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Elavil®
(Amitriptyline HCl)
Also see:
Celexa Effexor Fluoxetine
Lexapro Paxil
Paxil CR Prozac
Remeron Zoloft
Cymbalta
Drug Uses
Elavil is indicated for the relief of
symptoms of depression. Endogenous depression is more likely to be alleviated
than are other depressive states.
How Taken
Elavil comes as a tablet to take by mouth.
It is usually taken one to four times a day and may be taken with or without
food. Take Elavil exactly as directed. Do not take more or less of it or take it
more often than prescribed by your doctor. Continue to take Elavil even if you
feel well. Do not stop taking Elavil without talking to your doctor, especially
if you have taken large doses for a long time. Your doctor probably will want to
decrease your dose gradually. This drug must be taken regularly for a few weeks
before its full effect is felt.
Warnings/Precautions
Before taking Elavil, tell your doctor if
you have liver disease; kidney disease; asthma; thyroid disease; diabetes;
stomach or intestinal problems; high blood pressure or heart disease; had a
heart attack in the last 6 weeks; an enlarged prostate or difficulty urinating;
or glaucoma. You may not be able to take Elavil, or you may require a dosage
adjustment or special monitoring during treatment if you have any of the
conditions listed above. Elavil may be harmful to an unborn baby. Do not take
Elavil without first talking to your doctor if you are pregnant or could become
pregnant during treatment. Elavil passes into breast milk and may affect a
nursing baby. Do not take Elavil without first talking to your doctor if you are
breast-feeding a baby. If you are over 60 years of age, you may be more likely
to experience side effects such as drowsiness, dizziness, unsteadiness, feeling
uncoordinated and low blood pressure. Your doctor may prescribe a lower dose of
this medication.
Missed Dose
Take the missed dose as soon as you
remember. If it is almost time for the next regularly scheduled dose, skip the
missed dose and take the next one as directed. Do not take a double dose of this
medication unless otherwise directed by your doctor.
Possible Side Effects
Side effects cannot be anticipated. If any
develop or change in intensity, inform your doctor as soon as possible. Only
your doctor can determine if it is safe for you to continue taking Elavil. Older
adults are especially liable to certain side effects of Elavil, including rapid
heartbeat, constipation, dry mouth, blurred vision, sedation, and confusion, and
are in greater danger of sustaining a fall. Side effects may include: Abnormal
movements, anxiety, black tongue, blurred vision, breast development in males,
breast enlargement, coma, confusion, constipation, delusions, diarrhea,
difficult or frequent urination, difficulty in speech, dilation of pupils,
disorientation, disturbed concentration, dizziness on getting up, dizziness or
light-headedness, drowsiness, dry mouth, excessive or spontaneous flow of milk,
excitement, fatigue, fluid retention, hair loss, hallucinations, headache, heart
attack, hepatitis, high blood pressure, high fever, high or low blood sugar,
hives, impotence, inability to sleep, increased or decreased sex drive,
increased perspiration, increased pressure within the eye, inflammation of the
mouth, intestinal obstruction, irregular heartbeat, lack or loss of
coordination, loss of appetite, low blood pressure, nausea, nightmares,
numbness, rapid and/or fast, fluttery heartbeat, rash, red or purple spots on
skin, restlessness, ringing in the ears, seizures, sensitivity to light, stomach
upset, strange taste, stroke, swelling due to fluid retention in the face and
tongue, swelling of testicles, swollen glands, tingling and pins and needles in
the arms and legs, tremors, vomiting, weakness, weight gain or loss, yellowed
eyes and skin. Side effects due to rapid decrease or abrupt withdrawal from
Elavil include: Headache, nausea, vague feeling of bodily discomfort Side
effects due to gradual dosage reduction may include: Dream and sleep
disturbances, irritability, and restlessness.
Storage
Store Elavil tablets in a well-closed
container. Avoid storage at temperatures above 30°C (86°F). In addition, Elavil
tablets 10 mg must be protected from light and stored in a well-closed,
light-resistant container.
