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Atorvastatin Uses, Dosage, Side Effects & Price | DrugsAtlas

Authoritative Clinical Reference

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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