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The physician’s psychoactive medication resource guide
25% of your patients taking an antidepressant will have
weight gain and the weight gain is directly caused by the antidepressant.
Brand Name (Celexa)
Celexa withdrawal. Celexa withdrawal side effects, Celexa withdrawal warnings, Celexa withdrawal
precautions, Celexa withdrawal adverse effects, overdose, withdrawal symptoms and Celexa natural
alternatives. Before you begin the spiral down with Celexa, try giving your body what it really wants.
While taking Celexa or discontinuing Celexa several adverse reactions occur. They can range from
anxiety/insomnia to fatigue and debilitating head symptoms. The book How to Get Off Psychiatric
Drugs safely by James Harper N.C. describes in detail what to do for your patients. Your patients will
also be able to take the step-by-step instructions found in this book and put them to use instantly.
This book is written for physicians, pharmacists and patients. You can click here and get the book
Whether you want your patient to remain on Celexa or discontinue Celexa, getting relief from the
adverse drug reactions is essential. How to Get Off Psychiatric Celexa Safely has the answers.
Celexa Withdrawal and Celexa Side Effects.
SSRI Antidepressants May Up Stroke Risk After Menopause
Date Published: Thursday, December 17th, 2009
Post-menopausal women taking selective serotonin reuptake inhibitor (SSRI) antidepressants have a
small, though statistically higher risk of stroke, according to a newly published study. SSRIs include
the drugs Prozac, Paxil, Zoloft, Lexapro, and Celexa.
Antidepressant use in the US has more than quintupled since the early 1990s, and SSRIs have
replaced older medications called tricyclic antidepressants, which can be toxic the heart. According
to a press release announcing this latest study, SSRI antidepressants have fewer side effects in
general and are known to have aspirin-like effects on bleeding, which could protect against clot-
related cardiovascular disorders. But not much is known about how SSRIs affect the heart. This is
especially true in the case of postmenopausal women, who are at increased risk for both heart
disease and depression.
The study, which was published in the December 14 Archives of Internal Medicine, involved 136,000
participants in the Women’s Health Initiative (WHI). None of the women were taking antidepressants
when they enrolled in the WHI.
The women included in the analysis had their first follow-up visit either one or three years after
enrolling in WHI. At that time, 5,500 women reported taking either tricyclic or SSRI antidepressants.
After six years, there was no association between antidepressant use and heart disease. However,
researchers did find that women taking SSRIs had a 45 percent increase in risk of stroke and a 32
percent increase in risk of dying from any cause during follow up, compared with nonusers. Use of
older tricyclic antidepressants wasn’t linked to stroke, but it did increase by 67 percent the risk of
death during follow-up.
The authors of the study said it wasn’t clear if the increased risk was the result of antidepressants or
depression itself. Depression is a known risk factor for cardiovascular problems.
“There are a lot of things this study couldn’t tell us, such as whether this risk truly is attributable to
the drugs and not to depression itself and whether participants were being treated for depression or
for anxiety, which also has cardiovascular risks,” Jordan W. Smoller, MD, ScD, of the Massachusetts
General Hospital (MGH) Department of Psychiatry, the study’s lead author, said in a press release.
“We also don’t know whether there is any similar association in younger women or in men, since they
were not part of this study.” The authors of the study called for more research into the relationship
between antidepressants and death.
Celexa - Alert from the F.D.A.
FDA ALERT [07/2005]: Suicidal Thoughts or Actions in Children and Adults
Patients with depression or other mental illnesses often think about or attempt suicide. Closely watch anyone taking antidepressants,
especially early in treatment or when the dose is changed. Patients who become irritable or anxious, or have new or increased thoughts
of suicide or other changes in mood or behavior (or their care givers) should contact their healthcare professional right away.
Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50 people 18 years or younger. FDA has approved
Zoloft for use in children only if they have obsessive-compulsive disorder.
Several recent scientific publications report the possibility of an increased risk for suicidal behavior in adults who are being treated with
antidepressant medications. Even before these reports became available, FDA began a complete review of all available data to
determine whether there is an increased risk of suicidal thinking or behavior in adults being treated with antidepressant medications. It is
expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that adults being treated with
antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and
for increased suicidal thinking or behavior.
