1.ELAVIL HISTORY
How was Elavil discovered?

Elavil is a product of Merck Sharp & Dohme.

Merck Sharp & Dohme is a subsidiary of Merck & Co.

The FDA approved Elavil in May 2000.

Note: World-drugs.net sells generic version of Elavil

2.ELAVIL FACTS

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in over 20 therapeutic categories.

Merck performs about 1 percent of the biomedical research in the world. To tap into the remaining 99 percent, Merck reaches out to universities, research institutions and companies worldwide to bring the best of technology and potential products into Merck.

3.ABOUT ELAVIL MEDICATION

Elavil 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.

Elavil 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 Elavil may not occur for two to four weeks.

What is depression?

Depression is a medical illness, like diabetes or high blood pressure. People don't choose to be depressed. It's not because they're weak or "crazy." Depression affects more than 17 million people in the United States each year. It's twice as common in women as in men. Symptoms of depression include the following:

• Feeling sad most of the day, nearly every day, for 2 weeks or longer
• Loss of interest in things you used to enjoy
• Lack of energy
• Sleep and appetite disturbances
• Weight changes
• Feelings of hopelessness, helplessness and worthlessness
• Not being able to make decisions
• Thoughts of death and suicide

What causes depression?

The exact cause of depression is not known. Doctors think it may be caused by a chemical imbalance in the brain. The imbalance could be caused by your genes or by events in your life. Sometimes there aren't enough chemical messengers (called neurotransmitters) in the brain. Two primary messengers, called serotonin (say "seer-o-tone-in") and norepinephrine (say "nor-ep-in-ef-rin"), are responsible for your moods (how you feel).

What are antidepressants?

Antidepressants are medicines used to help people who have depression. Most people with depression get better with treatment with antidepressants.

How do antidepressants work?

Most antidepressants are believed to work by slowing the removal of certain chemicals from the brain. These chemicals are called neurotransmitters. Neurotransmitters are needed for normal brain function. Antidepressants help people with depression by making these natural chemicals more available to the brain.

How long will you have to take an antidepressant?

Antidepressants are typically taken for at least 4 to 6 months. In some cases, patients and their doctors may decide that antidepressants are needed for a longer time.

What are the different kinds of antidepressants?

Antidepressants are put into groups based on which chemicals in the brain they affect. There are many different kinds of Antidepressants, including:

Selective serotonin reuptake inhibitors (SSRIs)

• citalopram
• escitalopram
• fluoxetine
• paroxetine
• sertraline

These medicines tend to have fewer side effects than other antidepressants. Some of the side effects that can be caused by SSRIs include dry mouth, nausea, nervousness, insomnia, sexual problems and headache.

Tricyclics

• amitriptyline
• desipramine
• imipramine
• nortriptyline

Common side effects caused by these medicines include dry mouth, blurred vision, constipation, difficulty urinating, worsening of glaucoma, impaired thinking and tiredness. These antidepressants can also affect a person's blood pressure and heart rate.

Serotonin and norepinephrine reuptake inhibitors (SNRIs)

• venlafaxine
• duloxetine

Some common side effects caused by these medicines include nausea and loss of appetite, anxiety and nervousness, headache, insomnia and tiredness. Dry mouth, constipation, weight loss, sexual problems, increased heart rate and increased cholesterol levels can also occur.

Norepinephrine and dopamine reuptake inhibitors (NDRIs)

• bupropion

Some of the Common side effects in people taking NDRIs include agitation, nausea, headache, loss of appetite and insomnia. It can also cause increase blood pressure in some people.

Combined reuptake inhibitors and receptor blockers

• trazodone
• nefazodone
• maprotiline
• mirtazapine

Common side effects of these medicines are drowsiness, dry mouth, nausea and dizziness. If you have liver problems, you should not take nefazodone. If you have seizures, you should not take maprotiline.

Monamine oxidase inhibitors (MAOIs)

• isocarboxazid
• phenelzine
• tranlcypromine
• MAOIs are used less commonly than the other antidepressants. They can have serious side effects, including weakness, dizziness, headaches and trembling. Taking an MAOI antidepressant while you're taking another antidepressants or certain over-the-counter medicines for colds and flu can cause a dangerous reaction. Your doctor will also tell you what foods and alcoholic beverages you should avoid while you are taking an MAOI. You should not take an MAOI unless you clearly understand what medications and foods to avoid. If you are taking an MAOI and your doctor wants you to start taking one of the other antidepressants, he or she will have you stop taking the MAOI for a while before you start the new medicine. This gives the MAOI time to clear out of your body.

How will my doctor choose an antidepressant for me?

