For the Treatment of Major Depressive Disorder in Adults1
Citalopram Capsules 30 mg
Not an actual patient.
Citalopram Capsules 30 mg provides an additional dosing option between 20 mg and 40 mg.
Important Safety Information
Please see additional IMPORTANT SAFETY INFORMATION below.
Reduce your patients' pill burden
You can replace multiple tablets per day with a single Citalopram 30 mg capsule.
Prescribing Citalopram Capsules 30 mg1
- Do not initiate treatment with Citalopram Capsules; use another citalopram product for initial dosage titration or dosages other than 30 mg once daily
- Administer once daily with or without food
- When discontinuing Citalopram Capsules, reduce dose gradually. Gradual dosage reduction will require use of another citalopram product
Important Safety Information
Indication for use
Citalopram Capsules are indicated for the treatment of Major Depressive Disorder in adults.
Contraindications
Citalopram Capsules is contraindicated in patients
- taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), because of an increased risk of serotonin syndrome
- taking pimozide because of risk of QT prolongation
- with known hypersensitivity to citalopram or any of the inactive ingredients in Citalopram Capsules. Reactions have included angioedema and anaphylaxis
Warnings and Precautions
QT-Prolongation and Torsade de Pointes
- Citalopram causes dose-dependent QTc prolongation, an ECG abnormality associated with Torsade de pointes, ventricular tachycardia, and sudden death.
- Avoid use of Citalopram Capsules in the following patients:
- CYP2C19 poor metabolizers, patients receiving concomitant cimetidine or another CYP2C19 inhibitor, patients with hepatic impairment as well as those patients over 60 because Citalopram Capsules are only available in a 30 mg dose strength and dosage adjustments are not possible;
- with congenital long QT syndrome, bradycardia, hypokalemia or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure and patients taking other drugs that prolong the QTc interval.
- Electrolyte and/or ECG monitoring is recommended in patients at risk of hypokalemia and/or hypomagnesemia.
- Discontinue Citalopram Capsules in patients who are found to have persistent QTc measurements >500 ms.
- Avoid use of Citalopram Capsules in the following patients:
Serotonin Syndrome
- Citalopram can precipitate serotonin syndrome, a potentially life-threatening condition. The risk is increased with concomitant use of other serotonergic drugs and with drugs that impair metabolism of serotonin.
Increased Risk of Bleeding
- Citalopram Capsules increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may add to this risk. There is an association between drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage. For patients taking warfarin, carefully monitor the international normalized ratio.
Activation of Mania or Hypomania
- In patients with bipolar disorder, treating a depressive episode with Citalopram Capsules may precipitate a mixed/manic episode. Prior to treatment, screen patients for any personal or family history of bipolar disorder, mania, or hypomania.
Discontinuation Syndrome
- Adverse reactions after discontinuation of serotonergic antidepressants, particularly after abrupt discontinuation, include: nausea, sweating, dysphoric mood, irritability, agitation, dizziness, sensory disturbances, tremor, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. A gradual reduction in dosage rather than abrupt cessation is recommended.
Seizures
- Citalopram has not been systematically evaluated in patients with seizure disorder and should be prescribed with caution in these patients.
Angle-Closure Glaucoma
- Citalopram Capsules may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid use in patients with untreated anatomically narrow angles.
Hyponatremia
- Hyponatremia may occur with Citalopram Capsules. In patients with symptomatic hyponatremia, discontinue Citalopram Capsules and institute appropriate medical intervention. Elderly patients, patients taking diuretics, and those who are volume-depleted may be at greater risk of developing hyponatremia.
Sexual Dysfunction
- Citalopram Capsules may cause symptoms of sexual dysfunction. In male patients, use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, use may result in decreased libido and delayed or absent orgasm.
Adverse reactions
- Most commonly observed adverse reactions with citalopram are fever, arthralgia, myalgia, anorexia, yawning, sinusitis, ejaculation disorder, decreased libido, and impotence.
Use in Specific Populations
- Pregnancy: Use of Citalopram Capsules in the month before delivery may be associated with an increased risk of postpartum hemorrhage. SSRI use, particularly late in pregnancy, may increase the risk for persistent pulmonary hypertension and symptoms of poor adaptation (respiratory distress, temperature instability, feeding difficulties, hypotonia, tremor, irritability) in the neonate.
- Elderly patients: Not recommended
- Hepatic Impairment: Not recommended
For additional safety information about Citalopram Capsules, please see the Full Prescribing Information, including BOXED WARNING, and Medication Guide.
You are encouraged to report negative side effects of prescription drugs to Almatica at 1-877-447-7979 or the FDA at www.fda.gov/medwatch, or call 1-800-FDA-1088.