PARNATE 10 MG — DIN 01919598

What is PARNATE?

PARNATE 10 MG contains TRANYLCYPROMINE (TRANYLCYPROMINE SULFATE) : 10 MG. It is listed in the Health Canada Drug Product Database under DIN 01919598, held by GLAXOSMITHKLINE INC, supplied as TABLET for ORAL administration. Health Canada currently lists it as marketed, status dated 16-Jul-2002. 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 PARNATE used for?

PARNATE (tranylcypromine sulfate) is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. PARNATE is not indicated for the initial treatment of MDD due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions.

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

How is it administered?

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. 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 PARNATE, 10 mg BID can usually be given during the series, then reduced to 10 mg daily for maintenance therapy. Instruct patients to avoid foods and beverages with high tyramine content while being treated with PARNATE and for 2 weeks after stopping PARNATE, avoid use of all alcoholic beverages while taking PARNATE, and take their dose of PARNATE at approximately the same time each day. Taking the last dose before 3 p.m. may be a potential method for managing insomnia. In the case of a missed dose of PARNATE, instruct patients to take their next dose at its regularly scheduled time.

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

Contraindications

PARNATE 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. PARNATE is contraindicated in patients with cerebrovascular or cardiovascular disorders (e.g., arteriosclerosis, hypertension), history of recurrent or frequent headaches, liver damage or blood dyscrasias, phaeochromocytoma and catecholamine-releasing paragangliomas. PARNATE is contraindicated in combination with other monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs) or serotonin and noradrenaline reuptake inhibitors (SNRIs), tricyclic antidepressants, other antidepressant drugs (e.g. amoxapine, bupropion, maprotiline, nefazodone, trazodone, vilazodone, vortioxetine), serotonin releasing agents (e.g. amphetamine and methylphenidate and their derivatives), triptans (e.g. sumatriptan or rizatriptan), sympathomimetics (e.g. pseudoephedrine, phenylephedine, ephedrine, methyldopa, dopamine, and levodopa and tryptophan), other individual drugs (buspirone, carbamazepine, cyclobenzaprine, dextromethorphan, dopamine, hydroxytryptophan, levodopa, meperidine, methyldopa, milnacipran, rasagiline, reserpine, s-adenosyl-L-methionine (SAM-e), tapentadol, tetrabenazine, tryptophan), and foods and beverages with a high tyramine content.

Warnings and precautions

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. PARNATE is not approved for use in pediatric patients. Hypertensive crisis: When excessive amounts of tyramine are consumed in conjunction with PARNATE, or within 2 weeks of stopping treatment, a serious and sometimes fatal hypertensive reaction may occur. The most important adverse reaction associated with PARNATE 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 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 PARNATE to detect evidence of any pressor response. If a hypertensive reaction occurs, PARNATE should be discontinued. Patients should be managed according to standard of care. Hypotension, which may be postural, has been observed during PARNATE therapy, particularly at doses above 30 mg daily. It is seen most commonly (but not exclusively) in patients with pre-existing hypertension. 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, PARNATE should be discontinued. When PARNATE is combined with phenothiazine derivatives or other compounds known to cause hypotension, the possibility of additive hypotensive effects should be considered. MAOIs may have the capacity to suppress anginal pain that would otherwise serve as a warning of myocardial ischemia. There have been reports of drug dependency in patients using doses of PARNATE significantly in excess of the therapeutic range. Some of these patients had a history of previous substance abuse. PARNATE should be tapered according to the patient's clinical reaction when discontinuation is necessary. Symptoms reported after stopping PARNATE without tapering include sleep disturbances, depression, confusion, delirium, tremor, agitation, convulsion, anxiety, hallucinations, fatigue, and headache. Some PARNATE adverse reactions (e.g. dizziness, drowsiness, etc.) may affect the patient's ability to drive or operate machinery. For patients who experience these symptoms, due caution should be exercised when driving or operating a vehicle or potentially dangerous machinery. PARNATE may cause an acute attack of glaucoma. Having your eyes examined before you take this drug could help identify if you are at risk of having angle-closure glaucoma.