Chear 25 mg tablet: Each tablet contains Sertraline Hydrochloride INN equivalent to Sertraline 25 mg.
Chear 50 mg tablet: Each tablet contains Sertraline Hydrochloride INN equivalent to Sertraline 50 mg.
Chear 100 mg tablet: Each tablet contains Sertraline Hydrochloride INN equivalent to Sertraline 100 mg.
Chear is a preparation of Sertraline Hydrochloride which is an orally administered selective serotonin reuptake inhibitor (SSRI). Chear potentiates serotonergic activity in the central nervous system through inhibition of neuronal reuptake of serotonin (5-HT). In vitro studies suggest that Chear has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitro studies have shown that Chear has no significant affinity for adrenergic (alpha1, alpha2, beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT1A, 5HT1B, 5HT2), or benzodiazepine receptors.
Uses Chear® is indicated for the treatment oJ sympioms of depressive illness, including accompanying symptoms of anxiety. Following satisfactory response, continuation with Chear® therapy is effective in preventing relapse of the initial episode of depression or recurrence of further depressive episodes, including accompanying symptoms of anxiety.
Route of administration: Chear should be taken in oral route.
Patients with MDD, OCD, PD, PTSD, and SAD: The recommended initial dosage and maximum Chear dose in patients with MDD, OCD, PD, PTSD, and SAD are given in the table. A dose of 25 mg or 50 mg per day is the initial therapeutic dose. For adults and pediatric patients, subsequent doses may be increased in case of an inadequate response in 25 to 50 mg per day increments once a week, depending on tolerability, up to a maximum of 200 mg per day. Given the 24 hour elimination half-life of Chear, the recommended interval between dose changes is one week.
Adult MDD: Starting 50 mg, Therapeutic range 50–200 mg
Adult OCD: Starting 50 mg, Therapeutic range 50–200 mg
Adult PD, PTSD, SAD: Starting 25 mg, Therapeutic range 50–200 mg
Children OCD (ages 6–12 years old): Starting 25 mg
Children OCD (ages 13–17 years old): Starting 50 mg
Patients with PMDD: The recommended starting Chear® dose in adult women with PMDD is 50 mg per day. Chear® may be administered either continuously (every day throughout the menstrual cycle) or intermittently (only during the luteal phase of the menstrual cycle, i.e., starting the daily dose 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing would be repeated with each new cycle. When dosing continuously, patients not responding to a 50 mg dose may benefit from dose increases at 50 mg increments per menstrual cycle up to 150 mg per day. When dosing intermittently, patients not responding to a 50 mg dose may benefit from increasing the dose up to a maximum of 100 mg per day during the next menstrual cycle (and subsequent cycles) as follows: 50 mg per day during the first 3 days of dosing followed by 100 mg per day during the remaining days in the dosing cycle.
Patients with hepatic impairment: The recommended dosage in patients with mild hepatic impairment is half the recommended dosage due to increased exposure in this patient population. The use of sertraline in patients with moderate or severe hepatic impairment is not recommended.
Patients with renal impairment: No dose adjustment is needed in patients with mild to severe renal impairment. Sertraline exposure does not appear to be affected by renal impairment.
MAO inhibitors risk fatal serotonin syndrome (contraindicated; allow 14 days before/after); pimozide co-administration increases pimozide levels and QT prolongation (contraindicated); serotonergic agents (triptans, tramadol, linezolid, St. John's wort) increase serotonin syndrome risk; antiplatelets/NSAIDs/warfarin increase bleeding risk; potent inhibitor of CYP2D6.
Sertraline is contraindicated in patients with a known hypersensitivity to sertraline or any components of this product. It is also contraindicated in patients taking or within 14 days of stopping MAOIs and patients taking pimozide.
Common: Nausea, diarrhea, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure, decreased libido.
Overdose
The most common signs and symptoms associated with sertraline overdosage were somnolence, vomiting, tachycardia, nausea, dizziness, agitation and tremor. No cases of fatal overdosage with only sertraline have been reported.
Category C. Safety in human pregnancy not established; persistent pulmonary hypertension reported in newborns exposed in late pregnancy. Lactation: Excreted in breast milk; discontinue nursing or discontinue drug.
Store below 25°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.