Cloles
Generic Name
Clolestatin 10 mg Tablet
Manufacturer
MediCorp Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| cloles 10 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Cloles 10 mg Tablet contains Clolestatin, a synthetic lipid-lowering agent. It belongs to the class of HMG-CoA reductase inhibitors, commonly known as statins. It is used to reduce elevated cholesterol levels (LDL-C, total cholesterol, and triglycerides) and increase HDL-C in patients with hypercholesterolemia and mixed dyslipidemia.
Uses & Indications
Dosage
Adults
Initial dose 10 mg once daily, preferably in the evening. Dose may be adjusted at intervals of 4 weeks to a maximum of 40 mg once daily.
Elderly
No dosage adjustment required for elderly patients with normal renal function.
Renal_impairment
No dosage adjustment needed for mild to moderate renal impairment. For severe renal impairment, use with caution; a starting dose of 5 mg daily may be considered.
How to Take
Take orally, once daily, with or without food. It is generally recommended to take it in the evening.
Mechanism of Action
Clolestatin selectively inhibits HMG-CoA reductase, an enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis. This inhibition reduces cholesterol production in the liver, leading to an upregulation of LDL receptors on the hepatocyte surface, which increases the uptake and catabolism of LDL. It also reduces VLDL and triglyceride levels.
Pharmacokinetics
Onset
Lipid-lowering effects begin within 2 weeks; maximal effect within 4-6 weeks.
Excretion
Excreted primarily via the bile (approximately 90%), with a small amount excreted in urine.
Half life
Approximately 14 hours.
Absorption
Rapidly absorbed from the gastrointestinal tract, with peak plasma concentrations occurring within 1-2 hours.
Metabolism
Primarily metabolized in the liver by CYP3A4 enzymes to active and inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Clolestatin or any component of the tablet
- Active liver disease or unexplained persistent elevations of serum transaminases
- Pregnancy and lactation
- Concomitant use with strong CYP3A4 inhibitors
Drug Interactions
Cyclosporine
Significantly increases Clolestatin exposure, avoid concomitant use or reduce Clolestatin dose.
Gemfibrozil and other Fibrates
Increased risk of myopathy/rhabdomyolysis.
Strong CYP3A4 Inhibitors (e.g., Itraconazole, Ketoconazole, Erythromycin, Clarithromycin)
Increased plasma concentrations of Clolestatin, leading to an increased risk of myopathy/rhabdomyolysis.
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 treatment for Clolestatin overdose. In the event of an overdose, treatment should be symptomatic and supportive. Liver function and CK levels should be monitored.
Pregnancy & Lactation
Clolestatin is contraindicated during pregnancy and breastfeeding. Women of childbearing potential should use effective contraception during treatment. If pregnancy occurs, Clolestatin should be discontinued immediately.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Available in pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Patented
Clinical Trials
Extensive Phase III clinical trials demonstrated efficacy in lowering LDL-C by an average of 35-50% and reducing major cardiovascular events. Post-marketing surveillance continues to monitor safety and long-term outcomes.
Lab Monitoring
- Liver function tests (LFTs) should be performed at baseline and periodically thereafter, especially if symptoms of liver injury develop.
- Creatine Kinase (CK) levels should be measured at baseline and if muscle symptoms develop.
- Lipid panel (Total cholesterol, LDL-C, HDL-C, Triglycerides) should be monitored to assess therapeutic response.
Doctor Notes
- Emphasize the importance of lifestyle modifications (diet, exercise) alongside Cloles therapy.
- Educate patients about symptoms of myopathy (muscle pain, tenderness, weakness) and advise them to report these promptly.
- Monitor LFTs and lipid panel as per guidelines.
Patient Guidelines
- Take Cloles exactly as prescribed by your doctor.
- Do not stop taking the medicine without consulting your doctor, even if you feel well.
- Report any unexplained muscle pain, tenderness, or weakness immediately to your doctor.
- Avoid excessive alcohol consumption during treatment.
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 continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Cloles is generally not expected to affect the ability to drive or operate machinery. However, if you experience dizziness or visual disturbances, you should avoid such activities.
Lifestyle Advice
- Adopt a cholesterol-lowering diet, rich in fruits, vegetables, and whole grains, and low in saturated and trans fats.
- Engage in regular physical activity (e.g., at least 30 minutes of moderate-intensity exercise most days of the week).
- Maintain a healthy weight and quit smoking.
- Manage stress effectively.
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