, which may be postural, has been observed during tranylcypromine tablets therapy, particularly at doses above 30 mg daily. It is seen most commonly (but not exclusively) in patients with pre-existing hypertension. In most instances, it affects the systolic readings.
Rare instances of syncope have been seen. Dosage increases should be made more gradually in patients showing a tendency toward hypotension at the starting dose. Postural hypotension can usually be relieved by having the patient lie down until blood pressure returns to normal.
This side effect is usually temporary, but if it persists, M-TRANYLCYPROMINE should be discontinued. Blood pressure usually returns rapidly to pre-treatment levels upon discontinuation of M-TRANYLCYPROMINE. g. triluoperazine) or other compounds known to cause hypotension, the possibility of additive hypotensive effects should be considered (see
If no signs of a response appear within 2 to 3 weeks, increase dosage to 30 mg daily (20 mg in the morning and 10 mg in the afternoon). Continue this dosage for at least 1 week. If no improvement occurs, continued administration is unlikely to be beneficial.
Although dosages above 30 mg per day have been used, consider that the incidence and severity of side effects may increase as dosage is raised. Dosage increases should be made in increments of 10 mg per day at intervals of 1 to 3 weeks to a maximum daily dose of 60 mg.
M-TRANYLCYPROMINE (tranylcypromine tablets) Page 6 of 26 When a satisfactory response is obtained, dosage may be reduced to a maintenance level. Some patients will be maintained on 20 mg per day; many will need only 10 mg daily. When Electroconvulsive therapy (ECT) is being administered concurrently with M-TRANYLCYPROMINE, 10 mg BID can usually be given during the series, then reduced to 10 mg daily for maintenance therapy.
Switching to or from other Contraindicated Drugs Allow 1 week to elapse between the discontinuance of M-TRANYLCYPROMINE and the administration of any other drug that is contraindicated with M-TRANYLCYPROMINE. The prescribing information for individual products should be consulted.
Because the effect of many antidepressant drugs may persist for 10 to 20 days, do not start M-TRANYLCYPROMINE treatment within less than 1 week of discontinuing treatment with such drugs; then use half the normal dosage for the first week.
Discontinuing Treatment Consider discontinuing M-TRANYLCYPROMINE therapy by slow, gradual dosage reduction. Withdrawal effects, including delirium, have been reported with abrupt discontinuation of tranylcypromine tablets therapy. Higher daily doses and longer duration of use appear to be associated with a higher risk of withdrawal effects.
When tranylcypromine is withdrawn, monoamine oxidase activity is recovered in 3 to 5 days, although the drug is excreted in 24 hours; however, inhibition of MAO activity may persist for up to 1 week.
Geriatrics (>60 years of age):
Use with caution. Consider more gradual dosage increases as this population may have an increased risk for hypotension (see 7 WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics).
Pediatrics (<18 years of age):
M-TRANYLCYPROMINE is not indicated for use in children or adolescents less than 18 years of age. 4 Administration Instruct patients to: • avoid foods and beverages with high tyramine content while being treated with M-TRANYLCYPROMINE and for 2 weeks after stopping M-TRANYLCYPROMINE (see 2 CONTRAINDICATIONS) • avoid use of all alcoholic beverages while taking M-TRANYLCYPROMINE • take their dose of M-TRANYLCYPROMINE at approximately the same time each day.
m. may be a potential method for managing insomnia. 5 Missed Dose In the case of a missed dose of M-TRANYLCYPROMINE, instruct patients to take their next dose at its regularly scheduled time. M-TRANYLCYPROMINE (tranylcypromine tablets) Page 7 of 26 5 OVERDOSAGE Symptoms The characteristic symptoms are usually those which have already been described […]