Sertraline Hydrochloride Tablets 100mg - 10tab

Indications and Usage

Treatment of major depressive disorder; treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD); treatment of panic disorder with or without agoraphobia; treatment of posttraumatic stress disorder (PTSD); treatment of premenstrual dysphoric disorder; treatment of social anxiety disorder (social phobia).

Unlabeled Uses

Cholestatic pruritus, hot flashes, nocturnal enuresis. Contraindications Hypersensitivity to any components; concomitant use in patients taking MAOIs or pimozide; oral concentrate is contraindicated with disulfiram because of the alcohol content in the oral concentrate.

Dosage

SSRI. Depression: Patients > 18 years of age: Initially, 50 mg once daily; increase dosage gradually, if needed, at 1-week intervals. Maximum: 200 mg/day. Maintenance: lowest effective dose. Panic disorder: 25 mg once daily and increase, if necessary, by 50 mg increments at intervals of no less than 1 week, to a maximum of 200 mg/day. Obsessive-compulsive disorder (OCD): Initially, 50 mg/day. Thereafter, increase the dosage, if necessary, by 50 mg increments, over several weeks or months, to a maximum of 200 mg/day. Sertraline effectiveness for more than 12 weeks of therapy in panic disorder and OCD not yet established.

Contraindications

Not to be use with an MAOI or within 14 days of starting or discontinuing MAOI therapy. Concomitant use with pimozide.

Drug Interactions

5-HT 1 agonists (eg, naratriptan, rizatriptan, sumatriptan, zolmitriptan) Weakness, hyperreflexia, and incoordination reported rarely. Alcohol, CNS depressants May enhance CNS depressant effects. Alcohol use is not recommended. Carbamazepine Sertraline plasma levels may be reduced, decreasing the pharmacologic effects. Cimetidine Increased sertraline AUC (50%), C max (24%), and half-life (26%). Cisapride Concurrent use reduced cisapride AUC and C max by approximately 35%. Clozapine Elevated serum clozapine levels have occurred. Closely monitor patients during coadministration. Cyclosporine Elevated cyclosporine levels may occur. Cyproheptadine May decrease the pharmacologic effects of sertraline. Diazepam IV Cl for diazepam decreased 32%. Disulfiram Sertraline oral concentrate is contraindicated with disulfiram because of the oral concentrate's alcohol content. Drugs highly bound to plasma proteins (eg, warfarin, digitoxin) May cause a shift in plasma concentrations resulting in adverse reactions. Drugs interfering with hemostasis (eg, aspirin, non-selective NSAIDs [eg, ibuprofen], warfarin) Risk of bleeding may be increased. Drugs metabolized by CYP2D6 (eg, carvedilol, risperidone) Plasma concentrations of these drugs may be elevated, increasing the pharmacologic effects and adverse reactions. Hydantoins (eg, phenytoin) Plasma levels may be increased by sertraline, increasing the pharmacologic effects and adverse reactions. L-tryptophan Concurrent use is not recommended. Lithium, macrolide antibiotics (eg, erythromycin), metoclopramide, sibutramine, sympathomimetics, tramadol, trazodone Risk of serotonin syndrome may be increased. MAOIs, linezolid May cause serious, even fatal reactions. Concomitant use is contraindicated. Discontinue MAOIs at least 14 days before starting sertraline; at least 14 days should be allowed after stopping sertraline before starting an MAOI. Pimozide Increase in pimozide AUC and C max of about 40%; coadministration is contraindicated. St. John's wort Sedative-hypnotic effects of sertraline may be increased. Avoid concurrent use. Tolbutamide Sertraline significantly decreased the Cl of tolbutamide (16%). Tricyclic antidepressants (eg, amitriptyline) Pharmacologic and toxic effects may be increased by sertraline; “serotonin syndrome” has been reported. Type 1C antiarrhythmics (eg, flecainide, propafenone) Plasma levels may be increased. Monitor cardiac function. Zolpidem Onset of action of zolpidem may be shortened and the effect increased. Laboratory Test Interactions None well documented.

