Oroxat
Generic Name
Paroxetine
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| oroxat 50 mg tablet | ৳ 285.00 | ৳ 855.00 |
Description
Overview of the medicine
Oroxat 50 mg Tablet contains Paroxetine, a selective serotonin reuptake inhibitor (SSRI) used to treat major depressive disorder, panic disorder, obsessive-compulsive disorder (OCD), social anxiety disorder, generalized anxiety disorder (GAD), and post-traumatic stress disorder (PTSD). It works by increasing the level of serotonin in the brain, which helps to improve mood and reduce anxiety.
Uses & Indications
Dosage
Adults
The usual starting dose for depression is 20 mg once daily, usually in the morning with food. The dose may be increased in 10 mg increments at weekly intervals, up to a maximum of 50 mg/day, based on patient response and tolerability. For other indications, starting doses vary, often increased up to 50 mg/day.
Elderly
A lower starting dose (e.g., 10 mg/day) is recommended, with gradual titration, not exceeding a maximum of 40 mg/day due to reduced metabolism and increased risk of side effects.
Renal_impairment
In severe renal impairment (creatinine clearance < 30 mL/min) or hepatic impairment, a lower starting dose (e.g., 10 mg/day) and slower titration should be considered. Maximum dose typically should not exceed 40 mg/day.
How to Take
Take Oroxat 50 mg Tablet orally once daily, preferably in the morning with food to minimize gastrointestinal upset. Swallow the tablet whole; do not chew or crush it. Do not stop taking this medication abruptly without consulting your doctor.
Mechanism of Action
Paroxetine selectively inhibits the reuptake of serotonin (5-HT) into presynaptic neurons, thereby increasing the concentration of serotonin in the synaptic cleft and enhancing serotonergic neurotransmission.
Pharmacokinetics
Onset
Initial therapeutic effects may be observed within 1-2 weeks, with full antidepressant effects often taking 4-6 weeks.
Excretion
Approximately 64% of a dose is excreted in the urine (2% as unchanged drug, 62% as metabolites) and 36% in the feces (1% as unchanged drug, 35% as metabolites).
Half life
Approximately 21-24 hours.
Absorption
Well absorbed from the gastrointestinal tract after oral administration. Peak plasma concentrations are reached within 3-8 hours.
Metabolism
Extensively metabolized in the liver, primarily by CYP2D6. Active and inactive metabolites are formed.
Side Effects
Contraindications
- Hypersensitivity to Paroxetine or any component of the formulation.
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing an MAOI.
- Concomitant use with thioridazine or pimozide due to increased risk of QT prolongation and ventricular arrhythmias.
Drug Interactions
MAOIs
Concomitant use is contraindicated due to risk of serotonin syndrome.
Cimetidine
May increase paroxetine plasma levels.
Warfarin, NSAIDs
Increased risk of bleeding due to effects on platelet function.
Other SSRIs, SNRIs
Increased risk of serotonin syndrome.
Thioridazine, Pimozide
Contraindicated due to increased risk of cardiac arrhythmias.
Phenobarbital, Phenytoin
May decrease paroxetine plasma levels.
Triptans (e.g., sumatriptan)
Increased risk of serotonin syndrome.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, somnolence, dilated pupils, tremor, agitation, tachycardia, and rarely, serotonin syndrome or seizures. Management is supportive and symptomatic; maintain airway, monitor cardiac and vital signs, and administer activated charcoal. No specific antidote is known.
Pregnancy & Lactation
Pregnancy Category D. Paroxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as it has been associated with increased risk of cardiovascular malformations and persistent pulmonary hypertension of the newborn (PPHN). It is excreted in breast milk; caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to Paroxetine or any component of the formulation.
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing an MAOI.
- Concomitant use with thioridazine or pimozide due to increased risk of QT prolongation and ventricular arrhythmias.
Drug Interactions
MAOIs
Concomitant use is contraindicated due to risk of serotonin syndrome.
Cimetidine
May increase paroxetine plasma levels.
Warfarin, NSAIDs
Increased risk of bleeding due to effects on platelet function.
Other SSRIs, SNRIs
Increased risk of serotonin syndrome.
Thioridazine, Pimozide
Contraindicated due to increased risk of cardiac arrhythmias.
Phenobarbital, Phenytoin
May decrease paroxetine plasma levels.
Triptans (e.g., sumatriptan)
Increased risk of serotonin syndrome.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, somnolence, dilated pupils, tremor, agitation, tachycardia, and rarely, serotonin syndrome or seizures. Management is supportive and symptomatic; maintain airway, monitor cardiac and vital signs, and administer activated charcoal. No specific antidote is known.
Pregnancy & Lactation
Pregnancy Category D. Paroxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as it has been associated with increased risk of cardiovascular malformations and persistent pulmonary hypertension of the newborn (PPHN). It is excreted in breast milk; caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic versions available, original patents expired
WHO Essential Medicine
YesClinical Trials
Paroxetine has undergone extensive clinical trials supporting its efficacy and safety for various psychiatric disorders. Post-marketing surveillance also continues to gather data.
Lab Monitoring
- No routine lab monitoring is required for most patients. However, electrolytes (especially sodium) may be monitored in elderly patients or those at risk of hyponatremia. Liver function tests may be considered in patients with hepatic impairment.
Doctor Notes
- Closely monitor patients, especially children, adolescents, and young adults, for worsening depression, suicidal ideation, or unusual behavioral changes, particularly at the initiation of therapy or after dose adjustments.
- Inform patients about the risk of serotonin syndrome, especially when co-administered with other serotonergic agents. Counsel patients on potential withdrawal symptoms and the importance of gradual discontinuation.
Patient Guidelines
- Take exactly as prescribed by your doctor and do not change the dose or stop the medication abruptly without consulting them.
- It may take several weeks to feel the full benefits of this medicine. Continue taking it even if you don't feel immediate improvement.
- Report any new or worsening symptoms of depression, suicidal thoughts, unusual changes in behavior, or other psychiatric symptoms to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Oroxat 50 mg Tablet may cause drowsiness, dizziness, or blurred vision. Avoid driving or operating heavy machinery until you know how this medication affects you.
Lifestyle Advice
- Maintain a regular sleep schedule, eat a balanced diet, and engage in regular physical activity. Avoid alcohol and illicit drugs, as they can worsen your condition or interfere with the medication.
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