Drug reference

Atorvastatin + Aspirin

Statin · Lipid-lowering agent + Antiplatelet

Also known as Atorva ASP, Storvas ASP, Aztor ASP, Lipikind Plus, Tonact ASP

StatinLipid-lowering agent + AntiplateletATC Atorvastatin: C10AA05; Aspirin: B01AC06

CDSCO approvedSchedule H (Prescription Drug)ATC Atorvastatin: C10AA05; Aspirin: B01AC06

Pharmacokineticsplasma · t hours

ONSET: 2w · Atorvastatin: Lipid-lowering effects observed within 2 weeks, maximal effect in 4 weeks. Aspirin: Antiplatelet effect within 1 hour.
PEAK: 1.5h · Atorvastatin: Plasma concentration peaks in 1-2 hours. Aspirin: Antiplatelet effect peaks within 1-2 hours.
t½: 1d · Atorvastatin: Approximately 14 hours (with active metabolites, ~20-30 hours). Aspirin: Plasma half-life of aspirin is short (15-20 minutes); active metabolite salicylic acid 2-3 hours (dose-dependent up to 15-30 hours at high doses).
DURATION: 1.2w · Atorvastatin: Lipid-lowering effect sustained over 24 hours. Aspirin: Irreversible inhibition of platelet aggregation for the life of the platelet (7-10 days).

EXCRETION

—

not curated

INTERACTIONS

12 major

SEVERE in our sources

PREGNANCY

Category X. Contraindicated during pregnancy due to potential fetal harm (both atorvastatin and aspirin in antiplatelet doses).

FDA category + note

Top interactionssee all 12 →

AmiodaroneSevereTextbookG&G 14e · p736
Azole AntifungalsSevereTextbookG&G 14e · p736
CyclosporineSevereTextbookG&G 14e · p736
ErythromycinSevereTextbookKDT 7e · p637

Mechanism

Atorvastatin, an HMG-CoA reductase inhibitor, reduces cholesterol synthesis in the liver, leading to increased LDL receptor expression and subsequent reduction in plasma LDL-C. Aspirin, a non-steroidal anti-inflammatory drug, irreversibly inhibits cyclooxygenase-1 (COX-1) in platelets, thereby preventing the synthesis of thromboxane A2 (TXA2), a potent inducer of platelet aggregation and vasoconstriction. This combination targets both dyslipidemia and platelet activation to provide comprehensive cardiovascular protection. Combination rationale: This Fixed Dose Combination provides comprehensive cardiovascular risk reduction by addressing two key pathological processes: dyslipidemia and platelet aggregation. Atorvastatin effectively lowers LDL-C, while aspirin inhibits platelet activation, thereby reducing the risk of atherothrombotic events. The combination improves patient adherence by simplifying complex regimens, leading to better outcomes in secondary prevention of cardiovascular diseases.

Indications

Secondary prevention of cardiovascular events (e.g., myocardial infarction, stroke) in patients with established atherosclerotic cardiovascular disease and dyslipidemia.Primary prevention in high-risk patients with both dyslipidemia and significant cardiovascular risk factors, where combined therapy is deemed appropriate by a physician.

Dosing

Adult: Typically Atorvastatin 10 mg, 20 mg, or 40 mg combined with Aspirin 75 mg or 150 mg, orally once daily, preferably at bedtime. The specific strength depends on the individual patient's lipid profile, cardiovascular risk, and tolerability.
Pediatric: Not recommended for pediatric use as safety and efficacy have not been established.
Renal adjustment: Atorvastatin: No dosage adjustment required for mild to moderate renal impairment. Aspirin: Use with caution; monitor renal function. Avoid in severe renal impairment (CrCl < 30 mL/min) due to increased risk of aspirin-related toxicity and bleeding.
Hepatic adjustment: Contraindicated in active liver disease or unexplained persistent elevations of serum transaminases (due to atorvastatin). Aspirin: Use with caution in hepatic impairment due to increased risk of bleeding; avoid in severe cases.
Geriatric: Use with caution due to increased risk of bleeding with aspirin and potential for polypharmacy interactions. Start with lower doses if appropriate and monitor closely for adverse effects, especially gastrointestinal bleeding.
Max dose: Atorvastatin: 80 mg daily. Aspirin (antiplatelet dose in FDC): Generally up to 150 mg daily, depending on formulation and clinical need.

Pharmacokinetics

Onset

Atorvastatin: Lipid-lowering effects observed within 2 weeks, maximal effect in 4 weeks. Aspirin: Antiplatelet effect within 1 hour.

Peak effect

Atorvastatin: Plasma concentration peaks in 1-2 hours. Aspirin: Antiplatelet effect peaks within 1-2 hours.

Duration

Atorvastatin: Lipid-lowering effect sustained over 24 hours. Aspirin: Irreversible inhibition of platelet aggregation for the life of the platelet (7-10 days).

Half-life

Atorvastatin: Approximately 14 hours (with active metabolites, ~20-30 hours). Aspirin: Plasma half-life of aspirin is short (15-20 minutes); active metabolite salicylic acid 2-3 hours (dose-dependent up to 15-30 hours at high doses).