TAction and Clinical Pharmacology
Citalopram hydrobromide is a highly selective and potent serotonin (5-hydroxytryptamine 5-HT) reuptake inhibitor with minimal effects
on the neuronal reuptake of norepinephrine (NE) and dopamine (DA). The ability
of citalopram to potentiate serotonergic activity in the central nervous system via inhibition of the neuronal reuptake of serotonin is
thought to be responsible for its antidepressant action. Tolerance to the inhibition of serotonin reuptake is not induced by long term (14
days) treatment of rats with citalopram.
Citalopram has no or very low affinity for a series of receptors including serotonin 5-HT
, dopamine D
, and D
adrenergic, histamine H
, muscarinic cholinergic, benzodiazepine, gamma aminobutyric acid (GABA) and opioid receptors.
Following the administration of a single oral dose of citalopram (40 mg) to healthy male volunteers, peak blood levels occurred at about
4 hours (range 1 to 6 hours). The absolute bioavailability of citalopram was about 80% (range 52 to 93%) relative to an intravenous
dose. Absorption was not affected by food.
After intravenous infusion in healthy male volunteers the apparent volume of distribution (V
)b was about 12 L/kg (range 9-17 L/kg),
indicating a pronounced tissue distribution: (V
)b oral was about 17 L/kg (range 14-17 L/kg). The binding of citalopram and its
demethylated metabolites to human plasma proteins is about 80%.
The single- and multiple dose pharmacokinetics of citalopram are linear and dose proportional in a dose range of 10 to 60 mg/day.
Steady-state plasma levels are achieved in patients in 1-2 weeks. At a daily dose of 40 mg, the average plasma concentration is about
83 ng/mL (n=114) with a range from 30 to 200 ng/mL. Citalopram does not accumulate during long term treatment. A clear relationship
between citalopram plasma levels and therapeutic response or side effects has not been established.
Citalopram is metabolized in the liver to demethylcitalopram (DCT), didemethylcitalopram (DDCT), citalopram N-oxide and a deaninated
propionic acid derivative. In vitro studies show that DCT, DDCT and citalopram-N-oxide also inhibit the neuronal reuptake of serotonin
but are less selective and less potent than the parent compound and are of minor clinical importance. Unchanged citalopram is the
predominant compound in plasma. In vitro studies indicated that the biotransformation of citalopram to its demethyl metabolites depends
on both CYP2C19 and CYP3A4, with a small contribution from CYP2D6.
The elimination half life of citalopram (t
) is approximately 37 hours (range 30-42 hours) which allows recommendation of once-daily
dosing. The systemic citalopram plasma clearance (Cl
) is 0.33 L/min. Citalopram is eliminated primarily via the liver (85%) and the
remainder via the kidneys; approximately 12% (range 6-21%) of the daily dose is excreted in urine as unchanged citalopram.
Elderly patients (4 males and 7 females aged 73-90 years), received a 20 mg/day dose of citalopram for 3-4 weeks. In the elderly,
steady state plasma levels were elevated (106 ng/mL), half-life prolonged (1.5-3.75 days) and clearance decreased (0.08-0.3 L/min).
Elevation of citalopram plasma levels occurred at an earlier age in females than in males, In this population, lower doses and a lower
maximum dose of citalopram are recommended.
Reduced Hepatic Function
The pharmacokinetics of citalopram were compared in patients with reduced hepatic function (3 female and 6 male patients aged 41-60
years) to those seen in 12 healthy male volunteers (aged 21-43 years), In patients with reduced hepatic function the half-life of
citalopram was approximately doubled (83 hours versus 37 hours), steady state citalopram concentrations increased by 61% and oral
clearance decreased by 37%. Consequently the use of citalopram in patients with reduced hepatic function should be approached with
caution and lower maximal doses should be prescribed (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).
Reduced Renal Function
In patients with mild to moderate reduction of the renal function (4 females and 3 males, aged 30-55 years), citalopram was being
eliminated more slowly than in 12 healthy male volunteers (aged 21-43 years), half-lives being 49 hours versus 37 hours. However, mild
to moderate renal impairment had no major influence on the kinetics of citalopram. At present, no information is available for chronic
treatment of patients with severely reduced renal function (creatinine clearance <20 mL/min).
Indications and Clinical Use
Citalopram hydrobromide is indicated for the symptomatic relief of depressive illness.
