Generic Celexa - Citalopram

1.CELEXA HISTORY
How was Celexa discovered?

Celexa is a product of Forest Laboratories, Inc.

The FDA approved Celexa in July 1998.

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

2.CELEXA FACTS

Citalopram was originally created by the pharmaceutical company Lundbeck although the patent for it expired in 2003, allowing Forest Laboratories, Inc. to legally produce generic versions.

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, which are used for the treatment of a wide range of illnesses.


3.ABOUT CELEXA MEDICATION

Celexa contains the active ingredient citalopram, which is a type of antidepressant known as a selective serotonin re-uptake inhibitor (SSRI). This type of medicine 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. In this way, Celexa helps relieve depression, panic and fear.

Diagrammatic representation for the mechanism of action of Celexa

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 Celexa 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
  • 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 antidepressants 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 antidepressants medicine for you:

  • If you were depressed before and a certain antidepressants 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 antidepressants 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.CELEXA EFFECTIVENESS
When is Celexa best taken?

The single and multiple dose pharmacokinetics of Celexa are linear and dose-proportional in a dose range of 10-60 mg/day. Biotransformation of Celexa is mainly hepatic, with a mean terminal half-life of about 35 hours. With once daily dosing, steady state plasma concentrations are achieved within approximately one week. At steady state, the extent of accumulation of Celexa in plasma, based on the half-life, is expected to be 2.5 times the plasma concentrations observed after a single dose.

Absorption and Distribution

Following a single oral dose of Celexa , peak blood levels occur at about 4 hours. The absolute bioavailability of Celexa was about 80% relative to an intravenous dose and absorption is not affected by food. The volume of distribution of Celexa is about 12 L/kg and the binding of citalopram (CT), demethylcitalopram (DCT) and didemethylcitalopram (DDCT) to human plasma proteins is about 80%.

Metabolism and Elimination

Following intravenous administrations of Celexa, the fraction of drug recovered in the urine as citalopram and DCT was about 10% and 5%, respectively. The systemic clearance of citalopram was 330 mL/min, with approximately 20% of that due to renal clearance.

Citalopram is metabolized to demethylcitalopram (DCT), didemethylcitalopram (DDCT), citalopram-N-oxide and a deaminated propionic acid derivative. In humans, unchanged citalopram is the predominant compound in plasma. At steady state, the concentrations of citalopram's metabolites, DCT and DDCT, in plasma are approximately one-half and one-tenth, respectively, that of the parent drug. In vitro studies show that citalopram is at least 8 times more potent than its metabolites in the inhibition of serotonin reuptake, suggesting that the metabolites evaluated do not likely contribute significantly to the antidepressant actions of citalopram.

5.CELEXA EFFECTS ON SPECIAL POPULATION
How do different people react to Celexa?

Labor and Delivery
The effect of Celexa on labor and delivery in humans is unknown.
Nursing Mothers

Celexa 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 Celexa therapy should take into account the risks of citalopram exposure for the infant and the benefits of Celexa treatment for the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Of 4422 patients in clinical studies of Celexa, 1357 were 60 and over, 1034 were 65 and over, and 457 were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Most elderly patients treated with Celexa in clinical trials received daily doses between 20 and 40 mg.

6.CELEXA EFFECTS ON MEDICAL CONDITIONS
How does Celexa affect your existing condition/ailment?)

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

Celexa should not be used if you have a history of bleeding disorders or mania/hypomania.


7.OTHER/ALTERNATE USES OF CELEXA

What else does Celexa treat?

Celexa 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. Celexa is also used in the treatment of bulimia (binge-eating followed by deliberate vomiting). Celexa has also been used to treat other eating disorders and obesity.

8.ADVERSE/SIDE EFFECTS of CELEXA
What are the side effects of Celexa?

The commonly observed adverse events in Placebo-Controlled Studies

Treatment-Emergent Adverse Events:
Incidence in Placebo-Controlled Clinical Trials

Body System/Adverse Event

(Percentage of Patients Reporting Event)

 

Celexa
(N=1063)

Placebo
(N=446)

