Zoloft

Zoloft

sertraline

Manufacturer:

Pfizer Manufacturing Deutschland

Distributor:

Viatris
Concise Prescribing Info
Contents
Sertraline HCl
Indications/Uses
Symptomatic treatment of depression including depression accompanied by symptoms of anxiety, patients w/ or w/o history of mania. Obsessive-compulsive disorder (OCD); ped patients w/ OCD; panic disorder w/ or w/o agoraphobia; PTSD; social phobia (social anxiety disorder); premenstrual dysphoric disorder (PMDD).
Dosage/Direction for Use
Depression & OCD 50 mg daily. Panic disorder, PTSD, & social phobia Initially 25 mg daily, increased to 50 mg once daily after 1 wk. Depression, OCD, panic disorder & PTSD Titration: Dose interval of at least 1 wk up to max: 200 mg daily. Change in dose should not be made more frequently than once/wk. PMDD Adult Initially 50 mg daily, either daily throughout the menstrual cycle or limited to luteal phase of menstrual cycle. May be increased to 50 mg increments/menstrual cycle up to 150 mg daily or 100 mg daily during the luteal phase. OCD Childn 13-17 yr Initially 50 mg daily, 6-12 yr Initially 25 mg daily, increased to 50 mg daily after 1 wk. May be increased subsequently in 50 mg daily increments up to 200 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ MAOIs & pimozide.
Special Precautions
Monitor for emergence of signs & symptoms of serotonin syndrome or NMS; glucose fluctuations. QTc prolongation/torsade de pointes. Switching from SSRIs, antidepressants or anti-obsessional drugs. Activation of mania/hypomania. Avoid use in patients w/ unstable epilepsy & controlled epilepsy should be carefully monitored; discontinue use if patient develops seizure. Suicide/suicidal thoughts or clinical worsening. Sexual dysfunction. History of bleeding disorders. Risk of hyponatremia in elderly or patients taking diuretics or who are vol-depleted; bone fractures. Loss of glycemic control including both hyperglycemia & hypoglycemia. Angle-closure glaucoma or history of glaucoma. Avoid co-administration w/ other drugs known to enhance effects of serotonergic neurotransmission eg, amphetamines, tryptophan, fenfluramine & fentanyl, 5-HT agonists or St. John's wort; drugs known to affect platelet function (eg, atypical antipsychotics & phenothiazines, TCAs, aspirin & NSAIDs). False +ve urine immunoassay screening tests. Hepatic insufficiency. May affect ability to drive & use machines. Employ an adequate method of contraception in women of childbearing potential. Pregnancy & lactation. Monitor childn & adolescent in long-term treatment for growth abnormalities & development. Elderly.
Adverse Reactions
Thrombocytopenia, leukopenia, abnormal platelet function test; anaphylactoid reaction, hypersensitivity; inappropriate antidiuretic hormone secretion, hyperprolactinemia, hypothyroidism; DM, hyponatremia, hypo/hyperglycemia, decreased/increased appetite; psychotic disorder, hallucination, aggression, confusional state, euphoric mood, depressive symptoms, anxiety, agitation, bruxism, nightmare, decreased libido, insomnia; serotonin syndrome, coma, convulsion, dystonia, akathisia, syncope, extrapyramidal disorder, involuntary muscle contractions, hypoesthesia, hyperkinesia, migraine, hypertonia, tremor, somnolence, paresthesia, dizziness, headache; visual impairment, mydriasis, periorbital edema; tinnitus; torsade de pointes; prolonged ECG QT, increased blood cholesterol, palpitations, tachycardia; cerebral vasoconstriction (including reversible cerebral vasoconstriction & Call-Fleming syndrome), hemorrhage, HTN, hot flush; bronchospasm, epistaxis, yawning; GI hemorrhage, pancreatitis, diarrhea, nausea, vomiting, constipation, abdominal pain, dry mouth, dyspepsia; liver injury, increased ALT & AST; TEN, SJS, angioedema, exfoliative rash, photosensitivity skin reaction, urticaria, purpura, pruritus, alopecia, rash, hyperhidrosis; rhabdomyolysis, trismus, muscle spasms, arthralgia; urinary retention/incontinence, hematuria, enuresis; priapism, galactorrhea, gynecomastia, ejaculation disorder, sexual dysfunction, irregular menstruation; face edema, drug w/drawal syndrome, gait disturbance, peripheral edema, chest pain, malaise, pyrexia, asthenia, fatigue; decreased/increased wt, abnormal lab tests; fracture.
Drug Interactions
Increased pimozide levels. Should not be used in combination or w/in 14 days of discontinuing treatment w/ disulfiram or MAOIs. Risk of QTc prolongation &/or ventricular arrhythmias w/ drugs that prolong QTc intervals eg, some antipsychotics & antibiotics. Not recommended in concomitant use w/ alcohol. Increased tremor w/ lithium. Reduced plasma levels w/ phenytoin. Serious reactions, sometimes fatal w/ MAOIs. Enhanced effects of serotonergic neurotransmission w/ amphetamines, tryptophan, fenfluramine, fentanyl, 5-HT agonists, or St. John's wort (Hypericum perforatum). Monitor prothrombin time w/ warfarin. Changes in pharmacokinetic parameters w/ diazepam, tolbutamide. Decreased clearance w/ cimetidine. Minimal elevation of steady-state plasma levels of desipramine. Sumatriptan; TCAs, 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 tab 50 mg
Packing/Price
28's (P3,717.78/pack);30's (P4,102.84/pack)
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