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 50 mg daily. Patients not responding to 50 mg dose may benefit from dose increases at intervals of at least 1 wk, up to max 200 mg daily. Dose changes should not be made more frequently than once per wk. Panic disorder, PTSD, & social phobia Initially 25 mg daily, increased to 50 mg once daily after 1 wk. Patients not responding to 50 mg dose may benefit from dose increases at intervals of at least 1 wk, up to max 200 mg daily. Dose changes 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. Patients not responding to 50 mg dose may benefit from dose increases 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. If 100 mg daily dose has been established w/ luteal phase dosing, utilize 50 mg daily titration step for 3 days at the beginning of each luteal phase during period. OCD Ped patient 13-17 yr Initially 50 mg daily. May be increased subsequently in 50 mg daily increments, up to 200 mg daily. Dose changes should not occur at intervals of <1 wk, 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. Dose changes should not occur at intervals of <1 wk.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ MAOIs & pimozide.
Special Precautions
Reports of development of potentially life-threatening syndromes eg, serotonin syndrome or NMS; QTc prolongation/torsade de pointes (TdP); activation of mania/hypomania; bleeding abnormalities; new-onset DM, loss of glycemic control including both hyperglycemia & hypoglycemia (in patients w/ or w/o preexisting diabetes). Monitor patients for emergence of signs & symptoms of serotonin syndrome or NMS. Caution in patients w/ risk factors for QTc prolongation; history of bleeding disorders; angle-closure glaucoma or history of glaucoma. Caution when switching from SSRIs, antidepressants or anti-obsessional drugs. Avoid use in patients w/ unstable epilepsy; carefully monitor patients w/ controlled epilepsy; 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 symptoms of 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. Reports of 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 recommended in nursing mothers unless benefits outweigh risks. Monitor ped patients 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; TdP, prolonged ECG QT, increased blood cholesterol, palpitations, tachycardia; cerebral vasoconstriction (including reversible cerebral vasoconstriction syndrome & 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 w/ or w/in 14 days of discontinuing treatment w/ disulfiram, MAOIs. Increased risk of QTc prolongation &/or ventricular arrhythmias (eg, TdP) w/ drugs that prolong QTc intervals (eg, some antipsychotics & antibiotics). Not recommended in concomitant use w/ alcohol. Increase in tremor w/ lithium. Reduced plasma levels w/ phenytoin. Rare post-marketing reports of weakness, hyperreflexia, incoordination, confusion, anxiety & agitation following use w/ sumatriptan. Reports of serious reactions, sometimes fatal, w/ MAOI including selegiline (selective MAOI), moclobemide (reversible MAOI), & linezolid (reversible non-selective MAOI) & methylene blue. Enhanced effects of serotonergic neurotransmission w/ other serotonergic drugs eg, amphetamines, tryptophan, fenfluramine, fentanyl, 5-HT agonists, or St. John's wort. Increase in 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 (marker of CYP2D6 isoenzyme activity). 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/box)