Autonomic Nervous System Disorders

   Dry Mouth

20%

14%

   Sweating Increased

11%

  9%

Central & Peripheral Nervous System Disorders

   Tremor

  8%

  6%

Gastrointestinal Disorders

   Nausea

21%

14%

   Diarrhea

  8%

  5%

   Dyspepsia

  5%

  4%

   Vomiting

  4%

  3%

   Abdominal Pain

  3%

  2%

General

   Fatigue

  5%

  3%

   Fever

  2%

<1%

Musculoskeletal System Disorders

   Arthralgia

  2%

  1%

   Myalgia

  2%

  1%

Psychiatric Disorders

   Somnolence

18%

10%

   Insomnia

15%

14%

   Anxiety

  4%

  3%

   Anorexia

  4%

  2%

   Agitation

  3%

  1%

   Dysmenorrhea

  3%

  2%

   Libido Decreased

  2%

<1%

   Yawning

  2%

<1%

Respiratory System Disorders

   Upper Respiratory Tract Infection

  5%

  4%

   Rhinitis

  5%

  3%

   Sinusitis

  3%

<1%

Urogenital

   Ejaculation Disorder

  6%

  1%

   Impotence

  3%

<1%

Other side effects may include

Cardiovascular

  • Frequent : tachycardia, postural hypotension, hypotension.
  • Infrequent : hypertension, bradycardia, edema (extremities), angina pectoris, extrasystoles, cardiac failure, flushing, myocardial infarction, cerebrovascular accident, myocardial ischemia.
  • Rare : transient ischemic attack, phlebitis, atrial fibrillation, cardiac arrest, bundle branch block.

Central and Peripheral Nervous System Disorders

  • Frequent : paresthesia, migraine.
  • Infrequent : hyperkinesia, vertigo, hypertonia, extrapyramidal disorder, leg cramps, involuntary muscle contractions, hypokinesia, neuralgia, dystonia, abnormal gait, hypesthesia, ataxia.
  • Rare : abnormal coordination, hyperesthesia, ptosis, stupor.

Endocrine Disorders

  • Rare : hypothyroidism, goiter, gynecomastia.

Gastrointestinal Disorders

  • Frequent: saliva increased, flatulence.
  • Infrequent : gastritis, gastroenteritis, stomatitis, eructation, hemorrhoids, dysphagia, teeth grinding, gingivitis, esophagitis.
  • Rare : colitis, gastric ulcer, cholecystitis, cholelithiasis, duodenal ulcer, gastroesophageal reflux, glossitis, jaundice, diverticulitis, rectal hemorrhage, hiccups.

General

  • Infrequent : hot flushes, rigors, alcohol intolerance, syncope, influenza-like symptoms.
  • Rare : hayfever.

Hemic and Lymphatic Disorders

•  Infrequent : purpura, anemia, epistaxis, leukocytosis, leucopenia, lymphadenopathy.

  • Rare : pulmonary embolism, granulocytopenia, lymphocytosis, lymphopenia, hypochromic anemia, coagulation disorder, gingival bleeding.

Metabolic and Nutritional Disorders

  • Frequent : decreased weight, increased weight.
  • Infrequent : increased hepatic enzymes, thirst, dry eyes, increased alkaline phosphatase, and abnormal glucose tolerance.
  • Rare : bilirubinemia, hypokalaemia, obesity, hypoglycemia, hepatitis, dehydration.

Musculoskeletal System Disorders

Psychiatric Disorders

  • Frequent : impaired concentration, amnesia, apathy, depression, increased appetite, aggravated depression, suicide attempt, and confusion.
  • Infrequent : increased libido, aggressive reaction, paroniria, drug dependence, depersonalization, hallucination, euphoria, psychotic depression, delusion, paranoid reaction, emotional lability, panic reaction, psychosis.
  • Rare : catatonic reaction, melancholia.

Reproductive Disorders in Female

  • Frequent : amenorrhea.
  • Infrequent : galactorrhea, breast pain, breast enlargement, and vaginal hemorrhage.

Respiratory System Disorders

  • Frequent : coughing.
  • Infrequent : bronchitis, dyspnea, and pneumonia.
  • Rare : asthma, laryngitis, bronchospasm, and pneumonitis, sputum increased.

Skin and Appendages Disorders

  • Frequent : rash, pruritus.
  • Infrequent : photosensitivity reaction, urticaria, acne, skin discoloration, eczema, alopecia, dermatitis, skin dry, and psoriasis.
  • Rare : hypertrichosis, decreased sweating, melanosis, keratitis, cellulitis, pruritus ani.

Special Senses

  • Frequent : accommodation abnormal, taste perversion.
  • Infrequent : tinnitus, conjunctivitis, and eye pain.
  • Rare : mydriasis, photophobia, diplopia, abnormal lacrimation, and cataract, taste loss.

Urinary System Disorders

  • Frequent : polyuria.
  • Infrequent : micturition frequency, urinary incontinence, urinary retention, dysuria.
Rare : facial edema, hematuria, oliguria, pyelonephritis, renal calculus, and renal pain.