1.ESKALITH HISTORY
(How was Eskalith discovered?)

Eskalith is a product of GlaxoSmithKline. 

The US FDA approved Eskalith in August 2002. 

GlaxoSmithKline (GSK) is a world leading research-based pharmaceutical company with a powerful combination of skills and resources that provides a platform for delivering strong growth in today's rapidly changing healthcare environment.

GSK's mission is to improve the quality of human life by enabling people to do more, feel better and live longer.

GlaxoSmithKline is headquartered in the UK and has operations based in the US ; the new company is one of the industry leaders, with an estimated seven per cent of the world's pharmaceutical market.

GSK also has leadership in four major therapeutic areas - anti-infectives, central nervous system (CNS), respiratory and gastro-intestinal/metabolic. In addition, it is a leader in the important area of vaccines and has a growing portfolio of oncology products.

GSK also has a Consumer Healthcare portfolio comprising over-the-counter (OTC) medicines; oral care products and nutritional healthcare drinks, all of which are among the market leaders. 

2.ESKALITH FACTS

Eskalith (Lithium Carbonate) is a type of medicine known as a mood stabilizer.

The way Eskalith works, as a mood stabilising agent is still not fully understood. It is thought that it modifies the production and turnover of certain chemical compounds called neurotransmitters that are found in the brain.

Neurotransmitters are involved in transmitting messages between the nerve cells in the brain. Serotonin is one example of a neurotransmitter, as is dopamine. It is thought that Eskalith may affect the activity of these compounds in the brain.

Eskalith is used in several ways. People with bipolar affective disorder (manic depression) suffer from episodes of severe mood swings, which range from abnormally high mood and extreme excitement (mania) to deep depression. Eskalith is used to treat the mania, and to stabilize mood after an acute episode of mood swings to decrease the frequency and intensity of these episodes.

3.ABOUT ESKALITH MEDICATION

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
• mirtazpine

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 antidepressant 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 Antidepressants, 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.ESKALITH EFFECTIVENESS
(When is Eskalith best taken?)

Preclinical studies have shown that Eskalith alters sodium transport in nerve and muscle cells and effects a shift toward intraneuronal metabolism of catecholamines, but the specific biochemical mechanism of Eskalith action in mania is unknown. 

5.ESKALITH EFFECTS ON SPECIAL POPULATION
(How do different people react to Eskalith?)

Usage in Pregnancy:

Adverse effects on implantation in rats, embryo viability in mice, and metabolism in vitro of rat testes and human spermatozoa have been attributed to Eskalith, as have teratogenicity in submammalian species and cleft palates in mice.

In humans, Eskalith may cause fetal harm when administered to a pregnant woman. Data from lithium birth registries suggest an increase in cardiac and other anomalies, especially Ebsteins anomaly. If this drug is used in women of childbearing potential, or during pregnancy, or if a patient becomes pregnant while taking Eskalith dose, the patient should be apprised of the potential hazard to the fetus.

Usage in Nursing Mothers:

Eskalith is excreted in human milk. Nursing should not be undertaken during lithium therapy except in rare and unusual circumstances where, in the view of the physician, the potential benefits to the mother outweigh possible hazards to the child.

Usage in Children:

Since information regarding the safety and effectiveness of Eskalith in children under 12 years of age is not available, its use in such patients is not recommended at this time.

There has been a report of a transient syndrome of acute dystonia and hyperreflexia occurring in a 15 kg. child who ingested 300 mg. of Eskalith.

Usage in the Elderly:

Elderly patients often require lower Eskalith dosages to achieve therapeutic serum levels. They may also exhibit adverse reactions at serum levels ordinarily tolerated by younger patients.

6.ESKALITH EFFECTS ON MEDICAL CONDITIONS
(How does Eskalith affect your existing condition/ailment?)

Eskalith should not be used if you suffer from decreased kidney function, untreated hypothyroidism or Addison's disease (inadequate production of natural steroid hormones by the adrenal glands.) 

7.OTHER/ALTERNATE USES OF ESKALITH
(What else does Eskalith treat?)

Eskalith is also used to treat recurrent Depression that has not been responsive to other Antidepressants, and aggressive and self-harming or self-mutilating behavior, though not all brands of Eskalith are licensed for these two uses.

8.ADVERSE/SIDE EFFECTS of ESKALITH
(What are the side effects of Eskalith?)

