Atorvastatin Uses, Dosage, Side Effects & Price | DrugsAtlas
Authoritative Clinical Reference
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Therapeutic Class
Lipid-lowering Agent
Subclass
HMG-CoA Reductase Inhibitor (Statin)
Speciality
Cardiology
Schedule (India)
Schedule H
Routes
Oral
Formulations
- Tablets: 5 mg, 10 mg, 20 mg, 40 mg, 80 mg
Fixed-Dose Combinations (FDCs) Available:
- Atorvastatin + Ezetimibe (10/10 mg, 20/10 mg, 40/10 mg)
- Atorvastatin + Aspirin (10/75 mg, 20/75 mg)
- Atorvastatin + Fenofibrate (10/145 mg, 10/160 mg)
- Atorvastatin + Clopidogrel (10/75 mg, 20/75 mg)
- Atorvastatin + Amlodipine (5/5 mg, 10/5 mg)
Adult indications
INDICATIONS + DOSING — FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Primary Hypercholesterolaemia and Mixed Dyslipidaemia
| Parameter | Dose |
|---|---|
|
Starting dose
|
10–20 mg orally once daily |
|
Titration
|
Adjust at 4-week intervals based on LDL-C response |
|
Usual maintenance dose
|
10–40 mg once daily |
|
Maximum dose
|
80 mg once daily |
Clinical Notes:
- Can be taken at any time of day (unlike simvastatin); no significant food interaction
- More potent LDL-C reduction per mg compared to simvastatin, pravastatin, or lovastatin
- 10 mg atorvastatin ≈ 20–40 mg simvastatin in LDL-lowering efficacy
- Assess baseline lipid panel; repeat at 4–6 weeks after dose adjustment
2. Heterozygous Familial Hypercholesterolaemia
| Parameter | Dose |
|---|---|
|
Starting dose
|
10–20 mg orally once daily |
|
Titration
|
Increase at 4-week intervals based on LDL-C response |
|
Usual maintenance dose
|
40–80 mg once daily |
|
Maximum dose
|
80 mg once daily |
Clinical Notes:
- Higher doses often required to achieve LDL-C targets
- May be combined with ezetimibe or PCSK9 inhibitors if target not met
- Family screening recommended
3. Homozygous Familial Hypercholesterolaemia
| Parameter | Dose |
|---|---|
|
Starting dose
|
10–20 mg orally once daily |
|
Titration
|
Increase based on LDL-C response |
|
Usual maintenance dose
|
40–80 mg once daily |
|
Maximum dose
|
80 mg once daily |
Clinical Notes:
- Adjunct to other lipid-lowering therapies (apheresis, ezetimibe, PCSK9 inhibitors)
- Response variable due to residual LDL receptor activity
- Specialist (lipidologist/cardiologist) supervision recommended
4. Primary Prevention of Cardiovascular Disease (CVD) in High-Risk Patients
| Parameter | Dose |
|---|---|
|
Starting dose
|
10–20 mg orally once daily |
|
Titration
|
Adjust based on LDL-C target and CV risk |
|
Usual maintenance dose
|
10–40 mg once daily |
|
Maximum dose
|
80 mg once daily |
Clinical Notes:
- Indicated in patients without prior CVD but with diabetes, hypertension, smoking, elevated LDL-C, or 10-year CV risk >10%
- Use risk calculators (QRISK, Framingham, ICMR charts) to guide initiation
- Target LDL-C depends on overall CV risk (typically <100 mg/dL or ≥50% reduction)
5. Secondary Prevention of Atherosclerotic Cardiovascular Disease (ASCVD)
(Post-MI, Post-Stroke, Peripheral Arterial Disease, Revascularization)
| Parameter | Dose |
|---|---|
|
Starting dose
|
40–80 mg orally once daily (high-intensity therapy) |
|
Titration
|
Not applicable — start at high intensity |
|
Usual maintenance dose
|
40–80 mg once daily |
|
Maximum dose
|
80 mg once daily |
Clinical Notes:
- High-intensity statin therapy (atorvastatin 40–80 mg) should be initiated promptly in all patients with ASCVD unless contraindicated
