Oroxat
Generic Name
Paroxetine
Manufacturer
Beacon Pharmaceuticals Ltd. (Assumed for example)
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
oroxat 100 mg tablet | ৳ 525.00 | ৳ 1,575.00 |
Description
Overview of the medicine
Oroxat 100 mg Tablet contains Paroxetine, which is a Selective Serotonin Reuptake Inhibitor (SSRI) used to treat major depressive disorder, panic disorder, obsessive-compulsive disorder (OCD), social anxiety disorder, and other anxiety-related conditions.
Uses & Indications
Dosage
Adults
Typical starting dose for Paroxetine is 20 mg once daily. The Oroxat 100 mg tablet may be prescribed for specific, severe, or treatment-resistant conditions, or it might represent an extended-release formulation to achieve a higher daily therapeutic dose. Dosage should be individualized and adjusted gradually, usually not exceeding 50-60 mg/day for standard release, or as per specific extended-release formulation instructions.
Elderly
Lower starting dose, typically 10 mg once daily, with gradual increases if necessary. Maximum daily dose usually not exceeding 40 mg.
Renal_impairment
For severe renal impairment (creatinine clearance <30 mL/min), a lower starting dose (e.g., 10 mg/day) and slower titration may be required. The 100 mg strength would likely be inappropriate for initial dosing in such patients.
How to Take
Take Oroxat 100 mg tablet orally, usually once daily in the morning, with or without food. Taking it with food may reduce gastrointestinal upset. Swallow the tablet whole; do not chew or crush it, especially if it is an extended-release formulation.
Mechanism of Action
Paroxetine works by selectively inhibiting the reuptake of serotonin in the brain, thereby increasing the concentration of serotonin in the synaptic cleft. This leads to an enhancement of serotonergic neurotransmission, which helps to improve mood, reduce anxiety, and alleviate symptoms of various mental health disorders.
Pharmacokinetics
Onset
Antidepressant effects typically begin within 1-4 weeks, with full effect taking 2-4 weeks or more.
Excretion
Approximately 64% excreted in urine (2% as unchanged drug) and 36% in feces, predominantly as metabolites.
Half life
Approximately 21 hours (range 3-65 hours), with variations due to genetic polymorphism.
Absorption
Well absorbed orally, peak plasma concentrations typically reached within 2-8 hours.
Metabolism
Extensively metabolized in the liver primarily by CYP2D6. Subject to significant first-pass metabolism.
Side Effects
Contraindications
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy.
- Concomitant use with thioridazine or pimozide due to increased risk of QT prolongation.
- Hypersensitivity to paroxetine or any component of the formulation.
Drug Interactions
MAOIs
Risk of serotonin syndrome (hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes).
Warfarin
Increased risk of bleeding due to inhibition of platelet aggregation and changes in metabolism.
Cimetidine
Increased paroxetine levels.
Metoprolol
Increased plasma levels of metoprolol, leading to enhanced beta-blockade.
Phenytoin, Phenobarbital
Reduced paroxetine levels.
Linezolid, Methylene Blue
MAOI-like effects, increased risk of serotonin syndrome.
Triptans (e.g., Sumatriptan)
Increased risk of serotonin syndrome.
Tricyclic Antidepressants (TCAs)
Increased plasma levels of TCAs, potentially leading to increased toxicity.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, coma, nausea, vomiting, tremor, tachycardia, dizziness, and very rarely, seizures or serotonin syndrome. Management involves supportive care, maintaining an open airway, monitoring vital signs, and gastric lavage or activated charcoal if indicated. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category D: There is positive evidence of human fetal risk (particularly cardiac malformations, e.g., ventricular septal defects), but the benefits from use in pregnant women may be acceptable despite the risk. Not recommended during breastfeeding as paroxetine is excreted in breast milk and may cause adverse effects in the infant.
Side Effects
Contraindications
- Concomitant use with Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of discontinuing MAOI therapy.
- Concomitant use with thioridazine or pimozide due to increased risk of QT prolongation.
- Hypersensitivity to paroxetine or any component of the formulation.
Drug Interactions
MAOIs
Risk of serotonin syndrome (hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes).
Warfarin
Increased risk of bleeding due to inhibition of platelet aggregation and changes in metabolism.
Cimetidine
Increased paroxetine levels.
Metoprolol
Increased plasma levels of metoprolol, leading to enhanced beta-blockade.
Phenytoin, Phenobarbital
Reduced paroxetine levels.
Linezolid, Methylene Blue
MAOI-like effects, increased risk of serotonin syndrome.
Triptans (e.g., Sumatriptan)
Increased risk of serotonin syndrome.
Tricyclic Antidepressants (TCAs)
Increased plasma levels of TCAs, potentially leading to increased toxicity.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include somnolence, coma, nausea, vomiting, tremor, tachycardia, dizziness, and very rarely, seizures or serotonin syndrome. Management involves supportive care, maintaining an open airway, monitoring vital signs, and gastric lavage or activated charcoal if indicated. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category D: There is positive evidence of human fetal risk (particularly cardiac malformations, e.g., ventricular septal defects), but the benefits from use in pregnant women may be acceptable despite the risk. Not recommended during breastfeeding as paroxetine is excreted in breast milk and may cause adverse effects in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from the date of manufacture, specific to the product batch.
Availability
Available in pharmacies
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Paroxetine has undergone extensive clinical trials demonstrating its efficacy and safety for various indications, including major depressive disorder, anxiety disorders, and obsessive-compulsive disorder.
Lab Monitoring
- Monitor liver function tests periodically, especially in patients with hepatic impairment.
- Monitor renal function in patients with renal impairment for dose adjustment.
- Monitor serum sodium levels, especially in elderly patients, as hyponatremia can occur.
- Periodic monitoring for suicidal ideation and behavioral changes during therapy initiation and dose adjustments.
Doctor Notes
- Emphasize the importance of gradual dose tapering when discontinuing Paroxetine to minimize withdrawal symptoms.
- Monitor patients, especially young adults, for signs of suicidal ideation or behavioral changes during initial therapy and dose adjustments.
- Advise patients about potential sexual side effects and discuss management strategies if applicable.
- Consider potential drug interactions, especially with other serotonergic agents or drugs metabolized by CYP2D6.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor and do not change the dose or stop taking it without consulting your doctor.
- Do not stop taking Paroxetine abruptly, as this can lead to withdrawal symptoms. Your doctor will gradually reduce your dose when it's time to stop.
- Report any new or worsening symptoms, especially changes in mood, behavior, or suicidal thoughts, to your doctor immediately.
- It may take several weeks to feel the full benefits of this medicine.
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 continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Paroxetine may cause drowsiness, dizziness, or blurred vision. Avoid driving or operating heavy machinery until you know how this medicine affects you.
Lifestyle Advice
- Maintain a healthy lifestyle, including a balanced diet and regular exercise, which can complement the therapeutic effects of the medicine.
- Practice stress-reduction techniques such as meditation or yoga.
- Limit alcohol consumption, as it can worsen some side effects or impair judgment.
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