Description
Product Overview:
CALIPTROL 40 mg Tablet contains Atorvastatin calcium, a member of the statin class of medications (HMG-CoA reductase inhibitors), used primarily to lower elevated levels of cholesterol and triglycerides in the blood. Atorvastatin works by inhibiting the enzyme HMG-CoA reductase, which plays a crucial role in the production of cholesterol in the liver. By reducing low-density lipoprotein cholesterol (LDL-C), total cholesterol, and triglycerides while modestly increasing high-density lipoprotein cholesterol (HDL-C), CALIPTROL helps reduce the risk of cardiovascular events such as heart attack and stroke.
Therapeutic Class:
HMG-CoA reductase inhibitor (Statin)
Active Ingredient:
Atorvastatin Calcium equivalent to Atorvastatin 40 mg
Indications:
- Primary hypercholesterolemia (heterozygous familial and non-familial)
- Combined (mixed) dyslipidemia
- Homozygous familial hypercholesterolemia (as an adjunct to other lipid-lowering treatments)
- Prevention of cardiovascular disease in patients at high risk, including those with diabetes or other risk factors
- Reduction of total cholesterol, LDL-C, apolipoprotein B, and triglycerides; and to increase HDL-C in patients with dyslipidemia
Key Benefits:
- Effectively lowers LDL-C (“bad cholesterol”) and triglycerides
- Modestly increases HDL-C (“good cholesterol”)
- Reduces the risk of cardiovascular morbidity and mortality
- Once-daily dosing for convenience and adherence
- Can be used alone or in combination with other lipid-lowering therapies
Dosage and Administration:
- Recommended Dose: 10–80 mg once daily.
- Typical Starting Dose: 10 or 20 mg once daily, adjusted at intervals of 4 weeks or more.
- Maximum Dose: 80 mg per day.
- Should be taken at any time of the day, with or without food.
Contraindications:
- Hypersensitivity to Atorvastatin or any excipients
- Active liver disease or unexplained persistent elevations of hepatic transaminases
- Pregnancy and lactation
- Women of childbearing potential not using appropriate contraception
Warnings and Precautions:
- Monitor liver function before and during treatment.
- Use with caution in patients with a history of liver disease, alcoholism, or renal impairment.
- Rare risk of myopathy or rhabdomyolysis, especially when used with other lipid-lowering agents.
- Monitor for signs of muscle pain, tenderness, or weakness.
Adverse Effects:
Common:
- Headache
- Myalgia (muscle pain)
- Diarrhea
- Arthralgia
- Nausea
Rare but Serious:
- Elevated liver enzymes
- Rhabdomyolysis
- Hepatitis
- Pancreatitis
- Hypersensitivity reactions
Drug Interactions:
- Increased risk of muscle toxicity with concurrent use of fibrates, niacin, cyclosporine, or certain antibiotics (e.g., clarithromycin).
- May interact with anticoagulants (e.g., warfarin), leading to increased bleeding risk.
- Use caution when combining with drugs that affect CYP3A4 metabolism (e.g., ketoconazole, HIV protease inhibitors).
Storage:
- Store below 25°C (77°F)
- Protect from moisture and direct sunlight
- Keep out of reach of children
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