Amlodipine belongs to a class of medications called calcium channel blockers. It lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard.

Amlodipine is used to treat certain types of angina (chest pain) and other conditions caused by coronary artery disease (narrowing of the blood vessels that supply blood to the heart).

Amlodipine controls chest pain by increasing the supply of blood to the heart. If taken regularly, this medicine controls chest pain, but it does not stop chest pain once it starts. Your doctor may prescribe a different medication to take when you have chest pain.

Amlodipine is also used alone or in combination with other medicines to treat high blood pressure (hypertension) in adults and children at least 6 years old. Lowering blood pressure may lower your risk of a stroke or heart attack.

Before taking amlodipine, tell your doctor if you have congestive heart failure or liver disease.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of amlodipine.

If you are being treated for high blood pressure, keep using amlodipine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Amlodipine is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Tell your doctor about all other heart or blood pressure medications you are taking.

Your chest pain may become worse when you first start taking amlodipine or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

Take amlodipine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Amlodipine is usually taken once per day.

Take the medicine at the same time each day, with or without food.

Shake the oral suspension (liquid). Measure a dose with the supplied measuring device (not a kitchen spoon).

Your blood pressure will need to be checked often.

If you have high blood pressure, keep using amlodipine even if you feel well. High blood pressure often has no symptoms.

Do not change your doses or stop taking any of your medications without your doctor's advice.

Your treatment may also include diet, exercise, weight control, and blood tests.

Store amlodipine tablets and oral solution (liquid) at room temperature away from moisture, heat, and light.

Store amlodipine oral suspension in the refrigerator, do not freeze.

Usual Adult Dose for Hypertension:

Initial dose: 5 mg orally once a day
Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day

Comments: Patients who are small or fragile may be started on 2.5 mg orally once a day.

Usual Adult Dose for Angina Pectoris:

Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day

Usual Adult Dose for Coronary Artery Disease:

Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day

Usual Geriatric Dose for Hypertension:

Initial dose: 2.5 mg orally once a day
Maintenance dose: 2.5 to 10 mg orally once a day
Maximum dose: 10 mg/day.

Usual Geriatric Dose for Angina Pectoris:

Initial dose: 5 mg orally once a day
Maintenance dose: 5 to 10 mg orally once a day
Maximum dose: 10 mg/day..

Uses: Alone or in combination with other antianginal agents for the symptomatic treatment of chronic stable angina
-Alone or in combination with other antianginal agents for the treatment of confirmed/suspected vasospastic angina
-To reduce the risk of hospitalization for angina and to reduce the risk of a coronary revascularization procedure in patients with recently documented CAD by angiography and without heart failure or an ejection fraction less than 40%

Usual Pediatric Dose for Hypertension:

6 to 17 years:
-Maintenance dose: 2.5 to 5 mg orally once a day
-Maximum dose: 5 mg/day

Comments: Doses higher than 5 mg have not been studied in pediatric patients.
The dosage should be adjusted according to patient response. In general, titration should proceed over 7 to 14 days. If clinically warranted, titration may proceed more rapidly, provided the patient is assessed frequently.

Use: Alone or in combination with other antihypertensive agents to treat hypertension

You should not take amlodipine if you are allergic to it.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• severe narrowing of a certain valve in your heart (aortic stenosis), or other heart problems;

• coronary artery disease (clogged arteries); or

• liver disease.

It is not known if amlodipine will harm an unborn baby. However, having high blood pressure during pregnancy may cause complications or medical problems in both mother and baby. The benefit of treating hypertension may outweigh any risks to the baby.

Tell your doctor if you are breastfeeding.

Take the medicine as soon as you can, but skip the missed dose if you are more than 12 hours late for the dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include rapid heartbeats, redness or warmth in your arms or legs, or fainting.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the suspension in the refrigerator and avoid freezing; protect it from light.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction to amlodipine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, when you first start taking this medicine, your chest pain may get worse or you could have a heart attack. Seek emergency medical attention or call your doctor right away if you have symptoms such as: chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating.

Amlodipine may cause serious side effects. Call your doctor at once if you have:

• worsening chest pain; or

• a light-headed feeling, like you might pass out.

Common amlodipine side effects may include:

• dizziness, drowsiness;

• swelling of your legs or ankles;

• irregular heartbeat;

• pounding heartbeats or fluttering in your chest;

• muscle stiffness;

• uncontrolled muscle movements;

• feeling tired;

• stomach pain, nausea; or

• flushing (sudden warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may interact with amlodipine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor. Your blood pressure should be checked regularly to determine your response to amlodipine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Azor® (containing Amlodipine, Olmesartan)
• Caduet® (containing Amlodipine, Atorvastatin)
• Consensi® (containing Amlodipine, Celecoxib)
• Exforge® (containing Amlodipine, Valsartan)
• Exforge® HCT (containing Amlodipine, Hydrochlorothiazide, Valsartan)
• Prestalia® (containing Amlodipine, Perindopril)
• Tribenzor® (containing Amlodipine, Hydrochlorothiazide, Olmesartan)
• Twynsta® (containing Amlodipine, Telmisartan)