Adverse Reactions

Cardiovascular Palpitations, chest pain (at least 1%); increased coagulation times, bradycardia, AV block, atrial arrhythmias, QT-interval prolongation, ventricular tachycardia (including torsades de pointes) (postmarketing). CNS Headache (25%); insomnia (21%); somnolence (13%); dizziness, fatigue (12%); malaise (9%); tremor (8%); decreased libido (6%); agitation, nervousness (5%); anxiety (4%); aggressive reaction, hyperkinesia (at least 2%); paresthesia (2%); asthenia, hypertonia, hypesthesia (at least 1%); extrapyramidal symptoms, NMS, oculogyric crisis, psychosis, serotonin syndrome (postmarketing). Dermatologic Sweating (7%); rash (3%); photosensitivity, Stevens-Johnson syndrome, vasculitis (postmarketing). EENT Abnormal vision (3%); tinnitus (at least 1%); blindness, cataract, optic neuritis (postmarketing). GI Nausea (25%); diarrhea (20%); dry mouth (14%); dyspepsia (8%); abdominal pain, anorexia, constipation (6%); vomiting (4%); increased appetite (at least 1%); pancreatitis (postmarketing). Genitourinary Abnormal ejaculation (14%); sexual dysfunction, urinary incontinence (at least 2%); impotence (at least 1%); priapism; acute renal failure (postmarketing). Hematologic Purpura (at least 2%); agranulocytosis, aplastic anemia, leukopenia, lupus-like syndrome, pancytopenia, serum sickness, thrombocytopenia (postmarketing). Hepatic Elevated liver enzymes (1%); increased bilirubin, hepatomegaly, hepatitis, jaundice, liver failure (postmarketing). Lab Tests Decrease in serum uric acid (7%); increased triglycerides (5%); increase in total cholesterol (3%). Metabolic Increased weight (at least 1%); hyperglycemia, hypothyroidism (postmarketing). Respiratory Epistaxis, sinusitis (at least 2%); rhinitis (at least 1%). Miscellaneous Pain (6%); fever, pain, weight loss (at least 2%); back pain, myalgia, yawning (at least 1%); anaphylaxis, angioedema, galactorrhea, hyperprolactinemia, pulmonary hypertension (postmarketing).

Precautions

Warnings Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in short-term studies in children, adolescents, and young adults with major depressive disorders and other psychiatric disorders. Closely observe all patients who are started on therapy for clinical worsening, suicidality, or unusual changes in behavior.

Overdosage

Symptoms Agitation, alopecia, bradycardia, bundle branch block, coma, convulsions, decreased libido, delirium, diarrhea, dizziness, ejaculation disorder, fatigue, hallucinations, hypertension, hypotension, insomnia, manic reaction, nausea, pancreatitis, QT-interval prolongation, serotonin syndrome, somnolence, stupor, syncope, tachycardia, tremor, vomiting.

Patient Information

* Advise patient to read patient information leaflet before starting therapy and with each refill. * If patient is a child or adolescent, advise patient, family, or caregiver to read the Medication Guide About Using Antidepressants in Children and Teenagers before starting therapy and with each refill. * Advise patient that medication usually is started at a low dose and then gradually increased until max benefit is obtained. * Advise patient to take prescribed dose once daily in the morning or evening without regard to meals but to take with food if stomach upset occurs. * Caution patient or caregiver that oral concentrate must be diluted before administration. Advise patient or caregiver to measure prescribed dose of oral concentrate using calibrated syringe and mix, immediately before use, with 4 oz (½ cup) of water, ginger ale, lemon/lime soda, lemonade or orange juice, and administer immediately after mixing. Caution patient or caregiver not to prepare ahead of time. * Caution patient or caregiver not to dilute oral concentrate with any other liquid than those previously noted. Advise patient or caregiver that a slight haze may appear after mixing oral concentrate but that this is expected and is not a concern. * Inform patient that it may take 1 to 4 wk to note improvement in symptoms and to continue with the prescribed therapy once improvement has been noted. * Instruct patient to notify health care provider if symptoms do not appear to be getting better, or if they worsen, or if bothersome adverse reactions (eg, unusual sweating, headache, drowsiness, insomnia, nausea, diarrhea, nervousness, changes in sexual function) occur. * Advise all patients, and family or caregiver of patient, to be alert for abnormal changes in mood or thinking and to immediately report any of the following to health care provider: anxiety; agitation; panic attacks; insomnia; irritability; hostility or aggressiveness; impulsivity; akathisia (psychomotor restlessness); suicidal thoughts or behavior. Advise families and caregivers of patients to observe for emergence on a day-to-day basis, because changes may be abrupt. * Advise patient that if medication needs to be discontinued it will be slowly withdrawn unless safety concerns (eg, rash) require a more rapid withdrawal. * Advise patient to take frequent sips of water, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs. * Advise patient to avoid alcoholic beverages and other depressants while taking sertraline. * Advise patient that drug may impair judgment, thinking, or reflexes, and to use caution while driving or performing other activities requiring mental alertness until tolerance is determined. * Instruct patient not to take any prescription or OTC drugs, including aspirin or NSAIDs (eg, ibuprofen), herbal preparations, or dietary supplements without consulting health care provider.