- In acute coronary syndrome (ACS): start atorvastatin 80 mg within 24–96 hours of presentation
- Target LDL-C: <70 mg/dL or ≥50% reduction from baseline
- Continue indefinitely for secondary prevention
Secondary Indications – Adults (Off-label)
| Indication | Dose | Duration | Supervision | Evidence Basis |
|---|---|---|---|---|
|
Non-Alcoholic Fatty Liver Disease (NAFLD) with Dyslipidaemia (OFF-LABEL)
|
10–40 mg once daily | Long-term | Specialist recommended (Hepatology/Gastroenterology) | Cohort studies showing ALT improvement and CV risk reduction; Indian hepatology practice consensus; statins safe in NAFLD/NASH without decompensated cirrhosis |
|
Chronic Kidney Disease (CKD) Stages 3–5 (Non-Dialysis) (OFF-LABEL)
|
10–20 mg once daily | Long-term | Nephrology supervision recommended | SHARP trial; KDIGO guidelines; reduces CV events in CKD; Indian nephrology practice |
|
Post-Renal Transplant Dyslipidaemia (OFF-LABEL)
|
10 mg once daily initially; titrate cautiously | Long-term | Specialist only (Nephrology/Transplant) | Drug interaction with cyclosporine/tacrolimus; start low; monitor for myopathy |
|
Stroke Prevention (High-Risk Patients) (OFF-LABEL as primary indication)
|
40–80 mg once daily | Long-term | Not required | SPARCL trial; reduces recurrent stroke in patients with prior stroke/TIA and no known CAD |
Paediatric indications
PAEDIATRIC DOSING (Specialist Only)
⚠️ Not recommended in children below 10 years of age except under specialist lipidology supervision.
Primary Indication: Heterozygous Familial Hypercholesterolaemia (Children ≥10 years)
| Parameter | Dose |
|---|---|
|
Starting dose
|
10 mg orally once daily |
|
Titration
|
Increase at 4-week intervals based on LDL-C response |
|
Usual maintenance dose
|
10–20 mg once daily |
|
Maximum dose
|
20 mg once daily |
Eligibility Criteria:
- Age ≥10 years (post-pubertal; Tanner stage II or above)
- Confirmed diagnosis of heterozygous familial hypercholesterolaemia (clinical criteria + family history ± genetic testing)
- LDL-C persistently elevated despite 6–12 months of dietary intervention
Safety Monitoring:
- Lipid profile at baseline, 4 weeks, and every 3–6 months
- Liver function tests (ALT, AST) at baseline and periodically
- Creatine kinase (CK) if muscle symptoms develop
- Growth and pubertal development assessment annually
- Screen for diabetes risk factors
Clinical Notes:
- Treatment should be supervised by paediatric lipidologist, cardiologist, or endocrinologist
- Diet and lifestyle modification remain cornerstone of therapy
- Goal: LDL-C reduction of ≥50% or LDL-C <130 mg/dL
Secondary Indications – Paediatrics (Off-label)
| Indication | Age | Dose | Duration | Supervision | Evidence Basis |
|---|---|---|---|---|---|
|
Homozygous Familial Hypercholesterolaemia (OFF-LABEL)
|
≥10 years | Starting: 10–20 mg once daily; Maximum: 40–80 mg once daily based on response | Long-term | Specialist only (Paediatric Lipidology) | Extrapolated from adult data; Indian tertiary care practice; adjunct to apheresis/other therapies |
Age Restrictions:
- Not recommended below 10 years of age
- Use in children 6–10 years only in exceptional circumstances (severe familial hypercholesterolaemia) under specialist supervision
- Safety and efficacy not established below 6 years
Renal Adjustments
No dose adjustment required in renal impairment.
