Purisal
Generic Name
Anxiolysate
Manufacturer
MediCare Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| purisal 2 mg tablet | ৳ 2.00 | ৳ 20.00 |
Description
Overview of the medicine
Purisal 2 mg Tablet contains Anxiolysate, which belongs to the class of anxiolytics. It is primarily used for the management of generalized anxiety disorder (GAD) and panic disorder.
Uses & Indications
Dosage
Adults
Initial dose 2 mg once daily, adjusted based on patient response, up to a maximum of 6 mg daily.
Elderly
Start with 1 mg once daily, cautiously titrated due to increased sensitivity and potential for adverse effects.
Renal_impairment
No specific dose adjustment required for mild to moderate impairment. Use with caution in severe renal impairment (CrCl < 30 mL/min).
How to Take
Take orally with water, with or without food. Do not crush or chew the tablet.
Mechanism of Action
Anxiolysate selectively modulates gamma-aminobutyric acid (GABA) receptors, enhancing the inhibitory effects of GABA in the central nervous system, leading to anxiolytic and mild sedative effects.
Pharmacokinetics
Onset
30-60 minutes
Excretion
Excreted mainly through the kidneys in the form of metabolites.
Half life
8-12 hours
Absorption
Rapidly absorbed from the gastrointestinal tract, reaching peak plasma concentrations within 1-2 hours.
Metabolism
Primarily metabolized in the liver via CYP3A4 and CYP2C19 enzymes into inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Anxiolysate or any component of the tablet
- Acute narrow-angle glaucoma
- Severe respiratory insufficiency
- Severe hepatic impairment
- Myasthenia gravis
Drug Interactions
Alcohol
Concomitant use increases CNS depressant effects, leading to enhanced sedation and impairment.
Opioids
Increased risk of respiratory depression, profound sedation, coma, and death.
CYP3A4 inducers (e.g., Carbamazepine, Rifampin)
May decrease Anxiolysate plasma levels, reducing efficacy.
CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May significantly increase Anxiolysate plasma levels, leading to increased adverse effects.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not freeze.
Overdose
Symptoms may include somnolence, confusion, impaired coordination, diminished reflexes, hypotension, respiratory depression, and coma. Treatment is supportive, including gastric lavage, activated charcoal, and symptomatic management. Flumazenil may be considered in severe cases, but caution is advised due to risk of withdrawal seizures.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding as it may pass into breast milk and potentially cause adverse effects in the infant.
Side Effects
Contraindications
- Hypersensitivity to Anxiolysate or any component of the tablet
- Acute narrow-angle glaucoma
- Severe respiratory insufficiency
- Severe hepatic impairment
- Myasthenia gravis
Drug Interactions
Alcohol
Concomitant use increases CNS depressant effects, leading to enhanced sedation and impairment.
Opioids
Increased risk of respiratory depression, profound sedation, coma, and death.
CYP3A4 inducers (e.g., Carbamazepine, Rifampin)
May decrease Anxiolysate plasma levels, reducing efficacy.
CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
May significantly increase Anxiolysate plasma levels, leading to increased adverse effects.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children. Do not freeze.
Overdose
Symptoms may include somnolence, confusion, impaired coordination, diminished reflexes, hypotension, respiratory depression, and coma. Treatment is supportive, including gastric lavage, activated charcoal, and symptomatic management. Flumazenil may be considered in severe cases, but caution is advised due to risk of withdrawal seizures.
Pregnancy & Lactation
Pregnancy Category C. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding as it may pass into breast milk and potentially cause adverse effects in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date.
Availability
Available in pharmacies nationwide
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Under patent (until 2035)
Clinical Trials
Phase III clinical trials demonstrated significant efficacy in reducing generalized anxiety disorder (GAD) symptoms compared to placebo, with a favorable safety profile. Long-term studies are ongoing to assess sustained efficacy and safety.
Lab Monitoring
- Liver function tests (baseline and periodically, especially in patients with hepatic impairment)
- Renal function tests (for severe impairment)
- Complete blood count (if long-term use is anticipated)
Doctor Notes
- Advise patients on potential for drowsiness, dizziness, and avoidance of alcohol or other CNS depressants.
- Emphasize the importance of gradual discontinuation to prevent severe withdrawal symptoms.
- Monitor for signs of worsening depression, suicidality, or paradoxical reactions, especially at the start of therapy or during dose adjustments.
- Consider lowest effective dose and shortest possible duration, particularly for elderly patients.
Patient Guidelines
- Do not stop taking Purisal abruptly, as it may cause withdrawal symptoms such as rebound anxiety, insomnia, irritability, and convulsions. Consult your doctor for gradual dose reduction.
- Avoid consuming alcohol and other CNS depressants while on this medication.
- Inform your doctor about all other medications, herbal products, and supplements you are taking.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not double the dose.
Driving Precautions
Purisal may cause drowsiness, dizziness, or impaired concentration. Avoid driving or operating heavy machinery until you know how this medicine affects your ability to perform such tasks safely.
Lifestyle Advice
- Practice stress-reducing techniques like meditation, deep breathing exercises, or yoga.
- Maintain a regular sleep schedule and ensure adequate sleep.
- Engage in regular physical activity appropriate for your health condition.
- Limit caffeine and nicotine intake, as these can exacerbate anxiety.
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