Xelpid 10 mg

Description

Indications Xelpid is prescribed as an adjunct to dietary modifications to lower elevated total cholesterol, LDL cholesterol, apolipoprotein B (Apo-B), and triglyceride levels in cases where dietary and non-pharmacological measures alone are insufficient. It is indicated for:

• Lowering total and LDL cholesterol levels in patients with heterozygous and homozygous familial hypercholesterolemia.
• Managing mixed dyslipidemia (Fredrickson Type Ia and Ib) by reducing elevated cholesterol and triglycerides.
• Treating patients with hypertriglyceridemia (Fredrickson Type IV) who have high serum triglyceride levels.
• Managing dysbetalipoproteinemia (Fredrickson Type III).
• Reducing cardiac ischemic events in individuals with asymptomatic or mild to moderate symptomatic coronary artery disease who have high LDL cholesterol levels.
• Lowering total and LDL cholesterol in patients with hypercholesterolemia associated with diabetes mellitus or post-renal transplantation.

Pharmacology Xelpid contains Atorvastatin, a selective inhibitor of HMG-CoA reductase, the enzyme responsible for converting HMG-CoA to mevalonate, a key precursor in cholesterol biosynthesis. By inhibiting this enzyme, Atorvastatin reduces plasma cholesterol and lipoprotein levels while enhancing hepatic LDL receptor activity, thereby increasing LDL uptake and breakdown.

• Absorption: Rapidly absorbed after oral administration, reaching peak plasma concentrations within 1 to 2 hours. Bioavailability is approximately 14%, with systemic availability of HMG-CoA reductase inhibitory activity at around 30%.
• Distribution: The mean volume of distribution is about 381 liters, and approximately 98% of the drug binds to plasma proteins.
• Metabolism: Primarily metabolized to active ortho- and parahydroxylated derivatives through the cytochrome P450 3A4 enzyme system.
• Excretion: Eliminated mainly in bile after hepatic metabolism, with less than 2% excreted via urine. The plasma elimination half-life is about 14 hours, while the inhibitory activity persists for 20 to 30 hours due to active metabolites.

Dosage & Administration

• Primary Hypercholesterolemia and Mixed Hyperlipidemia:
  • Adults: 10 mg once daily, increasing at 4-week intervals as needed, up to a maximum of 80 mg daily.
  • Children (10-18 years): Initial dose of 10 mg daily, increasing up to a usual maximum of 20 mg daily if necessary.
• Familial Hypercholesterolemia:
  • Adults: Start with 10 mg daily, increasing up to 40 mg daily; a maximum of 80 mg may be required, sometimes combined with anion-exchange resins.
  • Children (10-18 years): Start at 10 mg daily, increasing at 4-week intervals to a maximum of 80 mg daily.
• Prevention of Cardiovascular Events:
  • Adults: Start with 10 mg once daily, adjusting based on response.

Patients should follow a cholesterol-lowering diet before and during treatment. Lipid levels should be monitored every 2 to 4 weeks to adjust dosage accordingly.

Interactions

• Increased risk of myopathy with concurrent use of cyclosporine, fibric acid derivatives, niacin, erythromycin, or azole antifungals.
• Antacid: May reduce atorvastatin plasma concentrations by approximately 35% without altering LDL-C reduction.
• Colestipol: Reduces atorvastatin plasma levels by around 25%, but combined therapy shows greater LDL-C reduction.
• Digoxin: Increases steady-state plasma concentrations by approximately 20%, requiring monitoring.
• Oral Contraceptives: Increases norethindrone and ethinyl estradiol levels, which should be considered when choosing contraceptives.
• Warfarin: No clinically significant effects on prothrombin time.

Contraindications

• Hypersensitivity to any component of Xelpid.
• Active liver disease or persistent, unexplained elevation of liver enzymes.
• History of serious adverse reactions to HMG-CoA reductase inhibitors.

Side Effects Common side effects include constipation, flatulence, dyspepsia, and abdominal pain. Other possible reactions include infections, headaches, back pain, rash, fatigue, joint pain, and muscle pain.

Pregnancy & Lactation

• Pregnancy: Atorvastatin is contraindicated due to the potential for fetal harm. Pregnant women or those planning pregnancy should not use this medication.
• Lactation: It is unknown whether atorvastatin is excreted in human milk; hence, breastfeeding while on this medication is not recommended.

Precautions & Warnings

• Liver Function: Liver function tests should be conducted before and during treatment. Patients with alcohol use disorder or liver disease require caution.
• Muscle Effects: Therapy should be discontinued if significantly elevated creatine kinase (CPK) levels occur or if myopathy is diagnosed or suspected.

Use in Special Populations

• Geriatric: Higher plasma concentrations have been observed in elderly patients, but the clinical response is similar to younger adults.
• Pediatric: Pharmacokinetic data for pediatric patients are limited.
• Renal Impairment: No dose adjustment is required as renal disease does not significantly affect drug plasma levels.
• Hepatic Impairment: Plasma concentrations increase in patients with chronic alcoholic liver disease.
• Hemodialysis: Not expected to significantly enhance atorvastatin clearance.

Overdose Effects There is no specific treatment for atorvastatin overdose. Supportive measures should be implemented, including liver function tests and serum CK level monitoring. Hemodialysis is not expected to be effective due to the high plasma protein binding of the drug.

Therapeutic Class Statins, Other Anti-anginal & Anti-Ischemic Drugs.

Storage Conditions Store in a cool, dry place away from heat and light. Keep out of the reach of children.

Frequently Asked Questions

• What is Xelpid used for?
  • It is prescribed to lower cholesterol and triglycerides and reduce the risk of heart disease.
• How should I take Xelpid?
  • Once daily, with or without food, at the same time each day.
• Can Xelpid cause weight loss?
  • Weight loss is not a common side effect.
• Does Xelpid affect blood sugar?
  • It may slightly increase blood sugar levels; diabetics should monitor their levels regularly.
• Can I stop taking Xelpid suddenly?
  • Stopping abruptly may worsen your condition; consult your doctor before discontinuation.
• Is Xelpid a blood thinner?
  • No, it is a cholesterol-lowering medication, not a blood thinner.
• Can children take Xelpid?
  • It is recommended for children above 10 years, under medical supervision.

Quick Tips

• Take with food if experiencing stomach upset.
• Report any muscle pain, weakness, or fatigue to your doctor.
• Regular liver function tests are required.
• Avoid use during pregnancy and breastfeeding.
• Monitor blood sugar levels if diabetic.

For best results, use Xelpid under medical supervision and maintain a healthy lifestyle.