Diovan

Diovan is used alone or together with other medication to treat hypertension (high blood pressure). Hypertension adds to the workload of the heart and arteries. If this continues for an extended period of time, the heart and arteries may fail to work properly.

This can damage the blood vessels of the heart, brain, and kidneys, resulting in stroke, heart failure or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.

This medication is also used to treat heart failure and left ventricular failure after a heart attack. Left ventricular failure occurs when the left side of the heart becomes stiff and enlarged. This causes blood pooling in the lungs.

This medication is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. This medication relaxes the blood vessels and lowers blood pressure. A lower blood pressure will increase the supply of blood and oxygen to the heart.

This medication is only available with your doctor’s prescription. This medication is available in the following forms:

• Tablet
• Capsule

Before using Diovan, you must know all about the risks and complications associated with it. This is a decision that you and your doctor will make together.

For this medication, there are many things that need to be considered:

Allergies: Inform your doctor if you have ever had an allergic reaction to any other medications. It is also important to inform your doctor of any non-medicine allergies such as foods, dyes, preservatives or animals.

Pediatric: Up-to-date Pediatric Appropriate studies have not indicated any problems that would limit the use of this medication.

Geriatric: Up-to-date studies have not shown any problems specific to the elderly that would limit the use of this medication in the elderly population.

Pregnancy: This medication is listed as Pregnancy Category D. This means that studies in pregnant women have demonstrated a risk to the unborn child. However, the benefits of this medication in a life-threatening situation or serious disease may outweigh the potential risk.

Breastfeeding: There are no up-to-date studies in women for determining infant risk when using this medication while breastfeeding. Weigh the potential risks with the benefits before taking this medication while breastfeeding.

Drug Interactions: Certain medications should not be used together. However, in certain cases, two medications may be used together, even if an interaction might occur. In these cases, your doctor may want to change your dose or take other precautions.

When taking this medication, it is important that you inform your doctor if you are taking any of the medications listed below. The following interactions were selected on the basis of potential significance and are not all-inclusive. Using this medication with any of the following is not recommended.

Your doctor may decide not to treat you with this medication, or change some of the other medications you take:

• Aliskiren

Using this medication with any of the following medication is not recommended, but may be unavoidable in some cases.

Your doctor may make the decision not to treat you with this medication or change some of the other medications you take:

• Benazepril
• Captopril
• Enalapril
• Enalaprilat
• Fosinopril
• Lisinopril
• Lithium
• Moexipril
• Perindopril
• Quinapril
• Ramipril
• Simeprevir
• Trandolapril
• Trimethoprim

Other Interactions: Certain medications should not be used while eating, or while eating certain foods in the case of negative interactions. Using alcohol or tobacco with certain medications may also cause negative interactions. Talk with your doctor about the use of your medication with food, alcohol or tobacco.

Other Medical Problems: Pre-existing medical problems may affect the use of this medication.

Be sure to tell your doctor if you have any other medical problems, especially:

• Angioedema (an allergic reaction) with other blood pressure medicines (i.e. benazepril, enalapril, lisinopril, Lotrel, Vasotec, Zestoretic, Zestril) - Use with caution. Use may cause this condition to reoccur.
• Congestive heart failure, severe - Use may lead to kidney problems.
• Diabetic patients who are also taking aliskiren (Tekturna) - Should not be used in these patients.
• Electrolyte imbalances (i.e. low sodium in the body)
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea)
• Kidney disease, severe - Use with caution. May make these conditions worse.

To use Diovan properly, you must follow all instructions given by your doctor. Do not take more, less or for a longer or shorter period of time than your doctor tells you.

This medication comes with a patient information brochure. It is very important that your read this information. Ask your doctor if you have any questions.

This medication will not cure your hypertension, but it will help control it. You must continue to take this medication if you expect it to lower your blood pressure. You may have to take hypertension medication for the rest of your life.

