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Selrotine

Selrotine

sertraline

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Sertraline (equiv to sertraline HCl 55.953 mg)
Indications/Uses
Major depressive disorder (MDD), obsessive compulsive disorder (OCD), panic disorder w/ or w/o agoraphobia, social anxiety disorder (SAD), PTSD, premenstrual dysphoric disorder (PMDD).
Dosage/Direction for Use
Adult MDD & OCD Initially 50 mg once daily. Panic disorder, SAD, PTSD Initially 25 mg once daily, increased after 1 wk to 50 mg daily. Maintenance: Dose may be increased, if necessary, in increments of 50 mg daily at intervals of at least a wk to a max of 200 mg daily. PMDD Initially 50 mg once daily, either daily throughout the menstrual cycle or limited to the luteal phase of the menstrual cycle. Maintenance: Dose may be increased, if necessary, by 50 mg each menstrual cycle up to max of 150 mg daily when dosing daily throughout the menstrual cycle or 100 mg daily when dosing during the luteal phase of menstrual cycle. If a 100 mg daily dose has been established w/ luteal phase dosing, utilize 50 mg daily titration step for 3 days at beginning of each luteal phase dosing period. Childn OCD 13-17 yr Initially 50 mg daily, 6-12 yr Initially 25 mg daily. Maintenance: Dose may be increased, if necessary, in increments of 50 mg daily at intervals of at least a wk to a max of 200 mg daily. Management of depressive symptoms associated w/ Alzheimer's type dementia in elderly Initially 12.5-25 mg once daily, then gradually increase at 1-2 wk up to max dosage of 150-200 mg once daily.
Administration
May be taken with or without food: Take in the morning or evening at the same time every day. If somnolence is noted, give at bedtime.
Contraindications
Hypersensitivity. Concomitant use w/ MAOIs & pimozide.
Special Precautions
Discontinue therapy if seizures occurs. Immediately discontinue & initiate supportive & symptomatic treatment if signs & symptoms of serotonin syndrome or NMS develops. Closely observe patients for clinical worsening & suicidality, especially at the beginning of course of drug therapy or at the time of dose changes, either increases or decreases. Risk of bleeding associated w/ concomitant use of SSRIs w/ NSAIDs, aspirin, or other drugs affecting coagulation. Sertraline-induced hyponatremia (some w/ serum Na <110 mmol/L) in elderly, patients taking diuretics, & vol-depleted patients. Patients w/ history of mania; seizure. Significant wt loss especially in underwt depressed patients. Monitor wt change during therapy. Periodically re-evaluate SSRIs used for extended periods. Allow at least 2 wk after stopping SSRIs before starting MAOI. Not to be used in combination or w/in 14 days of discontinuing treatment w/ MAOI. Gradual dose reduction. Avoid alcohol during therapy. Asymptomatic elevations in AST/ALT. Hepatic impairment. Pregnancy, especially in late 3rd trimester. Lactation. Childn w/ OCD <6 yr; panic disorder, SAD, PTSD & PMDD <17 yr. May decrease plasma clearance in elderly.
Adverse Reactions
Edema, hypotension, peripheral ischemia, postural dizziness, aggravated HTN, cerebrovascular disorder, MI, precordial/substernal chest pain, atrial arrhythmia, AV block, bradycardia, pulmonary HTN, QT prolongation, ventricular tachycardia (including torsade de pointes); abnormal coordination & gait, aggravated depression, aggressive reaction, ataxia, delusion, euphoria, headache, hallucination, hyperesthesia, leg cramps, migraine, nystagmus, paranoid reaction, paroniria, choreoathetosis, coma, dyskinesia, dysphonia, hyporeflexia, hypotonia, illusion, decreased libido, ptosis, somnambulism, suicidal ideation, w/drawal syndrome, extrapyramidal symptoms, NMS-like events, psychosis, serotonin syndrome; alopecia, cold clammy skin, dry skin, erythematous rash, maculopapular rash, photosensitivity, urticaria, bullous eruption, contact dermatitis, dermatitis, eczema, hypertrichosis, follicular & pustular rash, skin discoloration, vasculitis, SJS; eructation, esophagitis, increased saliva, teeth grinding, aphthous stomatitis, colitis, diverticulitis, fecal incontinence, gastritis, glossitis, gum hyperplasia, hemorrhagic peptic ulcer, hiccough, melena, proctitis, rectal hemorrhage, stomatitis, tenesmus, tongue edema/ulceration, ulcerative stomatitis; amenorrhea, dysmenorrheal, menorrhagia, intermenstrual bleeding, leucorrhea, vag hemorrhage, acute female mastitis, atrophic vaginitis, female breast pain, breast enlargement, dysuria, nocturia, polyuria, urinary incontinence, cystitis, oliguria, hematuria, pyelonephritis, renal pain, strangury, acute renal failure, gynecomastia, balanoposthitis, priapism; arthrosis, dystonia, muscle cramps & weakness; bronchospasm, epistaxis, apnea, bradypnea, hemoptysis, hyperventilation, hypoventilation, laryngismus, laryngitis, stridor; conjunctivitis, xerophthalmia, eye pain, mydriasis, diplopia, photophobia, scotoma, visual field defect, blindness, optic neuritis, exophthalmos, glaucoma, cataract, abnormal accommodation & lacrimation, earache, hyperacusis, labyrinthine disorder; thirst, abnormal hepatic function, anemia, anterior chamber eye hemorrhage, facial edema, hypoglycemia, pallor, rigors, anaphylactoid reaction, angioedema, agranulocytosis, aplastic anemia, galactorrhea, hyperprolactinemia, hypothyroidism, increased coagulation time, leucopenia, lupus-like syndrome, oculogysis crisis, pancreatitis, pancytopenia, serum sickness, thrombocytopenia, liver events including elevated enzymes, increased bilirubin, hepatomegaly, hepatitis, jaundice, abdominal pain, vomiting, liver failure, & death.
Drug Interactions
Concomitant administration w/ other SSRIs or SNRIs. Non-selective MAOIs (phenelzine, isocarboxazid) or other drugs w/ MAO inhibition (linezolid). Concurrent selegiline (selective MAO-B inhibitor). Increased serum conc of pimozide. Increased plasma levels & risk of QT interval prolongation of thioridazine or mesoridazine. Increased levels/effects of amphetamines, selective β-blockers, bupropion, selected benzodiazepines, Ca channel blockers, cisapride, cyclosporine, dextromethorphan, ergot alkaloids, fluoxetine, selected HMG-CoA reductase inhibitors, lidocaine, mesoridazine, mirtazapine, nateglinide, nefazodone, paroxetine, phenytoin, promethazine, propofol, risperidone, ritonavir, selegiline, sildenafil (& other PDE-5 inhibitors), tacrolimus, thioridazine, TCAs, venlafaxine & other substrates of CYP2B6, 2D6 or 3A4. Increased prothrombin time w/ warfarin. Increased levels/effects w/ chlorpromazine, delavirdine, fluconazole, fluoxetine, fluvoxamine, gemfibrozil, INH, miconazole, omeprazole, paroxetine, pergolide, quinidine, quinine, ritonavir, ropinirole, ticlopidine & other CYP2C19 or 2D6 inhibitors. Increased risk of serotonin syndrome w/ combined use of SSRIs & amphetamines, buspirone, mereridine, nefazodone, serotonin agonists (eg, sumatriptan, naratriptan, rizatriptan & zolmitriptan), sibutramine, other SSRIs/SNRIs, sympathomimetics, ritonavir, tramadol & venlafaxine; bleeding w/ NSAIDs, aspirin or other drugs affecting coagulation. Concurrent use w/ lithium; loop diuretics (bumetamide, furosemide, torsemide). Concurrent use w/ lithium; loop diuretics (bumetamide, furosemide, torsemide). Decreased level/effects w/ aminoglutethimide, carbamazepine, phenytoin, rifampin & other CYP2C19 inducers. Decreased metabolism of tolbutamide. Decreased levels/effects of CYP2D6 prodrug substrates (eg, codeine, hydrocodone, oxycodone, tramadol). Increased free conc w/ highly protein-bound drugs (eg, warfarin, digoxin). Increased sedative-hypnotic effects w/ St. John's wort (Hypericum perforatum).
MIMS Class
Antipsychotics
ATC Classification
N06AB06 - sertraline ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
Presentation/Packing
Form
Selrotine FC tab 50 mg
Packing/Price
3 × 10's
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