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Pharmacologic class: Selective serotonin reuptake inhibitor
Therapeutic class: Antidepressant
Pregnancy risk category C
FDA Box Warning
• Drug may increase risk of suicidal thinking and behavior in children and adolescents with major depressive disorder and other psychiatric disorders, especially during first few months of therapy. Risk must be balanced with clinical need, as depression itself increases suicide risk. With patient of any age, observe closely for clinical worsening, suicidality, and unusual behavior changes when therapy begins. Advise family to observe patient closely and communicate with prescriber as needed.
• Drug isn't approved for use in pediatric patients.
Unclear. Thought to potentiate serotonergic activity in CNS by inhibiting neuronal uptake of serotonin.
Oral solution: 10 mg/5 ml
Tablets: 10 mg, 20 mg, 40 mg
Indications and dosages
Adults: Initially, 20 mg P.O. daily; may increase to maximum recommended dosage of 40 mg/day at an interval of no less than 1 week.
• Hepatic impairment
• CYP2C19 poor metabolizers or concurrent use of cimetidine or another CYP2C19 inhibitor
• Elderly patients
• Panic disorder
• Premenstrual dysphoria
• Social phobia
• Hypersensitivity to drug or its components
• Concurrent use of MAO inhibitors or pimozide
Use cautiously in:
• severe renal impairment, hepatic impairment
• bradycardia, hypokalemia, hypomagnesemia, hyponatremia, recent acute myocardial infarction, congenital long QT syndrome, or uncompensated heart failure (avoid use)
• concurrent use of drugs that prolong QTc interval (avoid use)
• concurrent use of serotonin precursors such as tryptophan (not recommended)
• concurrent use of aspirin, NSAIDs, warfarin, and other anticoagulants
• history of mania or seizure disorder
• elderly patients
• pregnant or breastfeeding patients
• children (safety not established).
• Administer drug in the morning or evening, with or without food.
☞ Don't give within 14 days of MAO inhibitor; life-threatening interactions may occur.
☞ Be aware that drug shouldn't be given at doses above 40 mg/day because of risk of QTc-interval prolongation.
☞ Gradually reduce dosage rather than abruptly stopping drug.
CNS: apathy, confusion, drowsiness, insomnia, migraine, weakness, agitation, amnesia, anxiety, dizziness, fatigue, poor concentration, tremor, paresthesia, deepening of depression, suicide attempt, neuroleptic malignant syndrome-like reactions
CV: orthostatic hypotension, tachycardia, ECG changes
EENT: abnormal visual accommodation
GI: nausea, vomiting, diarrhea, abdominal pain, dyspepsia, flatulence, increased saliva, dry mouth, increased appetite, anorexia
GU: polyuria, amenorrhea, dysmenorrhea, ejaculatory delay, erectile dysfunction, decreased libido
Musculoskeletal: joint pain, myalgia
Skin: rash, pruritus, diaphoresis, photosensitivity
Other: altered taste, fever, yawning, weight changes, serotonin syndromelike reactions
Drug-drug. Aspirin, NSAIDs, warfarin, other anticoagulants: increased risk of bleeding
Anti-infectives (such as gatifloxacin, moxifloxacin), antipsychotics (such as chlorpromazine, thioridazine), Class 1A antiarrhythmics (such as procainamide, quinidine), Class III antiarrhythmics (such as amiodarone, sotalol), CYP2C19 inhibitors (such as cimetidine), methadone, pentamidine: risk of prolonged QTc interval
Carbamazepine: decreased citalopram blood level
Centrally acting drugs (such as antihistamines, opioids, sedative-hypnotics): additive CNS effects
Erythromycin, itraconazole, ketoconazole, omeprazole: increased citalopram blood level
5-hydroxytryptamine1 receptor agonists (such as sumatriptan, zolmitriptan): increased risk of adverse reactions
Lithium: potentiation of serotonergic effects
MAO inhibitors: life-threatening reactions
Tricyclic antidepressants (TCAs): altered TCA pharmacokinetics
Drug-diagnostic tests. Serum sodium: decreased level
Drug-herbs. St. John's wort, S-adenosylmethionine (SAM-e): increased risk of serotonergic reactions, including serotonin syndrome
Drug-behaviors. Alcohol use: additive CNS depression
Sun exposure: photosensitivity
• If patient is receiving lithium concurrently, watch closely for potentiation of serotonergic effects.
• Monitor patient for signs of mania or hypomania, bleeding, serotonin syndrome-like reactions (including mental status changes, such as agitation, hallucinations, coma), autonomic instability (such as tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (such as hyperreflexia, incoordination), GI symptoms (such as nausea, vomiting, diarrhea) or neuroleptic malignant syndrome-like reactions (fever, muscle rigidity, mental status changes, irregular pulse or blood pressure, rapid heartbeats, excessive sweating).
• Monitor ECG and electrolyte levels in patients with cardiac conditions that may lead to QT-interval prolongation. Discontinue drug in patients with persistent QTc measurements of more than 500 ms.
• Be aware that drug should be discontinued in patients with symptomatic hyponatremia (headache, difficulty concentrating, memory impairment, confusion, weakness, unsteadiness). Signs and symptoms associated with more severe or acute cases have included hallucinations, syncope, seizures, coma, respiratory arrest, and death).
• When discontinuing drug, monitor patient for dysphoria, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia, and hypomania.
• Instruct patient to take drug with full glass of water with or without food at same time every day.
☞ Advise patient or caregiver (especially if drug is given to a child or adolescent) to immediately report suicidal thoughts or extreme depression.
• Instruct patient to move slowly when sitting up or standing, to avoid dizziness or light-headedness caused by sudden blood pressure decrease.
• Tell patient several weeks may pass before he starts to feel better.
• Instruct patient to immediately report irregular or rapid heartbeats, dizziness, fainting, palpitations, agitation, hallucinations, incoordination, nausea, vomiting, diarrhea, fever, muscle rigidity, altered mental status (including catatonic signs), excessive sweating, headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness.
• Tell patient about risk of bleeding associated with concomitant use of this drug and NSAIDs, aspirin, or other drugs that affect coagulation; tell patient to report bruising or other signs or symptoms of bleeding.
• Caution patient to avoid driving and other hazardous activities until drug's effects on concentration and alertness are known.
• Advise patient to avoid alcohol during therapy.
• Tell male patient he may experience inadequate filling of penile erectile tissue. Advise him to consult prescriber if he experiences adverse sexual effects.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.