Palotic
Generic Name
Palonosetron Hydrochloride
Manufacturer
Beximco Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| palotic 05 mg tablet | ৳ 20.00 | ৳ 200.00 |
Description
Overview of the medicine
Palotic 0.5 mg Tablet is an antiemetic medication containing Palonosetron Hydrochloride, primarily used for the prevention of chemotherapy-induced nausea and vomiting (CINV). It belongs to the class of 5-HT3 receptor antagonists.
Uses & Indications
Dosage
Adults
0.5 mg orally approximately 1 hour prior to chemotherapy. May be repeated on days 2 and 3 if necessary, depending on the chemotherapy regimen.
Elderly
No specific dose adjustment is required for elderly patients.
Renal_impairment
No dose adjustment is necessary for patients with renal impairment.
How to Take
Take the tablet whole with a glass of water, approximately 1 hour before chemotherapy. It can be taken with or without food.
Mechanism of Action
Palonosetron is a 5-HT3 receptor antagonist with a high affinity for this receptor and little or no affinity for other receptors. Chemotherapeutic agents cause the release of serotonin (5-HT) from enterochromaffin cells of the small intestine, which then stimulate 5-HT3 receptors located on vagal afferents, initiating the vomiting reflex. Palonosetron selectively blocks these 5-HT3 receptors, thereby preventing nausea and vomiting.
Pharmacokinetics
Onset
Within a few hours for full effect after oral administration.
Excretion
Primarily excreted via urine, with about 50% as unchanged drug and 18% as metabolites.
Half life
Approximately 40 hours, allowing for once-daily or less frequent dosing.
Absorption
Rapidly absorbed after oral administration. Peak plasma concentrations are reached approximately 5.1 hours after oral dosing.
Metabolism
Metabolized by CYP450 enzymes, primarily CYP2D6 and CYP3A4, to two inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to palonosetron or any component of the formulation.
Drug Interactions
Antidepressants (SSRIs/SNRIs)
Increased risk of serotonin syndrome. Monitor patients for symptoms such as mental status changes, autonomic instability, and neuromuscular abnormalities.
CYP2D6 or CYP3A4 inducers/inhibitors
Palonosetron is metabolized by these enzymes, so concurrent use might theoretically alter its plasma concentrations, though significant clinical effects are not well established or generally expected to require dose adjustment.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose symptoms are not well characterized. Supportive care and symptomatic treatment should be provided. Dialysis is not effective for removing palonosetron.
Pregnancy & Lactation
Pregnancy: Category B. Use only if clearly needed. Lactation: Unknown if excreted in human milk. Exercise caution when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to palonosetron or any component of the formulation.
Drug Interactions
Antidepressants (SSRIs/SNRIs)
Increased risk of serotonin syndrome. Monitor patients for symptoms such as mental status changes, autonomic instability, and neuromuscular abnormalities.
CYP2D6 or CYP3A4 inducers/inhibitors
Palonosetron is metabolized by these enzymes, so concurrent use might theoretically alter its plasma concentrations, though significant clinical effects are not well established or generally expected to require dose adjustment.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Overdose symptoms are not well characterized. Supportive care and symptomatic treatment should be provided. Dialysis is not effective for removing palonosetron.
Pregnancy & Lactation
Pregnancy: Category B. Use only if clearly needed. Lactation: Unknown if excreted in human milk. Exercise caution when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available
Clinical Trials
Numerous clinical trials have demonstrated the efficacy and safety of palonosetron in preventing chemotherapy-induced nausea and vomiting (CINV) in various patient populations, including those receiving highly and moderately emetogenic chemotherapy. Studies show its superiority or non-inferiority compared to other 5-HT3 antagonists for delayed CINV.
Lab Monitoring
- Generally not required for routine use. Monitor electrolyte levels in patients at risk of electrolyte imbalance, particularly hypokalemia or hypomagnesemia, as these can increase the risk of QT prolongation.
Doctor Notes
- Palonosetron is a highly effective 5-HT3 antagonist for both acute and delayed CINV, making it a valuable agent in supportive care for chemotherapy patients.
- Counsel patients on potential for constipation and recommend prophylactic measures if appropriate.
- Be vigilant for symptoms of serotonin syndrome, especially if co-administering with SSRIs/SNRIs or other serotonergic agents.
Patient Guidelines
- Take Palotic exactly as prescribed by your doctor, usually before chemotherapy.
- Do not stop taking the medicine without consulting your doctor, even if you feel better.
- Report any unusual or severe side effects, especially persistent headache, dizziness, or changes in heart rate, to your doctor immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next scheduled dose. Do not take a double dose to make up for a missed one. Consult your doctor if you are unsure.
Driving Precautions
Palonosetron may cause dizziness or fatigue. Patients should be advised to exercise caution when driving or operating machinery until they know how the medication affects them and if they can perform such activities safely.
Lifestyle Advice
- Maintain adequate hydration by drinking plenty of fluids.
- Eat small, frequent, bland meals to help manage nausea and discomfort during chemotherapy.
- Avoid spicy, greasy, or strong-smelling foods that might trigger nausea.
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