1.LEXAPRO HISTORY
How was Lexapro discovered?

Lexapro is a product of Forest Laboratories, Inc.

The FDA approved Lexapro in August 2002. 

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

2.LEXAPRO FACTS

Forest Pharmaceuticals, Inc., headquartered in St. Louis, Missouri is a wholly owned subsidiary of Forest Laboratories, Inc. The parent company is headquartered in New York City and publicly traded on the NYSE, under the trading symbol "FRX".

Forest Laboratories, Inc. manufactures, sells, and distributes both branded and generic forms of ethical products, which require a physician's prescription, as well as non-prescription pharmaceutical products sold over-the-counter (OTC), which are used for the treatment of a wide range of illnesses. 

3.ABOUT LEXAPRO MEDICATION

Lexapro contains the active ingredient escitalopram, which is a type of antidepressant known as a selective serotonin re-uptake inhibitor (SSRI). Lexapro acts on nerve cells in the brain.

In the brain there are numerous different chemical compounds called neurotransmitters. These act as chemical messengers between the nerve cells. Serotonin is one such neurotransmitter and has various functions that we know of.

When serotonin is released from nerve cells in the brain it acts to lighten mood. When it is reabsorbed into the nerve cells, it no longer has an effect on mood. It is thought that when depression occurs, there may be a decreased amount of serotonin released from nerve cells in the brain.

SSRIs work by preventing serotonin from being reabsorbed back into the nerve cells in the brain. This helps prolong the mood lightening effect of any released serotonin.

Diagrammatic representation for the mechanism of action of Lexapro 

1.Serotonin is released from one nerve cell and then picked up by the next nerve cell.

Some of this serotonin is also taken back up into the first nerve cell. 

2.However, people suffering from depression, panic disorder, obsessive-compulsive disorder, or posttraumatic stress disorder may have an imbalance of serotonin so the nerve cells cannot communicate properly.

 

3.What Lexapro does is block the serotonin from going back into the nerve cell that sends the chemical message.

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).

Symptoms of depression

You feel miserable and sad. You feel exhausted a lot of the time with no energy. You feel as if even the smallest tasks are sometimes impossible. You seldom enjoy the things that you used to enjoy-you may be off sex or food or may 'comfort eat' to excess. You feel very anxious sometimes. You don't want to see people or are scared to be left alone. Social activity may feel hard or impossible. You find it difficult to think clearly. You feel like a failure and/or feel guilty a lot of the time. You feel a burden to others. You sometimes feel that life isn't worth living. You can see no future. There is a loss of hope. You feel all you've ever done is make mistakes and that's all that you ever will do. You feel irritable or angry more than usual. You feel you have no confidence. You spend a lot of time thinking about what has gone wrong, what will go wrong or what is wrong about yourself as a person. You may also feel guilty sometimes about being critical of others (or even thinking critically about them). You feel that life is unfair. You have difficulty sleeping or wake up very early in the morning and can't sleep again. You seem to dream all night long and sometimes have disturbing dreams. You feel that life has/is 'passing you by.' You may have physical aches and pains, which appear to have no physical cause, such as back pain.

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.LEXAPRO EFFECTIVENESS
When is Lexapro best taken?

The single and multiple dose pharmacokinetics of Lexapro are linear and dose-proportional in a dose range of 10 to 30 mg/day. Biotransformation of Lexapro is mainly hepatic, with a mean terminal half-life of about 27-32 hours. With once daily dosing, steady state plasma concentrations are achieved within approximately one week. At steady state, the extent of accumulation of Lexapro in plasma in young healthy subjects was 2.2-2.5 times the plasma concentrations observed after a single dose of Lexapro.

Absorption and Distribution

Following a single oral dose of Lexapro, peak blood levels occur at about 5 hours. Absorption of Lexapro is not affected by food.

The absolute bioavailability of Lexapro is about 80% relative to an intravenous dose, and the volume of distribution of Lexapro is about 12 L/kg.

The binding of Lexapro to human plasma proteins is approximately 56%.

