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Elavil , Tryptanol (Amitriptyline)

Brand name : Elavil , Tryptanol

Generic Name : Amitriptyline

Manufacturer : Merck Sharp & Dohme

Medicine Category : Antidepressants

FDA Pregnant Category :

Category C : Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.

What is it used for ?

- Bedwetting (nocturnal enuresis)
- Depression


How does it work ?

This medicine contains the active ingredient amitriptyline hydrochloride, which is a type of medicine called a tricyclic antidepressant (TCA).

When depression occurs, there may be a decreased amount of the chemicals noradrenaline and serotonin released from nerve cells in the brain. When these chemicals are released from nerve cells they act to lighten mood. When they are reabsorbed into the nerve cells, they no longer have an effect on mood.

Amitriptyline works by preventing this re-absorption of noradrenaline and serotonin back into the nerve cells. Therefore, it helps prolong the mood-lightening effect of any released noradrenaline and serotonin. This helps relieve depression. The full benefits of treatment with amitriptyline may not occur for two to four weeks.

Amitriptyline also blocks receptors in other areas of the body resulting in side effects such as urinary retention. Therefore, amitriptyline may also be used in the treatment of bed-wetting (nocturnal enuresis). When used for this purpose, amitriptyline should generally only be used for a maximum of three months.

How should Elavil , Tryptanol (Amitriptyline) be used ?

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. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. 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. Amitriptyline must be taken regularly for a few weeks before its full effect is felt.

Warning

- Do not drink alcohol whilst taking this medicine.
- This medicine may reduce your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.

- This medicine may cause low blood sodium levels (hyponatraemia), which can result in drowsiness, confusion, muscle twitching or convulsions. Consult your doctor if you develop any of these symptoms while taking this medicine.

- Treatment with this medicine should not be stopped suddenly, but withdrawn gradually according to directions from your doctor. Abrupt withdrawal may cause symptoms such as nausea, vomiting, loss of appetite, headache, giddiness, chills, insomnia or anxiety.
- The use of this medication in children to treat nocturnal enuresis may result in behavioural changes.

Use with caution in

- Blood disorders
- Closed angle glaucoma
- Decreased liver function
- Difficulty in passing urine (urinary retention)
- Disease involving the heart and blood vessels (cardiovascular disease)
- Elderly people
- Enlarged prostate gland (prostatic hypertrophy)
- History of epilepsy
- Hyperthyroidism
- People receiving electroconvulsive therapy (ECT)
- Psychotic illness

Not to be used in

- Allergy to other tricyclic antidepressants (TCAs)
- Breastfeeding
- Children under 7 years of age
- Congestive heart failure
- Decreased blood supply to the heart (coronary insufficiency)
- Defect of the heart's electrical message pathways resulting in decreased function of the heart (heart block)
- History of heart attack
- Irregular heart beats (arrhythmias)
- Mania
- Severe liver disease

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby.Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

- This medicine is not to be used during pregnancy, especially during the first and third trimesters.
- This medicine passes into breast milk. It is recommended that mothers should avoid using this medicine while breastfeeding. Seek medical advice from your doctor.

Label warnings

- This medication may cause drowsiness. If affected do not drive or operate machinery. Avoid alcoholic drink.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

- Constipation
- Blurred vision
- Faster than normal heart beat (tachycardia)
- Difficulty in passing urine (urinary retention)
- Dry mouth
- Drowsiness
- Confusion
- Sweating
- Blood disorders
- Disturbances of the gut such as diarrhoea, constipation, nausea, vomiting or abdominal pain
- Low blood pressure (hypotension)
- Sexual problems

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines ?

Amitriptyline should not be taken with a monoamine oxidase inhibitor (MAOI) antidepressant. Treatment with amitriptyline should not be started until 2 weeks after stopping a MAOI.

Amitriptyline blood levels may be decreased by barbiturates.

There may be a sudden and marked increase in blood pressure and heart rate when amitriptyline is taken with medicines causing blood vessel narrowing, such as phenylephrine and adrenaline. These medicines should not be used together.

Amitriptyline may decrease the blood pressure lowering effect of:
Bethanidine
Debrisoquine
and guanethidine.

Amitriptyline may increase the sedating effects of alcohol.

Recommended dosage

ADULTS

The usual starting dosage is 75 milligrams per day divided into 2 or more smaller doses. Your doctor may gradually increase this dose to 150 milligrams per day. The total daily dose is generally never higher than 200 milligrams.
Alternatively, your doctor may want you to start with 50 milligrams to 100 milligrams at bedtime. He or she may increase this bedtime dose by 25 or 50 milligrams up to a total of 150 milligrams a day.

For long-term use, the usual dose ranges from 40 to 100 milligrams taken once daily, usually at bedtime.

CHILDREN

Use of Elavil is not recommended for children under 12 years of age.
The usual dose for adolescents 12 years of age and over is 10 milligrams, 3 times a day, with 20 milligrams taken at bedtime.

OLDER ADULTS

The usual dose is 10 milligrams taken 3 times a day, with 20 milligrams taken at bedtime.

Overdosage

An overdose of Elavil can prove fatal.

Manifestations: High doses may cause temporary confusion, disturbed concentration, or transient visual hallucinations. Over-dosage may cause drowsiness; hypothermia; tachycardia and other arrhythmic abnormalities, such as bundle branch block; ECG evidence of impaired conduction; congestive heart failure; dilated pupils; disorders of ocular motility; convulsions; severe hypotension; stupor; coma and polyradiculoneuropathy; constipation.

Other symptoms may be agitation, hyperactive reflexes, muscle rigidity, vomiting, hyperpyrexia, or any of those listed under Adverse Effects.

All patients suspected of having taken an overdose should be admitted to a hospital as soon as possible. Treatment is symptomatic and supportive. Empty the stomach as quickly as possible by emesis followed by gastric lavage upon arrival at the hospital. Following gastric lavage, activated charcoal may be administered. Twenty to 30 g of activated charcoal may be given every four to six hours during the first 24 to 48 hours after ingestion. An ECG should be taken and close monitoring of cardiac function instituted if there is any sign of abnormality. Maintain an open airway and adequate fluid intake; regulate body temperature.

The intravenous administration of 1-3 mg of physostigmine salicylate has been reported to reverse the symptoms of tricyclic antidepressant poisoning. Because physostigmine is rapidly metabolised, the dosage of physostigmine should be repeated as required particularly if life-threatening signs such as arrhythmias, convulsions and deep coma recur or persist after the initial dose of physostigmine. Because physostigmine itself may be toxic, it is not recommended for routine use.

Standard measures should be used to manage circulatory shock and metabolic acidosis. Cardiac arrhythmias may be treated with neostigmine, pyridostigmine, or propranolol. Should cardiac failure occur, the use of digitalis should be considered. Close monitoring of cardiac function of not less than five days is advisable.

Anticonvulsants may be given to control convulsions. AMITRIPTYLINE increases the CNS depressant action but not the anticonvulsant action of barbiturates; therefore, an inhalation anaesthetic, diazepam, or paraldehyde is recommended for control of convulsions.

Dialysis is of no value because of low plasma concentrations of the medicine.

Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Deaths by deliberate or accidental overdosage have occurred with this class of medicine.

When you miss a dose

Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time.

If you take a single daily dose at bedtime, do not make up for it in the morning. It may cause side effects during the day.

Storage

Keep Amitriptyline in a tightly closed container. Store at room temperature. Protect from light and excessive heat.

 

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