Serlin 50

Serlin 50

sertraline

Manufacturer:

Zydus Cadila

Distributor:

Pharmaland
Concise Prescribing Info
Contents
Sertraline HCl
Indications/Uses
Depression, obsessive-compulsive disorder, & panic disorder w/ or w/o agoraphobia, PTSD, social phobia, premenstrual dysphoric disorder (PMDD).
Dosage/Direction for Use
Depression & obsessive-compulsive disorder Initially 50 mg once daily. Dose change should be made at least 1-wk interval, max 200 mg daily. Panic disorder, PTSD & social phobia Initially 25 mg once daily. May be increased to 50 mg once daily after 1 wk. Max: 200 mg daily. PMDD Initially 50 mg once daily, during menstrual cycle or luteal phase of menstrual cycle. May be increased by 50 mg increment/menstrual cycle up to 150 mg daily during menstrual cycle or 100 mg daily during luteal phase of menstrual cycle. Obsessive-compulsive disorder Childn 13-17 yr Initially 50 mg daily, 6-12 yr Initially 25 mg daily increased to 50 mg daily after 1 wk. Subsequent doses may be increased in 50 mg daily increments up to 200 mg daily, as needed.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ MAOIs or pimozide.
Special Precautions
Discontinue use in patients who develop seizures. Avoid use in patients w/ unstable epilepsy. Hypomania or mania; possibility of suicide attempt. Patients w/ history of mania. Carefully monitor patients w/ controlled epilepsy. Closely supervise patients during early course of therapy. Not to be used in combination w/ MAOI; allow 14 days interval before starting MAOI after sertraline. Avoid use w/ drugs that enhance effects of serotonergic neurotransmission (eg, tryptophan or fenfluramine or 5-HT agonists. Switching from SSRIs, antidepressants or anti-obsessional drugs. Hepatic disease. Renal impairment. Pregnancy & lactation.
Adverse Reactions
Diarrhea, dry mouth, dyspepsia, nausea, abdominal pain, constipation, pancreatitis, vomiting; anorexia, increased appetite, hyponatremia; dizziness, somnolence, tremor, coma, convulsions, headache, hypoesthesia, migraine, movement disorders; sexual dysfunction, galactorrhea, gynecomastia, menstrual irregularities; increased sweating; leucopenia, thrombocytopenia; palpitation, tachycardia; tinnitus; hyperprolactinemia, hypothyroidism, SIADH; mydriasis, abnormal vision; asthenia, chest pain, peripheral edema, fever, malaise; arthralgia, muscle cramps; aggression, agitation, anxiety, depression, euphoria, hallucination, decreased libido, paroniria, psychosis; urinary incontinence & retention; abnormal bleeding (eg, epistaxis, GI bleeding, hematuria), hot flushes, HTN.
Drug Interactions
Increased level/effect of selected β-blockers, bupropion, selected benzodiazepines, Ca channel blockers, cisapride, cyclosporine, dextromethorphan, ergot alkaloids, fluoxetine, paroxetine, phenytoin, risperidone, selegiline & sildenafil. Increased levels/effects w/ chlorpromazine, fluconazole, fluoxetine, fluvoxamine, gemfibrozil, INH, miconazole, omeprazole, quinine & ticlopidine. Increased risk of serotonin syndrome w/ buspirone, nefazodone, serotonin agonists (eg, sumatriptan), ritonavir, tramadol & venlafaxine. Increased risk of nephrotoxicity w/ lithium. Increased risk of hyponatremia w/ loop diuretics eg, bumetanide, furosemide, torsemide. Increased prothrombin time w/ warfarin. Concomitant use w/ alcohol in depressed patients. Increased risk of bleeding w/ NSAIDs, aspirin or other drug affecting coagulation. Increased plasma levels & risk of QTc interval prolongation w/ thioridazine or mesoridazine. Decreased levels/effects w/ aminoglutethimide, carbamazepine, phenytoin, rifampin.
MIMS Class
Antidepressants
ATC Classification
N06AB06 - sertraline ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
Presentation/Packing
Form
Serlin 50 FC tab 50 mg
Packing/Price
3 × 10's
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