3 months to expiry Ghana · FDA Ghana

COLESTOP 40MG FILM-COATED TABLETS

Astorvastatin calcium

FDA/SD.223-111642 Astorvastatin calcium 40mg

What it does

Astorvastatin is a medication used to help lower cholesterol levels in the blood, which can reduce the risk of heart disease.

Commonly used for: high cholesterol (hyperlipidemia), heart disease prevention

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.223-111642
Registration date
2022-11-15
Expiry date
2026-05-01
Status
3 months to expiry
Active ingredient
Astorvastatin calcium
Dosage form
Astorvastatin calcium
Strength
40mg
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Lek Pharmaceuticals
Applicant / LTR
Novartis Ghana Ltd
Country of origin
-
Manufacturer location
Verovškova ulica 57, 1526 Ljubljana, Slovenia

Source: Food and Drugs Authority · fetched 2026-04-18 08:48:19 · updated 2026-05-01 08:00:12

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Astorvastatin is a medication used to help lower cholesterol levels in the blood, which can reduce the risk of heart disease.

What it treats

  • high cholesterol (hyperlipidemia)
  • heart disease prevention

How it works

Astorvastatin works by blocking a substance your body needs to make cholesterol, leading to lower cholesterol levels in the blood.

Who it's for

This medication is for adults who need help managing their cholesterol levels to prevent heart problems.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: astorvastatin

Atorvastatin is a statin medication used to lower cholesterol levels in the blood. It works by inhibiting HMG-CoA reductase, an enzyme involved in the synthesis of cholesterol in the liver. By lowering levels of low-density lipoprotein (LDL) cholesterol and triglycerides, atorvastatin helps reduce the risk of cardiovascular diseases, including heart attacks and strokes.

Indications

  • Primary hyperlipidemia
  • Mixed dyslipidemia
  • Prevention of cardiovascular disease
  • Familial hypercholesterolemia

Dosage

Children: Refer to the BNF for Children for specific dosing guidelines.

Adults: Refer to the BNF for specific dosing guidelines.

Mechanism of action

Atorvastatin selectively inhibits HMG-CoA reductase, the rate-limiting enzyme in the cholesterol biosynthesis pathway. This inhibition leads to decreased cholesterol production in the liver, resulting in increased uptake of LDL cholesterol from the bloodstream, thus lowering overall LDL cholesterol levels.

Pharmacodynamics

Atorvastatin reduces total cholesterol, LDL cholesterol, and triglycerides while modestly increasing high-density lipoprotein (HDL) cholesterol. Its lipid-lowering effects are dose-dependent, and it may also have pleiotropic effects, including improving endothelial function and exerting anti-inflammatory effects.

Pharmacokinetics

Atorvastatin is well-absorbed after oral administration, with peak plasma concentrations occurring within 1 to 2 hours. It undergoes extensive first-pass metabolism in the liver, primarily by cytochrome P450 3A4, leading to the formation of active metabolites. Its elimination half-life is approximately 14 hours, and it is primarily excreted in the bile. Atorvastatin's pharmacokinetics can be affected by factors such as age, liver function, and concomitant medications.

Contra-indications

  • Active liver disease
  • Pregnancy
  • Breastfeeding
  • Hypersensitivity to atorvastatin or any component of the formulation

Adverse effects

  • Muscle pain or weakness (myopathy, rhabdomyolysis)
  • Liver enzyme elevation
  • Gastrointestinal disturbances (nausea, diarrhea, constipation)
  • Headache
  • Rash
  • Increased blood sugar levels

Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, erythromycin) may increase atorvastatin levels
  • CYP3A4 inducers (e.g., rifampin, St. John's Wort) may decrease atorvastatin levels
  • Gemfibrozil may increase the risk of myopathy
  • Warfarin may have increased effects when used with atorvastatin

Precautions

  • Use with caution in patients with a history of liver disease
  • Monitor liver function tests before and during treatment
  • Caution in patients with a history of muscle disorders
  • Consider risk of diabetes in high-risk patients

Pregnancy

Atorvastatin is contraindicated in pregnancy due to the potential for fetal harm.

Breast-feeding

Atorvastatin is contraindicated during breastfeeding as it may pass into breast milk and affect the infant.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

  • Tablets (10 mg, 20 mg, 40 mg, 80 mg)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.