The relapse rate was significantly lower in citalopram-treated patients than in placebo-treated patients in two placebo-controlled studies,
that were conducted over a 24-week period in patients who responded to 6 or 8 weeks of acute treatment with citalopram (see
CLINICAL TRIALS under ACTION AND CLINICAL PHARMACOLOGY.) Nevertheless, the physician who elects to use citalopram for
extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
Citalopram hydrobromide is contraindicated in patients with known hypersensitivity to citalopram hydrobromide or the excipients of the
Monoamine Oxidase Inhibitors
In patients, receiving selective serotonin reuptake inhibitors (SSRIs) in combination with a monoamine oxidase inhibitor (MAOI), there
have been reports of serious, sometimes fatal, reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible
rapid fluctuations of vital signs, and mental status changes, including extreme agitation progressing to delirium and coma. These
reactions have also been reported in patients who have recently discontinued SSRI treatment and have been started on a MAOI. Some
cases presented with features resembling serotonin syndrome. Therefore, it is recommended that citalopram should not be used in
combination with a MAOI or within 14 days of discontinuing treatment with a MAOI. Similarly, at least 14 days should elapse after
discontinuing citalopram treatment before starting a MAOI.
The possibility of a suicide attempt is inherent in depression and may persist until remission occurs. Therefore, high risk patients should
be closely supervised throughout therapy with Citalopram hydrobromide and consideration should be given to the possible need for
hospitalization. In order to minimize the opportunity for overdosage, prescription for citalopram should be written for the smallest quantity
of drug consistent with good patient management.
Activation of Mania/Hypomania
In placebo-controlled trials with citalopram, some of which included patients with bipolar disorder, mania/hypomania was reported in
0.1% of 1027 patents treated with citalopram versus none of the 426 patients treated with placebo. Activation of mania/hypomania has
also been reported in a small proportion of patients with major affective disorders treated with other marketed antidepressants. If a
patient enters a manic phase, citalopram should be discontinued.
Citalopram has not been systematically evaluated in patients with a seizure disorder. These patients were excluded from clinical studies
during the premarketing testing of citalopram. In clinical trials, seizures occurred in 0.25% of patients treated with citalopram and in
0.23% patients treated with placebo. Like other antidepressants, citalopram should be used with caution in patients with a history of
Rarely, the occurrence of serotonin syndrome has been reported in patients receiving SSRIs. A combination of symptoms, possibly
including agitation, confusion, tremor, myoclonus and hyperthermia, may indicate the development of this condition.
There have been rare postmarketing reports describing patients with weakness, hyperreflexia and incoordination, following the
concomitant use of a SSRI and the antimigraine drug sumatriptan, a 5-HT
agonist. Such interaction should be considered if citalopram
is to be used in combination with a 5-HT
Hyponatremia and SIADH (syndrome of inappropriate antidiuretic hormone secretion) have been reported with citalopram use as a rare
Pregnancy and Nursing Mothers
The safety of citalopram during pregnancy and lactation has not been established. Therefore, citalopram should not be used during
pregnancy, unless, in the opinion of the physician, the expected benefits to the patient markedly outweigh the possible hazards to the
fetus. Citalopram is excreted in human milk. Citalopram should not be administered to nursing mothers unless, in the opinion of the
treating physician, the expected benefits to the patient markedly outweigh the possible hazards to the child.
Safety and effectiveness in patients below the age of 18 have not been established.
In premarketing clinical trials, 800 elderly patients (>=65 years of age) have been treated with citalopram. Of these patients 298 were
>=75 years old. In a pharmacokinetic study (n=11, age 73 to 90 years), clearance was substantially decreased and half-life prolonged
(see PHARMACOKINETICS). In a 6-week placebo-controlled study, approximately equal numbers of patients received citalopram at 20
or 30 mg per day, as the final dose. In about 5% of patients, the final dose was 10 mg per day (see CLINICAL TRIALS). Consequently,
elderly patients should be administered lower doses and a lower maximum dose.
Citalopram clearance was significantly decreased and plasma concentrations, as well as elimination half-life significantly increased (see
PHARMACOKINETICS). Consequently, the use of citalopram in hepatically impaired patients should be approached with caution and a
lower maximum dosage is recommended.
