Palotic
Generic Name
Palotic 75 mg Injection
Manufacturer
MediPharma Inc.
Country
USA
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| palotic 0075 mg injection | ৳ 75.00 | N/A |
Description
Overview of the medicine
Palotic 75 mg Injection is a novel intravenous antiplatelet agent used to reduce the rate of thrombotic cardiovascular events in patients undergoing percutaneous coronary intervention (PCI). It rapidly inhibits platelet aggregation.
Uses & Indications
Dosage
Adults
Initial bolus of 75 mg administered intravenously, followed by a continuous intravenous infusion of 1.25 mg/kg/minute for at least 2 hours or for the duration of the PCI procedure. A maintenance infusion may follow, depending on clinical need.
Elderly
No specific dose adjustment is required for elderly patients based on age alone. Monitor closely for bleeding.
Renal_impairment
No dose adjustment is required for mild to moderate renal impairment. Use with caution in severe renal impairment (CrCl <30 mL/min) due to limited data.
How to Take
For intravenous use only. Administer as a bolus injection followed by continuous infusion. It must be prepared and administered by healthcare professionals in a hospital setting. Do not administer intramuscularly or subcutaneously.
Mechanism of Action
Palotic is a direct-acting, reversible P2Y12 platelet receptor inhibitor. It selectively binds to the P2Y12 receptor on platelets, preventing the binding of adenosine diphosphate (ADP) and subsequent ADP-mediated platelet activation and aggregation. This leads to a rapid and potent inhibition of platelet function, essential for preventing clot formation in acute settings.
Pharmacokinetics
Onset
Within 5 minutes.
Excretion
Excreted predominantly in urine and feces as inactive metabolites.
Half life
Approximately 3-6 minutes (elimination half-life).
Absorption
Rapidly absorbed into systemic circulation following intravenous administration. Peak plasma concentration reached within 5-10 minutes.
Metabolism
Primarily hydrolyzed by esterases in the blood to an inactive metabolite. Not significantly metabolized by cytochrome P450 enzymes.
Side Effects
Contraindications
- Active pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding).
- History of stroke or transient ischemic attack (TIA).
- Severe hepatic impairment.
- Hypersensitivity to Palotic or any component of the formulation.
Drug Interactions
Fibrinolytics
Concomitant use is associated with a very high risk of bleeding.
Anticoagulants (e.g., Heparin, Warfarin)
Concomitant use significantly increases the risk of bleeding. Close monitoring and dose adjustment may be necessary.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May increase the risk of gastrointestinal bleeding. Administer with caution.
Other Antiplatelet Agents (e.g., Aspirin, Clopidogrel)
Concomitant use may increase the risk of bleeding. Use with caution.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Do not freeze. Reconstituted solution should be used immediately.
Overdose
Overdose of Palotic may lead to an increased risk of bleeding. Management should include discontinuation of the drug and supportive measures. Since Palotic is a reversible inhibitor with a short half-life, platelet function generally recovers quickly after discontinuation. Platelet transfusions may be considered in cases of severe, life-threatening bleeding.
Pregnancy & Lactation
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Palotic should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Palotic is excreted in human milk. Exercise caution when administered to a nursing mother.
Side Effects
Contraindications
- Active pathological bleeding (e.g., intracranial hemorrhage, gastrointestinal bleeding).
- History of stroke or transient ischemic attack (TIA).
- Severe hepatic impairment.
- Hypersensitivity to Palotic or any component of the formulation.
Drug Interactions
Fibrinolytics
Concomitant use is associated with a very high risk of bleeding.
Anticoagulants (e.g., Heparin, Warfarin)
Concomitant use significantly increases the risk of bleeding. Close monitoring and dose adjustment may be necessary.
NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
May increase the risk of gastrointestinal bleeding. Administer with caution.
Other Antiplatelet Agents (e.g., Aspirin, Clopidogrel)
Concomitant use may increase the risk of bleeding. Use with caution.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Do not freeze. Reconstituted solution should be used immediately.
Overdose
Overdose of Palotic may lead to an increased risk of bleeding. Management should include discontinuation of the drug and supportive measures. Since Palotic is a reversible inhibitor with a short half-life, platelet function generally recovers quickly after discontinuation. Platelet transfusions may be considered in cases of severe, life-threatening bleeding.
Pregnancy & Lactation
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Palotic should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Palotic is excreted in human milk. Exercise caution when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from manufacturing date when stored as recommended.
Availability
Hospitals, Clinics
Approval Status
Approved (Hypothetical)
Patent Status
Patented
Clinical Trials
Extensive clinical trials (e.g., PALO-PCI trial) have demonstrated Palotic's efficacy in reducing thrombotic events during PCI compared to placebo, with an acceptable safety profile, primarily associated with an increased risk of bleeding.
Lab Monitoring
- Complete Blood Count (CBC) with platelet count before and during treatment.
- Coagulation parameters (e.g., aPTT, PT/INR) if clinically indicated.
- Renal function tests, especially in patients with pre-existing renal impairment.
Doctor Notes
- Ensure patient is not actively bleeding before administration.
- Carefully monitor activated clotting time (ACT) or other coagulation parameters as per hospital protocol during PCI.
- Have reversal agents (e.g., platelet concentrates) readily available in case of severe bleeding.
Patient Guidelines
- This medicine is administered by a healthcare professional in a hospital or clinic setting.
- Report any signs of unusual bleeding, such as prolonged bleeding from cuts, nosebleeds, blood in urine or stool, or excessive bruising, to your doctor or nurse immediately.
- Do not try to administer this injection yourself.
Missed Dose Advice
Palotic is typically administered in acute, monitored settings. Missing a dose is unlikely. If there are concerns about the administration schedule, a healthcare professional should be consulted immediately.
Driving Precautions
Palotic is administered in an acute care setting, and patients are typically not in a condition to drive immediately after administration. If released, be aware of potential dizziness as a side effect and avoid driving if affected.
Lifestyle Advice
- Avoid activities that may lead to injury and bleeding, especially during the period of drug administration.
- Inform all healthcare providers, including dentists, that you are receiving Palotic, as it may affect certain procedures.
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