pms-Citalopram Dosage/Direction for Use

Dosing Considerations: pms-CITALOPRAM is not indicated for use in children under 18 years of age (see General: Potential Association with Behavioral and Emotional Changes, Including Self-Harm under Precautions).
General: pms-CITALOPRAM should be administered once daily, in the morning or evening, with or without food.
Recommended Dose and Dosage Adjustment: Adults: pms-CITALOPRAM should be administered as a single oral dose of 20 mg/day. In patients who do not respond adequately, an increase of dosage to a maximum of 40 mg/day should be considered. Dose increases should usually occur at intervals of no less than one week.
Treatment of Pregnant Women: The safety of citalopram hydrobromide during pregnancy has not been established. Therefore, pms-CITALOPRAM should not be used during pregnancy, unless, in the opinion of the physician, the expected benefits to the patient markedly outweigh the possible risk to the fetus.
Post-marketing reports indicate that some neonates exposed to SSRIs such as citalopram hydrobromide and other newer antidepressants late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see Pregnant Women: Complications following late third trimester exposure to SSRIs under Use in Pregnancy & Lactation). When treating pregnant women with pms-CITALOPRAM during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering pms-CITALOPRAM in the third trimester.
Geriatrics (≥ 65 years of age): A longer half-life and decreased clearance have been demonstrated in the elderly, therefore lower doses and a lower maximum dose should be considered. It may be desirable to start at 10 mg daily and titrate upwards as needed and tolerated. A single oral dose of 20 mg/day is the recommended dose for most elderly patients. Some patients may respond to a 10 mg/day dose (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions). The dose may be titrated to a maximum of 20 mg/day if needed and tolerated. As with other SSRIs, caution should be exercised in treating elderly female patients who may be more susceptible to adverse events such as hyponatremia and SIADH (syndrome of inappropriate antidiuretic hormone secretion) (see Renal: Hyponatremia under Precautions).
Hepatic Impairment: Dosages should be restricted to the lower end of the dose range in patients with mild to moderate hepatic insufficiency. Accordingly, an initial single oral dose of 10 mg daily is recommended. Subsequently, the dose may be increased based on the patient's response and clinical judgement. Patients with reduced hepatic function should receive dosages of no more than 20 mg/day (see Hepatic/Biliary/Pancreatic: Hepatic Impairment under Precautions). Citalopram should be used with additional caution in patients with severe hepatic impairment.
Renal Impairment: No dosage adjustment is necessary for patients with mild to moderate renal impairment. Since there is no information available on the pharmacokinetic or pharmacodynamic effects of citalopram hydrobromide in patients with severe renal impairment, citalopram hydrobromide should be used with caution in these patients.
CYP2C19 Poor Metabolisers: An initial dose of 10 mg daily during the first two weeks of treatment is recommended for patients who are known to be poor metabolisers of CYP2C19. The dose may be increased to a maximum of 20 mg daily depending on individual patient response (see Pharmacology: Pharmacokinetics: Metabolism under Actions).
Maintenance Treatment: Evaluation of citalopram hydrobromide in two placebo-controlled studies has shown that its antidepressant efficacy was maintained for periods of up to 24 weeks, following 6 or 8 weeks of initial treatment (total of 32 weeks) (see Pharmacology: Pharmacodynamics: Clinical Trials under Actions). In the flexible dose study, the great majority of patients were receiving 20 or 40 mg/day doses both at 12 and 24 weeks. During maintenance therapy, the dosage should be kept at the lowest effective level and patients should be periodically reassessed to determine the need for continued treatment.
Switching Patients To or From a MAOI: At least 14 days should elapse between discontinuation of a MAOI and initiation of therapy with citalopram hydrobromide. Similarly, at least 14 days should be allowed after stopping citalopram hydrobromide before starting a MAOI (see Monoamine Oxidase Inhibitors under Contraindications).
Discontinuation of pms-CITALOPRAM Treatment: Symptoms associated with the discontinuation or dosage reduction of citalopram hydrobromide have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or during dosage reduction (see General: Discontinuation Symptoms under Precautions and Clinical Trial Adverse Drug Reactions: Adverse Reactions following Discontinuation of Treatment (or Dose Reduction) under Adverse Reactions).
A gradual reduction in the dose over a period of at least one to two weeks rather than abrupt cessation is recommended to reduce the risk of withdrawal reactions. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient's clinical response (see General: Discontinuation Symptoms under Precautions and Clinical Trial Adverse Drug Reactions: Adverse Reactions following Discontinuation of Treatment (or Dose Reduction) under Adverse Reactions).
Missed dose: In the event that a dose is missed, the patient should take the next dose when it is due.