Generic Name
SertralineTherapeutic Class: Drugs of Nervous System (SSRIs & related anti-depressant drugs)
Indications:
Storage:
Store at 25° C.
- Depressive illness
- Obsessive-compulsive disorder
- Post-traumatic stress disorder
- Panic disorder
Presentation:
Sertraline 25: Each tablet contains Sertraline Hydrochloride INN equivalent to Sertraline 25 mg.
Sertraline50: Each tablet contains Sertraline Hydrochloride INN equivalent to Sertraline 50 mg.
Sertraline 100: Each tablet contains Sertraline Hydrochloride INN equivalent to Sertraline 100 mg.
Description:
Sertraline has a potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. The reduction of Serotonin turnover in the brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once-daily administration.
Dosage & Administration:
Sertraline 25: Each tablet contains Sertraline Hydrochloride INN equivalent to Sertraline 25 mg.
Sertraline50: Each tablet contains Sertraline Hydrochloride INN equivalent to Sertraline 50 mg.
Sertraline 100: Each tablet contains Sertraline Hydrochloride INN equivalent to Sertraline 100 mg.
Description:
Sertraline has a potent and selective inhibitory action on CNS neuronal reuptake of 5-HT resulting in increased 5-HT concentrations at the synaptic clefts, leading to facilitation of its sustained activity at the postsynaptic receptor sites. It ultimately results in an improvement of depression. The reduction of Serotonin turnover in the brain by Sertraline is also another contributing fact implicated in its action. Its prolonged elimination half-life offers a benefit of once-daily administration.
Dosage & Administration:
Depressive illness :
Initially, 50 mg daily, increased if necessary by increments of 50 mg over several weeks to a maximum of 200 mg daily. The usual maintenance dose is 50 mg daily. Children and adolescents less than 18 years are not recommended.
Obsessive-compulsive disorder :
Adult and adolescent over 13 years- Initially 50 mg daily, increased if necessary in steps of 50 mg over several weeks. The usual dose range is 50-200 mg daily.
Child (6-12 years) - Initially 25 mg daily, increased to 50 mg daily after 1 week, further increased if necessary in steps of 50 mg at intervals of at least 1 week (maximum 200 mg daily).
Post-traumatic stress disorder:
Initially, 25 mg daily, increased after 1 week to 50 mg daily; if the response is partial and if the drug is tolerated, the dose can be increased in steps of 50 mg over several weeks to a maximum of 200 mg daily. Children and adolescents less than 18 years are not recommended.
Side Effects:
Sertraline may cause side effects like upset stomach, diarrhea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat, etc.
Precautions:
Precaution 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 a monoamine oxidase inhibitor in the last five weeks.
Use in Pregnancy & Lactation:
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.
Initially, 50 mg daily, increased if necessary by increments of 50 mg over several weeks to a maximum of 200 mg daily. The usual maintenance dose is 50 mg daily. Children and adolescents less than 18 years are not recommended.
Obsessive-compulsive disorder :
Adult and adolescent over 13 years- Initially 50 mg daily, increased if necessary in steps of 50 mg over several weeks. The usual dose range is 50-200 mg daily.
Child (6-12 years) - Initially 25 mg daily, increased to 50 mg daily after 1 week, further increased if necessary in steps of 50 mg at intervals of at least 1 week (maximum 200 mg daily).
Post-traumatic stress disorder:
Initially, 25 mg daily, increased after 1 week to 50 mg daily; if the response is partial and if the drug is tolerated, the dose can be increased in steps of 50 mg over several weeks to a maximum of 200 mg daily. Children and adolescents less than 18 years are not recommended.
Side Effects:
Sertraline may cause side effects like upset stomach, diarrhea, constipation, vomiting, dry mouth, loss of appetite, weight changes, drowsiness, dizziness, headache, pain, burning or tingling in the hands or feet, excitement, sore throat, etc.
Precautions:
Precaution 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 a monoamine oxidase inhibitor in the last five weeks.
Use in Pregnancy & Lactation:
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.
Interaction:
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 that is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely, adverse effects may result from the 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, Atenolol, etc.
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 that is tightly bound to protein, (e.g. warfarin, digitoxin) may cause a shift in plasma concentrations potentially resulting in an adverse effect. Conversely, adverse effects may result from the 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, Atenolol, etc.
Store at 25° C.