rosuvastatin and valsartan

C10BX10

Forms & Strengths

Rosuvastatin/Valsartan fixed-dose combination capsules or tablets: 5 mg/80 mg, 5 mg/160 mg, 10 mg/80 mg, 10 mg/160 mg, 20 mg/160 mg, 20 mg/320 mg

Adult Dosing

Hypertension and dyslipidemia co-management: Initiate based on individual component requirements.
Maximum recommended daily dose: Rosuvastatin 40 mg / Valsartan 320 mg.
Renal impairment (CrCl < 30 mL/min): Rosuvastatin starting dose 5 mg daily; maximum 10 mg daily.

Pediatric Dosing

Safety and efficacy in pediatric patients not established; fixed-dose combination not recommended for children.

Indications

Management of essential hypertension and co-existing primary hypercholesterolemia or mixed dyslipidemia in adults already controlled on the individual agents administered concurrently.

Mechanism of Action

Rosuvastatin: Selective and competitive inhibitor of HMG-CoA reductase, halting hepatic cholesterol synthesis and upregulating LDL receptors.
Valsartan: Selective, reversible antagonist of the angiotensin II type 1 (AT1) receptor, causing vasodilation and decreasing aldosterone secretion.

Contraindications

Hypersensitivity to rosuvastatin, valsartan, or any component
Active liver disease or unexplained persistent elevations of serum transaminases
Pregnancy (due to fetal toxicity from the ARB component)
Lactation
Co-administration with aliskiren in patients with diabetes mellitus

Adverse Reactions

Drug Interactions

Cyclosporine: Significantly increases rosuvastatin exposure; avoid co-administration or limit rosuvastatin to 5 mg daily.
Gemfibrozil: Increases rosuvastatin exposure; avoid co-administration or limit to 10 mg daily.
Potassium-sparing diuretics, potassium supplements, or salt substitutes: May lead to severe hyperkalemia when combined with valsartan.
Lithium: Valsartan can increase serum lithium concentrations and toxicity risk.
NSAIDs: May reduce antihypertensive efficacy and increase renal impairment risk.

Curated Content: Needs Vetting Before Put to Clinical Use