📌 COMPOSITION

Each F/C tablet contains: Sertraline hydrochloride equivalent to Sertraline 50 mg.

📌 DESCRIPTION

Sertex (Sertraline) is a potent and selective serotonin reuptake inhibitor (SSRI). After oral administration, peak blood levels occur at about 6-8 hours. Approximately 98% of the circulating drug is bound to plasma proteins. The plasma half‑life of Sertraline is approximately 26 hours. Sertraline is extensively metabolised, and the resultant metabolites are excreted in the faeces and urine in equal amounts; only a small amount of unchanged Sertraline is excreted in urine.

📌 INDICATIONS

Sertex is indicated in the treatment of the following cases:

• Major depressive disorders in adult patients.
• Obsessive‑compulsive disorders (OCD) both in adult and paediatric patients (6-12 years).
• Panic disorder with or without agoraphobia.

📌 DOSAGE & ADMINISTRATION

Sertex should be given as a single daily dose. It can be administered with or without food.

Adults:

• Major depressive disorder and obsessive‑compulsive disorder: therapeutic dose is 50 mg/day.
• Panic disorder: treatment should be initiated with a dose of 25 mg/day, increasing to 50 mg/day after one week.

"The daily dose for all indications may be increased in case of lack of response in 50 mg increments (at intervals of at least one week) to a maximum of 200 mg/day."

Children:

The safety and efficacy of Sertex has been established in paediatric OCD patients (aged 6-17 years):

• From 13 to 17 years: Therapy should commence at 50 mg/day.
• From 6 to 12 years: Therapy should commence at 25 mg/day, increasing to 50 mg/day after one week.

"Subsequent doses may be increased in case of lack of response in 50 mg/day increments up to 200 mg/day as needed. However, the generally lower body weights of children compared to adults should be taken into consideration in advancing the dose from 50 mg, in order to avoid excessive dosing."

📌 RESTRICTIONS ON USE

Contraindications

• In patients with hypersensitivity to Sertraline or to other agents which are closely related from a chemical point of view.
• In patients with unstable epilepsy.
• In patients receiving electroconvulsive therapy.
• In patients with a recent history of myocardial infarction or unstable heart diseases.

Precautions

• When treatment is discontinued, the dose should be gradually reduced so as to minimise the seriousness of the symptoms that occur when the drug is abruptly discontinued.
• If Sertraline is administered to patients with hepatic impairment, lower or less frequent doses should be considered.
• Sertraline should be used with caution in patients with renal insufficiency.
• The treatment should be discontinued in any patient who develops seizures.

Effect on the capacity to drive vehicles or use machines

Sertraline has no effect on psychomotor performance but, as with drugs used to treat depression, OCD or panic, caution should be taken during driving vehicles or using machines.

Use in pregnancy and lactation

The drug should be used during pregnancy and lactation only if the benefits outweigh the risks.

📌 DRUG INTERACTIONS

• Sertraline should not be used in combination with MAO inhibitors or within 14 days of discontinuing treatment with a MAOI. Similarly, at least 14 days should elapse after discontinuing Sertraline before starting a MAO inhibitor.
• Co‑administration of Sertraline with warfarin resulted in a small but statistically significant increase in prothrombin time.
• Co‑administration of Sertraline with lithium may lead to a higher incidence of serotonin‑associated side effects. Therefore, it is recommended that plasma lithium levels be monitored following initiation of Sertraline therapy, so that appropriate adjustments to the lithium dose may be made if necessary.
• Serotonergic drugs, such as tryptophan or fenfluramine, should not be used concomitantly with Sertraline.
• The concomitant use of alcohol and Sertraline should be avoided in depressed patients.
• Co‑administration of Sertraline with cimetidine caused a substantial decrease in Sertraline clearance.

📌 ADVERSE EFFECTS

The most common adverse effects occurred are: dry mouth, increased sweating, palpitation, headache, dizziness, tremor, nausea, diarrhoea, dyspepsia, anorexia, fatigue, insomnia, sexual dysfunction, somnolence and agitation.

📌 STORAGE INSTRUCTIONS

Store below 25°C in a dry place. Protect from light.

📌 PHARMACEUTICAL FORMS

• Sertex Tablets: Pack of 30 tablets and hospital packs of different sizes.

Mfd. By | P.O. Box: 4265 Sana'a / Yemen | 012-06-082 3/16 | Council of Arab Health Ministers | Union of Arab Pharmacists