Sertraline Sandoz

Sertraline HCl

Major depressive episodes; obsessive compulsive disorder (OCD) in adult & childn & adolescents 6-17 yr; panic disorder; PTSD, social phobia.

Dose increments should be in steps of 50 mg at min intervals of 1 wk, not to be performed more than once wkly. Max daily dose: 200 mg. Major depressive episodes 50 mg daily. OCD Initially 50 mg once daily. Childn & adolescent 13-17 yr Initially 50 mg as single daily dose, 6-12 yr Initially 25 mg as single daily dose. May be increased to 50 mg once daily after 1 wk. Panic disorder, PTSD, social phobia Initially 25 mg once daily, increase to 50 mg once daily after 1 wk.

May be taken with or without food.

Hypersensitivity. Discontinue for at least 7 days before starting treatment w/ irreversible MAOI. Concomitant treatment w/ irreversible MAOIs & pimozide. Not to be initiated for at least 14 days after discontinuation of treatment w/ irreversible MAOI.

Discontinue in any patient who develops seizures; w/ symptomatic hyponatraemia. Monitor for emergence of signs & symptoms of serotonin syndrome or NMS syndrome; any clinical worsening, suicidal behavior, or thoughts & unusual changes in behavior; paed patients on long term treatment for abnormalities in growth & development. Carefully monitor patients w/ history of suicide-related events, or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment; for appearance of suicidal symptoms. Avoid in patients w/ unstable & controlled epilepsy. Increased risk of suicidal thoughts, self-harm & suicide (suicide-related events). Increased risk of postpartum haemorrhage & may cause symptoms of sexual dysfunction w/ SSRIs/SNRIs. Patients w/ additional risk factors for QTc prolongation eg, cardiac disease, hypokalaemia or hypomagnesaemia, familial history of QTc prolongation, bradycardia & concomitant use of medicinal products prolonging QTc interval. History of mania/hypomania. Angle-closure glaucoma or history of glaucoma. Aggravated psychotic symptoms in schizophrenic patients. Bleeding abnormalities w/ SSRIs including cutaneous bleeding (ecchymoses and purpura) & other haemorrhagic events eg, GI or gynaecological bleeding, including fatal haemorrhages. Development of akathisia. May alter glycaemic control in patients w/ diabetes. Cases of serum Na levels <110 mmol/L. False +ve urine immunoassay screening tests for benzodiazepines. Gradually tapered when discontinuing treatment over a period of several wk or mth. Concomitant use of other serotonergic medicinal products (including other serotonergic antidepressants, amphetamines, triptans), w/ medicinal products impairing metabolism of serotonin (including MAOIs eg, methylene blue), antipsychotics & other dopamine antagonists, & w/ opiate medicinal products. Avoid co-administration w/ other active substances enhancing effects of serotonergic neurotransmission eg, amphetamines, tryptophan or fenfluramine or 5-HT agonists, or herbal medicine, St John's Wort (Hypericum perforatum). Concomitant use w/ medicinal products affecting platelet function (eg, anticoagulants, atypical antipsychotics & phenothiazines, most TCAs, ASA & NSAIDs). Not recommended w/ grapefruit juice. May affect ability to drive & use machines. Not be used in patients w/ severe hepatic impairment. Not recommended in pregnancy & lactation. Retarded growth & delayed puberty. Increased risk of persistent pulmonary HTN in newborn (PPHN). Not be used in childn & adolescents <18 yr, except for patients w/ OCD 6-17 yr. Greater risk of developing hyponatraemia in elderly patients.

Insomnia; dizziness, headache, somnolence; nausea, diarrhoea, dry mouth; ejaculation failure; fatigue. URTI, pharyngitis, rhinitis; decreased/increased appetite; anxiety, depression, agitation, decreased libido, nervousness, depersonalisation, nightmare, bruxism; tremor, movement disorders including extrapyramidal symptoms, paraesthesia, hypertonia, attention disturbance, dysgeusia; visual disturbance; tinnitus; palpitations; hot flush; yawning; dyspepsia, constipation, abdominal pain, vomiting, flatulence; hyperhidrosis, rash; back pain, arthralgia, myalgia; irregular menstruation, erectile dysfunction; malaise, chest pain, asthenia, pyrexia; increased wt; injury. Paed: Mania, anorexia, affect lability, aggression, hyperkinesia, migraine, urinary incontinence, acne, epistaxis.

Combination w/ irreversible MAOIs eg, selegiline; reversible & selective MAOI eg, moclobemide. Increased pimozide levels. Concomitant use w/ alcohol; other medicinal products prolonging QTc interval (eg, some antipsychotics & antibiotics); NSAIDs, acetylsalicylic acid & ticlopidine) & other medicines increasing bleeding risk. Reduced plasma levels w/ phenytoin & rifampicin. Significant increased prothrombin time w/ warfarin. Decreased clearance w/ cimetidine. Reduced plasma cholinesterase activity resulting in prolongation of neuromuscular blocking action of mivacurium or other neuromuscular blockers. Moderate elevation of steady-state desipramine plasma levels. Increased plasma levels w/ grapefruit juice. Increased exposure w/ potent CYP3A4 inhibitors eg, PIs, ketoconazole, itraconazole, posaconazole, voriconazole, clarithromycin, telithromycin & nefazodone. Avoid use w/ moderate CYP3A4 inhibitors eg, aprepitant, erythromycin, fluconazole, verapamil & diltiazem. Enhanced plasma levels w/ CYP2C19 poor metabolizers. Reduced plasma conc w/ metamizole. Linezolid & non-selective MAOI. Fentanyl (used in general anaesth or in treatment of chronic pain), other serotonergic medicinal products (including other serotonergic antidepressants, amphetamines, triptans), & w/ other opiate medicinal products. Lithium. Other CYP2D6 substrates w/ narrow therapeutic index eg, class 1C antiarrhythmics (propafenone & flecainide, TCAs & typical antipsychotics). Strong inhibitors of CYP2C19 eg, omeprazole, lansoprazole, pantoprazole, rabeprazole, fluoxetine.

Antidepressants

N06AB06 - sertraline ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.

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