Phenelzine Sulfate (Page 2 of 4)

Screening Patients for Bipolar Disorder

A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that phenelzine sulfate is not approved for use in treating bipolar depression.

It should be noted that phenelzine sulfate is not approved for use in treating any indications in the pediatric population.

The most serious reactions to phenelzine sulfate involve changes in blood pressure.

Hypertensive Crises

The most important reaction associated with phenelzine sulfate administration is the occurrence of hypertensive crises, which have sometimes been fatal.

These crises are characterized by some or all of the following symptoms: occipital headache which may radiate frontally, palpitation, neck stiffness or soreness, nausea, vomiting, sweating (sometimes with fever and sometimes with cold, clammy skin), dilated pupils, and photophobia. Either tachycardia or bradycardia may be present and can be associated with constricting chest pain.

NOTE: Intracranial bleeding has been reported in association with the increase in blood pressure.

Blood pressure should be observed frequently to detect evidence of any pressor response in all patients receiving phenelzine sulfate. Therapy should be discontinued immediately upon the occurrence of palpitation or frequent headaches during therapy.

Recommended treatment in hypertensive crisis

If a hypertensive crisis occurs, phenelzine sulfate should be discontinued immediately and therapy to lower blood pressure should be instituted immediately. On the basis of present evidence, phentolamine is recommended. (The dosage reported for phentolamine is 5 mg intravenously.) Care should be taken to administer this drug slowly in order to avoid producing an excessive hypotensive effect. Fever should be managed by means of external cooling.

Warning to the Patient

All patients should be warned that the following foods, beverages, and medications must be avoided while taking phenelzine sulfate, and for two weeks after discontinuing use.

Foods and Beverages To Avoid

Meat and Fish
Pickled herring
Liver
Dry sausage (including Genoa salami, hard salami, pepperoni, and Lebanon bologna)

Vegetables
Broad bean pods (fava bean pods)
Sauerkraut

Dairy Products
Cheese (cottage cheese and cream cheese are allowed)
Yogurt

Beverages
Beer and wine
Alcohol-free and reduced-alcohol beer and wine products

Miscellaneous
Yeast extract (including brewer’s yeast in large quantities)
Meat extract
Excessive amounts of chocolate and caffeine

Also, any spoiled or improperly refrigerated, handled, or stored protein-rich foods such as meats, fish, and dairy products, including foods that may have undergone protein changes by aging, pickling, fermentation, or smoking to improve flavor should be avoided.

OTC Medications To Avoid

Cold and cough preparations (including those containing dextromethorphan)
Nasal decongestants (tablets, drops, or spray)
Hay-fever medications
Sinus medications
Asthma inhalant medications
Antiappetite medicines
Weight-reducing preparations
“Pep” pills
L-tryptophan containing preparations

Also, certain prescription drugs should be avoided. Therefore, patients under the care of another physician or dentist should inform him/her that they are taking phenelzine sulfate.

Patients should be warned that the use of the above foods, beverages, or medications may cause a reaction characterized by headache and other serious symptoms due to a rise in blood pressure, with the exception of dextromethorphan which may cause reactions similar to those seen with meperidine. Also, there has been a report of an interaction between phenelzine sulfate and dextromethorphan (ingested as a lozenge) causing drowsiness and bizarre behavior.

Patients should be instructed to report promptly the occurrence of headache or other unusual symptoms.

Concomitant Use with Dibenzazepine Derivative Drugs

If the decision is made to administer phenelzine sulfate concurrently with other antidepressant drugs, or within less than 10 days after discontinuation of antidepressant therapy, the patient should be cautioned by the physician regarding the possibility of adverse drug interaction.

A List of Dibenzazepine Derivative Drugs by Generic Name Follows:

nortriptyline hydrochloride
amitriptyline hydrochloride
perphenazine and amitriptyline hydrochloride
clomipramine hydrochloride
desipramine hydrochloride
imipramine hydrochloride
doxepin
carbamazepine
cyclobenzaprine HCl
amoxapine
maprotiline HCl
trimipramine maleate
protriptyline HCl
mirtazapine

Phenelzine sulfate should be used with caution in combination with antihypertensive drugs, including thiazide diuretics and β-blockers, since exaggerated hypotensive effects may result.

Use in Pregnancy

The safe use of phenelzine sulfate 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.

Doses of phenelzine sulfate in pregnant mice well exceeding the maximum recommended human dose have caused a significant decrease in the number of viable offspring per mouse. In addition, the growth of young dogs and rats has been retarded by doses exceeding the maximum human dose.

PRECAUTIONS

Information for Patients

Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with phenelzine sulfate and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for phenelzine sulfate. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking phenelzine sulfate.

Clinical Worsening and Suicide Risk

Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS—Clinical Worsening and Suicide Risk).

Anyone considering the use of phenelzine sulfate in a child or adolescent must balance the potential risks with the clinical need.

Phenelzine sulfate, as with other hydrazine derivatives, has been reported to induce pulmonary and vascular tumors in an uncontrolled lifetime study in mice.

In depressed patients, the possibility of suicide should always be considered and adequate precautions taken. It is recommended that careful observations of patients undergoing phenelzine sulfate treatment be maintained until control of depression is achieved. If necessary, additional measures (ECT, hospitalization, etc) should be instituted.

All patients undergoing treatment with phenelzine sulfate should be closely followed for symptoms of postural hypotension. Hypotensive side effects have occurred in hypertensive as well as normotensive and hypotensive patients. Blood pressure usually returns to pretreatment levels rapidly when the drug is discontinued or the dosage is reduced.

Because the effect of phenelzine sulfate on the convulsive threshold may be variable, adequate precautions should be taken when treating epileptic patients.

Of the more severe side effects that have been reported with any consistency, hypomania has been the most common. This reaction has been largely limited to patients in whom disorders characterized by hyperkinetic symptoms coexist with, but are obscured by, depressive affect; hypomania usually appeared as depression improved. If agitation is present, it may be increased with phenelzine sulfate. Hypomania and agitation have also been reported at higher than recommended doses or following long-term therapy.

Phenelzine sulfate may cause excessive stimulation in schizophrenic patients; in manic-depressive states it may result in a swing from a depressive to a manic phase.

Phenelzine sulfate should be used with caution in diabetes mellitus; increased insulin sensitivity may occur. Requirements for insulin or oral hypoglycemics may be decreased.

MAO inhibitors, including phenelzine sulfate, potentiate hexobarbital hypnosis in animals. Therefore, barbiturates should be given at a reduced dose with phenelzine sulfate.

MAO inhibitors inhibit the destruction of serotonin and norepinephrine, which are believed to be released from tissue stores by rauwolfia alkaloids. Accordingly, caution should be exercised when rauwolfia is used concomitantly with an MAO inhibitor, including phenelzine sulfate.

There is conflicting evidence as to whether or not MAO inhibitors affect glucose metabolism or potentiate hypoglycemic agents. This should be kept in mind if phenelzine sulfate is administered to diabetics.

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