Citalopram (Systemic)


VA CLASSIFICATION
Primary: CN603

Commonly used brand name(s): Celexa.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antidepressant—

Indications

Accepted

Depressive disorder, major (treatment)—Citalopram is indicated for the treatment of depression {01}{06}. Maintenance of antidepressant response for 24 weeks following 6 to 8 weeks of acute treatment was demonstrated in two placebo-controlled trials {01}{06}. Treatment of acute depressive episodes typically requires 6 to 12 months of antidepressant therapy, and patients with recurrent or chronic depression may require long-term treatment {03}.


Pharmacology/Pharmacokinetics

Physicochemical characteristics:

Chemical group—
    Citalopram is a racemic, bicyclic phthalane derivative, chemically unrelated to other selective serotonin reuptake inhibitors {01}.
Molecular weight—
    Citalopram base: 324.4 {02}
    Citalopram hydrobromide: 405.35 {01}

Solubility
    Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol {01}.

Mechanism of action/Effect:

The antidepressant effect of citalopram is presumed to be linked to specific serotonin (5-hydroxytryptamine [5-HT]) reuptake inhibition {01}. Citalopram, primarily through its (S)-enantiomer, blocks 5-HT reuptake, leading to potentiation of serotonergic activity in the central nervous system {01}. Neuronal uptake of norepinephrine and dopamine is minimally affected {01}. Citalopram has little or no affinity for serotonin 5-HT 1A or 5-HT 2A; dopamine D 1 or D 2; adrenergic alpha 1, alpha 2, or beta; histamine H 1; gamma aminobutyric acid (GABA); muscarinic cholinergic; or benzodiazepine receptors {01}{06}.


Other actions/effects:

One of the metabolites of citalopram, didemethylcitalopram (DDCT), was found to cause QT interval prolongation in beagle dogs at plasma concentrations many times higher than those seen in humans receiving citalopram at the maximum recommended human dose (MRHD) {01}. However, it is not known whether an individual patient might achieve higher-than-usual DDCT concentrations {01}. The significance of this finding to humans is unknown {01}.

Absorption:

Absolute bioavailability of an oral dose of citalopram as compared to an intravenous dose is about 80% and is not affected by food {01}{06}.

Distribution:

Vol D—About 12 liters per kg of body weight (L/kg){01}; range, 9 to 17 L/kg{06}. Citalopram is distributed into human breast milk {01}.

Protein binding:

High (approximately 80%) to plasma proteins {01}{06}.

Biotransformation:

Hepatic metabolism, primarily involving the cytochrome P450 3A4 (CYP3A4) and 2C19 (CYP2C19) isoenzymes and to a small extent, the cytochrome P450 2D6 (CYP2D6) isoenzyme, produces several metabolites. These metabolites inhibit the reuptake of serotonin with less potency and are present in the plasma at lower concentrations than the parent compound. Therefore, they are not thought to add significantly to the antidepressant effects of citalopram. {01}

Half-life:

Elimination—Terminal half-life is about 35 to 37 hours {01}{06}.

Onset of action:

1 to 4 weeks {01}.

Time to peak concentration:

About 4 hours (range, 1 to 6 hours){01}{06}.

Time to steady-state concentration

About 1 week with once-a-day dosing {01}.

Plasma concentration

Citalopram exhibits linear pharmacokinetics in a dosage range of 10 to 60 mg/day, and steady-state plasma concentrations are expected to be about 2.5 times single-dose plasma concentrations {01}. The parent compound is the predominant form in plasma {01}.

Elimination:
    Systemic clearance of citalopram was 330 mL per minute (mL/min), with approximately 20% due to renal clearance, after intravenous administration {01}. About 10% to 12% of the administered dose was recovered in the urine unchanged {01}{06}.
    Oral clearance of citalopram was reduced by 37% and 17% in patients with hepatic function impairment and mild to moderate renal function impairment, respectively {01}.


Precautions to Consider

Carcinogenicity

An increased incidence of small intestine carcinomas was found in rats receiving citalopram doses equal to approximately 1.3 and 4 times the maximum recommended human dose (MRHD) on a mg per square meter of body surface area (mg/m 2) basis for 24 months {01}. No evidence of carcinogenicity was seen in mice receiving citalopram doses equal to up to 20 times the MRHD on a mg/m 2 basis {01}.

