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Prestalia contains a combination of amlodipine and perindopril. Amlodipine is a calcium channel blocker. Amlodipine relaxes (widens) blood vessels and improves blood flow.

Perindopril is an ACE inhibitor. ACE stands for angiotensin converting enzyme. Perindopril also widens blood vessels and also prevents the body from retaining water.

Prestalia is used to treat high blood pressure (hypertension).

Prestalia may also be used for purposes not listed in this medication guide.

Important information

Do not use Prestalia if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Prestalia can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not use Prestalia if you have ever had angioedema (hives or severe swelling of deep skin tissues sometimes caused by allergic reaction).

If you have diabetes, do not use Prestalia together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

Before taking this medicine

You should not use Prestalia if:

  • you are allergic to amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide) or perindopril (Aceon);

  • you have ever had angioedema (hives or severe swelling of deep skin tissues sometimes caused by allergic reaction); or

  • you are allergic to any other ACE inhibitor, such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik).

If you have diabetes, do not use Prestalia together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo, Valturna).

You may also need to avoid taking Prestalia with aliskiren if you have kidney disease.

To make sure Prestalia is safe for you, tell your doctor if you have:

  • kidney disease (or if you are on dialysis);

  • liver disease;

  • heart disease or congestive heart failure;

  • high levels of potassium in your blood; or

  • if you are on a low-salt diet.

Do not use if you are pregnant. Stop using and tell your doctor right away if you become pregnant. Prestalia can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control.

Amlodipine and perindopril can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Prestalia.

How should I take Prestalia?

Take Prestalia exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Prestalia can be taken with or without food. Take the medicine at the same time each day.

Vomiting, diarrhea, or heavy sweating can cause you to become dehydrated. Drink plenty of water each day while you are taking this medicine.

Your blood pressure will need to be checked often. You may also need frequent blood tests at your doctor"s office.

If you need surgery, tell the surgeon ahead of time that you are using Prestalia. You may need to stop using the medicine for a short time.

You may have very low blood pressure while taking this medicine. Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. Prolonged illness can lead to a serious electrolyte imbalance, making it dangerous for you to use Prestalia.

Keep using this medicine as directed, 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.

Store Prestalia at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Prestalia dosing information

Usual Adult Dose of Prestalia for Hypertension:

Initial dose: Amlodipine 2.5 mg-Perindopril 3.5 mg orally once a day

Maximum dose: Amlodipine 10 mg-Perindopril 14 mg orally once a day

Comments:
-Wait 7 to 14 days between titration steps.
-May be used as initial therapy if multiple drugs are likely needed to achieve blood pressure goals.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If you are more than 12 hours late, skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Prestalia?

Drinking alcohol with this medicine can cause side effects.

Prestalia may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Do not use salt substitutes or potassium supplements while taking Prestalia, unless your doctor has told you to.

Prestalia side effects

Get emergency medical help if you have signs of an allergic reaction to Prestalia: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.

Call your doctor at once if you have:

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

  • swelling in your hands or feet, rapid weight gain;

  • new or worsened chest pain;

  • fever, chills, sore throat, body aches, flu symptoms;

  • high potassium--nausea, slow or unusual heart rate, weakness, loss of movement; or

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Prestalia side effects may include:

  • swelling;

  • cough;

  • dizziness; or

  • headache.

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.

See also: Side effects (in more detail)

What other drugs will affect Prestalia?

Many drugs can interact with amlodipine and perindopril. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • gold injections to treat arthritis;

  • heart or blood pressure medication;

  • lithium;

  • simvastatin;

  • a nonsteroidal anti-inflammatory drug (NSAID) such as ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;

  • a potassium supplement such as K-Dur, Klor-Con; or

  • a diuretic (water pill).

This list is not complete and many other drugs can interact with amlodipine and perindopril. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.


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