Amdova5 mg+10 mg

Amlodipine and atorvastatin combination tablets are indicated for patients for whom treatment with both components is appropriate:

Amlodipine component

• Hypertension (high blood pressure)
• Coronary artery disease: chronic stable angina, vasospastic (Prinzmetal's) angina, and angiographically documented coronary artery disease

Atorvastatin component

• Primary hyperlipidemia, as an adjunct to diet
• Heterozygous familial hypercholesterolemia in adults and children 10 years and older
• Homozygous familial hypercholesterolemia
• Prevention of cardiovascular disease in adults with multiple risk factors

Contains amlodipine (as amlodipine besilate) and atorvastatin (as atorvastatin calcium) as active ingredients, available as oral tablets in multiple fixed-dose combinations, commonly ranging from 2.5 mg/10 mg up to 10 mg/80 mg (amlodipine/atorvastatin), allowing each component to be dosed independently within the combination.

Amlodipine and atorvastatin is a combination tablet that pairs two cardiovascular medicines working through entirely different mechanisms: amlodipine, a calcium channel blocker that lowers blood pressure and relieves angina by relaxing blood vessels, and atorvastatin, a statin that lowers LDL cholesterol by reducing the liver's cholesterol production. It is used in patients who need treatment for both high blood pressure (or angina) and high cholesterol, simplifying their regimen into a single tablet. The two components are dosed independently within the fixed combination, so the specific tablet strength is chosen based on what each condition individually requires.

Therapeutic Class: Antihypertensive/Antianginal + Lipid-Lowering Combination

Amlodipine has a long half-life, supporting once-daily dosing and providing sustained 24-hour blood pressure control. In patients with chronic stable angina, intravenous amlodipine has not been shown to significantly alter cardiac conduction, and this favourable profile extends to combined use with beta-blockers. Atorvastatin undergoes extensive first-pass metabolism via CYP3A4, and both components can share overlapping metabolic pathways with certain other medicines, which is relevant to some of the drug interactions associated with this combination.

• Taken orally, once daily, at any time of day, with or without food
• Take at approximately the same time each day for consistency
• Swallow the tablet whole with water
• Continue dietary and lifestyle measures for both blood pressure and cholesterol management alongside this medicine

The following interactions require careful assessment, given the combined presence of both components:

• Strong CYP3A4 inhibitors (such as ketoconazole, clarithromycin, or ritonavir): can increase blood levels of both amlodipine and atorvastatin, increasing the risk of low blood pressure and myopathy respectively.
• Cyclosporine, gemfibrozil, and other fibrates: significantly increase atorvastatin exposure and myopathy risk; combinations are generally avoided or require reduced atorvastatin dosing.
• Simvastatin-type CYP3A4 substrates and other statins: not directly relevant here, but general caution about combining multiple lipid-lowering agents applies.
• Other antihypertensive medicines: may have additive blood-pressure-lowering effects with the amlodipine component; monitor blood pressure if combined.
• Digoxin: amlodipine may slightly increase digoxin levels; monitoring is advisable if combined.

Common side effects

• Peripheral oedema (ankle/leg swelling) - an expected effect of the amlodipine component
• Headache
• Dizziness
• Flushing
• Abdominal pain, constipation, dyspepsia, flatulence

Serious side effects (require prompt medical attention)

• Myopathy and rhabdomyolysis: unexplained muscle pain, tenderness, or weakness, particularly with fever or unusual fatigue, or dark urine, requires immediate medical attention - a recognized effect of the atorvastatin component.
• Hepatotoxicity: yellowing of the skin or eyes, dark urine, or unusual fatigue; liver function testing is performed as clinically indicated.
• Worsening angina or myocardial infarction: can occur, particularly on starting or increasing the dose of the amlodipine component, especially in patients with severe obstructive coronary artery disease.
• Severe hypotension: particularly in patients with severe aortic stenosis.
• Serious skin reactions (rare): Stevens-Johnson syndrome, toxic epidermal necrolysis, or erythema multiforme.
• Cardiac failure, reported rarely with amlodipine.

Pregnancy

Contraindicated in pregnancy. Atorvastatin may cause fetal harm, since cholesterol and cholesterol derivatives are essential for normal fetal development; discontinue as soon as pregnancy is recognized, and use effective contraception during treatment. There are also risks to mother and fetus associated with poorly controlled hypertension in pregnancy, which should be managed with pregnancy-appropriate alternatives if needed.

Breastfeeding

Not recommended during breastfeeding. It is not known whether this combination passes into human milk in clinically significant amounts, but statins are generally not recommended during breastfeeding, given the theoretical risk to a nursing infant from reduced cholesterol synthesis.

• Myopathy monitoring: report unexplained muscle pain, tenderness, or weakness promptly, given the atorvastatin component's known myopathy risk, particularly with certain interacting medicines.
• Liver function: monitor as clinically indicated, particularly at treatment initiation; contraindicated in active liver disease.
• Absolute pregnancy contraindication: discuss future pregnancy plans and appropriate contraception with your doctor, and stop this medicine immediately if pregnancy occurs.
• Worsening angina: a small increase in angina frequency, duration, or severity, or acute myocardial infarction, can occur on starting the amlodipine component or increasing its dose, particularly in patients with severe obstructive coronary artery disease.
• Discuss all other medicines with your doctor or pharmacist before starting, given the combined interaction profile of both components.

Overdose could cause excessive peripheral vasodilation (from the amlodipine component) with marked, potentially prolonged hypotension and reflex tachycardia, alongside exaggerated risk of atorvastatin-related myopathy or liver effects. Suspected significant overdose requires prompt medical evaluation; treatment is generally supportive, with cardiovascular monitoring and support as clinically indicated, provided in a medical facility. There is no specific antidote for either component.

Store at controlled room temperature, protected from moisture and light, in the original container.

• Elderly, small, or fragile patients: May be started on a lower amlodipine dose (2.5 mg); atorvastatin dosing follows the same individualized approach as in younger adults.
• Hepatic impairment: Amlodipine dosing may need adjustment (lower starting dose); atorvastatin is contraindicated in active liver disease.
• Renal impairment: No specific dose adjustment is generally required for either component based on renal function alone.
• Children 10 years and older (atorvastatin component, HeFH indication): Established dosing exists for atorvastatin alone in this population; use of the fixed combination in children has not been established.

This combination is generally used as ongoing, long-term therapy for both blood pressure/angina management and cholesterol control, for as long as it is tolerated and clinically effective, with periodic monitoring of blood pressure, lipid levels, liver function, and myopathy symptoms, as directed by the treating physician.

Drug Class: Dihydropyridine calcium channel blocker (amlodipine) combined with an HMG-CoA reductase inhibitor (atorvastatin)

Amlodipine blocks calcium channels in the smooth muscle of blood vessel walls, causing them to relax and widen, which lowers blood pressure and, in coronary arteries, increases blood flow to the heart muscle, relieving angina. Atorvastatin inhibits HMG-CoA reductase, the enzyme the liver uses to produce cholesterol, reducing the liver's own cholesterol synthesis and prompting increased clearance of LDL cholesterol from the bloodstream. These two mechanisms work independently, addressing blood pressure/angina and cholesterol as separate cardiovascular risk factors within a single combined tablet.

Safety and effectiveness of this specific fixed-dose combination have not been established in pediatric patients. Atorvastatin alone has established dosing for heterozygous familial hypercholesterolemia in children 10 years and older, and amlodipine alone has some pediatric hypertension data, but treatment decisions for children needing both components should use individually titrated components under specialist guidance.