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Zoloft/Zoloft ODT

Zoloft/Zoloft ODT

sertraline

Manufacturer:

Viatris

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Sertraline HCl
Indications/Uses
Symptoms of depression including depression accompanied by symptoms of anxiety, in patients w/ or w/o history of mania. Obsessive-compulsive disorder (OCD) in adults & ped patients ≥6 yr. Panic disorder w/ or w/o agoraphobia; PTSD; social phobia; premenstrual dysphoric disorder (PMDD).
Dosage/Direction for Use
Depression & OCD 50 mg daily. Max: 200 mg daily. Panic disorder, PTSD & social phobia Initially 25 mg daily. May be increased to 50 mg once daily after 1 wk. Max: 200 mg daily. Dose changes should be made at least 1-wk intervals & not >1/wk. Max: 150 mg daily. PMDD Initially 50 mg daily (either daily throughout menstrual cycle or limited to luteal phase of menstrual cycle). May increase at 50 mg increments/menstrual cycle up to 150 mg daily when dosing daily throughout menstrual cycle, or 100 mg daily when dosing during luteal phase of menstrual cycle. Luteal phase dosing (100 mg daily): Titrate at 50 mg daily for 3 days at the start of each luteal phase dosing period. OCD Ped patient 13-17 yr Initially 50 mg daily, 6-12 yr Initially 25 mg daily increasing to 50 mg daily after 1 wk. Subsequent doses may be increased up to 200 mg daily. Dose changes should not occur at intervals <1 wk.
Administration
May be taken with or without food: Zoloft ODT: Place in the mouth, on the tongue & let it disintegrate then swallow. May be taken w/ or w/o water.
Contraindications
Hypersensitivity. Concomitant use w/ MAOI(s) & pimozide.
Special Precautions
Discontinue treatment if seizure develops. Consider discontinuation of treatment in patients w/ symptomatic hyponatremia. Avoid use in patients w/ unstable epilepsy. Increased risk of serotonin syndrome or NMS w/ concomitant use of serotonergic drugs including amphetamines, triptans & opioids (eg, fentanyl & its analogues, tramadol, dextromethorphan, tapentadol, meperidine, methadone, pentazocine), w/ drugs that impair serotonin metabolism (including MAOIs), antipsychotics & other dopamine antagonists; bone fractures. Monitor patients for signs & symptoms of serotonin syndrome or NMS including mental status changes (eg, agitation, hallucinations, coma), autonomic instability (eg, tachycardia, labile BP, hyperthermia), neuromuscular aberrations (eg, hyperreflexia, incoordination) &/or GI symptoms (eg, nausea, vomiting, diarrhea), & those resembling NMS including hyperthermia, muscle rigidity, autonomic instability w/ possible rapid fluctuation of vital signs & mental status changes; clinical worsening, suicidal behavior or thoughts & unusual behavioral changes especially when initiating therapy or during any change in dose or dosage regimen; signs & symptoms of glucose fluctuations; w/ controlled epilepsy. QTc prolongation/Torsades de pointes. Mania/hypomania activation; seizures. Risk of suicide attempt in depressed patients. Observe patients w/ depression while treating OCD, panic disorder, PTSD or social phobia. Long-lasting sexual dysfunction. Bleeding abnormalities from ecchymoses & purpura to life-threatening hemorrhage. Hyponatremia as result of SIADH particularly in elderly & patients taking diuretics or who are vol-depleted. Loss of glycemic control including both hyper-/hypoglycemia in patients w/ & w/o pre-existing diabetes. Patients w/ QTc prolongation risk factors; history of bleeding disorders & glaucoma; angle-closure glaucoma. Carefully monitor glycemic control in diabetic patients. False +ve urine immunoassay screening test for benzodiazepines & may expect for several days following discontinuation of therapy. Avoid co-administration w/ amphetamines, tryptophan, fenfluramine & fentanyl, 5-HT agonists, or St. John's wort (Hypericum perforatum). Not be used in combination w/ MAOI including selegiline (selective), moclobemide (reversible), linezolid (reversible, non-selective) & methylene blue, or w/in 14 days of discontinuing treatment w/ MAOI. Switching therapy from SSRIs, antidepressants or anti-obsessional drugs particularly from long-acting agents eg, fluoxetine. Concomitant use w/ SSRIs, drugs affecting platelet function (eg, atypical antipsychotics & phenothiazines, most TCAs, aspirin & NSAIDs). May impair ability to drive or operate machinery. Hepatic impairment. Women of childbearing potential should use adequate method of contraception during therapy. Pregnancy & lactation. Increased risk of suicidality in childn, adolescents, & young adults (18-24 yr) w/ major depression & other psychiatric disorders. Monitor growth & development abnormalities in ped patients 6-16 yr on long-term treatment.
Adverse Reactions
Insomnia; dizziness, headache; diarrhoea, nausea. Decreased/increased appetite; depressive symptoms, anxiety, agitation, bruxism, nightmare, decreased libido; hypertonia, tremor, somnolence, paraesthesia; visual impairment; tinnitus; palpitations; hot flush; yawning; vomiting, constipation, abdominal pain, dry mouth, dyspepsia; rash, hyperhidrosis; arthralgia; ejaculation disorder, sexual dysfunction, irregular menstruation; chest pain, malaise, pyrexia, asthenia, fatigue; increased wt. TEN, SJS.
Drug Interactions
Increased risk of QT prolongation &/or ventricular arrhythmias w/ QTc prolonging drugs eg, antipsychotics & antibiotics. May cause reduction of plasma levels w/ phenytoin. Significant increase in prothrombin time w/ warfarin. Changes in pharmacokinetic parameters w/ diazepam or tolbutamide. Decreased clearance w/ cimetidine. Reduced plasma conc w/ metamizole. Concomitant use w/ alcohol, lithium, sumatriptan, protein-bound drugs, CYP2D6 substrates w/ narrow therapeutic index including TCAs & class 1c antiarrhythmics (eg, propafenone & flecainide).
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
Zoloft FC tab 100 mg
Packing/Price
30's
Form
Zoloft FC tab 50 mg
Packing/Price
60's
Form
Zoloft ODT OD tab 50 mg
Packing/Price
30's
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