ACOLOFT 50 SERTRALINE FILM COATED TABLET BP 50 MG [SIN16385P]

Product Info

ACOLOFT 50 SERTRALINE FILM COATED TABLET BP 50 MG

[SIN16385P]

4.1 Therapeutic Indications

Sertraline is indicated for the treatment of symptoms of depression, including depression accompanied by symptoms of anxiety, in patients with or without a history of mania. Following satisfactory response, continuation with sertraline therapy is effective in preventing relapse of the initial episode of depression or recurrence of further depressive episodes.

Sertraline is also indicated for the treatment of obsessive compulsive disorder (OCD). Following initial response, sertraline has been associated with sustained efficacy, safety and tolerability in up to 2 years of treatment of OCD.

Sertraline is indicated for the treatment of panic disorder, with or without agoraphobia.

Sertraline is indicated for the treatment of post-traumatic stress disorder (PTSD).

Sertraline is indicated for the treatment of social phobia (social anxiety disorder).

Sertraline is indicated for the treatment of pre-menstrual dysphoric disorder (PMDD).

Sertraline is not indicated for use in children and adolescents under 18 years of age (see section 4.4 – Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and Method of Administration

Sertraline should be administered once daily, either in the morning or evening. Sertraline tablets can be administered with or without food.

Initial Treatment

Depression and OCD – Sertraline treatment should be administered at a dose of 50 mg/day.

Panic Disorder, PTSD and Social Phobia – Therapy should be initiated at 25 mg/day. After one week, the dose should be increased to 50 mg once daily. This dosage regimen has been shown to reduce the frequency of early- treatment-emergent side effects characteristic of panic disorder.

Pre-menstrual Dysphoric Disorder – Sertraline treatment should be initiated at a dose of 50 mg/day, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle, depending on physician assessment.

Titration

Depression, OCD, Panic Disorder, and PTSD – Patients not responding to a 50 mg dose may benefit from dose increases. Dose changes should be made at intervals of at least one week, up to a maximum of 200 mg/day. Changes in dose should not be made more frequently than once per week given the 24-hour elimination half-life of sertraline.
The onset of therapeutic effect may be seen within 7 days. However, longer periods are usually necessary to demonstrate therapeutic response, especially in OCD.

Pre-menstrual Dysphoric Disorder – Patients not responding to a 50 mg/day dose may benefit from dose increases (at 50 mg increments/menstrual cycle) up to 150 mg/day when dosing daily throughout the menstrual cycle, or 100 mg/day when dosing during the luteal phase of the menstrual cycle. If a 100 mg/day dose has been established with luteal phase dosing, a 50 mg/day titration step for three days should be utilized at the beginning of each luteal phase dosing period.

Maintenance – Dosage during long-term therapy should be kept at the lowest effective level, with subsequent adjustment depending on therapeutic response.

Use in the Elderly – The same dose range as in younger patients may be used in the elderly. Over 700 elderly patients (>65 years) have participated in clinical studies that demonstrated the efficacy of sertraline in this patient population. The pattern and incidence of adverse reactions in the elderly were similar to that in younger patients.

Use in Hepatic Insufficiency – The use of sertraline in patients with hepatic disease should be approached with caution. A lower or less frequent dose should be used in patients with hepatic impairment (see section 4.4 – Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Use in Renal Insufficiency – Sertraline is extensively metabolized. Excretion of unchanged drug in urine is a minor route of elimination. As expected from the low renal excretion of sertraline, sertraline dosing does not have to be adjusted based on the degree of renal impairment (see section 4.4 – Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Discontinuation

Patients currently taking sertraline should not be discontinued abruptly, due to risk of discontinuation symptoms. At the time that a medical decision is made to discontinue, a gradual reduction in the dose rather than an abrupt cessation is recommended.

4.3 Contraindications

Sertraline is contraindicated in patients with a known hypersensitivity to sertraline.

Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (see section 4.4 – Special Warnings and Precautions for Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Concomitant use in patients taking pimozide is contraindicated (see section 4.5 – Interaction with Other Medicinal Products and Other Forms of Interaction – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).