Exulten

Exulten

sertraline

Manufacturer:

Medichem

Distributor:

United Lab
Concise Prescribing Info
Contents
Sertraline HCl
Indications/Uses
Major depressive disorder (MDD), obsessive-compulsive disorder (OCD) in adult & childn 6-17 yr, panic disorder w/ or w/o agoraphobia, post-traumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD) & social anxiety disorder/social phobia.
Dosage/Direction for Use
Adult MDD & OCD Initially 50 mg once daily. Dose increase should be made in 50 mg intervals at least 1 wk. Max dose: 200 mg/day. Panic disorder w/ or w/o agoraphobia, PTSD, social anxiety disorder Initially 25 mg once daily. Dose may be increased to 50 mg at intervals of at least 1 wk. Max dose: 200 mg/day. PMDD Initially 50 mg once daily, may be increased (at 50 mg increments/menstrual cycle) up to 150 mg/day throughout menstrual cycle or 100 mg/day during luteal phase of menstrual cycle. OCD Childn 13-17 yr 50 mg once daily, 6-12 yr 25 mg once daily. Dose may be increased to 50 mg once daily after 1 wk. Max: 200 mg/day.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ MAOIs & pimozide.
Special Precautions
Not to be used in treating bipolar depression. Patients w/ seizure disorder; disease or conditions that could affect metabolism or hemodynamic response. Increased risk of suicidal thinking & behavior in patients w/ MDD. Monitor signs & symptoms of serotonin syndrome or neuroleptic malignant syndrome-like reactions. May activate mania/hypomania; cause wt loss; decrease serum uric acid; increase risk of bleeding & alter platelet function &/or abnormal laboratory results. Monitor signs & symptoms of glucose fluctuations & glycemic control in diabetic patients. Discontinue use in patients w/ symptomatic hyponatremia. Avoid abrupt w/drawal. Concomitant use of serotonergics (including triptans, fentanyl), antipsychotics or other dopamine antagonists; aspirin, NSAIDs, warfarin & other anticoagulants. May impair ability to drive or operate machinery. Pregnancy & lactation. Not to be used in childn <18 yr (except for OCD in childn 6-17 yr). Elderly.
Adverse Reactions
Fatigue, pain, back pain, malaise, asthenia, fever, rigors; hot flushes, flushing, palpitation, vasodilation, chest pain, HTN, aggravated HTN, pulmonary HTN, hypotension, postural hypotension, tachycardia, ventricular tachycardia (including torsades de pointes-type arrhythmia), bradycardia, postural dizziness, edema (periorbital, peripheral, dependent, generalized, face), peripheral ischemia, syncope, precordial chest pain, substernal chest pain, MI, cerebrovascular disorder, AV block, atrial arrhythmias, QT-interval prolongation; anorexia; thirst; increased appetite; increased wt; hypoglycemia; hyperglycemia; DM; increased total cholesterol, triglycerides; decreased serum uric acid; hypothyroidism; hyperprolactinemia; ejaculation failure; increased/decreased libido; impotence; priapism; dry mouth, aggravated tooth caries, gum hyperplasia, hiccups, increased saliva, dyspepsia, dysphagia, abdominal pain, vomiting, constipation, esophagitis, gastroenteritis, stomatitis, aphthous stomatitis, gastritis, hemorrhagic peptic ulcer, proctitis, ulcerative stomatitis, melena, glossitis, eructation, diarrhea/loose stools, tenesmus, colitis, diverticulitis, fecal incontinence, rectum hemorrhage, pancreatitis; anemia, aplastic anemia, agranulocytosis, pancytopenia, leukopenia, thrombocytopenia, lupus-like syndrome, serum sickness, increased coagulation time; abnormal hepatic function, asymptomatic elevations in serum transaminases, increased bilirubin, hepatomegaly, hepatitis, jaundice, liver failure; myalgia, arthralgia, dystonia, arthrosis, muscle cramps, muscle weakness; nausea, dizziness, vertigo, headache, migraine, tremor, twitching, hypertonia, paresthesia, hypoesthesia, hyperesthesia, hyperkinesia, hypokinesia, hypotonia, hyporeflexia, ataxia, abnormal coordination, choreoathetosis, extrapyramidal symptoms, leg cramps, abnormal gait, dyskinesia, depression, aggravated depression, anxiety, confusion, amnesia, insomnia, somnolence, paroniria, abnormal dreams, somnambulism, illusion, euphoria, paranoid reaction, hallucination, emotional lability, apathy, psychosis, aggressive reaction, agitation, nervousness, delusions, withdrawal syndrome, suicide ideation, serotonin syndrome, dysphonia, teeth-grinding, coma; rash (erythematous, maculopapular, follicular, pustular), increased sweating, cold clammy skin, pallor, allergic reaction, allergy, anaphylactoid reaction, angioedema, pruritus, acne, urticaria, alopecia, dry skin, photosensitivity reaction, eczema, dermatitis, contact dermatitis, bullous eruption, hypertrichosis, skin discoloration, Stevens-Johnson syndrome; polyuria, dysuria, nocturia, oliguria, hematuria, urinary incontinence, urinary retention, cystitis, pyelonephritis, renal pain, strangury, acute renal failure, gynecomastia, menstrual disorder, dysmenorrhea, intermenstrual bleeding, vag hemorrhage, atrophic vaginitis, amenorrhea, menorrhagia, leukorrhea, balanoposthitis, female breast pain, breast enlargement, galactorrhea, acute female mastitis; rhinitis, coughing, dyspnea, upper resp tract infection, epistaxis, bronchospasm, sinusitis, hyperventilation, bradypnea, stridor, apnea, bronchitis, hemoptysis, hypoventilation, laryngismus, laryngitis, yawning; abnormal vision, mydriasis, glaucoma, nystagmus, ptosis, exophthalmos, anterior chamber eye hemorrhage, blindness, optic neuritis, cataract, tinnitus, conjunctivitis, eye pain, abnormal accommodation, xerophthalmia, photophobia, diplopia, oculogyric crisis, abnormal lacrimation, scotoma, visual field defect, tongue edema, tongue ulceration, hyperacusis, labyrinthine disorder, earache.
Drug Interactions
MAOIs (selegiline, moclobemide, linezolid). Increased Cmax & AUC w/ pimozide. Avoid alcohol intake. Reduced plasma levels w/ phenytoin. Potential serotonin syndrome w/ drugs affecting serotonergic neurotransmitter system eg, triptans, linezolid, lithium, tramadol & St. John's wort. May cause weakness, hyperreflexia, incoordination, confusion, anxiety & agitation w/ sumatriptan. Increase in tremor w/ lithium. Altered plasma conc level resulting in adverse effects w/ protein bound drugs (eg, warfarin, digoxin). Increased risk of abnormal bleeding w/ drugs that interfere w/ hemostasis (eg, NSAIDs, aspirin, warfarin). Decreased clearance w/ cimetidine. Valproate, CNS-active drugs (eg, diazepam), hypoglycemic drugs (eg, tolbutamide, glibenclamide, biguanides). Drugs metabolized by cytochrome P450 (CYP) 2D6 eg, class I antiarrhythmics (eg, propafenone, flecainide, TCAs & other typical antipsychotics). Microsomal enzyme induction.
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
Exulten tab 50 mg
Packing/Price
30's (P1,612.5/pack, P53.75/tab)
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