rosuvastatin, amlodipine and telmisartan

C10BX24

Forms & Strengths

Adult Dosing

Hypertension and dyslipidemia: One capsule once daily, individualized based on component titration.
Maximum recommended dose: Rosuvastatin 20 mg, amlodipine 10 mg, and telmisartan 80 mg once daily.

Pediatric Dosing

Safety and efficacy in pediatric patients have not been established; use is not recommended.

Indications

Management of hypertension in patients already controlled with the individual component drugs given concurrently at the same dose level.
Treatment of dyslipidemia and reduction of cardiovascular risk in hypertensive patients.

Mechanism of Action

Rosuvastatin: Competitive inhibitor of HMG-CoA reductase, increasing hepatic LDL receptors and decreasing hepatic synthesis of VLDL and LDL-C.
Amlodipine: Dihydropyridine calcium channel blocker that inhibits transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle, causing peripheral vasodilation.
Telmisartan: Selective, reversible angiotensin II receptor blocker (ARB) at the AT1 receptor subtype, preventing vasoconstriction and aldosterone-secreting effects of angiotensin II.

Contraindications

Hypersensitivity to rosuvastatin, amlodipine, telmisartan, dihydropyridines, or any component of the formulation.
Pregnancy (second and third trimesters): Risk of fetal and neonatal morbidity and death.
Active liver disease or unexplained persistent elevations of serum transaminases.
Concomitant use with aliskiren in patients with diabetes mellitus or severe renal impairment (eGFR < 60 mL/min/1.73m2).
Severe hepatic impairment, cholestasis, and biliary obstructive disorders.

Adverse Reactions

Peripheral edema, flushing, and dizziness (amlodipine-related).
Hyperkalemia, hypotension, and back pain (telmisartan-related).
Myalgia, headache, asthenia, and nasopharyngitis (rosuvastatin-related).
Rare: Rhabdomyolysis, angioedema, acute kidney injury, and hepatic transaminase elevations.

Drug Interactions

Cyclosporine: Significantly increases rosuvastatin exposure; avoid coadministration or limit rosuvastatin to 5 mg daily.
Lithium: Increased serum lithium concentrations and toxicity monitored during concomitant ARB use.
CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): May increase systemic exposure of amlodipine.
Dual blockade of the renin-angiotensin system (ACE inhibitors, ARBs, or aliskiren): Increased risk of hypotension, hyperkalemia, and renal dysfunction.
Potassium-sparing diuretics, potassium supplements, or salt substitutes containing potassium: Increased risk of hyperkalemia.
Antacids (aluminum/magnesium hydroxide): Decreases rosuvastatin plasma concentrations; administer at least 2 hours apart.

Curated Content: Needs Vetting Before Put to Clinical Use