sertraline hydrochloride(redirected from Novo-Sertraline)
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.
Inhibits neuronal uptake of serotonin in CNS, potentiating serotonin activity; has little effect on norepinephrine or dopamine uptake
Oral concentrate: 20 mg/ml
Tablets: 25 mg, 50 mg, 100 mg
Indications and dosages
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.
• Premature ejaculation
• Hypersensitivity to drug or its components
• MAO inhibitor use within past 14 days
• Concurrent pimozide use
• Concurrent use of disulfiram (oral concentrate)
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
• 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.
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
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
☞ 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.
• 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.