Pfizer Corporation Hong Kong Limited 美國輝瑞科研製藥

Indications¹

Zoloft® is indicated for the treatment of symptoms of depression, obsessive-compulsive disorder (OCD), pediatric patients with OCD, panic disorder with or without agoraphobia, post-traumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), and social anxiety disorder.

Safety Profile¹

VERY COMMON AND COMMON ADVERSE EVENTS: Diarrhea/loose stools, dry mouth, dyspepsia, nausea, anorexia, dizziness, somnolence, tremor, insomnia, sexual dysfunction (principally ejaculatory delay in males) and increased sweating.

DRUG INTERACTIONS: Monoamine oxidase inhibitors (MAOIs), alcohol, lithium, phenytoin, pimozide, sumatriptan, other serotonergic drugs which enhance the effects of serotonergic neurotransmission (eg, tryptophan, fenfluramine, 5-HT agonists, and St. John’s Wort), protein-bound drugs, warfarin, diazepam, tolbutamide, cimetidine, and drugs metabolized by cytochrome P450 (CYP) 2D6.

Dosages¹

Adults

Depression and OCD: Initially 50 mg/day; dose changes made at intervals of at least 1 week, up to a maximum of 200 mg/day
Panic disorder, PTSD, social anxiety disorder: Initially 25 mg/day; increase to 50 mg daily after 1 week; dose changes made at intervals of at least 1 week, up to maximum of 200 mg/day
PMDD: Initially 50 mg/day throughout the menstrual cycle or limited to the luteal phase; dose increased up to 150 mg/day (at 50-mg increments/menstrual cycle) or 100 mg/day during luteal phase

Children

OCD (13–17 years): Initially 50 mg/day
OCD (6–12 years): Initially 25 mg/day; increased to 50 mg/day after 1 week; subsequent dose titration may be made in 50 mg/day increments up to a maximum of 200 mg/day

Strengths¹

50 mg

Packing¹

Film-coated tablet: 50 mg x 30's

Important Safety Information

COMMON ADVERSE EVENTS: Diarrhea/loose stools, dry mouth, dyspepsia, nausea, anorexia, dizziness, somnolence, tremor, insomnia, sexual dysfunction (principally ejaculatory delay in males) and increased sweating.

CONTRAINDICATIONS: Concomitant use with monoamine oxidase inhibitors (MAOIs) and pimozide; hypersensitivity to sertraline

SAFETY PRECAUTIONS: The development of potentially life-threatening syndromes like serotonin syndrome (SS) or neuroleptic malignant syndrome (NMS) has been reported with selective serotonin reuptake inhibitors (SSRIs), including sertraline. The risk of SS or NMS with SSRIs is increased with concomitant use of serotonergic drugs, drugs that impair metabolism of serotonin, antipsychotics and other dopamine antagonists. Zoloft® should not be used in combination with a MAOI or within 14 days of discontinuing MAOI treatment.

Exercise caution during concomitant use with serotonergic drugs that enhance the effects of serotonergic neurotransmission (tryptophan, fenfluramine, 5-HT agonists and St. John’s Wort), and switching from other SSRIs especially fluoxetine, antidepressants or anti-obsessional drugs.

Activation of mania/hypomania has been reported in a small proportion of patients with major affective disorder treated with other marketed antidepressant and anti-obsessional durgs. Since sertraline has not been evaluated in patients with a seizure disorder, it should be avoided in patients with unstable epilepsy; patients with controlled epilepsy should be carefully monitored. Sertraline should be discontinued in any patient who develops seizures.

Patients should be closely supervised during the early course of therapy for suicidality. Observe care in concomitant use of drugs known to affect platelet function (eg, atypical antipsychotics and phenothiazines, most tricyclic antidepressants, aspirin and non-steroidal anti-inflammatory drugs [NSAIDs] as well as in patients with a history of bleeding disorders).

Hyponatremia and/or the syndrome of inappropriate antidiuretic hormone secretion (SIADH) may occur especially in patients who are volume-depleted, belong to the elderly group, and are taking diuretics. A lower or less frequent dose should be used in patients with hepatic impairment. Zoloft® may impair ability to drive or operate machinery.

POST-MARKETING ADVERSE EVENTS: Leucopenia, thrombocytopenia, palpitations, tachycardia, tinnitus, hyperprolactinemia, hypothyroidism, syndrome of inappropriate ADH secretion (SIADH), mydriasis, abnormal vision; abnormal pain, constipation, pancreatitis, vomiting; asthenia, chest pain, peripheral edema, fatigue, fever, malaise; serious liver events, asymptomatic elevations in serum transaminases (SGOT and SGPT); allergic reaction, allergy, anaphylactoid reaction, abnormal clinical laboratory results, altered platelet function, increased serum cholesterol; weight decrease, weight increase, increased appetite; hyponatremia, arthralgia, muscle cramps; coma, convulsions, headache, hypoesthesia, migraine, movement disorders, involuntary muscle contractions, paresthesia; syncope, aggressive reaction, agitation, anxiety, depressive symptoms, euphoria, hallucination, decreased libido, paroniria, psychosis; enuresis, urinary incontinence, urinary retention; galactorrhea, gynecomastia, menstrual irregularities, priapism; bronchospasm, yawning, alopecia, angioedema, face edema, periorbital edema; photosensitivity skin reaction, pruritus, rash, urticaria, abnormal bleeding; hot flushes, hypertension, and discontinuation symptoms including agitation, anxiety, dizziness, headache, nausea and paresthesia

INTERACTIONS: MAOIs, alcohol, lithium, phenytoin, pimozide, sumatriptan, other serotonergic drugs which enhance the effects of serotonergic neurotransmission (eg, tryptophan, fenfluramine, 5-HT agonists, and St. John’s Wort), protein-bound drugs, warfarin, diazepam, tolbutamide, cimetidine, and drugs metabolized by cytochrome P450 (CYP) 2D6.

PREGNANCY and LACTATION: Pregnancy Category C – Use of Zoloft® in nursing mothers is not recommended unless physician assessment determines that the benefit outweighs the risk.

Please refer to the full prescribing information for safety information.

Please review the full product information or package insert before prescribing.

Reference

Zoloft® (sertraline) Prescribing Information . Pfizer Corporation Hong Kong Limited: 20 July 2009.

Please review the full product information or package insert before prescribing.

ZOL11001P