The occurrence and severity of adverse reactions are generally directly related to serum lithium concentrations as well as to individual patient sensitivity to Eskalith, and generally occur more frequently and with greater severity at higher concentrations.

Adverse reactions may be encountered at serum Eskalith levels below 1.5 mEq./l. Mild to moderate adverse reactions may occur at levels from 1.5 to 2.5 mEq./l., and moderate to severe reactions may be seen at levels of 2.0 mEq./l. and above.

Fine hand tremor, polyuria, and mild thirst may occur during initial therapy for the acute manic phase, and may persist throughout treatment. Transient and mild nausea and general discomfort may also appear during the first few days of Eskalith administration.

These side effects usually subside with continued treatment or a temporary reduction or cessation of dosage. If persistent, cessation of Eskalith therapy may be required.

Diarrhea, vomiting, drowsiness, muscular weakness, and lack of coordination may be early signs of Eskalith intoxication, and can occur at Eskalith levels below 2.0 mEq./l. At higher levels, ataxia, giddiness, tinnitus, blurred vision, and a large output of dilute urine may be seen. Serum lithium levels above 3.0 mEq./l may produce a complex clinical picture, involving multiple organs and organ systems. Serum Eskalith levels should not be permitted to exceed 2.0 mEq./l during the acute treatment phase.

The following reactions have been reported and appear to be related to serum Eskalith levels, including levels within the therapeutic range:

Neuromuscular/Central Nervous System: tremor, muscle hyperirritability (fasciculations, twitching, clonic movements of whole limbs), hypertonicity, ataxia, choreo-athetotic movements, hyperactive deep tendon reflex, extrapyramidal symptoms including acute dystonia, cogwheel rigidity, blackout spells, epileptiform seizures, slurred speech, dizziness, vertigo, downbeat nystagmus, incontinence of urine or feces, somnolence, psychomotor retardation, restlessness, confusion, stupor, coma, tongue movements, tics, tinnitus, hallucinations, poor memory, slowed intellectual functioning, startled response, worsening of organic brain syndromes;

Cardiovascular: cardiac arrhythmia, hypotension, peripheral circulatory collapse, bradycardia, sinus node dysfunction with severe bradycardia;

Gastrointestinal : anorexia, nausea, vomiting, diarrhea, gastritis, salivary gland swelling, abdominal pain, excessive salivation, flatulence, indigestion;

Genitourinary : glycosuria, decreased creatinine clearance, albuminuria, oliguria, and symptoms of nephrogenic diabetes insipidus including polyuria, thirst, and polydipsia;

Dermatologic : drying and thinning of hair, alopecia, anesthesia of skin, acne, chronic folliculitis, xerosis cutis, psoriasis or its exacerbation, generalized pruritus with of without rash, cutaneous ulcers, angioedema;

Autonomic : blurred vision, dry mouth, impotence/sexual dysfunction;

Thyroid Abnormalities : euthyroid goiter and/or hypothyroidism (including myxedema) accompanied by lower T3 and T4.I131 uptake may be elevated.

EEG Changes : diffuse slowing, widening of the frequency spectrum, potentiation and disorganization of background rhythm;

EKG Changes : reversible flattening, isoelectricity or inversion of T-waves;

Miscellaneous: fatigue, lethargy, transient scotomata, dehydration, weight loss, leukocytosis, headache, transient hyperglycemia, hypercalcemia, hyperparathyroidism, excessive weight gain, edematous swelling of ankles or wrists, metallic taste, dysgeusia/ taste distortion, salty taste, thirst, swollen lips, tightness in chest, swollen and/or painful joints, fever, polyarthralgia, dental caries.

Some reports of nephrogenic diabetes insipidus, hyperparathyroidism and hypothyroidism, which persist after lithium discontinuation have been received.

A few reports have been received of the development of painful discoloration of fingers and toes and coldness of the extremities within one day of the starting of treatment with Eskalith. The mechanism through which these symptoms (resembling Raynaud's syndrome) developed is not known. Recovery followed discontinuance.

Cases of pseudotumor cerebri (increased intracranial pressure and papilledema) have been reported with Eskalith use. If undetected, this condition may result in enlargement of the blind spot, constriction of visual fields and eventual blindness due to optic atrophy.

Eskalith should be discontinued, if clinically possible, if this syndrome occurs.