Metabolism and Elimination

Following oral administrations of Lexapro, the fraction of drug recovered in the urine as Lexapro and S-demethylcitalopram (S-DCT) is about 8% and 10%, respectively. The oral clearance of Lexapro is 600 mL/min, with approximately 7% of that due to renal clearance.

Lexapro is metabolized to S-DCT and S-didemethylcitalopram (S-DDCT). In humans, unchanged Lexapro is the predominant compound in plasma. At steady state, the concentration of the Lexapro metabolite S-DCT in plasma is approximately one-third that of Lexapro.

In vitro studies using human liver microsomes indicated that CYP3A4 and CYP2C19 are the primary isozymes involved in the N-demethylation of Lexapro.

5.LEXAPRO EFFECTS ON SPECIAL POPULATION
How do different people react to Lexapro?

Labor and Delivery

The effect of Lexapro on labor and delivery in humans is unknown.

Nursing Mothers

Lexapro like many other drugs, is excreted in human breast milk. There have been two reports of infants experiencing excessive somnolence, decreased feeding, and weight loss in association with breast feeding from a citalopram-treated mother; in one case, the infant was reported to recover completely upon discontinuation of citalopram by its mother and, in the second case, no follow up information was available. The decision whether to continue or discontinue either nursing or Lexapro therapy should take into account the risks of citalopram exposure for the infant and the benefits of Lexapro treatment for the mother.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established. One placebo-controlled trial in 264 pediatric patients with MDD has been conducted with Lexapro, and the data were not sufficient to support a claim for use in pediatric patients. Anyone considering the use of Lexapro in a child or adolescent must balance the potential risks with the clinical need.

Geriatric Use

Approximately 6% of the 1144 patients receiving escitalopram in controlled trials of Lexapro in major depressive disorder and GAD were 60 years of age or older; elderly patients in these trials received daily doses of Lexapro between 10 and 20 mg. The number of elderly patients in these trials was insufficient to adequately assess for possible differential efficacy and safety measures on the basis of age. Nevertheless, greater sensitivity of some elderly individuals to effects of Lexapro cannot be ruled out.

6.LEXAPRO EFFECTS ON MEDICAL CONDITIONS
How does Lexapro affect your existing condition/ailment?

Lexapro should not be used if you suffer from manic episodes of manic depression or uncontrolled epilepsy.

Lexapro should not be used if you have taken a monoamine-oxidase inhibitor antidepressant (MAOI) in the last 14 days. 

7.OTHER/ALTERNATE USES OF LEXAPRO
(What else does Lexapro treat?)

Lexapro is also prescribed to treat obsessive-compulsive disorder. An obsession is a thought that won't go away; a compulsion is an action done over and over to relieve anxiety.

Lexapro is also used in the treatment of bulimia (binge-eating followed by deliberate vomiting).

8.ADVERSE/SIDE EFFECTS of LEXAPRO
What are the side effects of Lexapro?

Adverse event information for Lexapro was collected from 715 patients with major depressive disorder who were exposed to Lexapro and from 592 patients who were exposed to placebo in double-blind, placebo-controlled trials. An additional 284 patients with major depressive disorder were newly exposed to Lexapro in open-label trials.

The adverse event information for Lexapro in patients with GAD was collected from 429 patients exposed to Lexapro and from 427 patients exposed to placebo in double-blind, placebo-controlled trials.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Events Associated with Discontinuation of Treatment

Major Depressive Disorder

Among the 715 depressed patients who received Lexapro in placebo-controlled trials, 6% discontinued treatment due to an adverse event, as compared to 2% of 592 patients receiving placebo. In two fixed-dose studies, the rate of discontinuation for adverse events in patients receiving 10 mg/day Lexapro was not significantly different from the rate of discontinuation for adverse events in patients receiving placebo. The rate of discontinuation for adverse events in patients assigned to a fixed dose of 20 mg/day Lexapro was 10%, which was significantly different from the rate of discontinuation for adverse events in patients receiving 10 mg/day Lexapro (4%) and placebo (3%). Adverse events that were associated with the discontinuation of at least 1% of patients treated with Lexapro, and for which the rate was at least twice that of placebo, were nausea (2%) and ejaculation disorder (2% of male patients).