Mutagenicity

Citalopram was mutagenic in two of five bacterial strains in the in vitro bacterial reverse mutation assay (Ames test) without metabolic activation and was clastogenic in the in vitro Chinese hamster lung cell assay for chromosomal aberrations with and without metabolic activation {01}. Citalopram was not mutagenic in the in vitro mammalian forward gene mutation assay in mouse lymphoma cells or in a coupled in vitro/in vivo unscheduled DNA synthesis assay in rat liver {01}. Citalopram was not clastogenic in two in vivo mouse micronucleus assays or in the in vitro chromosomal aberration assay in human lymphocytes {01}.

Pregnancy/Reproduction
Fertility—
Male and female rats administered citalopram orally prior to and throughout mating and gestation showed decreased mating activity {01}. Also, at doses of five times the MRHD on a mg/m 2 basis and greater, fertility was decreased, and at doses of eight times the MRHD on a mg/m 2 basis, gestation was prolonged {01}.

Pregnancy—
Adequate and well-controlled studies have not been done in humans {01}.

Administration of citalopram to pregnant rats during the period of organogenesis at a dosage of approximately 18 times the MRHD on a mg/m 2 basis resulted in decreased fetal growth and survival, fetal abnormalities, including cardiovascular and skeletal defects, and maternal toxicity. No adverse developmental effects were seen in the offspring of rats and rabbits administered citalopram at dosages of up to approximately nine and five times, respectively, the MRHD on a mg/m 2 basis. Administration of citalopram to pregnant rats from late gestation through weaning at a dosage of approximately five times the MRHD on a mg/m 2 basis or throughout gestation and early lactation at a dosage of approximately four times the MRHD on a mg/m 2 basis resulted in increased offspring mortality during the first 4 days after birth and persistent offspring growth retardation. {01}

FDA Pregnancy Category C {01}.


Labor and delivery—

The effect of citalopram on labor and delivery in humans is unknown {01}.

Breast-feeding

Citalopram is distributed into human breast milk {01}{06}. Excessive somnolence, decreased feeding, and weight loss have been reported in two nursing infants whose mothers were taking citalopram {01}. When one of the mothers discontinued citalopram, the infant recovered completely {01}.

Pediatrics

No information is available on the relationship of age to the effects of citalopram in pediatric patients. Safety and efficacy have not been established {01}{06}.


Geriatrics


No differences in safety or efficacy were seen between elderly and younger subjects in studies that included geriatric patients {01}. However, the area under the plasma concentration–time curve (AUC) and half-life of citalopram are increased in elderly patients {01}. The recommended dosage for elderly patients is lower than that for younger patients {01}{06}.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: In vitro studies indicate that the primary isoenzymes involved in citalopram metabolism are cytochrome P450 3A4 (CYP3A4) and 2D19 (CYP2C{08}19) {01}. Interactions with medications that inhibit CYP3A4, such as ketoconazole, itraconazole, fluconazole, and erythromycin, or with medications that inhibit CYP2C{08}19, such as omeprazole, should be considered {01}.
Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Alcohol    (although studies indicate that the cognitive and motor effects of alcohol are not potentiated by citalopram, concurrent use is not recommended {01}{06})


Antidepressants, tricyclic (TCAs)    (in subjects taking 40 mg per day of citalopram, the plasma concentration of desipramine, the active metabolite of imipramine, was increased by 50% after administration of a single 100-mg dose of imipramine; there was no effect on imipramine or citalopram concentration {01})


Carbamazepine    (although a short-term pharmacokinetic study showed no changes in plasma concentrations of carbamazepine or citalopram during concurrent use, the long-term enzyme-inducing effect of carbamazepine could lead to increased clearance of citalopram {01})


Cimetidine    (AUC and maximum plasma concentration of citalopram were increased by 41% to 43% and 39%, respectively, by concomitant cimetidine use {01}{06})


Metoprolol    (plasma concentrations of metoprolol were increased twofold by concomitant citalopram use; however, no clinically significant effects on heart rate or blood pressure were seen {01}{06})


» Monoamine oxidase (MAO) inhibitors, including furazolidone, procarbazine, and selegiline    (serious and sometimes fatal reactions have occurred in patients receiving a serotonin reuptake inhibitor with an MAO inhibitor; reactions have included hyperthermia, rigidity, myoclonus, autonomic instability with rapid fluctuation of vital signs, and mental status changes including extreme agitation progressing to delirium and coma; some cases presented with features resembling neuroleptic malignant syndrome [NMS]; concurrent use of an MAO inhibitor and citalopram is contraindicated; at least 14 days should elapse between discontinuation of one medication [MAO inhibitor or citalopram] and the initiation of the other {01}{06})


