Amitriptyline

What is Amitriptyline?

• Amitriptyline (Amitid; Amitril; Elavil; Endep), a dibenzocycloheptadiene derivative used as an antidepressant with sedative effects.

Amitriptyline molecule ball

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What are the uses of this medicine?

• Amitriptyline (Amitid; Amitril; Elavil; Endep), is used for the relief of symptoms of depression.

How does this medicine work?

• Amitriptyline is believed to exert its antidepressant effects through the inhibition of serotonin and norepinephrine reuptake within synaptic clefts in the central nervous system.
• By increasing the brain levels of these neurotransmitters, amitriptyline can alleviate depressive symptoms.
• 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 reuptake of norepinephrine and/or serotonin is believed by some to underlie the antidepressant activity of amitriptyline.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypersensitivity to amantadine hydrochloride or to any of the other ingredients in amantadine hydrochloride tablets.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• antihistamines
• cimetidine (Tagamet)
• diet pills
• disulfiram (Antabuse)
• guanethidine (Ismelin)
• ipratropium (Atrovent)
• quinidine (Quinidex)
• medications for irregular heartbeats such as flecainide (Tambocor) and propafenone (Rythmol)
• medications for anxiety, asthma, colds, irritable bowel disease, mental illness, nausea, Parkinson's disease, seizures, ulcers, or urinary problems
• other antidepressants
• phenobarbital (Bellatal, Solfoton)
• sedatives
• selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft)
• sleeping pills
• thyroid medications
• tranquilizers

Is this medicine FDA approved?

• Amitriptyline was discovered in the late 1950s by scientists at Merck and approved by the US Food and Drug Administration (FDA) in 1961.

How should this medicine be used?

Recommended dosage: Initial Dosage for Adults:

• For outpatients, 75 mg of amitriptyline HCl a day in divided doses is usually satisfactory.
• If necessary, this may be increased to a total of 150 mg per day.
• Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop.
• Hospitalized patients may require 100 mg a day initially.
• This can be increased gradually to 200 mg a day if necessary.

Adolescent and Elderly Patients:

• Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages.

• The usual maintenance dosage of amitriptyline HCl is 50 to 100 mg per day.
• In some patients, 40 mg per day is sufficient.
• For maintenance therapy, the total daily dosage may be given in a single dose, preferably at bedtime.

Administration:

• Amitriptyline comes as a tablet to take by mouth.
• It is usually taken one to four times a day.
• Take amitriptyline at around the same time every day.
• Your doctor will probably start you on a low dose of amitriptyline and gradually increase your dose.
• It may take a few weeks or longer before you feel the full benefit of amitriptyline.
• Continue to take amitriptyline even if you feel well.
• Do not stop taking amitriptyline without talking to your doctor.
• If you suddenly stop taking amitriptyline, you may experience withdrawal symptoms such as nausea, headache, and lack of energy.
• Your doctor will probably decrease your dose gradually.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride.

This medicine is available in fallowing brand namesː

• Amitid; Amitril; Elavil; Endep

What side effects can this medication cause?

The most common side effects of this medicine include:

• Dizziness
• Headache
• Drowsiness
• Restlessness
• Confusion
• Gastrointestinal upset
• Increased appetite
• Weight gain
• Blurred vision
• Dry mouth
• Urinary retention

Less common side effects may include:

• Cardiovascular: Myocardial infarction; stroke; nonspecific ECG changes and changes in AV conduction; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; syncope; hypertension; tachycardia; palpitation.
• CNS and Neuromuscular: Coma; seizures; hallucinations; delusions; confusional states; disorientation; incoordination; ataxia; tremors; peripheral neuropathy; numbness, tingling and paresthesias of the extremities; extrapyramidal symptoms including abnormal involuntary movements and tardive dyskinesia; dysarthria; disturbed concentration; excitement; anxiety; insomnia; restlessness; nightmares; drowsiness; dizziness; weakness; fatigue; headache; syndrome of inappropriate ADH (antidiuretic hormone) secretion; tinnitus; alteration in EEG patterns.
• Anticholinergic: Paralytic ileus, hyperpyrexia; urinary retention, dilatation of the urinary tract; constipation; blurred vision, disturbance of accommodation, increased ocular pressure, mydriasis; dry mouth.
• Allergic: Skin rash; urticaria; photosensitization; edema of face and tongue.
• Hematologic: Bone marrow depression including agranulocytosis, leukopenia, thrombocytopenia; purpura; eosinophilia.
• Gastrointestinal: Rarely hepatitis (including altered liver function and jaundice); nausea; epigastric distress; vomiting; anorexia; stomatitis; peculiar taste; diarrhea; parotid swelling; black tongue.
• Endocrine: Testicular swelling and gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido; impotence; elevation and lowering of blood sugar levels.
• Other: Alopecia; edema; weight gain or loss; urinary frequency; increased perspiration.