Generalized Anxiety Disorder

Among the 429 GAD patients who received Lexapro 10-20 mg/day in placebo-controlled trials, 8% discontinued treatment due to an adverse event, as compared to 4% of 427 patients receiving placebo. Adverse events that were associated with the discontinuation of at least 1% of patients treated with Lexapro, and for which the rate was at least twice the placebo rate, were nausea (2%), insomnia (1%), and fatigue (1%).

Incidence of Adverse Events in Placebo-Controlled Clinical Trials

Major Depressive Disorder

Table 1 enumerates the incidence, rounded to the nearest percent, of treatment emergent adverse events that occurred among 715 depressed patients who received Lexapro at doses ranging from 10 to 20 mg/day in placebo-controlled trials. Events included are those occurring in 2% or more of patients treated with Lexapro and for which the incidence in patients treated with Lexapro was greater than the incidence in placebo-treated patients.

The prescriber should be aware that these figures can not be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

The most commonly observed adverse events in Lexapro patients (incidence of approximately 5% or greater and approximately twice the incidence in placebo patients) were insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, sweating increased, fatigue, and somnolence (TABLE 1).

TABLE 1 Treatment-Emergent Adverse Events: Incidence in Placebo-Controlled Clinical Trials for Major Depressive Disorder
	(Percentage of Patients Reporting Event)
Body System /	Lexapro	Placebo
Adverse Event	(N=715)	(N=592)
Autonomic Nervous System Disorders
Dry Mouth	6%	5%
Sweating Increased	5%	2%
Central & Peripheral Nervous System Disorders
Dizziness	5%	3%
Gastrointestinal Disorders
Nausea	15%	7%
Diarrhea	8%	5%
Constipation	3%	1%
Indigestion	3%	1%
Abdominal Pain	2%	1%
General
Influenza-like Symptoms	5%	4%
Fatigue	5%	2%
Psychiatric Disorders
Insomnia	9%	4%
Somnolence	6%	2%
Appetite Decreased	3%	1%
Libido Decreased	3%	1%
Respiratory System Disorders
Rhinitis	5%	4%
Sinusitis	3%	2%
Urogenital
Ejaculation Disorder	9%	<1%
Impotence	3%	<1%
Anorgasmia	2%	<1%

Generalized Anxiety Disorder

Table 2 enumerates the incidence, rounded to the nearest percent of treatment-emergent adverse events that occurred among 429 GAD patients who received Lexapro 10 to 20 mg/day in placebo-controlled trials. Events included are those occurring in 2% or more of patients treated with Lexapro and for which the incidence in patients treated with Lexapro was greater than the incidence in placebo-treated patients.

The most commonly observed adverse events in Lexapro patients (incidence of approximately 5% or greater and approximately twice the incidence in placebo patients) were nausea, ejaculation disorder (primarily ejaculatory delay), insomnia, fatigue, decreased libido, and anorgasmia (see TABLE 2).

TABLE 2 Treatment-Emergent Adverse Events: Incidence in Placebo-Controlled Clinical Trials for Generalized Anxiety Disorder
	(Percentage of Patients Reporting Event)
Body System /	Lexapro	Placebo
Adverse Event	(N=429)	(N=427)
Autonomic Nervous System Disorders
Dry Mouth	9%	5%
Sweating Increased	4%	1%
Central & Peripheral Nervous System Disorders
Headache	24%	17%
Paresthesia	2%	1%
Gastrointestinal Disorders
Nausea	18%	8%
Diarrhea	8%	6%
Constipation	5%	4%
Indigestion	3%	2%
Vomiting	3%	1%
Abdominal Pain	2%	1%
Flatulence	2%	1%
Toothache	2%	0%
General
Fatigue	8%	2%
Influenza-like Symptoms	5%	4%
Musculoskeletal
Neck/Shoulder Pain	3%	1%
Psychiatric Disorders
Somnolence	13%	7%
Insomnia	12%	6%
Libido Decreased	7%	2%
Dreaming Abnormal	3%	2%
Appetite Decreased	3%	1%
Lethargy	3%	1%
Yawning	2%	1%
Urogenital
Ejaculation Disorder	14%	2%
Anorgasmia	6%	<1%
Menstrual Disorder	2%	1%

