Amlodipine + Valsartan

Amlodipine + Valsartan is used to treat hypertension (high blood pressure). This is a combination of two medicines that helps control blood pressure. It lowers blood pressure by relaxing blood vessels and making it easier for your heart to pump blood around your body. This will reduce your risk of having a heart attack or a stroke.

You can take Amlodipine + Valsartan on an empty stomach or along with food. However, it is better to take it regularly at a fixed time each day, as prescribed by your doctor. The dose will depend on your condition and how you respond to the medicine. It's important to keep taking this medicine even if you feel well. By lowering your blood pressure, it is reducing your risk of heart attack or stroke so do not stop taking it unless your doctor tells you to.

You can help this medicine work better by making a few changes to your lifestyle such as keeping active, stopping smoking, and eating a low salt and low fat diet. The most common side effects of this medicine include swelling in your ankles or feet (edema), headache, sleepiness, dizziness, tiredness, taste change, and upset stomach.

Since it may cause sleepiness and dizziness, do not drive or do anything requiring concentration until you know how it affects you. Before taking this medicine, let your doctor know if you have any kidney or liver problems or severe dehydration. Pregnant or breastfeeding women should also consult their doctor before taking it. While using this medicine, your blood pressure will need to be checked often and your kidney function may also need to be tested.

• Hypertension (high blood pressure) - especially in patients whose blood pressure is not adequately controlled on monotherapy
• Patients likely to need multiple antihypertensive agents

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Amlodipine has a greater effect on vascular smooth muscle cells than on cardiac muscle cells. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Valsartan is an angiotensin II type 1 (AT1) receptor antagonist. It produces its blood pressure lowering effects by inhibiting angiotensin II-induced vasoconstriction, aldosterone release and renal reabsorption of sodium.

Amlodipine relaxes and widens blood vessels, lowering blood pressure and improving blood flow. Valsartan blocks the action of angiotensin II, helping blood vessels stay relaxed and lowering blood pressure. Both have complementary mechanisms - amlodipine blocks calcium influx and valsartan reduces angiotensin II vasoconstriction. Together, they relax blood vessels and make the heart more efficient at pumping blood throughout the body.

Adult Dose:

• Recommended dose: 1 tablet once daily
• Initial therapy: Usually 5/80 mg once daily, titrate up to maximum 10/320 mg as needed
• May be switched from monotherapy when not adequately controlled
• Caution in patients with impaired liver or renal function, CHF, sick-sinus syndrome, severe ventricular dysfunction, hypertrophic cardiomyopathy, severe aortic stenosis
• During second and third trimesters of pregnancy, associated with fetal injury including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death
• Discontinue as soon as pregnancy is detected

Renal Dose: No dose adjustment needed for mild to moderate renal impairment. Contraindicated in severe renal impairment (GFR <30 ml/min).

Hepatic Dose: Caution in hepatic impairment. Contraindicated in severe hepatic impairment, biliary cirrhosis or cholestasis.

Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Amlodipine + Valsartan may be taken with or without food, but it is better to take it at a fixed time. It is recommended to take with water.

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose to catch up.

• Peripheral edema (swelling of hands, ankles, or feet) - lower incidence with combination than amlodipine alone
• Headache
• Dizziness
• Tiredness
• Palpitations
• Increased potassium level in blood
• Sleepiness
• Taste change
• Flushing (sense of warmth in the face, ears, neck and trunk)
• Upset stomach
• Nasal congestion, sore throat, difficulty swallowing
• Upper respiratory tract infection

[UNSAFE] Amlodipine + Valsartan may cause side effects which could affect your ability to drive. May cause dizziness, headaches, nausea or tiredness, all of which could affect your ability to concentrate and drive.

Get up slowly when rising from a sitting or lying position. Avoid consuming alcohol as it may enhance the blood pressure lowering effect. If you experience ankle or foot swelling, raise your legs while sitting and talk to your doctor if it does not go away.

Serious Warnings:

• Do not use during pregnancy - can cause serious harm to unborn baby
• Caution in patients with severe aortic stenosis, severe obstructive coronary artery disease
• Heart failure patients need monitoring of kidney function and potassium
• Tell your doctor if you go for kidney dialysis
• Caution in hepatic or renal impairment

• Hypersensitivity to Amlodipine or Valsartan
• Hypersensitivity to dihydropyridine derivatives
• Pregnancy (especially second and third trimesters)
• Severe hepatic impairment, biliary cirrhosis or cholestasis
• Severe renal impairment (GFR <30 ml/min/1.73m²) and dialysis patients
• Co-administration with aliskiren-containing products in patients with diabetes or renal impairment (GFR <60 ml/min/1.73m²)
• Severe hypotension
• Shock (including cardiogenic shock)
• Left ventricular outflow tract obstruction (e.g. obstructive hypertrophic cardiomyopathy and high-grade aortic stenosis)

• Aliskiren: Contraindicated with aliskiren in patients with diabetes or renal impairment (GFR <60 ml/min)
• NSAIDs (e.g. Ibuprofen): May reduce blood pressure lowering effect and affect kidney function
• Potassium supplements and potassium-sparing diuretics: May increase risk of hyperkalemia
• Sildenafil: Each agent independently exerts its own blood pressure lowering effect
• Antihypertensive agents: Additive effects may occur

[UNSAFE] It is unsafe to consume alcohol with Amlodipine + Valsartan. Alcohol may enhance the blood pressure lowering effect and increase risk of liver damage.

[CONSULT YOUR DOCTOR] Amlodipine + Valsartan is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby (Pregnancy Category D - second and third trimesters, Category C - first trimester). When pregnancy is detected, discontinue as soon as possible. Please consult your doctor.

[CAUTION] Limited information is available on use during breastfeeding. It is not known whether amlodipine is excreted in human milk. A decision should be made whether to discontinue nursing or discontinue the drug, considering the importance of the drug to the mother.

Safety and effectiveness in pediatric patients (below 18 years) have not been established. Amlodipine + Valsartan is not recommended for use in patients aged below 18 years.

Caution is required when increasing the dosage in elderly patients (65 years or above). Amlodipine clearance decreases in elderly patients.

[CAUTION] Amlodipine + Valsartan is contraindicated in severe renal impairment (GFR <30 ml/min/1.73m²) and dialysis patients. No dose adjustment needed for mild to moderate renal impairment. Monitoring of potassium and creatinine is advised in moderate renal impairment.

[CAUTION] Amlodipine + Valsartan is contraindicated in severe hepatic impairment, biliary cirrhosis or cholestasis. Caution in mild to moderate hepatic impairment.

Amlodipine: Overdosage may cause excessive peripheral vasodilation and marked hypotension. Administration of activated charcoal significantly decreases amlodipine absorption. Hemodialysis is not likely to be of benefit.

Valsartan: Overdose most likely causes peripheral vasodilation, hypotension, tachycardia, or bradycardia. Valsartan is not removed by hemodialysis.

Store below 30°C, protect from light and moisture, and keep out of the reach of children.