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

Comments:

• 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

Contraindicated

Patients with abnormal liver function tests: Contraindicated
Patients who develop signs/symptoms of hepatotoxicity: Discontinue treatment

Dose Adjustments

Switching FROM:

• Fluoxetine: Allow at least 5 weeks after stopping fluoxetine and starting this drug.
• Other contraindicated antidepressant drugs: Allow at least 4 to 5 half-lives of the drug or any active metabolite before starting treatment.

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.

Patients who require emergency use of a contraindicated agent (e.g., linezolid, IV methylene blue, direct-acting sympathomimetics): Discontinue treatment as soon as possible before starting treatment with the contraindicated agent; patients should be monitored closely for adverse reactions.

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.

Switching TO:

• 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.

Precautions

US BOXED WARNINGS:
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.
• This drug is not approved for use in pediatric patients.

HYPERTENSIVE CRISIS WITH SIGNIFICANT TYRAMINE USE:

• Excessive consumption of foods or beverages with significant tyramine content or the use of certain drugs with this drug or after discontinuation of this drug can precipitate hypertensive crisis.
• Monitor blood pressure and allow for medication-free intervals between administration of this drug and interacting drugs.
• Instruct patients to avoid ingestion of foods and beverages with high tyramine content.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:

• 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.

Storage requirements:

• Store below 25C
• Store in original package to protect from light and moisture

General:

• 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.

Monitoring:

• 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.

Patient advice:

• 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.

Frequently asked questions

• What are some common side effects of antidepressants?