» Serotonergics or other medications or substances with serotonergic activity (see Appendix II )    (increased risk of developing the serotonin syndrome, a rare but potentially fatal hyperserotonergic state that may occur in patients receiving serotonergic medications such as citalopram, usually in combination; symptoms typically occur shortly [hours to days] after the addition of a serotonergic agent to a regimen that includes other serotonin-enhancing drugs or after an increase in dosage of a serotonergic agent; symptoms include agitation, diaphoresis, diarrhea, fever, hyperreflexia, incoordination, mental status changes [confusion, hypomania], myoclonus, shivering, or tremor {04}{06})


Warfarin    (although citalopram did not alter warfarin pharmacokinetics in one study, prothrombin time was increased by 5% {01})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Diabetic patients    (rare occurrences of hypoglycemia have been reported in diabetic patients receiving citalopram{06})


Drug abuse or dependence, or history of    (patients with a history of drug abuse should be observed closely for signs of misuse or abuse, as with any new central nervous system [CNS] agent {01})


» Hepatic function impairment    (citalopram clearance is reduced; cautious dosage titration and a lower maximum dosage are recommended {01}{06})


Mania or hypomania, history of    (condition may be re-activated {01})


Renal function impairment, severe    (although citalopram clearance was reduced to a clinically insignificant extent in patients with mild to moderate renal function impairment, there is no experience in patients with severe impairment; caution is recommended in these patients {01}{06})


Seizure disorders, history of    (as with all antidepressants, citalopram should be introduced with caution in patients with a history of seizures {01}{06})


Sensitivity to citalopram{06}

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Careful supervision of patients with suicidal tendencies    (recommended especially during early treatment phase before peak effectiveness of citalopram is achieved; providing the patient with immediate access to the smallest total amount of medication necessary for good patient management is recommended to decrease the risk of overdose {01}{06})


Patients with pre-existing slow heart rates    (citalopram has caused small but statistically significant reductions in heart rate{06})




Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
    
Sexual dysfunction, including abnormal ejaculation {01}{06}
anorgasmia {01}
decreased libido {01}{06}
or impotence {01} (decrease in sexual ability or desire)

Note: Abnormal ejaculation, especially ejaculatory delay, is the most frequent form of sexual dysfunction associated with citalopram use {01}. Impotence may be dose-related {01}.


Incidence less frequent
    
Abnormal accommodation {01} (blurred vision)
    
agitation {01}
    
amnesia {01} (loss of memory)
    
apathy {01} (lack of emotion)
    
confusion {01}
    
dyspnea {01} (trouble in breathing)
    
fever {01}
    
menstrual changes {01}
    
polyuria {01} (increase in frequency of urination or amount of urine produced)
    
skin rash or itching {01}

Incidence rare
    
Abnormal bleeding or thrombocytopenia {01} (nose bleed {01}; purple or red spots on skin {01}; bleeding gums {01})
    
bradycardia (slow or irregular heartbeat [less than 50 beats per minute]){06}
    
breast tenderness or enlargement {01}
or galactorrhea {01} (unusual secretion of milk )—in females {01}
    
cardiac arrhythmia {01} ( dizziness or fainting; irregular heartbeat )
    
epidermal necrolysis {01} (redness, tenderness, itching, burning, or peeling of skin; red or irritated eyes; sore throat, fever, and chills )
    
extrapyramidal effects {01} (unusual or sudden body or facial movements or postures)
    
hypoglycemia (anxiety; behavior change similar to drunkenness ; difficulty in concentrating; increased hunger; nervousness; shakiness){06}
    
hyponatremia {01} (confusion; drowsiness; dryness of mouth; increased thirst; lack of energy; seizures){06}
    
micturition disturbances ( trouble in holding or releasing urine {01}; painful urination {01})
    
mood or mental changes, including aggressive reaction {01}
delusions {01}
depersonalization {01}
emotional lability {01}
euphoria {01}
hallucinations {01}
mania or hypomania {01}
panic reaction {01}
paranoid reaction {01}
or psychosis {01}
    
serotonin syndrome {01} (agitation; confusion; diarrhea; fever; overactive reflexes; poor coordination; restlessness; shivering; sweating; talking or acting with excitement you cannot control; trembling or shaking; twitching)

