Amlodipine + Olmesartan Medoxomil

Amlodipine + Olmesartan Medoxomil is used to treat hypertension (high blood pressure). This is a combination of two medicines that helps control blood pressure. It helps to lower high blood pressure and thus reduces the chances of future heart attack and stroke.

You can take Amlodipine + Olmesartan Medoxomil 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. Keep taking it for as long as advised by your doctor. Even if you feel well, do not stop this medicine on your own because high blood pressure often has no symptoms. If you stop taking it, your condition may get worse.

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

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 be monitored regularly and your kidney function may also need to be tested.

• Hypertension (high blood pressure)
• Patients likely to need multiple antihypertensive agents
• When monotherapy fails to achieve blood pressure goals

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.

Angiotensin II, formed from angiotensin I in a reaction catalyzed by angiotensin-converting enzyme (ACE), is a potent vasoconstrictor and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Olmesartan Medoxomil blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues. Olmesartan Medoxomil does not inhibit ACE (kinase II).

Amlodipine relaxes and widens blood vessels, lowering blood pressure and improving blood flow. Olmesartan blocks the action of angiotensin II, helping blood vessels remain relaxed and lowering blood pressure. Together, they relax blood vessels and make the heart more efficient at pumping blood throughout the body.

Adult Dose:

• Initial therapy: 5/20 mg once daily for 1-2 weeks, titrate as needed up to maximum 10/40 mg once daily
• For elderly patients (≥75 years): Starting dose of Amlodipine is 2.5 mg
• Drugs acting on renin-angiotensin system can cause fetal injury in 2nd and 3rd trimesters
• Discontinue as soon as pregnancy is detected
• Symptomatic hypotension may occur in volume and/or salt-depleted patients
• Caution in renal impairment; monitor serum creatinine and potassium periodically
• Avoid use in severe renal & hepatic impairment
• Caution in aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy

Renal Dose: Dose adjustment may be needed for patients with renal impairment.

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 + Olmesartan Medoxomil may be taken with or without food, but it is better to take it at a fixed time.

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.

• Sleepiness
• Taste change
• Ankle swelling
• Headache
• Flushing (sense of warmth in the face, ears, neck and trunk)
• Dizziness
• Tiredness
• Palpitations
• Upset stomach
• Increased potassium level in blood

[UNSAFE] Amlodipine + Olmesartan Medoxomil 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.

Caution in patients with severe aortic stenosis, severe obstructive coronary artery disease, renal impairment, hepatic impairment. Do not take if you are pregnant, planning to conceive or breastfeeding.

• Hypersensitivity to Amlodipine or Olmesartan Medoxomil
• Pregnancy (especially second and third trimesters)
• Co-administration with Aliskiren in patients with diabetes
• Biliary obstruction
• Safety and effectiveness in pediatric patients have not been established

• NSAIDs (including selective COX-2 inhibitors): May attenuate the antihypertensive effect of Olmesartan Medoxomil
• Aliskiren: Contraindicated with Aliskiren in patients with diabetes
• Blood pressure, renal function and electrolytes should be closely monitored with other agents that affect the RAS

[UNSAFE] It is unsafe to consume alcohol with Amlodipine + Olmesartan Medoxomil. Alcohol may enhance the blood pressure lowering effect.

[CONSULT YOUR DOCTOR] Amlodipine + Olmesartan Medoxomil is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby (Pregnancy Category D - second and third trimesters). However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. When pregnancy is detected, discontinue as soon as possible. Please consult your doctor.

[CONSULT YOUR DOCTOR] Amlodipine + Olmesartan Medoxomil is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness have not been established in pediatric patients.

No overall differences in safety or effectiveness were observed between subjects 65 years of age or older and younger subjects.

[CAUTION] Amlodipine + Olmesartan Medoxomil should be used with caution in patients with severe kidney disease. Dose adjustment may be needed. Please consult your doctor. Regular monitoring of blood pressure is advisable for dose adjustment.

[CAUTION] Amlodipine + Olmesartan Medoxomil should be used with caution in patients with liver disease. Dose adjustment may be needed. Please consult your doctor. Amlodipine + Olmesartan Medoxomil is started at a lower dose in patients with liver disease and further increased slowly with careful monitoring.

There is no information on overdosage in humans. Overdose may cause hypotension. Unabsorbed drugs may be removed by gastric lavage or administration of activated charcoal. Symptomatic treatment is suggested.

Do not store above 30°C. Keep away from light and out of the reach of children.