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HOME >> API >> API List 3 >> Sertraline Hcl

Molecular Structure




Sertraline Hcl

Molecular Formula C17H17Cl2N.HCl

Molecular Weight 342.69

CAS Registry Number 79559-97-0

Chemical data

Formula C17H17Cl2N
Mol. mass 306.229 g/mol
SMILES eMolecules & PubChem

Pharmacokinetic data

Bioavailability 44%
Metabolism N-demethylation (liver)
Half life Approximately 26 hours
Excretion Renal

Sertraline hydrochloride is a white crystalline powder that is slightly soluble in water and isopropyl alcohol, and sparingly soluble in ethanol.

Sertraline hydrochloride is supplied for oral administration as scored tablets containing sertraline hydrochloride equivalent to 25, 50 and 100 mg of sertraline and the following inactive ingredients: dibasic calcium phosphate dihydrate, D & C Yellow #10 aluminum lake (in 25 mg tablet), FD & C Blue #1 aluminum lake (in 25 mg tablet), FD & C Red #40 aluminum lake (in 25 mg tablet), FD & C Blue #2 aluminum lake (in 50 mg tablet), hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, synthetic yellow iron oxide (in 100 mg tablet), and titanium dioxide.

Sertraline hydrochloride oral concentrate is available in a multidose 60 mL bottle. Each mL of solution contains sertraline hydrochloride equivalent to 20 mg of sertraline. The solution contains the following inactive ingredients: glycerin, alcohol (12%), menthol, butylated hydroxytoluene (BHT). The oral concentrate must be diluted prior to administration

DOSAGE AND ADMINISTRATION
Initial Treatment
Dosage for Adults
Major Depressive Disorder and Obsessive-Compulsive Disorder

Sertraline hydrochloride treatment should be administered at a dose of 50 mg once daily.
Panic Disorder, Posttraumatic Stress Disorder and Social Anxiety Disorder

Sertraline hydrochloride treatment should be initiated with a dose of 25 mg once daily. After one week, the dose should be increased to 50 mg once daily.

While a relationship between dose and effect has not been established for major depressive disorder, OCD, panic disorder, PTSD or social anxiety disorder, patients were dosed in a range of 50-200 mg/day in the clinical trials demonstrating the effectiveness of Sertraline hydrochloride for the treatment of these indications. Consequently, a dose of 50 mg, administered once daily, is recommended as the initial therapeutic dose. Patients not responding to a 50 mg dose may benefit from dose increases up to a maximum of 200 mg/day. Given the 24 hour elimination half-life of Sertraline hydrochloride, dose changes should not occur at intervals of less than 1 week.

Information Associated with Product:
DRUG DESCRIPTION DOSAGE SIDE EFFECTS PRECAUTIONS INTERACTION CONSUMER INFORMATION
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