Note: The serotonin syndrome is more likely to occur after an increase in dosage. Cardiac arrhythmias, coma, disseminated intravascular coagulation, hypertension or hypotension, renal failure, respiratory failure, seizures, and severe hyperthermia have been reported effects of the syndrome. {04}


Incidence not determined
——Observed during clinical practice ; estimates of frequency cannot be determined {07}.    
Angioedema (large, hive-like swelling on face, eyelids, lips, tongue or throat )
    
choreoathetosis (restlessness or agitation; uncontrolled jerking or twisting movements)
    
erythema multiforme (blistering, peeling, loosening of skin; chills; cough )
    
hepatic necrosis (abdominal or stomach pain; black, tarry stools)
    
neuroleptic malignant syndrome (difficult or fast breathing; drooling; fast heartbeat; impaired consciousness, ranging from confusion to coma;)
    
pancreatitis ( bloating; constipation; darkened urine; indigestion )
    
priapism (penile erections, frequent or continuing)
    
spontaneous abortion
    
thrombocytopenia
    
torsades de pointes (fast, irregular heartbeat)
    
ventricular arrhythmia (fast, slow or irregular heartbeat )
    
withdrawal syndrome
{07}


Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Drowsiness {01}{06}
    
dryness of mouth {01}{06}
    
insomnia {01} (trouble in sleeping )
    
nausea {01}{06}

Note: Drowsiness and insomnia may be dose-related {01}.


Incidence less frequent
    
Abdominal pain {01}
    
anorexia {01} (loss of appetite )
    
anxiety {01}
    
arthralgia or myalgia {01} (pain in muscles or joints)
    
asthenia or fatigue {01} (unusual tiredness or weakness)
    
diarrhea {01}
    
dyspepsia {01} (heartburn)
    
flatulence {01} (gas)
    
hypotension or postural hypotension {01} (dizziness or fainting)—especially when getting up from a lying or sitting position
    
increased salivation {01} (watering of mouth )
    
increased sweating {01}{06}
    
increased yawning {01}
    
migraine ( headache, severe and throbbing){01}
    
paresthesia {01} (tingling, burning, or prickly feelings on skin)
    
rhinitis or sinusitis {01} (headache; stuffy or runny nose)
    
taste perversion {01} (change in sense of taste)
    
tooth grinding {01}
    
tremor {01}{06} (trembling or shaking)
    
unusual increase or decrease in weight {01}
    
vomiting {01}

Note: Fatigue, increased sweating, and increased yawning may be dose-related {01}.




Those indicating the need for medical attention if they occur after medication is discontinued
    
Anxiety {05}
    
dizziness {05}
    
nervousness {05}
    
tremor {05} (trembling or shaking)

Note: Discontinuation symptoms have been reported very rarely following citalopram use {01}. This rarity is believed to be due to the intermediate half-life of citalopram, which provides self-tapering, and to the selectivity of citalopram for serotonin reuptake inhibition (lack of noradrenergic effects) {05}. Tapering citalopram at discontinuation generally is not required {05}.





Overdose
For specific information on the agents used in the management of citalopram overdose, see Charcoal, Activated (Oral-Local) monograph.
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Clinical effects of overdose

Note: There have been reports of death after overdoses with citalopram alone, at doses of 2800 mg and 3920 mg, with no co-ingested substances {01}. However, patients have survived overdoses of up to 6000 mg {01}.

The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Acute
More frequent
    
Dizziness {01}
    
drowsiness {01}
    
nausea {01}
    
sinus tachycardia {01} ( fast heartbeat)
    
sweating {01}
    
tremor {01} (trembling or shaking)
    
vomiting {01}

Rare
    
Amnesia {01} ( loss of memory)
    
confusion {01}{06}
    
convulsions {01}{06}
    
coma {01}{06}
    
cyanosis {01}{06} (bluish colored skin or lips)
    
ECG changes, including nodal rhythm {01}
QT c prolongation {01}
torsades de pointes {01}
ventricular arrhythmia {01} (dizziness or fainting; fast, slow, or irregular heartbeat)
    
hyperventilation {01}{06} ( deep or fast breathing with dizziness)
    
rhabdomyolysis {01}{06} (general feeling of discomfort or illness; muscle pain; weakness)



Treatment of overdose
Treatment is essentially symptomatic and supportive {01}.

