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PARNATE 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: 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…
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.
When a satisfactory response is obtained, dosage may be reduced to a maintenance level. 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 WARNINGS AND PRECAUTIONS). PARNATE is not approved for use in pediatric patient. 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 (see WARNINGS AND PRECAUTIONS, Cardiovascular, Hypertensive crisis).
Page 5 of 24 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.
Switching to or from other Contraindicated Drugs Allow 1 week to elapse between the discontinuance of PARNATE and the administration of any other drug that is contraindicated with PARNATE. 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 PARNATE 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 PARNATE therapy by slow, gradual dosage reduction.
The most serious adverse reactions are as follows: Hypertensive crisis (see SERIOUS WARNINGS AND PRECAUTIONS BOX) New or Worsened Emotional or Behavioral Problems (see SERIOUS WARNINGS AND PRECAUTIONS BOX) Hypotension (see WARNINGS AND PRECAUTIONS, Cardiovascular, Hypotension) The following adverse reactions have been identified in clinical trials or during post-approval use of PARNATE.
Blood and lymphatic system disorders: agranulocytosis, leukopenia, thrombocytopenia, anemia Metabolism and nutrition disorders: anorexia Psychiatric disorders: overstimulation, manic symptoms, agitation, insomnia, anxiety, confusion, depression, delirium, hallucinations, habituation Nervous system disorders: dizziness, restlessness, tremor, muscle spasm, paresthesia, drowsiness, headaches (without blood pressure elevation), convulsion Page 11 of 24 Eye disorders: blurred vision Ear and labyrinth disorders: tinnitus Cardiac disorders: tachycardia, palpitations Vascular disorders: hypertensive crisis, hypotension Gastrointestinal disorders: diarrhea, constipation, nausea, abdominal pain, dry mouth Hepatobiliary disorders: hepatitis Skin and subcutaneous tissue disorders: rash, alopecia, sweating Renal and urinary disorders: urinary retention, micturition Reproductive system and breast disorders: impotence General disorders and administration site conditions: edema, chills, weakness, fatigue, sleep disturbances
Please see the SERIOUS WARNINGS AND PRECAUTIONS BOX at the beginning of Part I:
Health Professional Information. Cardiovascular Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet /10 mg tranylcypromine (as tranylcypromine sulfate) Carnauba Wax, Citric Acid, Croscarmellose Sodium, D&C red No.
7, FD&C Blue No. 2, FD&C yellow No. 6 aluminium lake (Sunset Yellow), Gelatin, Hydroxypropyl methylcellulose, Lactose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Purified Water, Talc, Titanium Dioxide Page 7 of 24 Hypertensive crisis: 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. 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, PARNATE should be discontinued. Patients should be managed according to standard of care.
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. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
, arteriosclerosis, hypertension). History of recurrent or frequent headaches. Liver damage or blood dyscrasias. Phaeochromocytoma and catecholamine-releasing paragangliomas. PARNATE 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.
Withdrawal effects, including delirium, have been reported with abrupt discontinuation of PARNATE 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 WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics).
Pediatrics (<18 years of age):
PARNATE is not indicated for use in children or adolescents less than 18 years of age. 3 Administration Instruct patients to: avoid foods and beverages with high tyramine content while being treated with PARNATE and for 2 weeks after stopping PARNATE (see CONTRAINDICATIONS) avoid use of all alcoholic beverages while taking PARNATE take their dose of PARNATE at approximately the same time each day.
m. may be a potential method for managing insomnia. 4 Missed Dose In the case of a missed dose of PARNATE, instruct patients to take their next dose at its regularly scheduled time. Page 6 of 24
Hypotension:
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. 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, PARNATE should be discontinued. Blood pressure usually returns rapidly to pre-treatment levels upon discontinuation of PARNATE. g. triluoperazine) or other compounds known to cause hypotension, the possibility of additive hypotensive effects should be considered (see DRUG INTERACTIONS).
Angina:
MAOIs may have the capacity to suppress anginal pain that would otherwise serve as a warning of myocardial ischemia. Dependence/Tolerance 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.
g. ) 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 Page 8 of 24 machinery.
Endocrine and Metabolism Hyperthyroidism:
Use PARNATE with caution in hyperthyroid patients because of their increased sensitivity to pressor amines.
Hematologic Diabetes:
Some MAOIs have contributed to hypoglycemic episodes in diabetic patients receiving insulin or oral hypoglycemic agents. Therefore, PARNATE should be used with caution in diabetics under treatment with these drugs.
Hepatic/Biliary/Pancreatic Patients with liver damage or blood dyscrasias:
Extensive clinical use and laboratory tests have revealed no evidence of liver toxicity or blood dyscrasias due to PARNATE therapy. Because rare cases of hepatitis have been reported, it is recommended that patients with known liver damage or blood dyscrasias should not be treated with PARNATE.
Immune Hypersensitivity:
The tablet coating contains an azo dye (FD&C Yellow No. 6 aluminium lake) which may cause allergic reactions.
Monitoring and Laboratory Tests Cardiovascular Monitoring:
Blood pressure should be followed closely in patients taking PARNATE 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.
Neurologic Epilepsy:
Because the influence of PARNATE on the convulsive threshold is variable in animal experiments, suitable precautions should be taken if epileptic patients are treated.
Ophthalmologic Angle-closure Glaucoma:
As with other antidepressants, PARNATE can cause mydriasis, which may trigger an angle-closure attack in a patient with anatomically narrow ocular angles. Patients should be examined to determine whether they are susceptible to angle-closure and be informed to seek immediate medical assistance if they experience eye pain, changes in vision or swelling or redness in or around the eye.
Peri-Operative Considerations Discontinue PARNATE at least 7 days before elective surgery because of possible interference with the action of certain anesthetics and analgesics. As with other MAOIs, PARNATE should be discontinued at least 48 hours before myelography and should not be resumed for at least 24 hours after […]