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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, in patients w/ or w/o history of mania. Treatment of obsessive-compulsive disorder (OCD); ped patients ≥6 yr 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 Initially 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 may be increased at interval of at least 1 wk, up to max 200 mg daily. Change in dose should not be made more frequently than once per wk. PMDD Adult Initially 50 mg daily, either daily throughout the menstrual cycle or limited to luteal phase of menstrual cycle. May be increased at 50 mg increments/menstrual cycle, up to 150 mg daily when dosing daily throughout the menstrual cycle, 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
Reports of serotonin syndrome or NMS; QTc prolongation/torsade de pointes; activation of mania/hypomania; bleeding abnormalities; new-onset DM, loss of glycemic control including both hyperglycemia & hypoglycemia. Caution when switching from SSRIs, antidepressants or anti-obsessional drugs. Avoid use in patients w/ unstable epilepsy, & controlled epilepsy should be carefully monitored; discontinue use if patient develops seizure. Monitor for any clinical worsening, suicidal behavior or thoughts & unusual changes in behavior especially when initiating therapy or during any change in dose or dosage regimen. May cause sexual dysfunction. Risk of hyponatremia. Increased risk of bone fractures. May have an effect on pupil size resulting in mydriasis. 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. False +ve urine immunoassay screening tests for benzodiazepines. Caution in patients w/ hepatic insufficiency. May impair mental or physical abilities required for performing hazardous tasks eg, driving or operating machinery. Employ an adequate method of contraception in women of childbearing potential. Should only be used during pregnancy if perceived benefits outweigh risks. Not recommending during lactation unless benefits outweigh risks. Monitor childn & adolescent on long-term treatment for abnormalities in growth & development.
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, eosinophilic pneumonia, 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/ 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/ serotonergic drugs eg, amphetamines, tryptophan, fenfluramine, fentanyl, 5-HT agonists, or St. John's wort (Hypericum perforatum). Monitor prothrombin time when concomitantly used w/ warfarin. Changes in pharmacokinetic parameters w/ diazepam, tolbutamide. Decreased clearance w/ cimetidine. Minimal elevation of steady-state plasma levels of desipramine (CYP2D6 substrate). Reduced plasma conc w/ metamizole (enzyme inducer).
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
30's (P4,102.84/pack)
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