Nardil has been found to be effective in depressed patients clinically characterized as "atypical," "nonendogenous," or "neurotic." These patients often have mixed anxiety and depression and phobic or hypochondriacal features. There is less conclusive evidence of its usefulness with severely depressed patients. Nardil should rarely be the first antidepressant drug used. Rather, it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions.
Nardil is a potent inhibitor of monoamine oxidase. Because this enzyme is widely distributed throughout the body, diverse pharmacologic effects can be expected to occur. When they occur, such effects tend to be mild or moderate in severity (see below), often subside as treatment continues, and can be minimized by adjusting dosage; rarely is it necessary to institute counteracting measures or to discontinue Nardil.
*Nervous System: Dizziness, headache, drowsiness, sleep disturbances (including
insomnia and hypersomnia), fatigue, weakness, tremors, twitching, myoclonic
movements (muscle spasms), hyperreflexia (Exaggeration of reflexes).
*Gastrointestinal: Constipation, dry mouth, gastrointestinal disturbances
*Metabolic: Weight gain.
*Cardiovascular: Postural hypotension (low blood pressure upon standing), edema (swelling).
*Genitourinary: Sexual disturbances such as anorgasmia (inability to reach climax) and ejaculatory disturbances and impotence.
Nardil should not be used in patients who are hypersensitive to the drug or its ingredients, with pheochromocytoma, congestive heart failure, a history of liver disease, or abnormal liver function tests.
Patients being treated with Nardil should not take sympathomimetic drugs (including amphetamines, cocaine, methylphenidate, dopamine, epinephrine and norepinephrine) or related compounds (including methyldopa, L-dopa, L-tryptophan, L-tyrosine, and phenylalanine).
Hypertensive crises (extreme high blood pressure) during Nardil therapy may also be caused by the ingestion of foods with a high concentration of tyramine or dopamine. Therefore, patients being treated with Nardil should avoid high protein food that has undergone protein breakdown by aging, fermentation, pickling, smoking or bacterial contamination. Patients should also avoid cheeses (especially aged varieties), pickled herring, beer, wine, liver, yeast extract (including brewer's yeast in large quantities), dry sausage (including Genoa salami, hard salami, pepperoni, and Lebanon bologna), pods of broad beans (fava beans), and yogurt. Excessive amounts of caffeine and chocolate may also cause hypertensive reactions.
Nardil should not be used in combination with dextromethorphan, which is contained in many over the counter cough remedies or with CNS depressants such as alcohol and certain narcotics. Excitation, seizures, delirium, hyperpyrexia, circulatory collapse, coma and death have been reported in patients receiving MAOI therapy who have been given a single dose of Meperidine. Nardil should not be administered together with or in rapid succession to other MAO inhibitors because HYPERTENSIVE CRISES and convulsive seizures, fever, marked sweating, excitation, delirium, tremor, coma, and circulatory collapse may occur.
Patients taking Nardil should not undergo elective surgery requiring general anesthesia. Also, they should not be given cocaine or local anesthesia containing sympathomimetic vasoconstrictors. The possible combined hypotensive effects of Nardil and spinal anesthesia should be kept in mind. Nardil should be discontinued at least 10 days prior to elective surgery.
OTC Medications To Avoid
Cold and cough preparations (including those containing dextromethorphan)
Nasal decongestants (tablets, drops, or spray)
Asthma inhalant medications
In depressed patients, the possibility of suicide should always be considered and adequate precautions taken. It is recommended that careful observations of patients undergoing Nardil treatment be maintained until control of depression is achieved. If necessary, additional measures (ECT, hospitalization, etc) should be instituted.
The safe use of Nardil during pregnancy or lactation has not been established. The potential benefit of this drug, if used during pregnancy, lactation, or in women of childbearing age, should be weighed against the possible hazard to the mother or fetus.
Nardil is not recommended for pediatric patients under 16 years of age, since there are no controlled studies of safety in this age group
Clinical studies of Nardil did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
The usual starting dose of Nardil is one tablet (15 mg) three times a day.
*Early phase treatment: Dosage should be increased to at least 60 mg per day at a fairly rapid pace consistent with patient tolerance. It may be necessary to increase dosage up to 90 mg per day to obtain sufficient MAO inhibition. Many patients do not show a clinical response until treatment at 60 mg has been continued for at least 4 weeks.
*Maintenance dose: After maximum benefit from Nardil is achieved; dosage should be reduced slowly over several weeks. Maintenance dose may be as low as one tablet, 15 mg, a day or every other day, and should be continued for as long as is required.
Accidental or intentional overdosage may be more common in patients who
are depressed. It should be remembered that multiple drugs and/or alcohol
may have been ingested.
Signs and symptoms of overdosage may include, alone or in combination, any of the following: drowsiness, dizziness, faintness, irritability, hyperactivity, agitation, severe headache, hallucinations, trismus (lockjaw), opisthotonus (Spasm of the body where the head and heels are bent backward and the body is bowed forward), rigidity, convulsions, and coma; rapid and irregular pulse, hypertension(high blood pressure), hypotension(low blood pressure), and vascular(blood vessels) collapse;, respiratory depression and failure, hyperpyrexia(exceptionally high fever), diaphoresis(excessive sweating), and cool, clammy skin.