Chear^®

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.

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.

Chear is indicated for the treatment of:

• Major depressive disorder (MDD)
• Obsessive-compulsive disorder (OCD)
• Panic disorder (PD)
• Post-traumatic stress disorder (PTSD)
• Social anxiety disorder (SAD)
• Premenstrual dysphoric disorder (PMDD)

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.

Age	Indication	Starting dose	Therapeutic range
Adult	MDD	50 mg	50–200 mg
	OCD	50 mg
	PD, PTSD, SAD	25 mg
Children	OCD (ages 6–12 years old)	25 mg
	OCD (ages 13–17 years old)	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.

Pregnancy: Although animal studies did not provide any evidence of teratogenicity, the safety of sertraline during human pregnancy has not been established.

Lactation: Sertraline is known to be excreted in breast milk. Its effects on the nursing infant have not yet been established. If treatment with sertraline is considered necessary, discontinuation of breastfeeding should be considered.

Use in children and adolescents
Safety and effectiveness in pediatric patients below the age of 6 have not been established. Safety and effectiveness have not been established in pediatric patients for indications other than OCD.

No Data

Caution should be exercised during taking this medication as sertraline may cause increase the risk of suicidal thinking and change of behavior. Caution should be taken in case of liver problems, kidney diseases, seizures, heart problems and any allergies. This drug may cause dizziness or drowsiness. Caution should be taken in activities requiring alertness such as driving or using machinery. Caution is advised while using this product in the elderly because they may be more sensitive to the effects of the drug. Do not take this drug if you have taken monoamine oxidase inhibitor in the last five weeks.

The most common side effects of sertraline are nausea, diarrhea, tremor, dyspepsia, decreased appetite, hyperhidrosis, ejaculation failure and decreased libido

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.

Drug interaction with medication: Potential effects of co-administration of drugs that are highly bound to plasma proteins as sertraline is tightly bound to plasma protein, the administration of sertraline to a patient taking another drug which is tightly bound to protein (e.g., warfarin and digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely, adverse effects may result from displacement of protein-bound sertraline by other tightly bound drugs. Sertraline may interact with other drugs such as cimetidine, CNS active drugs like diazepam, hypoglycemic drugs, and atenolol.

Drug interaction with food and others: Not applicable.

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.

No Data

Store in a cool dry place, protected from light.

Storage
Store in a cool and dry place protected from light. Keep away from the reach of children.

Packing
Chear 25 mg tablet: Cartons of 100 tablets in strips.
Chear 50 mg tablet: Cartons of 50 tablets in strips.
Chear 100 mg tablet: Cartons of 30 tablets in strips.