To decrease absorption—Considering gastric lavage or administration of activated charcoal {01}{06}.

Monitoring—Monitoring cardiac and vital signs {01}.

Supportive care—Establishing and maintaining airway {01}. Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.

Note: Because of citalopram's large volume of distribution, forced diuresis, dialysis, hemoperfusion, and exchange transfusions are not likely to be of benefit in the treatment of overdose {01}{06}.



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Citalopram (Systemic) .
In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to citalopram





Breast-feeding—Distributed into breast milk; drowsiness, decreased feeding, weight loss reported in two nursing infants





Use in the elderly—Clearance is reduced; lower dosage recommended



Contraindicated medications
Monoamine oxidase (MAO) inhibitors
Other medications, especially serotonergics or other medications or substances with serotonergic activity
Other medical problems, especially hepatic function impairment

Proper use of this medication
» Compliance with therapy; not taking more medication than prescribed

Taking with or without food, as directed by physician

» Four weeks of therapy may be required before antidepressant effects are seen; importance of continuing citalopram after symptoms are relieved

» Medication should not be abruptly discontinued by the patient

» Proper dosing
Missed dose: Discussing with physician what to do about any missed doses since some patients take citalopram in the morning and other patients take citalopram in the evening

» Proper storage

Precautions while using this medication
Regular visits to physician to check progress of therapy

» Not taking citalopram with or within 14 days of taking an MAO inhibitor; not taking an MAO inhibitor within 14 days of taking citalopram

Avoiding use of alcoholic beverages

Possible drowsiness, impairment of judgment, thinking, or motor skills; caution when driving or doing jobs requiring alertness or coordination until effects of medication are known


Side/adverse effects
Signs of potential side effects, especially sexual dysfunction, abnormal accommodation, agitation, amnesia, apathy, confusion, dyspnea, fever, menstrual changes, polyuria, skin rash or itching, abnormal bleeding or thrombocytopenia, breast tenderness or enlargement or galactorrhea (in females), cardiac arrhythmia (including bradycardia), epidermal necrolysis, extrapyramidal effects, hypoglycemia, hyponatremia, micturition disturbances, mood or mental changes, serotonin syndrome, angioedema, choreoathetosis, spontaneous abortion, erythema multiforme, hepatic necrosis, neuroleptic malignant syndrome, pancreatitis, priapism, ventricular arrhythmia, torsades de pointes, or withdrawal syndrome.


General Dosing Information
Potentially suicidal patients should not have immediate access to large quantities of citalopram since they may continue to exhibit suicidal tendencies until significant improvement occurs {01}. Providing the patient with the smallest total amount of medication consistent with good patient management is recommended to decrease the risk of overdose {01}{06}.

Activation of hypomania or mania has been reported in patients treated with citalopram {01}.

Because of the intermediate half-life of citalopram and its lack of adrenergic effects, tapering before discontinuation generally is not necessary {05}. However, adverse effects seen with abrupt discontinuation (anxiety, headache, migraine, paresthesia, tremor) may be mitigated by gradual withdrawal, with tapering over 1 to 2 weeks.{06}

Diet/Nutrition
Citalopram may be taken with or without food, on a full or empty stomach {01}.

For treatment of adverse effects
Serotonin syndrome—The serotonin syndrome usually resolves shortly after discontinuation of serotonergic medications. Treatment is essentially symptomatic and supportive. However, the nonspecific serotonergic receptor antagonists cyproheptadine and methysergide have been reported to be of some use in shortening the duration of the serotonin syndrome. {04}


Oral Dosage Forms

Note: The available dosage form contains citalopram hydrobromide, but dosage and strength are expressed in terms of the base.


CITALOPRAM HYDROBROMIDE TABLETS

Usual adult dose
Antidepressant
Oral, initially 20 mg (base) a day as a single dose in the morning or evening (with or without food){06}. Dosage may be increased by 20 mg a day at intervals of at least one week. Generally, the dosage is increased to 40 mg a day; however, some patients may require a dosage of 60 mg a day. {01}{06}

Note: A dose-response study found no advantage of 60 mg a day over 40 mg a day. Therefore, a dosage of 60 mg a day is not recommended ordinarily. {01}
For patients with hepatic function impairment, a dosage of 20 mg a day is recommended, with only nonresponsive patients being titrated to 30 {06} or 40 mg a day. {01}



Usual adult prescribing limits
60 mg (base) per day {01}.