This medication may be taken with or without food and should be taken at the same time every day. If a child takes the liquid form of this medication, shake the bottle for at least 10 seconds before giving a dose.

Dosing: Different patients will be given a different dose of this medication based on the strength of the medication. The number of doses you take each day, the time between doses and the length of time you take this medication depends on the reason you are taking this medication.

The following information only includes the average dose of this medication. If your dose is different, do not change it without first speaking to your doctor.

For heart failure:

• Adults - Start with 40mg twice a day. Your doctor may adjust your dose as needed. The dose is not normally more than 320mg per day.
• Children - Use and dose must be determined by your doctor.

For hypertension:

• Adults - Start with 60-160mg once a day. Your doctor may adjust your dose as needed. The dose is not normally more than 320mg per day.
• Children 6-16 years of age - Dose is based on body weight and must be determined by your doctor. The starting dose is 1.3mg per kilogram of body weight once a day. Your doctor may adjust the dose as needed. The dose is not normally more than 2.7mg per kilogram of body weight or 160mg per day.
• Children younger than 6 years of age - Use is not recommended.

For left ventricular failure after heart attack:

• Adults - Start with 30mg twice a day. Your doctor may adjust your dose as needed. The dose is not normally more than 320mg per day.
• Children - Use and dose must be determined by your doctor.

Missed dose: If you miss a dose of this medication, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not double dose.

Storage: Store this medication in a closed container at room temperature. Keep it away from heat, moisture, and direct light. Do not freeze.

Keep our of the reach of children. Do not keep expired medication or medication you no longer need. Ask your doctor how to dispose of any medication you do not use.

Before using Diovan, there are some precautions you must take. It is very important that your doctor checks in with you often while you are receiving this medication to make sure that it is working properly. Do not take other prescription or over-the-counter medications without asking your doctor.

Using this medication while pregnant can harm your unborn child. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant, inform your doctor immediately.

Dizziness, lightheadedness or fainting may occur after you take this medication, espelying when getting up suddenly from a laying or sitting position. Getting up slowly may lessen this problem. If you feel dizzy, lie back down so you do not faint. Sit for a few moments before standing to prevent the dizziness or lightheadedness from returning.

Inform your doctor immediately if you become sick while taking this medication, especially if you have severe and continuous nausea, vomiting or diarrhea. These conditions may cause you to lose too much water and lead to hypotension (low blood pressure).

You can also lose water by sweating, so it is important to drink plenty of water during exercise and hot weather. Ask your doctor before you use medications, supplements or salt substitutes that contain potassium.

As with many medications, there are several potential side effects associated with Diovan. Although not all of these side-effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if you experience any of the following side-effects:

Less common:

• Bloody urine
• Cold sweats
• Confusion
• Decreased frequency or amount of urine
• Difficult breathing
• Dizziness, faintness, or lightheadedness when getting up from a lying position
• Fainting (syncope)
• Increased thirst (polydipsia)
• Irregular heartbeat (arrhythmia)
• Loss of appetite
• Lower back or side pain
• Nausea
• Nervousness
• Numbness or tingling in the hands, feet, or lips
• Swelling of the face, fingers, or lower legs
• Unusual fatigue or weakness
• Vomiting
• Weight gain

Rare:

• Chills
• Fever
• Hoarseness
• Sore throat
• Sudden difficulty swallowing or breathing
• Swelling of the mouth, hands or feet

Some side effects that may occur do not normally need medical attention. These may leave as your body becomes accustomed to treatment. Ask your doctor about ways to prevent or reduce some of these side effects.

Talk to your doctor if any of the following side effects continue or are bothersome, or if you have questions:

Less common:

• Abdominal or stomach pain
• Back pain
• Blurred vision
• Cold or flu-like symptoms
• Coughing
• Diarrhea
• Difficulty moving
• Headache
• Muscle pain or stiffness
• Pain, swelling, or redness in the joints

Some patients may experience other side effects that are not listed. Check with your doctor if you notice any other side effects. Ask your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.