No dosage adjustment is needed in patients with mild to moderate renal impairment. To date, no information is available on the
pharmacokinetic or pharmacodynamic effects of citalopram in patients with severely reduced renal function (creatinine clearance <20
Use in Patients with Cardiac Disease
Citalopram has not been systematically evaluated in patients with a recent history of myocardial infarction or unstable heart disease.
Patients with these diagnoses were generally excluded from clinical trials during the drugs premarketing assessment. However, the
electrocardiograms of patients, who received citalopram in clinical trials, indicate that citalopram was not associated with the
development of clinically significant ECG abnormalities.
In clinical trials, citalopram caused small but statistically significant decreases in heart rate (see ECG under ADVERSE REACTIONS)
Consequently, caution should be observed when citalopram is initiated in patients with pre-existing slow heart rate.
Use in Diabetic Patients
Citalopram has not been systematically evaluated in diabetic patients since diabetes constituted an exclusion criterion. Although 13
patients did receive insulin during the studies, this number is too small to determine whether citalopram affects the response to insulin.
Rare events of hypoglycemia were reported. Citalopram should be used with caution in diabetic patients on insulin or other antidiabetic
Interference with Cognitive and Motor Performance
In studies in normal volunteers, citalopram in doses of 40 mg/day did not impair cognitive function or psychomotor performance.
However, psychotropic medications may impair judgement, thinking or motor skills. Consequently, patients should be cautioned against
driving a car or operating hazardous machinery until they are reasonably certain that citalopram does not affect them adversely.
Electroconvulsive Therapy (ECT)
The safety and efficacy of the concurrent use of citalopram and ECT have not been studied.
After 8 weeks of treatment with citalopram, abrupt discontinuation of treatment caused a higher incidence of anxiety, emotional
indifference, impaired concentration, headache, migraine, paresthesia, and tremor than was seen in patients who continued on
citalopram. These symptoms are not indicative of addiction.
Although it is not known whether gradual discontinuation will prevent the discontinuation symptoms, it is recommended that the dosage
of citalopram should be tapered off over 1 to 2 weeks.
Additional Adverse Events Observed During the Premarketing Evaluation of Citalopram
The events listed below include all adverse events that were reported in the overall development program of citalopram (n=3652). All
reported events are included except those already listed in Table 1 and those events which occurred in only one patient. It is important
to emphasize that, although the events reported occurred during treatment with citalopram, they were not necessarily caused by it. The
events are enumerated using the following criteria: frequent: adverse events that occurred on one or more occasions in at least 1/100
patients; infrequent: adverse events that occurred in less than 1/100 patients but at least in 1/1000 patients; rare: adverse events that
occurred in fewer than 1/1000 patients.
Body as a Whole - General Disorders
Frequent: Influenza-like symptoms, nonpathological trauma, pain. Infrequent: Alcohol intolerance, allergic reaction, allergy, chest pain,
edema, hot flushes, leg pain, malaise. rigors, syncope. Rare: Peripheral edema, sudden death, traumatic injury.
Frequent: Postural hypotension, tachycardia. Infrequent: Angina pectoris, arrhythmia. bradycardia, cardiac failure, cerebrovascular
disorders, edema dependent, extrasystoles, flushing, hypertension, hypotension, myocardial infarction, myocardial ischemia, peripheral
ischemia. Rare: Aggravated hypertension, bundle branch block, cardiac arrest, coronary artery disorder, ECG abnormal, heart disorder,
phlebitis, supraventricular extrasystoles.
Central and Peripheral Nervous System Disorders
Frequent: Migraine, paraesthesia. Infrequent: Abnormal gait, ataxia, convulsions, dysphonia, dystonia, extrapyramidal disorder,
hyperkinesia, hypertonia, hypoesthesia, hypokinesia, involuntary muscle contractions, leg cramps, neuralgia, speech disorder, vertigo
Rare: Abnormal coordination, convulsions grand mal, hyperesthesia, ptosis, sensory disturbance, stupor.
Rare: Rheumatoid arthritis.
Rare: Goiter, gynecomastia, hypothyroidism.
