Prescribing Information
The Cipramil Prescribing Information available in this section has been prepared in accordance with regulations regarding use of prescription drugs as mandated by the Kingdom of Denmark and is a direct translation of the Prescribing Information approved by Danish Health Authorities. The Prescribing Information is a legal document outlining indications of the product, dosage, contra-indications, pregnancy and lactation, precautions, drug interactions, adverse events and overdoses. If you wish to receive the Prescribing Information for your specific market/country, please use this link contact us.
Presentation
Cipramil tablets 10 mg, each containing 10 mg of citalopram as the hydrobromide. Cipramil tablets 20 mg, each containing 20 mg of citalopram as the hydrobromide. Cipramil tablets 40 mg, each containing 40 mg of citalopram as the hydrobromide. Cipramil drops 40 mg/ml, each ml containing 40 mg of citalopram as the hydrochloride. Cipramil infusion 40 mg concentrate containing 40 mg of citalopram as the hydrochloride.
Indications
Treatment of depression and prevention of relapse/recurrence. Treatment of panic disorder, with or without agoraphobia. Obsessive compulsive disorder (OCD).
Dosage: Treating depression
Adults: 20 mg OD. Depending upon individual patient response and severity, this may be increased in 20 mg increments to a maximum of 60 mg. Tablets should be taken as a single oral daily dose without regard for food. Treatment for at least 6 months is usually necessary to provide adequate maintenance against the potential for relapse.
Treating panic disorder
10 mg daily for the first week, increasing to 20 mg daily. Depending upon individual patient response, dosage may be further increased to a maximum of 60 mg daily depending upon individual patient response. To maintain response, prolonged treatment is often necessary.
Elderly
20 mg OD increasing to a maximum of 40 mg depending upon individual patient response.
Children
Not recommended.
Reduced hepatic/renal function
Restrict dosage to lower end of range in hepatic impairment. No information available in severe renal impairment (creatinine clearance<20 ml/min).
Contra-indications
Combined use of MAO inhibitors. Hypersensitivity to citalopram.
Pregnancy and lactation
Animal studies have not shown any evidence of teratogenic potential and citalopram does not affect reproduction or perinatal conditions. Due to limited human data, CIPRAMIL should only be used in pregnancy if considered necessary and under the close supervision of a physician. Citalopram appears in breast milk in very low concentrations. In nursing mothers, caution is recommended as it is not known whether citalopram excreted in milk may affect the infant.
Drug interactions
MAO inhibitors (see Contra-indications). Use lithium with caution. Citalopram and demethylcitalopram are negligible or weak inhibitors of hepatic isozymes and unlikely to interfere with P450-mediated drug metabolism.
Adverse events
Most commonly nausea, sweating, tremor, somnolence, and dry mouth. With citalopram, adverse effects are in general mild and transient. When they occur, they are most prominent during the first two weeks of treatment and usually attenuate as the depressive state improves. Discontinuation of citalopram should be avoided.
Overdose
Symptoms have included core nausea, dizziness, tachycardia, tremor, drowsiness, convulsions, and ECG changes. No specific antidote. Treatment is symptomatic and supportive. Early gastric lavage suggested. Abbreviated product information, local data sheet may deviate. Further information available upon request.
Product licence holder
H.Lundbeck A/S, Ottiliavej 9, 2500 Valby, Copenhagen, Denmark. "Cipramil®" is a registered trademark.
© 2000 H.Lundbeck A/S. Date of preparation: November 2000.