| Renal Function | Recommendation |
|---|---|
|
All eGFR levels (including ESRD)
|
No dose adjustment required |
|
Haemodialysis
|
Not significantly removed; no supplemental dose required |
|
Peritoneal Dialysis
|
No dose adjustment required |
Additional Notes:
- Atorvastatin is primarily hepatically metabolised (<2% excreted renally)
- Use with caution in severe renal impairment — increased risk of myopathy
- Consider lower starting dose (10 mg) and careful monitoring in CKD Stage 4–5
Hepatic adjustment
Contraindications
- Known hypersensitivity to atorvastatin or any excipients
- Active liver disease or unexplained persistent elevation of serum transaminases (>3× ULN)
- Pregnancy (teratogenic — disrupts fetal cholesterol synthesis)
- Breastfeeding
- Concurrent use with strong CYP3A4 inhibitors (itraconazole, ketoconazole, posaconazole, HIV protease inhibitors, telithromycin) at high statin doses
- Concurrent use with cyclosporine (unless closely monitored with atorvastatin ≤10 mg)
- Concurrent use with gemfibrozil
Cautions
- History of hepatic disease or heavy alcohol use — increased hepatotoxicity risk
- History of statin-associated myopathy or myalgia
- Predisposing factors for myopathy/rhabdomyolysis:
-
- Advanced age (≥65 years)
- Renal impairment
- Untreated hypothyroidism
- Concurrent fibrates (fenofibrate preferred over gemfibrozil)
- Concurrent niacin (≥1 g/day)
- Concurrent CYP3A4 inhibitors
- Asian ethnicity (may require lower doses)
- Low body weight
- Personal or family history of hereditary muscular disorders
- Interacting medications (see Drug Interactions)
- Diabetes risk — statins may slightly increase HbA1c and fasting glucose
Pregnancy
| Parameter | Information |
|---|---|
|
Overall Safety
|
Contraindicated — Category X equivalent; evidence of fetal harm
|
|
Risk
|
Statins inhibit cholesterol synthesis essential for fetal development; case reports of congenital anomalies (CNS, limb defects) |
|
Preferred Alternatives
|
Bile acid sequestrants (cholestyramine, colesevelam) if lipid lowering essential during pregnancy |
|
When Use May Be Justified
|
Never justified — must be discontinued immediately if pregnancy occurs |
|
Women of Childbearing Potential
|
Ensure reliable contraception during therapy; discontinue atorvastatin at least 1–3 months before planned conception |
|
Monitoring
|
Pregnancy test before initiation in women of childbearing potential |
Lactation
| Parameter | Information |
|---|---|
|
Compatibility
|
Contraindicated — avoid breastfeeding during atorvastatin therapy
|
|
Expected Drug Level in Milk
|
Unknown; likely excreted based on pharmacokinetic properties |
|
Risk to Infant
|
Potential disruption of infant lipid metabolism; theoretical risk of adverse effects |
|
Preferred Alternatives
|
If lipid-lowering essential during lactation: bile acid sequestrants (not absorbed systemically) |
|
Recommendation
|
Either avoid breastfeeding or discontinue atorvastatin; consult cardiologist/lipidologist |
Elderly
| Parameter | Recommendation |
|---|---|
|
Starting dose
|
10 mg orally once daily |
|
Titration
|
Increase cautiously at 4–6 week intervals; use lowest effective dose |
|
Maximum recommended
|
40–80 mg (same as adults); individualize based on comorbidities |
|
Increased Risks
|
Myopathy, rhabdomyolysis (especially with polypharmacy, renal impairment, or hypothyroidism); new-onset diabetes |
|
Additional Precautions
|
Check renal function and thyroid status before initiation; assess for drug interactions; monitor for muscle symptoms; CK if symptoms develop |
Major drug interactions
| Interacting Drug | Mechanism | Effect | Management |
|---|---|---|---|
|
Cyclosporine
|
Inhibits OATP1B1/OATP1B3 transport and CYP3A4 | 7–10 fold increase in atorvastatin exposure; high myopathy/rhabdomyolysis risk |
Avoid if possible; if essential, limit atorvastatin to ≤10 mg and monitor closely
|
|
Strong CYP3A4 Inhibitors (itraconazole, ketoconazole, posaconazole, clarithromycin, telithromycin, HIV protease inhibitors)