Your doctor will probably think about the following 10 points when choosing an antidepressant medicine for you:

• If you were depressed before and a certain antidepressant worked well, that antidepressant might be the right choice of medicine for you again.
• If any of your brothers or sisters, parents, uncles or aunts had depression and a certain antidepressant worked well for them, that medicine might work for you too.
• The choice of an antidepressant depends on your health. If a certain antidepressant would have a bad effect on a health problem you have, that medicine wouldn't be the right choice for you.
• Antidepressants may cause side effects. The right medicine for you may be the one that gives you the fewest side effects.
• The choice of an antidepressant depends on how often you have to take it. The less often you have to take the medicine, the easier it is for you to take all the doses you need to treat your depression.
• Some antidepressants cost more than others. Your doctor will choose an antidepressant that works for you and that you can afford.
• Your doctor will want to choose a medicine he or she has experience prescribing.
• Your doctor will choose an antidepressant that will help you with symptoms like sleeplessness, anxiety and lack of energy.
• If you're taking other medicines, your doctor will consider how an antidepressant will work with these other medicines.
• Some antidepressants don't work well with certain foods. If your doctor gives you one of these antidepressant, he or she will let you know which foods you should stop eating.

Will antidepressants affect my other medicines?

Antidepressants can have an effect on many other medicines. If you're going to take an antidepressant, tell your doctor about all the other medicines you take, including over-the-counter medicines and herbal health products (such as St. John's wort). Ask your doctor and pharmacist if any of your regular medicines can cause problems when combined with an antidepressant.

4.ELAVIL EFFECTIVENESS
When is Elavil best taken?

Initial Dosage for Adults : For outpatients 75 mg of Elavil 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.

An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg Elavil at bedtime. The dose may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day.

Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day.

Maintenance : The usual maintenance dosage of Elavil 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. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. It is appropriate to continue maintenance therapy 3 months or longer to lessen the possibility of relapse.

Plasma Levels : Because of the wide variation in the absorption and distribution of tricyclic antidepressant in body fluids, it is difficult to directly correlate plasma levels and therapeutic effect. However, determination of plasma levels may be useful in identifying patients who appear to have toxic effects and may have excessively high levels, or those in whom lack of absorption or noncompliance is suspected. Adjustments in dosage should be made according to the patient's clinical response and not on the basis of plasma levels.

5.ELAVIL EFFECTS ON SPECIAL POPULATION
How do different people react to Elavil?

Elavil may block the antihypertensive action of guanethidine or similarly acting compounds.

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.

Patients with cardiovascular disorders should be watched closely. Tricyclic antidepressant drugs, including Elavil, particularly when given in high doses, have been reported to produce arrhythmias, sinus tachycardia, and prolongation of the conduction time. Myocardial infarction and stroke have been reported with drugs of this class.

Close supervision is required when Elavil is given to hyperthyroid patients or those receiving thyroid medication.

Usage in pregnancy

Elavil has been shown to cross the placenta. Although a causal relationship has not been established, there have been a few reports of adverse events, including CNS effects, limb deformities, or developmental delay, in infants whose mothers had taken Elavil during pregnancy.

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

Nursing Mothers :

Elavil is excreted into breast milk. In one report in which a patient received Elavil 100 mg/day while nursing her infant, levels of 83 - 141 ng/ml were detected in the mother's serum. Levels of 135 - 151 ng/ml were found in the breast milk, but no trace of the drug could be detected in the infant's serum.

Because of the potential for serious adverse reactions in nursing infants from Elavil, 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.

Adolescent and Elderly Patients : In general, lower dosages are recommended for these patients. 10 mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages.

Use in Pediatric Patients : In view of the lack of experience with the use of this drug in children, it is not recommended at the present time for patients under 12 years of age.

6.ELAVIL EFFECTS ON MEDICAL CONDITIONS
How does Elavil affect your existing condition/ailment?

Elavil should not be used if you suffer from severely decreased kidney or liver function, diabetes or epilepsy. It may worsen the condition.

Elavil should not be used if you have a history of bleeding disorders or mania or history of heart attack.

Do not use Elavil if you suffer from coronary insufficiency or defect of the heart's electrical message pathways resulting in decreased function of the heart (heart block).

7 .OTHER/ALTERNATE USES OF ELAVIL
What else does Elavil treat?

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

Some doctors also prescribe Elavil to treat bulimia (an eating disorder), to control chronic pain, to prevent migraine headaches, and to treat a pathological weeping and laughing syndrome associated with multiple sclerosis.

Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with Elavil. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when Elavil is administered.

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.

Withdrawal Symptoms: After prolonged administration, abrupt cessation of treatment may produce nausea, headache, and malaise. Gradual dosage reduction has been reported to produce, within two weeks, transient symptoms including irritability, restlessness, and dream and sleep disturbance.

These symptoms are not indicative of addiction. Rare instances have been reported of mania or hypomania occurring within 2-7 days following cessation of chronic therapy with tricyclic antidepressants.

Causal Relationship Unknown : Other reactions, reported under circumstances where a causal relationship could not be established, are listed to serve as alerting information to physicians:

Body as a Whole: Lupus-like syndrome (migratory arthritis, positive ANA and rheumatoid factor).

Digestive : Hepatic failure