A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Nardil Warnings, Precautions, Pregnancy, Nursing, Abuse - Phenelzine
Nardil Warnings, Precautions, Pregnancy, Nursing, Abuse - Phenelzine
WARNINGS
The most serious reactions to Nardil involve changes in blood pressure.
Hypertensive Crises: The most important reaction associated with Nardil
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 Nardil. 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, Nardil 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 Nardil, 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 they are taking
Nardil.
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 Nardil 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 Nardil 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
amitriptyline hydrochloride
perphenazine and amitriptyline
hydrochloride
perphenazine and amitriptyline
hydrochloride
clomipramine hydrochloride
desipramine hydrochloride
desipramine hydrochloride
imipramine hydrochloride
doxepin
doxepin
carbamazepine
cyclobenzaprine HCl
amoxapine
maprotiline HCl
trimipremine maleate
protriptyline HCl
mirtazapine
Nardil should be used with caution in combination with antihypertensive drugs,
including thiazide diuretics and (beta) -blockers, since exaggerated
hypotensive effects may result.
Use in Pregnancy: 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.
Doses of Nardil 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.
Use in Pediatric Patients: Nardil is not recommended for
pediatric patients under 16 years of age, since there are no controlled studies
of safety in this age group. Nardil, as with other hydrazine derivatives, has
been reported to induce pulmonary and vascular tumors in an uncontrolled lifetime
study in mice.
PRECAUTIONS
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.
All patients undergoing treatment with Nardil 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 Nardil 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 Nardil. Hypomania
and agitation have also been reported at higher than recommended doses or following
long-term therapy.
Nardil may cause excessive stimulation in schizophrenic patients; in manic-depressive
states it may result in a swing from a depressive to a manic phase.
MAO inhibitors, including Nardil, potentiate hexobarbital hypnosis in animals.
Therefore, barbiturates should be given at a reduced dose with Nardil.
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 Nardil.
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
Nardil is administered to diabetics.
Drug Interactions
In patients receiving nonselective monoamine oxidase (MOA) inhibitors in combination
with serotoninergic agents (e.g., dexfenfluramine, fluoxetine, fluvoxamine,
paroxetine, sertraline, venlafexine) there have been reports of serious, sometimes
fatal, reactions. Because Nardil is a monoamine oxidase (MAO) inhibitor, Nardil
should not be used concomitantly with a serotoninergic agent (See CONTRAINDICATIONS).
Geriatric Use
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.
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