Usual pediatric dose
Antidepressant
Safety and efficacy have not been established {01}.


Usual geriatric dose
Antidepressant
Oral, 20 mg (base) a day as a single dose in the morning or evening. Dosage may be increased to 40 mg a day in nonresponding patients. {01} Some elderly patients may respond to 10 mg a day.{06}


Usual geriatric prescribing limits
40 mg (base) per day {01}.

Strength(s) usually available
U.S.—


20 mg (base) (Rx) [Celexa (scored) (copolyvidone) (corn starch) (crosscarmellose sodium) (glycerin ) (lactose monohydrate) ( magnesium stearate) (hydroxypropyl methylcellulose ) (microcrystalline cellulose) ( polyethylene glycol) (titanium dioxide) (iron oxides){01}]


40 mg (base) (Rx) [Celexa (scored) (copolyvidone) (corn starch) (crosscarmellose sodium) (glycerin ) (lactose monohydrate) ( magnesium stearate) (hydroxypropyl methylcellulose ) (microcrystalline cellulose) ( polyethylene glycol){01}]

Canada—


20 mg (base) (Rx) [Celexa (scored) (copolyvidone) (cornstarch) ( croscarmellose sodium) (glycerin ) (lactose monohydrate) ( magnesium stearate) ( methylhydroxypropyl cellulose ) (microcrystalline cellulose) ( polyethylene glycol) (titanium dioxide){06}]


40 mg (base) (Rx) [Celexa (scored) (copolyvidone) (cornstarch) ( croscarmellose sodium) (glycerin ) (lactose monohydrate) ( magnesium stearate) (methylhydroxypropyl cellulose ) (microcrystalline cellulose) ( polyethylene glycol) ( titanium dioxide){06}]

Packaging and storage:
Store at 25 ºC (77 ºF), with excursions permitted between 15 and 30 ºC (59 and 86 ºF) {01}, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Avoid alcoholic beverages.
   • May cause dizziness or drowsiness.


CITALOPRAM HYDROBROMIDE ORAL SOLUTION

Usual adult dose
See Citalopram Hydrobromide Tablets .{07}

Usual adult prescribing limits
See Citalopram Hydrobromide Tablets .{07}

Usual pediatric dose
Antidepressant
Safety and efficacy have not been established {07}.


Usual geriatric dose
See Citalopram Hydrobromide Tablets{07}

Usual geriatric prescribing limits:
See Citalopram Hydrobromide Tablets{07}

Strength(s) usually available
U.S.—


2 mg per mL (Rx) [Celexa (sorbitol) ( purified water) (methylparaben) ( natural peppermint flavor) (propylparaben){07}]

Canada—
Not commercially available.

Packaging and storage:
Store at 25 °C (77 °F); excursions permitted between 15 and 30 °C (59 and 86 °F).{07}

Auxiliary labeling:
   • May cause dizziness or drowsiness
   • Avoid alcoholic beverages



Developed: 09/02/1998
Revised: 12/14/2001



References
  1. Citalopram package insert (Celexa, Forest—US), Rev 7/98, Rec 7/98.
  1. Canada JR, editor. USP dictionary of USAN and international drug names 1998. Rockville, MD: The United States Pharmacopeial Convention Inc; 1997. p. 172.
  1. Psychiatric Disease Advisory Panel Meeting, 11/7/94.
  1. Reviewers" responses to Psychiatric Disease Advisory Panel Memos #7 of 4/30/97 and #9 of 6/10/97; Reviewers" responses to Neurology Advisory Panel Memos #8 of 4/30/97 and #9 of 6/10/97.
  1. Personal communication, citalopram clinical development group, Forest Laboratories, 8/6/98.
  1. Product Information: Celexa®, citalopram. Lundbeck, Canada. In: Welbanks L (ed): Compendium of Pharmaceuticals and Specialties, 35th ed. Canadian Pharmaceutical Association, Ottawa, Ontario, Canada, 2000. p. 291–294.
  1. Product Information: Celexa®, citalopram. Forest Laboratories, Inc., St. Louis, MO. (PI revised 12/2000) Reviewed 09/2001.
  1. Expert committee comments, 11/21/01.
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