Apo-Sertraline

Apo-Sertraline

sertraline

Manufacturer:

Apotex

Distributor:

Pharmaforte
Concise Prescribing Info
Contents
Sertraline HCl
Indications/Uses
Symptoms of depression including depression accompanied by symptoms of anxiety in patients w/ or w/o history of mania. Obsessive-compulsive disorders (OCD). Panic disorder w/ or w/o agoraphobia, post-traumatic stress disorder (PTSD). Prevention of initial depression episode relapse or recurrence of further depressive episodes.
Dosage/Direction for Use
Depression & OCD Initially 50 mg daily. Panic disorder & PTSD Initially 25 mg daily, increase dose to 50 mg daily after 1 wk. Patient not responding to 50-mg dose Titration: Increase dose at intervals of at least 1 wk up to a max of 200 mg daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Concomitant use w/ MAOIs. Tab: Concomitant use w/ pimozide.
Special Precautions
Switching from SSRIs, antidepressants or antiobsessional drugs. Activation of mania/hypomania. Avoid in patients w/ unstable epilepsy; carefully monitor patients w/ controlled epilepsy. Discontinue use in patients who develop seizures. May cause sexual dysfunction symptoms. Possibility of suicide attempt is inherent in depression & may persist until significant remission occurs; closely supervise patients during the early course of therapy. Observe same precautions when treating patients w/ depression, OCD, panic disorder or PTSD. Hepatic impairment. May impair mental or physical abilities required for the performance of potentially hazardous tasks (eg, driving a car or operating machinery). Women of childbearing potential should employ an adequate contraception method. Pregnancy & lactation.
Adverse Reactions
Dry mouth, increased sweating; dizziness, tremor; diarrhea/loose stools, dyspepsia, nausea; anorexia, insomnia, somnolence; sexual dysfunction (principally ejaculation delay in males).
Drug Interactions
Not to be used in combination w/ MAOI or w/in 14 days of discontinuing MAOI due to possible serious or potentially fatal reactions. Co-administration w/ other serotonergic neurotransmission-enhancing drugs (eg, tryptophan, fenfluramine). Not recommended to be used concomitantly w/ alcohol. Possible pharmacodynamic interaction w/ lithium. Monitor phenytoin plasma conc. Concomitant use w/ sumatriptan. Potential to interact w/ other plasma protein-bound drugs. Increased prothrombin time when co-administered w/ warfarin. Changes in some pharmacokinetic parameters when co-administered w/ diazepam or tolbutamide. Clearance may substantially decreased w/ cimetidine. May inhibit the activity of isozyme CYP2D6. Tab: Contraindicated w/ pimozide due to potentially increased pimozide levels.
MIMS Class
Antidepressants
ATC Classification
N06AB06 - sertraline ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
Presentation/Packing
Form
Apo-Sertraline cap 50 mg
Packing/Price
100's
Form
Apo-Sertraline tab 50 mg
Packing/Price
100's;30's
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