Atorvastatin calcium
Class: HMG-CoA reductase inhibitor (statin)
Manufacturer: Micro Labs Limited (India)
Dosage Form: Film-coated oral tablets
Similar Brands: Atorid (atorvastatin)
Uses:
- Primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia (Fredrickson types IIa and IIb) — to reduce elevated total cholesterol, LDL-C, apolipoprotein B, and triglycerides, and increase HDL-C.
- Homozygous familial hypercholesterolemia — as adjunct to other lipid-lowering treatments or when other therapies are inadequate.
- Prevention of cardiovascular events (myocardial infarction, stroke, revascularization procedures, angina) in adult patients with:
- Clinically evident coronary heart disease (CHD) or
- Multiple risk factors for CHD (e.g., diabetes, hypertension, smoking, family history, low HDL-C).
- Adjunct to diet in patients with elevated serum triglyceride levels (Fredrickson type IV) and primary dysbetalipoproteinemia (type III).
Not for acute treatment of hyperlipidemia or as sole therapy—used with lifestyle changes (diet, exercise, smoking cessation).
Dosage:
Oral, once daily (any time of day, but consistent). Start with diet/exercise; adjust every 4 weeks based on lipid response and tolerability.
Adults — usual starting dose: 10–20 mg once daily.
Adults — usual starting dose: 10–20 mg once daily.
- Maintenance: 10–80 mg once daily (most patients reach goal at 10–40 mg).
- High-intensity therapy (e.g., established atherosclerotic CVD or high-risk diabetes): 40–80 mg once daily.
Heterozygous familial hypercholesterolemia: 10–80 mg/day.
Homozygous familial hypercholesterolemia: 10–80 mg/day (often with other therapies).
Children (10–17 years, heterozygous FH): Starting 10 mg once daily; max 20 mg/day (limited data; specialist use).
Renal impairment: No adjustment needed.
Hepatic impairment: Contraindicated in active liver disease or unexplained persistent LFT elevations.
Elderly: No adjustment but monitor for side effects.
Concomitant use with certain drugs (e.g., cyclosporine, gemfibrozil): Lower starting/max dose.
Side Effects:
Common (>1–10%): Nasopharyngitis, arthralgia/myalgia, diarrhea, urinary tract infection, insomnia, headache, nausea, elevated liver enzymes (ALT/AST), elevated CK (asymptomatic).
Less common: Rash, abdominal pain, constipation, dyspepsia, fatigue, dizziness.
Serious (rare, seek immediate care): Myopathy/rhabdomyolysis (muscle pain/weakness + CK >10× ULN, dark urine, fever—stop drug), severe liver injury (jaundice, fatigue, right upper quadrant pain), new-onset diabetes (small risk), hypersensitivity reactions (rash, angioedema), immune-mediated necrotizing myopathy.
Less common: Rash, abdominal pain, constipation, dyspepsia, fatigue, dizziness.
Serious (rare, seek immediate care): Myopathy/rhabdomyolysis (muscle pain/weakness + CK >10× ULN, dark urine, fever—stop drug), severe liver injury (jaundice, fatigue, right upper quadrant pain), new-onset diabetes (small risk), hypersensitivity reactions (rash, angioedema), immune-mediated necrotizing myopathy.
Warnings & Precautions:
Monitor liver function tests before starting and as clinically indicated (discontinue if persistent ALT >3× ULN).
Report unexplained muscle pain/weakness/tenderness (especially with fever/malaise)—stop drug and check CK.
Higher myopathy risk with: high doses, renal impairment, elderly, hypothyroidism, alcohol abuse, fibrates, cyclosporine, HIV protease inhibitors, erythromycin/clarithromycin.
Avoid grapefruit juice (increases atorvastatin levels).
May increase blood glucose/HbA1c (monitor in prediabetics/diabetics).
Not for active liver disease, unexplained persistent LFT elevations, or pregnancy/breastfeeding.
Report unexplained muscle pain/weakness/tenderness (especially with fever/malaise)—stop drug and check CK.
Higher myopathy risk with: high doses, renal impairment, elderly, hypothyroidism, alcohol abuse, fibrates, cyclosporine, HIV protease inhibitors, erythromycin/clarithromycin.
Avoid grapefruit juice (increases atorvastatin levels).
May increase blood glucose/HbA1c (monitor in prediabetics/diabetics).
Not for active liver disease, unexplained persistent LFT elevations, or pregnancy/breastfeeding.
Pregnancy & Lactation:
Pregnancy: Contraindicated (Category X); can cause fetal harm (reduced fetal growth, skeletal malformations in animals)—stop immediately if pregnancy occurs; use effective contraception.
Lactation: Contraindicated—atorvastatin passes into breast milk; discontinue breastfeeding or drug.
Lactation: Contraindicated—atorvastatin passes into breast milk; discontinue breastfeeding or drug.
Drug Interactions:
Major (avoid or dose limit atorvastatin): Cyclosporine, gemfibrozil, tipranavir + ritonavir, telaprevir, darunavir + ritonavir (myopathy risk).
Moderate: Erythromycin/clarithromycin, itraconazole, HIV protease inhibitors, nefazodone, diltiazem, verapamil, amiodarone (dose ≤20–40 mg atorvastatin).
Other: Grapefruit juice (limit or avoid), fibrates (myopathy risk), warfarin (monitor INR), digoxin (monitor levels), oral contraceptives (possible increased levels).
Moderate: Erythromycin/clarithromycin, itraconazole, HIV protease inhibitors, nefazodone, diltiazem, verapamil, amiodarone (dose ≤20–40 mg atorvastatin).
Other: Grapefruit juice (limit or avoid), fibrates (myopathy risk), warfarin (monitor INR), digoxin (monitor levels), oral contraceptives (possible increased levels).
Contraindications:
Hypersensitivity to atorvastatin or components.
Active liver disease or unexplained persistent elevations in hepatic transaminases.
Pregnancy and breastfeeding.
Concomitant use with certain strong CYP3A4 inhibitors (e.g., cyclosporine, gemfibrozil in some cases).
Active liver disease or unexplained persistent elevations in hepatic transaminases.
Pregnancy and breastfeeding.
Concomitant use with certain strong CYP3A4 inhibitors (e.g., cyclosporine, gemfibrozil in some cases).
Price: Ksh 351/- (Avas 20mg 30s), 1545/- (Avas 40mg 30s)
Notes:
Pack Size: 30s
Strengths: 10 mg, 20 mg, 40 mg, 80 mg atorvastatin calcium.