Applies to the following strengths: 10 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Depression
30 mg per day, orally, in divided doses
-If improvement does not occur in a reasonable period (up to 2 weeks), the dose may be increased by 10 mg per day at 1 to 3 week intervals.
-Maximum dose: 60 mg/day
-Adjust dosage to the requirements of the individual patient.
-Improvement usually occurs within 48 hours to 3 weeks after starting therapy.
-Suitable candidates for treatment are patients who have failed to respond to drugs more commonly used to treat depression.
-The effectiveness in patients with major depression with melancholia (endogenous features) has not been established.
Use: Treatment of major depressive episode without melancholia
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Patients with abnormal liver function tests: Contraindicated
-Fluoxetine: Allow at least 5 weeks after stopping fluoxetine and starting this drug.
-Sertraline or paroxetine: Allow at least 2 weeks after stopping sertraline or paroxetine and starting this drug.
-SNRI: Allow at least 1 week after stopping an SNRI and starting this drug.
Switching TO/FROM this drug from another MAOI or from a dibenzazepine-related entity:
-Allow a medication-free interval of at least a week.
-Initiate this drug at half the normal starting dose for at least the first week of therapy.
Overstimulation/excessive therapeutic action: The dose should be reduced OR a phenothiazine tranquilizer should be administered concomitantly.
Adverse reactions occurring during treatment (e.g., restlessness, insomnia, weakness, drowsiness, dizziness, dry mouth, nausea, diarrhea, abdominal pain, constipation): The dose should be reduced OR the patient should be given a suitable concomitant medication.
-Bupropion: Allow at least 14 days after stopping this drug.
-Buspirone: Allow at least 10 days after stopping this drug.
-High tyramine content foods: Allow at least 2 weeks after stopping this drug.
-Meperidine: Allow at least 2 to 3 weeks after stopping this drug.
US BOXED WARNINGS:
SUICIDALITY AND ANTIDEPRESSANT DRUGS:
-Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.
-Anyone considering the use of this drug or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.
-Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior.
-Families and caregivers should be advised of the need for close observation and communication with the prescriber.
-This drug is not approved for use in pediatric patients.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Insomnia may be reduced by giving the last dose no later than 3 pm, reducing the dosage, or with the concomitant use of a mild hypnotic.
-Tablets should be taken with a glass of water.
-Store below 25C
-Store in original package to protect from light and moisture
-This drug should be limited to patients who can be closely supervised.
-Limitation of use: This drug is not recommended for patients with mild depressive illness resulting from temporary situational difficulties.
-Cardiovascular: Blood pressure, heart rate, signs/symptoms of hypertensive crisis and palpitations
-Hepatic: Liver function tests
-Nervous system: Headaches (change or presence)
-Psychiatric: Emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
-Patients should be told not to take sympathomimetic drugs (including amphetamines, cocaine, methylphenidate, dopamine, epinephrine, and norepinephrine) or related compounds (including methyldopa, L-dopa, L-tryptophan, L-tyrosine, and phenylalanine).
-Patients should avoid high protein foods that have undergone protein breakdown by aging, fermentation, pickling, smoking, or bacterial contamination.
-Patients should avoid cooked or plain cheeses (especially aged varieties), pickled herring, beer, lager, wine, alcohol-free or reduced-alcohol beer or wine, liver, yeast extract (including large quantities of brewer's yeast and Marmite), dry sausage (including Genoa salami, hard salami, pepperoni, and Lebanon bologna), pods of broad beans (fava beans), sauerkraut, meat extract, flavored textured vegetable protein, fermented soy bean extract, hung game, and yogurt.
-Tyramine levels in foods vary brand to brand and batch to batch; having no reaction to a prohibited food on one occasion does not mean they will not react on a different occasion.
-Excessive amounts of caffeine and chocolate may cause hypertensive reactions; patients should be told to avoid excessive amounts of chocolate or caffeine (e.g. tea and coffee).
-Patients should avoid the following over-the-counter medications: cold and cough preparations (including those with dextromethorphan), nasal decongestants (tablets, drops, or spray), hay fever medications, sinus medications, anti-appetite medicines, weight reducing preparations, "pep" pills, L-tryptophan containing preparations.
-Patients should be instructed to inform their other physician(s) and their dentist that they are using this drug.
-Patients should promptly report headache, palpitations, throat tightness, or other unusual symptoms (e.g., neck stiffness, nausea, vomiting, chest constriction, tachycardia, sweating, dizziness).
-This medicine may cause impaired judgment, thinking, or motor skills; do not drive a car or operate dangerous machinery until you know how this drug affects you.
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- Drug class: monoamine oxidase inhibitors
Other brands: Parnate