Marplan (Page 4 of 6)

Drug Interactions

See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONSsections for information on drug interactions.

Marplan should be administered with caution to patients receiving Antabuse® (disulfiram, Wyeth-Ayerst Laboratories). In a single study, rats given high intraperitoneal doses of an MAO inhibitor plus disulfiram experienced severe toxicity, including convulsions and death.

Concomitant use of Marplan and other psychotropic agents is generally not recommended because of possible potentiating effects. This is especially true in patients who may subject themselves to an overdosage of drugs. If combination therapy is needed, careful consideration should be given to the pharmacology of all agents to be used. The monoamine oxidase inhibitory effects of Marplan may persist for a substantial period after discontinuation of the drug, and this should be borne in mind when another drug is prescribed following Marplan. To avoid potentiation, the physician wishing to terminate treatment with Marplan and begin therapy with another agent should allow for an interval of 10 days.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies to evaluate carcinogenic potential have not been conducted with this drug, and there is no information concerning mutagenesis or impairment of fertility.

Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressant, including MARPLAN, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants

The potential reproductive toxicity of isocarboxazid has not been adequately evaluated in animals. It is also not known whether isocarboxazid can cause embryo/fetal harm when administered to a pregnant woman or can affect reproductive capacity. Marplan should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Levels of excretion of isocarboxazid and/or its metabolites in human milk have not been determined, and effects on the nursing infant are unknown. Marplan should be used in women who are nursing only if clearly needed.

Pediatric Use

Marplan is not recommended for use in patients under 16 years of age, as safety and effectiveness in pediatric populations have not been demonstrated.

ADVERSE REACTIONS

Adverse Findings Observed in Short-Term, Placebo-Controlled Trials

Systematically collected data are available from only 86 patients exposed to Marplan, of whom only 52 received doses of ≥50 mg/day, including only 11 who were dosed at ≥60 mg/day. Because of the limited experience with systematically monitored patients receiving Marplan at the higher end of the currently recommended dose range of up to 60 mg/day, caution is indicated in patients for whom a dose of 40 mg/day is exceeded ( see WARNINGS).

The table that follows enumerates the incidence, rounded to the nearest percent, of treatment emergent adverse events that occurred among 86 depressed patients who received Marplan at doses ranging from 20 to 80 mg/day in placebo-controlled trials of 6 weeks in duration. Events included are those occurring in 1% or more of patients treated with Marplan and for which the incidence in patients treated with Marplan was greater than the incidence in placebo-treated patients.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

The commonly observed adverse event that occurred in Marplan patients with an incidence of 5% or greater and at least twice the incidence in placebo patients were nausea, dry mouth, and dizziness (see Table).

In three clinical trials for which the data were pooled, 4 of 85 (5%) patients who received placebo, 10 of 86 (12%) who received <50 mg of Marplan per day, and 1 of 52 (2%) who received ≥50 mg of Marplan per day prematurely discontinued treatment. The most common reasons for discontinuation were dizziness, orthostatic hypotension, syncope, and dry mouth.

Treatment-Emergent Adverse Events Incidence in Placebo-Controlled Clinical Trials with Marplan Doses of 40 to 80 mg/day1
BODY SYSTEM/ ADVERSE EVENT PLACEBO (N=85) MARPLAN <50 mg (N=86) MARPLAN 50 mg (N=52) 2
MISCELLANEOUS
Drowsy 0 4% 0%
Anxiety 1 2% 0%
Chills 0% 2% 0%
Forgetful 1% 2% 2%
Hyperactive 0% 2% 0%
Lethargy 0% 2% 2%
Sedation 1% 2% 0%
Syncope 0% 2% 0%
INTEGUMENTARY
Sweating 0% 2% 2%
MUSCULOSKELETAL
Heavy feeling 0% 2% 0%
CARDIOVASCULAR
Orthostatic hypotension 1% 4% 4%
Palpitations 1% 2% 0%
GASTROINTESTINAL
Dry mouth 4% 9% 6%
Constipation 6% 7% 4%
Nausea 2% 6% 4%
Diarrhea 1% 2% 0%
UROGENITAL
Impotence 0% 2% 0%
Urinary frequency 1% 2% 0%
Urinary hesitancy 0% 1% 4%
CENTRAL NERVOUS SYSTEM
Headache 13% 15% 6%
Insomnia 4% 4% 6%
Sleep disturbance 0% 5% 2%
Tremor 0% 4% 4%
Myoclonic jerks 0% 2% 0%
Paresthesia 1% 2% 0%
SPECIAL SENSES
Dizziness 14% 29% 15%

1 Events reported by at least 1% of patients treated with Marplan are presented, except for those that had an incidence on placebo greater than or equal to that on Marplan.

2 All patients also received Marplan at doses <50 mg.

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