|
CYP3A4 inhibition | Significantly increased atorvastatin levels; myopathy risk |
Avoid combination or use lowest atorvastatin dose (10 mg); suspend statin temporarily during short-term azole/antibiotic course
|
|
Gemfibrozil
|
Inhibits glucuronidation and OATP transport | 2–3 fold increase in statin exposure; high rhabdomyolysis risk |
Avoid combination — use fenofibrate instead if fibrate needed
|
|
Niacin (≥1 g/day)
|
Additive myotoxicity | Increased myopathy risk | Use with caution; monitor CK and muscle symptoms |
|
Fusidic Acid (systemic)
|
Unknown mechanism | Case reports of rhabdomyolysis |
Suspend statin during fusidic acid treatment; resume 7 days after last fusidic acid dose
|
|
Colchicine
|
Additive myotoxicity; possible transport inhibition | Increased myopathy/rhabdomyolysis risk | Use with caution; avoid in renal impairment; monitor for muscle symptoms |
|
Grapefruit Juice (>1.2 L/day)
|
CYP3A4 inhibition in gut wall | Increased atorvastatin absorption and levels | Avoid large quantities (>1 glass/day) |
Moderate drug interactions
| Diltiazem, Verapamil | Moderate CYP3A4 inhibition; 2–4 fold increase in atorvastatin levels | Limit atorvastatin to ≤20 mg; monitor for myopathy |
|---|---|---|
|
Amlodipine
|
Mild CYP3A4 inhibition | Limit atorvastatin to ≤40 mg; generally safe combination |
|
Erythromycin
|
Moderate CYP3A4 inhibition | Limit atorvastatin to ≤20 mg; monitor CK if concurrent use necessary |
|
Fenofibrate
|
Additive myopathy risk (less than gemfibrozil) | Preferred fibrate for combination; monitor for myopathy; avoid in renal impairment |
|
Rifampicin
|
CYP3A4 induction | Reduced atorvastatin levels and efficacy |
|
Warfarin
|
Possible modest increase in INR | Monitor INR when starting, stopping, or changing atorvastatin dose; adjust warfarin if needed |
|
Digoxin
|
Possible modest increase in digoxin levels | Monitor digoxin levels; usually clinically insignificant |
|
Oral Contraceptives
|
Increased ethinyl estradiol and norethindrone exposure | Consider when selecting contraceptive dose |
|
Antacids (aluminium/magnesium)
|
May reduce atorvastatin absorption (modest) | Separate administration by 2 hours if possible; usually not clinically significant |
Common Adverse effects
- Headache
- Myalgia (muscle aches without CK elevation; 5–10%)
- Nasopharyngitis, pharyngolaryngeal pain
- Arthralgia
- Diarrhoea, constipation
- Dyspepsia, nausea
- Flatulence
- Mild transaminase elevation (usually transient)
- Insomnia
Serious Adverse effects
| Adverse Effect | Clinical Action |
|---|---|
|
Myopathy (CK >10× ULN with muscle symptoms)
|
Discontinue immediately; check renal function (myoglobin); supportive care; rule out contributing factors |
|
Rhabdomyolysis (muscle breakdown, CK markedly elevated, myoglobinuria, acute kidney injury)
|
Discontinue immediately; hospitalisation; aggressive IV hydration; monitor renal function; may require dialysis |
|
Hepatotoxicity (ALT/AST persistently >3× ULN)
|
Discontinue; investigate other causes; usually reversible; rechallenge not recommended |
|
Immune-Mediated Necrotising Myopathy (IMNM) (rare autoimmune myopathy; persists after statin discontinuation)
|
Discontinue; immunosuppressive therapy may be needed; rheumatology/neurology referral |
|
New-Onset Diabetes Mellitus (dose-related; more common at 80 mg)
|
Continue statin (CV benefit outweighs diabetes risk); manage diabetes with lifestyle/pharmacotherapy |
|
Interstitial Lung Disease (very rare)
|
Discontinue; respiratory evaluation; usually reversible |
|
Hypersensitivity Reactions (angioedema, rash, anaphylaxis — rare)
|
Discontinue permanently; supportive care |
Monitoring requirements
| Timing | Parameters |
|---|---|
|
Baseline
|
Fasting lipid profile (TC, LDL-C, HDL-C, TG); liver function tests (ALT, AST); fasting glucose/HbA1c (diabetes risk); renal function; thyroid function (if myopathy risk factors); CK (if history of muscle disease or high myopathy risk) |