What special precautions should I follow?

• 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.
• While on therapy with amitriptyline hydrochloride, patients should be advised as to the possible impairment of mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.
• It should be used with caution in patients with a history of seizures and, because of its atropine-like action, in patients with a history of urinary retention, angle-closure glaucoma or increased intraocular pressure. In patients with angle-closure glaucoma, even average doses may precipitate an attack.
• Tricyclic antidepressant drugs, including amitriptyline hydrochloride, particularly when given in high doses, have been reported to produce arrhythmias, sinus tachycardia, and prolongation of the conduction time. Patients with cardiovascular disorders should be watched closely.
• Close supervision is required when amitriptyline hydrochloride is given to hyperthyroid patients or those receiving thyroid medication.
• Amitriptyline may enhance the response to alcohol and the effects of barbiturates and other CNS depressants. In patients who may use alcohol excessively, it should be borne in mind that the potentiation may increase the danger inherent in any suicide attempt or overdosage.
• Amitriptyline is excreted into breast milk. Because of the potential for serious adverse reactions in nursing infants from amitriptyline, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma.
• Changes in the electrocardiogram particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity.
• In addition, a rightward axis shift in the terminal QRS complex together with a prolonged QT interval and sinus tachycardia are specific and sensitive indicators of first generation tricyclic overdose.
• Prolonged PR interval, ST-T wave changes, ventricular tachycardia and fibrillation may also occur.

Other signs of overdose may include: impaired myocardial contractility, confusion, disturbed concentration, transient visual hallucinations, dilated pupils, disorders of ocular motility, agitation, hyperactive reflexes polyradiculoneuropathy, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Obtain an ECG and immediately initiate cardiac monitoring.
• Protect the patient’s airway, establish an intravenous line and initiate gastric decontamination.
• A minimum of six hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary.
• If signs of toxicity occur at any time during the period extended monitoring is required.
• There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death and most received inadequate gastrointestinal decontamination.
• Monitoring of plasma drug levels should not guide management of the patient.
• All patients suspected of tricyclic antidepressant overdose should receive gastrointestinal decontamination. This should include, large volume gastric lavage followed by activated charcoal.
• Seizures should be controlled with benzodiazepines, or if these are ineffective, other anticonvulsants (e.g., phenobarbital, phenytoin).
• Psychiatric referral may be appropriate.
• Hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in tricyclic antidepressant poisoning.
• Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45 to 7.55. If the pH response is inadequate, hyperventilation may also be used. Concomitant use of hyperventilation and sodium bicarbonate should be done with extreme caution, with frequent pH monitoring.
• Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are no adequate and well-controlled studies in pregnant women.
• Amitriptyline hydrochloride should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in the pediatric population have not been established.
• It is not recommended at the present time for patients under 12 years of age.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• amitriptyline hydrochloride

Inactive ingredients:

• silicon dioxide
• croscarmellose sodium
• lactose monohydrate
• lecithin, soybean
• magnesium stearate
• cellulose, microcrystalline
• polyvinyl alcohol
• ferric oxide red
• talc
• titanium dioxide
• xanthan gum

Who manufactures and distributes this medicine?

Manufactured For:

• Accord Healthcare, Inc.,
• 1009, Slater Road,
• Suite 210-B,
• Durham, NC,
• USA.

Manufactured By:

• Intas Pharmaceuticals Limited,
• Ahmedabad, India.

What should I know about storage and disposal of this medication?

• Store at 20º to 25ºC (68º to 77ºF).
• Dispense in a tight, light-resistant container.

• Dailymed label info on Amitriptyline
• FDA Amitriptyline

Amitriptyline Resources
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The following are antidepressant subclasses and drugs

MAO Inhibitors Isocarboxazid, Phenelzine, Tranylcypromine

SNRIs Duloxetine, Levomilnacipran, Venlafaxine

SSRIs Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Vilazodone, Vortioxetine

Tricyclics Amitriptyline, Amoxapine, Clomipramine, Desipramine, Doxepin, Imipramine, Nortriptyline, Protriptyline, Trimipramine

Miscellaneous Bupropion, Flibanserin, Mirtazapine, Nefazodone, Trazodone