Seroxat/Seroxat CR

Seroxat/Seroxat CR

paroxetine

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Paroxetine HCl hemihydrate
Indications/Uses
Seroxat Treatment of major depressive episode; obsessive compulsive disorder (OCD); panic disorder w/ or w/o agoraphobia; social anxiety disorder/social phobia; generalised anxiety disorder; post-traumatic stress disorder. Seroxat CR Symptomatic relief of major depressive disorder. Symptomatic treatment of panic disorder w/ or w/o agoraphobia. Symptomatic relief of generalised social phobia. Symptomatic treatment of premenstrual dysphoric disorder (PMDD).
Dosage/Direction for Use
Seroxat Major depressive episode 20 mg daily. If there is insufficient response, may be increased gradually up to max 50 mg daily in 10-mg steps according to the patient's response. OCD 40 mg daily, start on 20 mg daily, may be increased gradually in 10-mg increments to the recommended dose. If there is insufficient response after some wk, may be increased gradually up to max 60 mg daily. Panic disorder 40 mg daily, start on 10 mg daily, gradually increased in 10-mg steps according to the patient's response up to the recommended dose. If insufficient response is seen after some wk, may be increased gradually up to max 60 mg daily. Social anxiety disorder/social phobia 20 mg daily, may be increased gradually in 10-mg steps up to max 50 mg daily, if insufficient response is seen after some wk on the recommended dose. Generalised anxiety disorder 20 mg daily, may be increased gradually in 10-mg steps up to max 50 mg daily, if insufficient response is seen after some wk on the recommended dose. Post-traumatic stress disorder 20 mg daily, may be increased gradually in 10-mg steps up to max 50 mg daily, if insufficient response is seen after some wk on the recommended dose. Seroxat CR Depression Initially 25 mg/day, up to max of 62.5 mg/day. Dose changes should occur in 12.5-mg/day increments at intervals of at least 1 wk. Panic disorder Initially 12.5 mg/day, may be increased to max 75 mg/day. Dose changes should occur in 12.5 mg/day-increments at intervals of at least 1 wk. Social anxiety disorder Initially 12.5 mg/day, may be increased up to max of 37.5 mg/day. Dose changes should occur in 12.5 mg/day-increments at intervals of at least 1 wk. PMDD Initially 12.5 mg/day limited to the luteal phase of the menstrual cycle, starting 14 days prior to the expected onset of menses, & terminating on the 1st day of menses. May be increased to 25 mg/day. Dose changes should occur in 12.5-mg/day-increments at intervals of at least 1 wk.
Administration
IR tab: Should be taken with food: Swallow whole, do not chew/crush. CR tab: May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Concomitant use w/ thioridazine or pimozide. Concomitant use w/ MAOI or w/in 2 wk after discontinuation of an irreversible MAOI or w/in 24 hr after discontinuation of a reversible MAOI.
Special Precautions
Cautiously initiate treatment 2 wk after terminating treatment w/ an irreversible MAOI or 24 hr after terminating treatment w/ a reversible MAOI (eg, moclobemide, linezolid, methylene blue). Patients w/ a history of suicide-related events, or those exhibiting a significant degree of suicidal ideation; history of mania; epilepsy; narrow angle glaucoma or history of glaucoma; cardiac conditions; history of bleeding disorders or conditions which may predispose to bleeding; patients at risk of hyponatraemia; DM. Development of akathisia. Serotonin syndrome or neuroleptic malignant syndrome-like events. Patients w/ hepatic impairment or severe renal impairment. Discontinue in any patient who develops seizures. Cutaneous bleeding abnormalities. Concomitant use w/ other serotonergic &/or neuroleptic drugs; oral anticoagulants, drugs known to affect platelet function or other drugs that may increase risk of bleeding; tamoxifen. Concurrent administration w/ electroconvulsive therapy. Gradually taper dose when discontinuing treatment. May affect ability to drive or operate machinery. May affect sperm quality. Pregnancy & lactation. Should not be used in childn & adolescents <18 yr. Elderly. Seroxat CR Increased risk of bone fracture. Diseases or conditions that could affect metabolism or hemodynamic responses. Increased LDL-cholesterol levels. Contains azo dyes which may cause allergic reactions.
Adverse Reactions
Nausea; sexual dysfunction. Increases in cholesterol levels; decreased appetite; somnolence, insomnia, agitation, abnormal dreams; dizziness, tremor, headache, impaired concentration; blurred vision; yawning; constipation, diarrhoea, vomiting, dry mouth; sweating; asthenia, wt gain. Seroxat CR Abnormal ejaculation, diarrhoea, sweating, abnormal vision, decreased libido, female genital disorders, nausea, trauma, impotence.
Drug Interactions
Serotonin syndrome w/ other serotonergic drugs (eg, L-tryptophan, triptans, tramadol, linezolid, methylthioninium Cl, SSRIs, lithium, fentanyl, pethidine & St. John's Wort prep). Increased pimozide levels. Prolonged neuromuscular blocking action of mivacurium & suxamethonium. Decreased plasma levels w/ fosamprenavir/ritonavir. Increased plasma levels of procyclidine; CYP2D6 substrates (eg, TCAs, phenothiazine neuroleptics, risperidone, atomoxetine, certain Type 1c antiarrhythmics & metoprolol). Risk of reduced efficacy of tamoxifen. Increased effect of oral anticoagulants. Increased haemorrhagic risk w/ NSAIDs/acetylsalicylic acid, or drugs known to affect platelet function or increase risk of bleeding. Increased blood glucose levels w/ pravastatin. Consider dose adjustment w/ drug metabolising enzyme inhibitor. Avoid alcohol use. Seroxat CR Increased incidence of adverse experiences w/ anticonvulsants. Neuroleptic malignant syndrome w/ antipsychotics/neuroleptics. Elevated theophylline levels. Elevated steady state of paroxetine w/ cimetidine.
MIMS Class
Antidepressants
ATC Classification
N06AB05 - paroxetine ; Belongs to the class of selective serotonin reuptake inhibitors. Used in the management of depression.
Presentation/Packing
Form
Seroxat CR tab 12.5 mg
Packing/Price
30's
Form
Seroxat CR tab 25 mg
Packing/Price
30's
Form
Seroxat IR tab 20 mg
Packing/Price
20's
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