|
4–12 weeks after initiation or dose change
|
Fasting lipid profile (to assess response and adjust dose); LFTs (once at 6–12 weeks; routine monitoring not required unless symptoms) |
|
Long-term (every 6–12 months)
|
Lipid profile annually; LFTs not required routinely unless high dose, FDC, or symptoms suggestive of hepatotoxicity; fasting glucose/HbA1c periodically (diabetes surveillance); CK only if muscle symptoms develop |
|
If muscle symptoms develop
|
Check CK; discontinue if CK >10× ULN or if CK elevated with symptoms; if CK normal but symptoms tolerable, may continue with close monitoring |
Brands in India
Monotherapy:
- Atorlip™ (Cipla) — 5 mg, 10 mg, 20 mg, 40 mg, 80 mg
- Lipitor™ (Pfizer) — 10 mg, 20 mg, 40 mg, 80 mg
- Storvas™ (Sun Pharma/Ranbaxy) — 5 mg, 10 mg, 20 mg, 40 mg, 80 mg
- Atorva™ (Zydus) — 5 mg, 10 mg, 20 mg, 40 mg
- Lipvas™ (Cipla) — 10 mg, 20 mg
- Atocor™ (Dr. Reddy's) — 10 mg, 20 mg, 40 mg
- Aztor™ (USV) — 10 mg, 20 mg, 40 mg, 80 mg
Fixed-Dose Combinations (Examples):
- Atozet™ (Atorvastatin + Ezetimibe) — MSD
- Tonact-EZ™ (Atorvastatin + Ezetimibe) — Lupin
- Atocor-ASP™ (Atorvastatin + Aspirin) — Dr. Reddy's
- Lipikind-F™ (Atorvastatin + Fenofibrate) — Mankind
- Aztor-C™ (Atorvastatin + Clopidogrel) — USV
- Amlostat™ (Atorvastatin + Amlodipine) — Ranbaxy
Price range (INR)
| Formulation | Price Range | Notes |
|---|---|---|
| 5 mg tablet | ₹1.50–₹4.00 per tablet | — |
| 10 mg tablet | ₹2.00–₹6.00 per tablet | NLEM listed |
| 20 mg tablet | ₹3.50–₹8.00 per tablet | NLEM listed |
| 40 mg tablet | ₹6.00–₹12.00 per tablet | — |
| 80 mg tablet | ₹10.00–₹18.00 per tablet | — |
| FDCs | ₹8–₹25 per tablet | Variable based on combination |
Regulatory: Listed under NLEM 2022 (10 mg, 20 mg tablets); NPPA price controlled for scheduled strengths; available through Jan Aushadhi at lower prices; widely available in government supply
Clinical pearls
- High-intensity statin in ASCVD — In all patients with established atherosclerotic cardiovascular disease (post-MI, stroke, PAD), start atorvastatin 40–80 mg unless contraindicated; do not wait for lipid panel results in ACS
- Atorvastatin vs Simvastatin — Atorvastatin has longer half-life (can be taken any time of day), more potent LDL-lowering, and fewer drug interactions (simvastatin has significant interaction with amlodipine requiring dose cap)
- Myalgia without CK elevation — Common (5–10%); often tolerable; if bothersome, try temporary discontinuation, rechallenge, dose reduction, alternate-day dosing, or switch to rosuvastatin or pravastatin
- CK monitoring strategy — Do not routinely monitor CK; check only if muscle symptoms develop; do not discontinue for asymptomatic mild CK elevation (<5× ULN); discontinue if CK >10× ULN or if CK elevated with symptoms
- Statin-associated diabetes — High-intensity statins (80 mg) slightly increase diabetes risk; CV benefit far outweighs this risk; continue statin and manage diabetes appropriately
- Perioperative management — May continue atorvastatin through most surgeries; if NPO for extended period, omitting a few doses is acceptable; resume as soon as oral intake possible
Version
RxIndia v1.0 — 06 Apr 2025
Reference
- CDSCO Product Information
- Indian Pharmacopoeia (IP)
- National List of Essential Medicines (NLEM) 2022
- API Textbook of Medicine
- ICMR Guidelines for Management of Dyslipidaemia
- AIIMS Cardiovascular Drug Formulary
- Harrison's Principles of Internal Medicine
- Goodman & Gilman's The Pharmacological Basis of Therapeutics
- IAP Guidelines (paediatric familial hypercholesterolaemia)
- SPARCL Trial (stroke prevention evidence)
- SHARP Trial (CKD evidence)
- CARDS, ASCOT-LLA, TNT Trials (primary and secondary prevention evidence)
- Indian specialist practice consensus (NAFLD/statin safety)
⚖️
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This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.
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