A fixed-dose combination (FDC) of an ACE inhibitor (Ramipril) and an HMG-CoA reductase inhibitor (Atorvastatin). It is primarily indicated for the management of hypertension and dyslipidemia in patients with concomitant cardiovascular risk factors, particularly in secondary prevention of cardiovascular events. This combination addresses two major modifiable risk factors (hypertension and hypercholesterolemia) simultaneously, improving adherence and therapeutic outcomes in the Indian population where polypharmacy is a significant concern.
Adult: One tablet (Ramipril 2.5mg + Atorvastatin 10mg) once daily, preferably in the evening or at bedtime for optimal lipid-lowering effect of Atorvastatin. Dose must be individualized based on BP and lipid response.
Note: Swallow whole with a glass of water. Can be taken with or without food, but consistency in timing is advised. Avoid taking with large amounts of grapefruit juice (>1 liter daily) due to interaction with Atorvastatin.
Ramipril inhibits the Angiotensin Converting Enzyme (ACE), preventing the conversion of angiotensin I to angiotensin II (a potent vasoconstrictor). This leads to vasodilation, reduced aldosterone secretion (decreasing sodium and water retention), and increased bradykinin levels. Atorvastatin competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in the mevalonate pathway of cholesterol synthesis in the liver. This depletion of intracellular cholesterol upregulates hepatic LDL receptors, increasing the catabolism of LDL-cholesterol from the blood.
Pregnancy: CONTRANDICATED. Ramipril is Pregnancy Category D (1st trimester) and Category D (2nd & 3rd trimesters - can cause injury and death to the developing fetus, including oligohydramnios, skull hypoplasia, pulmonary hypoplasia, renal failure). Atorvastatin is Pregnancy Category X (risk of fetal harm). Discontinue immediately if pregnancy is detected.
Driving: May cause dizziness, vertigo, or fatigue, especially during initiation of therapy. Patients should be cautioned about operating machinery or driving until they know how the medication affects them.
| Diuretics (especially potassium-sparing: Spironolactone, Amiloride) | Increased risk of hyperkalemia and severe hypotension (first-dose effect with Ramipril) | Major |
| NSAIDs (e.g., Ibuprofen, Diclofenac) | May reduce antihypertensive effect of Ramipril and increase risk of renal impairment | Major |
| Potassium supplements/Salt substitutes | Increased risk of hyperkalemia with Ramipril | Major |
| Lithium | Ramipril may increase Lithium levels and toxicity risk | Major |
| Cyclosporine, Gemfibrozil, Niacin | Increased risk of myopathy/rhabdomyolysis with Atorvastatin | Major |
| Potent CYP3A4 inhibitors (Itraconazole, Clarithromycin, Ritonavir) | Markedly increase Atorvastatin plasma levels, increasing toxicity risk | Contraindicated/Major |
| Oral anticoagulants (Warfarin) | Atorvastatin may potentiate anticoagulant effect; monitor INR | Moderate |
| Digoxin | Ramipril may slightly increase Digoxin levels | Moderate |
| Antacids | May decrease absorption of Atorvastatin; separate administration by at least 2 hours | Moderate |
| Colchicine | Increased risk of myopathy, especially in renal impairment | Major |
Same composition (Ramipril (2.5mg) + Atorvastatin (10mg)), different brands: