Xemi
Generic Name
Xemifibrate 320 mg
Manufacturer
PharmaCorp Innovations Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
xemi 320 mg tablet | ৳ 50.15 | ৳ 200.60 |
Description
Overview of the medicine
Xemi 320 mg Tablet is a lipid-lowering medication from the fibrate class, primarily used to treat high levels of triglycerides and cholesterol in the blood, especially in patients at risk of cardiovascular disease. It works by activating peroxisome proliferator-activated receptor alpha (PPARα) to improve lipid metabolism.
Uses & Indications
Dosage
Adults
One tablet (320 mg) once daily, preferably with a meal.
Elderly
No specific dose adjustment is required for elderly patients with normal renal function.
Renal_impairment
Dose adjustment required. For moderate renal impairment (CrCl 30-59 mL/min), reduce dose to 160 mg daily. Not recommended for severe renal impairment (CrCl < 30 mL/min).
How to Take
Take the tablet orally, once daily, preferably with the main meal to enhance absorption and reduce gastrointestinal upset. Swallow whole with water, do not crush or chew.
Mechanism of Action
Xemifibrate acts as a peroxisome proliferator-activated receptor alpha (PPARα) agonist. Activation of PPARα leads to increased expression of genes involved in fatty acid oxidation, reduced synthesis of triglycerides, and increased high-density lipoprotein (HDL) cholesterol levels. It also reduces the production of very-low-density lipoprotein (VLDL) in the liver.
Pharmacokinetics
Onset
Lipid-lowering effects begin within days, but full therapeutic effect is evident after 2-4 weeks.
Excretion
Mainly excreted in urine (60-70%) and feces (20-30%) as metabolites and unchanged drug.
Half life
Approximately 12-18 hours.
Absorption
Well absorbed from the gastrointestinal tract, especially when taken with food. Peak plasma concentrations are reached within 4-5 hours.
Metabolism
Primarily metabolized in the liver to inactive metabolites via glucuronidation.
Side Effects
Contraindications
- Hypersensitivity to Xemifibrate or any component of the formulation.
- Severe renal or hepatic impairment.
- Pre-existing gallbladder disease or cholelithiasis.
- Known photoallergy or phototoxic reaction during previous treatment with fibrates.
Drug Interactions
Cyclosporine
May increase the concentration of Xemifibrate and cyclosporine, potentially leading to renal toxicity. Avoid co-administration or monitor closely.
Statins (e.g., Atorvastatin)
Increased risk of myopathy and rhabdomyolysis when co-administered. Use with caution, monitor muscle symptoms and creatinine kinase.
Oral Anticoagulants (e.g., Warfarin)
May potentiate the effect of anticoagulants, increasing bleeding risk. Monitor INR closely and adjust anticoagulant dose.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for Xemifibrate overdose. Treatment should be symptomatic and supportive, including gastric lavage or induced emesis if ingestion is recent. Monitor vital signs and liver/renal function.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy unless potential benefits outweigh risks. Discontinue during lactation as it is unknown if Xemifibrate is excreted in human milk.
Side Effects
Contraindications
- Hypersensitivity to Xemifibrate or any component of the formulation.
- Severe renal or hepatic impairment.
- Pre-existing gallbladder disease or cholelithiasis.
- Known photoallergy or phototoxic reaction during previous treatment with fibrates.
Drug Interactions
Cyclosporine
May increase the concentration of Xemifibrate and cyclosporine, potentially leading to renal toxicity. Avoid co-administration or monitor closely.
Statins (e.g., Atorvastatin)
Increased risk of myopathy and rhabdomyolysis when co-administered. Use with caution, monitor muscle symptoms and creatinine kinase.
Oral Anticoagulants (e.g., Warfarin)
May potentiate the effect of anticoagulants, increasing bleeding risk. Monitor INR closely and adjust anticoagulant dose.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for Xemifibrate overdose. Treatment should be symptomatic and supportive, including gastric lavage or induced emesis if ingestion is recent. Monitor vital signs and liver/renal function.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy unless potential benefits outweigh risks. Discontinue during lactation as it is unknown if Xemifibrate is excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date
Availability
Available in pharmacies nationwide
Approval Status
Approved by national regulatory authorities
Patent Status
Patent Pending
Clinical Trials
Extensive Phase I, II, and III clinical trials have demonstrated the efficacy and safety of Xemifibrate in lowering lipid levels and reducing cardiovascular risk markers. Post-marketing surveillance is ongoing.
Lab Monitoring
- Liver function tests (AST, ALT) should be performed before initiation of therapy and periodically thereafter (e.g., every 3 months during the first year).
- Renal function tests (serum creatinine, eGFR) should be monitored, especially in patients with pre-existing renal impairment.
- Lipid panel (total cholesterol, LDL-C, HDL-C, triglycerides) should be monitored regularly to assess treatment efficacy.
Doctor Notes
- Prioritize lifestyle modifications (diet, exercise) before initiating Xemifibrate.
- Carefully assess renal and hepatic function before and during therapy.
- Educate patients on symptoms of myopathy and gallbladder issues, emphasizing immediate reporting.
Patient Guidelines
- Take Xemi 320 mg exactly as prescribed by your doctor.
- Do not stop taking this medication without consulting your doctor, even if you feel well.
- Maintain a low-fat diet and regular exercise regimen as advised by your healthcare provider.
- Report any unexplained muscle pain, tenderness, or weakness to your doctor immediately.
Missed Dose Advice
If a dose is missed, 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 double the dose to make up for a missed one.
Driving Precautions
Xemi 320 mg Tablet may cause dizziness or visual disturbances in some patients. If you experience these symptoms, avoid driving or operating machinery until you know how the medication affects you.
Lifestyle Advice
- Adopt a heart-healthy diet rich in fruits, vegetables, and whole grains, and low in saturated and trans fats.
- Engage in regular physical activity, aiming for at least 30 minutes of moderate-intensity exercise most days of the week.
- If you smoke, consider quitting. Smoking cessation significantly improves cardiovascular health.
- Limit alcohol intake.
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