sertraline hydrochloride

(redirected from Gen-Sertraline)

sertraline hydrochloride

Apo-Sertraline (CA), Co Sertraline, Dom-Sertraline, Gen-Sertraline (CA), Lustral (UK), Novo-Sertraline (CA), Nu-Sertraline (CA), PHL-Sertraline (CA), PMS-Sertraline (CA), Ratio-Sertraline (CA), Riva-Sertraline (CA), Sandoz Sertraline (CA), Zoloft

Pharmacologic class: Selective serotonin reuptake inhibitor (SSRI)

Therapeutic class: Antidepressant

Pregnancy risk category C

FDA Box Warning

• Drug may increase risk of suicidal thinking and behavior in children and adolescents with major depressive disorder (MDD) and other psychiatric disorders. Risk must be balanced with clinical need, as depression itself increases suicide risk. With patient of any age, observe closely for clinical worsening, suicidality, and unusual behavior changes when therapy begins. Advise family and caregivers to observe patient closely and communicate with prescriber as needed.

• Drug isn't approved for treating MDD in pediatric patients.

Action

Inhibits neuronal uptake of serotonin in CNS, potentiating serotonin activity; has little effect on norepinephrine or dopamine uptake

Availability

Oral concentrate: 20 mg/ml

Tablets: 25 mg, 50 mg, 100 mg

Indications and dosages

Depression

Adults: Initially, 50 mg/day P.O. depending on response. May increase at weekly intervals to a maximum of 200 mg/day.

Obsessive-compulsive disorder

Adults and children ages 13 to 17: Initially, 50 mg/day P.O. May increase at weekly intervals to a maximum of 200 mg/day.

Children ages 6 to 12: 25 mg/day P.O.

Panic disorder; social anxiety disorder; posttraumatic stress disorder

Adults: Initially, 25 mg/day P.O. After 1 week, may increase to 50 mg/day; depending on response, may then increase at weekly intervals to a maximum of 200 mg/day.

Premenstrual dysphoric disorder

Adults: Initially, 50 mg/day P.O., either throughout entire menstrual cycle or only during luteal phase. For maintenance, 50 to 150 mg/day.

Off-label uses

• Premature ejaculation

Contraindications

• Hypersensitivity to drug or its components
• MAO inhibitor use within past 14 days
• Concurrent pimozide use
• Concurrent use of disulfiram (oral concentrate)

Precautions

Use cautiously in:
• seizures disorders, severe hepatic or renal impairment, increased risk for suicide
• history of mania
• concurrent use of serotonergic agents such as tryptophan (use not recommended)
• pregnant or breastfeeding patients
• children.

Administration

• Give as a single dose in morning or evening.

Don't use rubber dropper when giving concentrate to patient with latex allergy.

Don't give concurrently with pimozide or within 14 days of MAO inhibitors.

Adverse reactions

CNS: dizziness, drowsiness, fatigue, headache, insomnia, agitation, anxiety, confusion, emotional lability, poor concentration, mania, nervousness, weakness, yawning, tremor, hypertonia, hypoesthesia, paresthesia, suicidal behavior or ideation (especially in child or adolescent), neuroleptic malignant syndrome-like reactions

CV: chest pain, palpitations

EENT: vision abnormalities, tinnitus, rhinitis, pharyngitis

GI: nausea, vomiting, diarrhea, constipation, dyspepsia, flatulence, abdominal pain, dry mouth, anorexia

GU: urinary frequency, urinary disorders, sexual dysfunction, menstrual disorders

Musculoskeletal: back pain, myalgia

Skin: diaphoresis, rash

Other: altered taste, increased appetite, fever, thirst, hot flashes, serotonin syndrome

Interactions

Drug-drug.Adrenergics: increased adrenergic sensitivity, increased risk of serotonin syndrome

Cimetidine: increased sertraline blood level and effects

Clozapine, most benzodiazepines, phenytoin, tricyclic antidepressants, tolbutamide, warfarin: increased blood levels and effects of these drugs

Disulfiram: disulfiram reaction, indicated by nausea, vomiting, flushing, throbbing headache, diaphoresis, cardiovascular and respiratory reactions (with sertraline oral concentrate)

Drugs affecting serotonergic system (selective serotonin reuptake inhibitors, selective norepinephrine reuptake inhibitors), linezolid, lithium, tramadol, triptans, tryptophan: increased risk of serotonin syndrome

Drugs metabolized by CYP450-2DC or CYP450-3A4: increased blood levels of these drugs

MAO inhibitors: potentially fatal reactions (hyperthermia, rigidity, myoclonus, autonomic instability)

Pimozide: increased pimozide blood level

Sumatriptan: weakness, hyperreflexia, incoordination

Drug-diagnostic tests.Alanine aminotransferase, aspartate aminotransferase: increased levels

Immunoassay screening tests for benzodiazepines: false-positive results

Drug-herbs.S-adenosylmethionine (SAM-e), St. John's wort: increased risk of serotonergic side effects, including serotonin syndrome

Drug-behaviors.Alcohol use: increased CNS effects

Patient monitoring

Monitor patient's mental status carefully. Stay alert for mood changes and indications of suicidal ideation, especially in child or adolescent.

Monitor patient for development of potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome-like reactions.
• Evaluate neurologic status regularly. Institute safety measures, as appropriate, to prevent injury.
• Monitor temperature. Watch for fever and other signs or symptoms of infection.

Patient teaching

• Advise patient to take once a day, either in morning or night, with or without food.
• If evening dose causes insomnia, recommend switching to morning dose.
• Instruct patient to mix oral concentrate with 4 oz of recommended liquid only. Advise him to swallow diluted drug immediately after mixing.
• Tell patient using oral concentrate that drug contains alcohol.

Caution patient not to stop taking drug suddenly. Dosage must be tapered.
• Inform patient that drug may cause serious interactions with many common drugs. Instruct him to tell all prescribers he's taking it.

Advise patient (and significant other as appropriate) to monitor his mental status carefully and to immediately report increased depression or suicidal thoughts or behavior (especially in child or adolescent).

Teach patient to recognize and immediately report signs and symptoms of serotonin syndrome or neuroleptic malignant syndrome.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.