Bioavailability

Atorvastatin: Approximately 12% systemic bioavailability. Aspirin: 50-70% due to extensive first-pass metabolism.

Protein binding

Atorvastatin: >98%. Aspirin: 80-90% (salicylic acid).

Metabolism

Atorvastatin: Primarily hepatic via CYP3A4 to active ortho- and parahydroxylated metabolites. Aspirin: Rapidly hydrolyzed in the GI tract, liver, and blood to salicylic acid, then conjugated in the liver.

Excretion

Atorvastatin: Primarily biliary/fecal. Aspirin: Renal excretion of salicylic acid and its metabolites.

Contraindications

Active pathological bleeding (e.g., peptic ulcer, intracranial hemorrhage)
Hypersensitivity to atorvastatin, aspirin, or any excipients
Severe hepatic impairment or active liver disease, unexplained persistent elevations of serum transaminases
Pregnancy and lactation
Severe renal impairment (especially for aspirin)
Co-administration with potent CYP3A4 inhibitors (for atorvastatin)

Side effects

Common

Gastrointestinal upsetDyspepsiaNauseaAbdominal painHeadacheMyalgiaArthralgiaElevated liver transaminasesFlatulenceDiarrheaInsomnia

Serious

Gastrointestinal bleeding
Hemorrhagic stroke
Rhabdomyolysis
Myopathy
Hepatic failure
Angioedema
Hypersensitivity reactions
Thrombocytopenia
Pancreatitis

Pregnancy & lactation

Pregnancy

Category X. Contraindicated during pregnancy due to potential fetal harm (both atorvastatin and aspirin in antiplatelet doses).

Lactation

Contraindicated during lactation due to potential harm to the infant and excretion of both components into breast milk.

Drug interactions

Amiodarone

Severe

Textbook

Increased plasma concentrations of statins and their active metabolites, leading to an increased risk of myopathy and rhabdomyolysis.

Consider using pravastatin, fluvastatin, or rosuvastatin, as they are not extensively metabolized by CYP3A4. Carefully weigh the benefits against the risk of myopathy.

Source: G&G 14e · p736

Azole Antifungals

Severe

Textbook

Increased plasma concentrations of statins and their active metabolites, leading to an increased risk of myopathy and rhabdomyolysis.

Consider using pravastatin, fluvastatin, or rosuvastatin, as they are not extensively metabolized by CYP3A4. Carefully weigh the benefits against the risk of myopathy.

Source: G&G 14e · p736

Cyclosporine

Severe

Textbook

Increased risk of myopathy and rhabdomyolysis.

Consider using pravastatin, fluvastatin, or rosuvastatin, as they are not extensively metabolized by CYP3A4. Carefully weigh the benefits against the risk of myopathy. For simvastatin, coadministration is contraindicated.

Source: G&G 14e · p736

Erythromycin

Severe

Textbook

Increased risk of myopathy and rhabdomyolysis.

Concomitant use should be avoided or used with extreme caution, especially for statins metabolized by CYP3A4. Dose reduction of the statin and vigilant monitoring for muscle symptoms are necessary.

Source: KDT 7e · p637

Gemfibrozil

Severe

Textbook

Increased plasma concentration of statin hydroxy acids, leading to an increased risk of myopathy (including rhabdomyolysis).

Avoid coadministration. The FDA withdrew approval for statin drug combinations containing fibrates in 2016.

Source: G&G 14e · p736

Hiv Protease Inhibitor

Severe

Textbook

Increased risk of myopathy and rhabdomyolysis.

Concomitant use should be avoided or used with extreme caution, especially for statins metabolized by CYP3A4. Dose reduction of the statin and vigilant monitoring for muscle symptoms are necessary.

Source: KDT 7e · p637

Hiv Protease Inhibitors

Severe

Textbook

Increased plasma concentrations of statins and their active metabolites, leading to an increased risk of myopathy and rhabdomyolysis.

Source: G&G 14e · p736

Ketoconazole

Severe

Textbook

Increased risk of myopathy and rhabdomyolysis.

Concomitant use should be avoided or used with extreme caution, especially for statins metabolized by CYP3A4. Dose reduction of the statin and vigilant monitoring for muscle symptoms are necessary.

Source: KDT 7e · p637

Macrolide Antibiotics

Severe

Textbook

Increased plasma concentrations of statins and their active metabolites, leading to an increased risk of myopathy and rhabdomyolysis.

Source: G&G 14e · p736

Nefazodone

Severe

Textbook

Increased plasma concentrations of statins and their active metabolites, leading to an increased risk of myopathy and rhabdomyolysis.

Consider using pravastatin, fluvastatin, or rosuvastatin, as they are not extensively metabolized by CYP3A4. Carefully weigh the benefits against the risk of myopathy.

Source: G&G 14e · p736

Niacin

Severe

Textbook

Increased risk of myopathy.

Avoid coadministration. The FDA withdrew approval for statin drug combinations containing niacin in 2016.

Source: G&G 14e · p736

Nicotinic Acid

Severe

Textbook

Increased risk of myopathy and rhabdomyolysis.

A lower dose of statin is advisable when nicotinic acid is given concurrently. Close monitoring for muscle symptoms is essential.