Citalopram Hydrobromide

CITALOPRAM HYDROBROMIDE

Manufacturer: Denton Pharma, Inc. DBA Northwind Pharmaceuticals

Score: 144.0

Quick Summary

Citalopram is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of major depressive disorder (MDD) in adults. The initial dosage is 20 mg once daily, with a maximum recommended dosage of 40 mg once daily. However, for patients greater than 60 years of age, patients with hepatic impairment, and CYP2C19 poor metabolizers, the maximum recommended dosage is 20 mg once daily. Citalopram has several contraindications, including concomitant use of monoamine oxidase inhibitors (MAOIs) or pimozide, and known hypersensitivity to citalopram or any of the inactive ingredients. The drug has several important safety warnings, including an increased risk of suicidal thoughts and behaviors in pediatric and young adult patients, QT prolongation, serotonin syndrome, and increased risk of bleeding. Special population considerations include use during pregnancy, pediatric use, geriatric use, and nursing mothers.

Key Clinical Findings and Indications

Major depressive disorder (MDD) in adults
Selective serotonin reuptake inhibitor (SSRI)

Important Safety Information

Warning

Increased risk of suicidal thoughts and behaviors in pediatric and young adult patients

Contraindications

Concomitant use of monoamine oxidase inhibitors (MAOIs) or pimozide
Known hypersensitivity to citalopram or any of the inactive ingredients

Adverse Reactions

Nausea
Diarrhea
Dry mouth
Somnolence
Increased sweating
Tremor
Ejaculation disorder

Dosing Recommendations

General Guidance

For patients greater than 60 years of age, patients with hepatic impairment, and CYP2C19 poor metabolizers, the maximum recommended dosage is 20 mg once daily

Major depressive disorder (MDD)

Adult Dose

20 mg once daily, with a maximum recommended dosage of 40 mg once daily

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Use during pregnancy has been associated with an increased risk of persistent pulmonary hypertension of the newborn (PPHN)
Use during the month before delivery may be associated with an increased risk of postpartum hemorrhage

Nursing Mothers

Citalopram is excreted in human breast milk

Pediatric Use

The safety and effectiveness of citalopram have not been established in pediatric patients
Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients

Geriatric Use

Of 4422 patients in clinical studies of citalopram, 1357 were 60 and over, 1034 were 65 and over, and 457 were 75 and over
SSRIs, including citalopram, have been associated with cases of clinically significant hyponatremia in elderly patients

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