atorvastatin and acetylsalicylic acid

C10BX08

Forms & Strengths

Fixed-dose combination capsule: Atorvastatin 10 mg / Acetylsalicylic acid (Aspirin) 81 mg
Fixed-dose combination capsule: Atorvastatin 20 mg / Acetylsalicylic acid (Aspirin) 81 mg
Fixed-dose combination capsule: Atorvastatin 40 mg / Acetylsalicylic acid (Aspirin) 81 mg

Adult Dosing

Secondary prevention of cardiovascular events: 1 capsule (atorvastatin/aspirin 10/81 mg to 40/81 mg) orally once daily
Titrate atorvastatin component based on LDL-C reduction goals; aspirin component remains fixed at 81 mg daily

Pediatric Dosing

Safety and efficacy not established in pediatric patients; combination product is intended for adults

Indications

Secondary prevention of cardiovascular events in patients with established coronary heart disease and hyperlipidemia
Reduction of risk for myocardial infarction, stroke, and cardiovascular death in eligible adult patients

Mechanism of Action

Atorvastatin: Competitive inhibitor of HMG-CoA reductase, reducing hepatic cholesterol synthesis and increasing LDL receptors on hepatocytes
Acetylsalicylic acid (Aspirin): Irreversible inhibition of platelet cyclooxygenase-1 (COX-1), blocking thromboxane A2 production and inhibiting platelet aggregation

Contraindications

Hypersensitivity to atorvastatin, aspirin, other salicylates, or any component of the formulation
Active liver disease or unexplained persistent elevations of serum transaminases
Pregnancy and lactation
Asthma, rhinitis, or nasal polyps triggered by NSAIDs or salicylates (Aspirin triad)
Active pathological bleeding such as peptic ulcer or intracranial hemorrhage

Adverse Reactions

Atorvastatin-related: Myalgia, arthralgia, nasopharyngitis, diarrhea, elevated liver transaminases, creatine kinase elevation
Aspirin-related: Dyspepsia, gastrointestinal ulceration, gastritis, increased bleeding time, bruising
Rare: Rhabdomyolysis, immune-mediated necrotizing myopathy, severe hypersensitivity reactions, Reye's syndrome in youth

Drug Interactions

Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) increase atorvastatin exposure and myopathy risk
Anticoagulants and other antiplatelet agents increase the risk of severe bleeding episodes
NSAIDs may attenuate the antiplatelet effect of low-dose aspirin and increase GI ulceration risk
ACE inhibitors and ARBs combined with aspirin may exhibit reduced antihypertensive efficacy and increased renal impairment risk
Methotrexate clearance is decreased by aspirin, increasing toxicity risk

Curated Content: Needs Vetting Before Put to Clinical Use