Other Events Observed During the Premarketing Evaluation of Lexapro

Following is a list of WHO terms that reflect treatment-emergent adverse events, as defined in the introduction to the adverse reactions section, reported by the 1428 patients treated with Lexapro for periods of up to one year in double-blind or open-label clinical trials during its premarketing evaluation. All reported events are included except those already listed in Tables 1 & 2, those occurring in only one patient, event terms that are so general as to be uninformative, and those that are unlikely to be drug related. It is important to emphasize that, although the events reported occurred during treatment with Lexapro, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in less than 1/100 patients but at least 1/1000 patients.

Cardiovascular - Frequent: palpitation, hypertension. Infrequent: bradycardia, tachycardia, ECG abnormal, flushing, varicose vein.

Central and Peripheral Nervous System Disorders - Frequent: light-headed feeling, migraine. Infrequent: tremor, vertigo, restless legs, shaking, twitching, dysequilibrium, tics, carpal tunnel syndrome, muscle contractions involuntary, sluggishness, coordination abnormal, faintness, hyperreflexia, muscular tone increased. 

Gastrointestinal Disorders - Frequent: heartburn, abdominal cramp, gastroenteritis. Infrequent: gastroesophageal reflux, bloating, abdominal discomfort, dyspepsia, increased stool frequency, belching, gastritis, hemorrhoids, gagging, polyposis gastric, swallowing difficult.

General - Frequent: allergy, pain in limb, fever, hot flushes, chest pain. Infrequent: edema of extremities, chills, tightness of chest, leg pain, asthenia, syncope, malaise, anaphylaxis, fall.

Hemic and Lymphatic Disorders - Infrequent: bruise, anemia, nosebleed, hematoma, lymphadenopathy cervical.

Metabolic and Nutritional Disorders - Frequent: increased weight. Infrequent: decreased weight, hyperglycemia, thirst, bilirubin increased, hepatic enzymes increased, gout, hypercholesterolemia.

Musculoskeletal System Disorders - Frequent: arthralgia, myalgia. Infrequent: jaw stiffness, muscle cramp, muscle stiffness, arthritis, muscle weakness, back discomfort, arthropathy, jaw pain, joint stiffness.

Psychiatric Disorders - Frequent: appetite increased, lethargy, irritability, concentration impaired. Infrequent: jitteriness, panic reaction, agitation, apathy, forgetfulness, depression aggravated, nervousness, restlessness aggravated, suicide attempt, amnesia, anxiety attack, bruxism, carbohydrate craving, confusion, depersonalization, disorientation, emotional lability, feeling unreal, tremulousness nervous, crying abnormal, depression, excitability, auditory hallucination, suicidal tendency.

Reproductive Disorders/Female - Frequent: menstrual cramps, menstrual disorder. Infrequent: menorrhagia, breast neoplasm, pelvic inflammation, premenstrual syndrome, spotting between menses.

Respiratory System Disorders - Frequent: bronchitis, sinus congestion, coughing, nasal congestion, sinus headache. Infrequent: asthma, breath shortness, laryngitis, pneumonia, tracheitis.

Skin and Appendages Disorders - Frequent: rash. Infrequent: pruritus, acne, alopecia, eczema, dermatitis, dry skin, folliculitis, lipoma, furunculosis, dry lips, skin nodule. 

Special Senses - Frequent: vision blurred, tinnitus. Infrequent: taste alteration, earache, conjunctivitis, vision abnormal, dry eyes, eye irritation, visual disturbance, eye infection, pupils dilated, metallic taste.

Urinary System Disorders - Frequent: urinary frequency, urinary tract infection. Infrequent: urinary urgency, kidney stone, dysuria, blood in urine.