Overdose
Critical manifestations of overdose
include: cardiac dysrhythmias, severe hypotension, convulsions, and CNS
depression, including coma. Changes in the electrocardiogram, particularly in
QRS axis or width, are clinically significant indictors of tricyclic
antidepressant toxicity. Other signs of overdose may include: impaired
myocardial contractility, confusion, disturbed concentration, transient visual
hallucinations, and dilated pupils, disorders of ocular motility, agitation,
hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting,
hypothermia, and hyperpyrexia. Deaths may occur from over dosage with this class
of drugs.
More Information
Use caution when driving, operating
machinery, or performing other hazardous activities. Elavil may cause drowsiness
or dizziness. If you experience drowsiness or dizziness, avoid these activities.
Dizziness is likely to occur when you rise from a sitting or lying position.
Rise slowly to prevent dizziness and a possible fall. Use alcohol cautiously.
Alcohol may increase drowsiness and dizziness while you are taking Elavil. Do
not stop taking Elavil suddenly. This could cause symptoms such as nausea,
headache, and malaise.
Amitriptyline HCl is an antidepressant with
sedative effects. Its mechanism of action in man is not known. It is not a
monoamine oxidase inhibitor and it does not act primarily by stimulation of the
central nervous system.
Amitriptyline inhibits the membrane pump mechanism responsible for uptake of
norepinephrine and serotonin in adrenergic and serotonergic neurons.
Pharmacologically this action may potentiate or prolong neuronal activity since
reuptake of these biogenic amines is important physiologically in terminating
transmitting activity. This interference with the reuptake of norepinephrine
and/or serotonin is believed by some to underlie the antidepressant activity of
amitriptyline.
Metabolism
Studies in man following oral administration of 14C-labeled drug indicated that
amitriptyline is rapidly absorbed and metabolized. Radioactivity of the plasma
was practically negligible, although significant amounts of radioactivity
appeared in the urine by 4 to 6 hours and one-half to one-third of the drug was
excreted within 24 hours.
Amitriptyline is metabolized by N-demethylation and bridge hydroxylation in man,
rabbit, and rat. Virtually the entire dose is excreted as glucuronide or sulfate
conjugate of metabolites, with little unchanged drug appearing in the urine.
Other metabolic pathways may be involved.
Amitriptyline HCl is
3-(10,11-dihydro-5H-dibenzo [a,d]
cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride.
Its empirical
formula is C20H23N·HCl.
Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight
of 313.87. It is a white, odorless, crystalline compound which is freely soluble
in water.
Elavil (amitriptyline HCl) is supplied as 10 mg, 25 mg, 50 mg, 75 mg, 100 mg,
and 150 mg tablets and as a sterile solution for intramuscular use. Inactive
ingredients of the tablets are calcium phosphate, cellulose, colloidal silicon
dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose,
magnesium stearate, starch, stearic acid, talc, and titanium dioxide. 10 mg
amitriptyline HCl tablets also contain FD&C Blue 1. 25 mg amitriptyline HCl
tablets also contain D&C Yellow 10, FD&C Blue 1, and FD&C Yellow 6. 50 mg
amitriptyline HCl tablets also contain D&C Yellow 10, FD&C Yellow 6 and iron
oxide. 75 mg amitriptyline HCl tablets also contain FD&C Yellow 6. 100 mg
amitriptyline HCl tablets also contain FD&C Blue 2 and FD&C Red 40. 150 mg
amitriptyline HCl tablets also contain FD&C Blue 2 and FD&C Yellow 6.
Each Milliliter of the Sterile Solution Contains: Amitriptyline hydrochloride:
10 mg; Dextrose: 44 mg; Water for Injection, q.s.:1 ml
Added as Preservatives: Methylparaben: 1.5 mg; Propylparaben: 0.2 mg
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