Prestalia

Prestalia is a prescription medication used to treat high blood pressure.

It is a single product containing 2 medications: perindopril and amlodipine. Perindopril belongs to a group of drugs called angiotensin-converting enzyme (ACE) inhibitors, which relax blood vessels to lower blood pressure and make the heart more efficient. Amlodipine belongs to a group of drugs called calcium channel blockers, which help relax blood vessels. This makes it easier for the heart to pump blood.

This medication comes in tablet form and is usually taken once daily.

Common side effects of Prestalia include swelling of the hands, legs, and feet, cough, and headache.

Prestalia can also cause dizziness. Do not drive or operate heavy machinery until you know how Prestalia affects you.

Prestalia is a prescription medication used to treat high blood pressure.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication

The recommended initial dose of Prestalia for the treatment of high blood pressure is 3.5 mg perindopril/2.5 mg amlodipine once daily. The dose should be adjusted according to blood pressure goals and response to medication.

WARNING: FETAL TOXICITY

When pregnancy is detected, discontinue Prestalia as soon as possible.

Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Serious side effects have been reported with Prestalia including the following:

• anaphylactoid reactions, including swelling of the head, neck, face, or intestines
• myocardial infarction

Do not take Prestalia if you:

• are allergic to Prestalia or to any of its ingredients
• have a history of allergy or sensitivity to amlodipine or any angiotensin-converting enzyme (ACE) inhibitor

Do not use Prestalia with aliskiren in patients with diabetes.

Serious side effects have been reported with Prestalia. See the “Prestalia Precautions” section.

Common side effects of Prestalia include:

• swelling of the hands, legs, and feet
• cough
• headache
• dizziness

This is not a complete list of Prestalia side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• potassium supplements
• potassium-sparing diuretics such as spironolactone (Aldactone), triamterene (Dyrenium), amiloride (Midamor)
• lithium (Eskalith, Lithobid)
• injectable gold
• other medications for high blood pressure such as furosemide (Lasix), hydrochlorothiazide, torsemide (Demadex)
• non-steroidal anti-inflammatory drugs such as celecoxib (Celebrex), diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others), etodolac (Lodine), ibuprofen (Advil, Motrin, Nuprin), indomethacin (Indocin, Indocin SR), ketoprofen (Orudis, Actron, Oruvail), ketorolac (Toradol), meloxicam (Mobic), nabumetone (Relafen), naproxen (Naprosyn), naproxen sodium (Aleve, Anaprox, Naprelan), oxaprozin (Daypro),piroxicam (Feldene)

This is not a complete list of Prestalia drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Prestalia falls into category D. It has been shown that use of Prestalia in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Prestalia crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Prestalia.