Gastrointestinal System Disorders
Frequent: Flatulence. Infrequent: Colitis, dental abscess, dysphagia, eructation, gastritis, gastroenteritis, gastrointestinal disorder (not
specified), hemorrhoids, increased saliva, teeth-grinding, toothache. Rare: Appendicitis, esophagitis, gastric ulcer, gastroesophageal
reflux, gingivitis, stomatitis, tooth disorder, ulcerative stomatitis.
Hematopoietic and Lymphatic Disorders
Infrequent: Anemia, epistaxis, leukocytosis, purpura. Rare: Coagulation disorder, gingival bleeding, granuloytopenia, hematoma,
leukopenia, lymphadenopathy, lymphocytosis, pulmonary embolism.
Liver and Biliary System Disorders.
Infrequent: Cholecystitis, cholelithiasis, increased gamma-GT, increased SGPT. Rare: Bilirubinemia, increased SGOT, jaundice.
Metabolic and Nutritional Disorders
Frequent: Weight decrease, weight increase. Infrequent: Leg edema, xerophthalmia. Rare: Dehydration, edema, hypoglycemia,
hypokalemia, increased alkaline phosphatase, obesity, thirst.
Musculo-Skeletal System Disorders
Infrequent: Arthralgia, arthritis, arthrosis, dystonia, muscle weakness, myalgia. Rare: Bone disorder, bursitis, osteoporosis, tendon
Rare: Breast neoplasm malignant female.
Frequent: Abnormal dreaming, aggravated depression, amnesia, apathy, confusion, depression, impaired concentration, increased
appetite, sleep disorder, suicide attempt. Infrequent: Abnormal thinking, aggressive reaction, delusion, depersonalization, drug abuse,
drug dependence, emotional lability, euphoria, hallucination, increased libido, manic reaction, neurosis, paranoid reaction, paroniria,
psychosis, psychotic depression. Rare: Catatonic reaction, hysteria, personality disorder.
Reproductive Disorders, Female
Infrequent: Amenorrhea, breast pain, lactation nonpuerperal, menorrhagia, menstrual disorder, premenstrual syndrome, salpingitis,
unintended pregnancy, vaginal dryness, vaginitis. Rare: Breast enlargement, vaginal hemorrhage.
Reproductive Disorders, Male
Infrequent: Penis disorder, prostatic disorder, testis disorder.
Resistance Mechanism Disorders
Infrequent: Abscess, fungal infection, herpes simplex infection, otitis media, viral infection. Rare: Bacterial infection, moniliasis, sepsis.
Respiratory System Disorders
Infrequent: Bronchitis, coughing, dyspnea, pneumonia. Rare: Asthma, bronchospasm, increased sputum, laryngitis, pneumonitis,
Skin and Appendage Disorders
Frequent: Pruritus, rash. Infrequent: Acne, alopecia, dermatitis, dry skin, eczema, photosensitivity reaction, psoriasis, rash
erythematous, rash maculo-papular, skin discoloration, urticaria. Rare: Cellulitis, decreased sweating, hypertrichosis, melanosis, pruritus
Special Senses, Vision, Hearing and Vestibular Disorders
Frequent: Abnormal accommodation. Infrequent: Conjunctivitis, earache, eye pain, mydriasis, taste perversion, tinnitus. Rare: Eye
abnormality, keratitis, photophobia.
Urinary System Disorders
Frequent: Polyuria. Infrequent: Abnormal urine, cystitis, hematuria, micturition frequency, urinary incontinence, urinary retention, urinary
tract infection. Rare: Dysuria, facial edema, oliguria, renal calculus, renal pain.
Events Observed During the Post-Marketing Evaluation of Citalopram
It is estimated that approximately 8 million patients have been treated with citalopram since market introduction. The following adverse
events have been reported to be temporarily associated with citalopram treatment in at least 3 patients and are not described elsewhere
Abnormal hepatic function, aggravated condition, aggravated migraine, angioedema, asthma, choreoathetosis, decreased drug level,
decreased prothrombin time, dyskinesia, eosinophilia, erythema multiforms, gynecological problems, hepatitis, hyperprolactinemia,
hyponatremia, increased drug level, increased prothrombin time, mydriasis, neuroleptic malignant syndrome, neuropathy, pancreatitis,
pancytopenia, postural hypotension, serotonin syndrome, SIADH, spontaneous abortion/fetal death, thrombocytopenia, ventricular
arrhythmia, Torsade de pointes, withdrawal syndrome.