HIGHLIGHT
Exulten

Exulten

sertraline

Manufacturer:

United Pharma

Distributor:

JDS
Concise Prescribing Info
Contents
Sertraline HCl
Indications/Uses
Major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder w/ or w/o agoraphobia, post-traumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), social anxiety disorder or phobia in adults. OCD in childn 6-17 yr.
Dosage/Direction for Use
Adult MDD & OCD Initially 50 mg once daily. Dose increases should be in steps of 50 mg at intervals of at least 1 wk. Max: 200 mg daily. Panic disorder, PTSD & social anxiety disorder Initially 25 mg once daily. Increase dose to 50 mg once daily after 1 wk. Dose increases should be in steps of 50 mg at intervals of at least 1 wk. Max: 200 mg daily. PMDD 50 mg once daily throughout the menstrual cycle or limited to the luteal phase of menstrual cycle. Dose may be increased (at 50 mg increments/menstrual cycle) up to 150 mg daily throughout menstrual cycle or 100 mg daily during luteal phase of menstrual cycle. Utilize 50 mg daily titration step for 3 days at the beginning of each luteal phase dosing period if 100 mg daily dose has been established w/ luteal phase dosing. OCD Childn 13-17 yr 50 mg once daily. Max: 200 mg daily, 6-12 yr 25 mg once daily. May be increased to 50 mg once daily after 1 wk. Max: 200 mg daily.
Administration
May be taken with or without food: May take in the morning or evening.
Contraindications
Hypersensitivity. Concomitant use w/ MAOIs & pimozide.
Special Precautions
Discontinue in patients w/ symptomatic hyponatremia. Not for use in bipolar depression. Screen patients w/ depressive symptoms if they are at risk of bipolar disorder prior to treatment. Increased risk of suicidal thinking & behavior in patients w/ MDD & other psychiatric disorders. Closely monitor for clinical worsening, suicidality or unusual changes in behavior. Avoid abrupt w/drawal. Activation mania/hypomania. May cause wt loss; decrease serum uric acid; alter platelet function &/or abnormal laboratory results. Patients w/ seizure disorder; diseases or conditions that could affect metabolism or hemodynamic responses. Monitor for signs & symptoms of serotonin syndrome or neuroleptic malignant syndrome; glucose fluctuations & glycemic control in diabetic patients. Not to be used w/ MAOI or w/in 14 days of discontinuing MAOI. Concomitant use w/ aspirin, NSAIDs, warfarin & other anticoagulants may increase risk of bleeding events. May impair ability required for performance of tasks eg, driving car or operating machinery. Pregnancy & lactation. Not to be used in childn & adolescents <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
Drugs metabolized by cytochrome P450 (CYP) 2D6 eg, class IC antiarrhythmics (eg, propafenone, flecainide, TCAs & other typical antipsychotics) may have clinically relevant interactions. Plasma levels may be reduced w/ phenytoin. Potential serotonin syndrome w/ drugs that may affect serotonergic neurotransmitter systems eg, triptans, linezolid, lithium, tramadol & St. John's wort. Weakness, hyperreflexia, incoordination, confusion, anxiety & agitation w/ sumatriptan. Increased tremor w/ lithium. May shift plasma conc resulting in adverse effects w/ tightly protein-bound drugs eg, warfarin, digoxin. Potentiate risk of abnormal bleeding w/ medicines that interfere w/ hemostasis eg, NSAIDs, aspirin, warfarin. Monitor plasma valproate levels. Decreased clearance w/ cimetidine. Small changes in pharmacokinetic parameters w/ CNS-active (eg, diazepam) & hypoglycemic (eg, tolbutamide, glibenclamide, biguanides) drugs. Microsomal enzyme induction. Contraindicated: MAOIs eg, selegiline, moclobemide (risk of serotonin syndrome), linezolid. Increased AUC & Cmax of pimozide. Not recommended: Alcohol; other SNRIs & SSRIs or tryptophan due to potential serotonin syndrome.
MIMS Class
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
3 × 10's
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