Ava-Valsartan HCT (Avanstra, 80 mg / 12.5 mg, ..., 320 mg / 12.5 mg): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Ava-Valsartan HCT is a combination of an angiotensin II AT₁ receptor blocker (valsartan) and a diuretic (hydrochlorothiazide). Valsartan and hydrochlorothiazide work together to lower your blood pressure.

High blood pressure increases the workload of the heart and arteries. If this condition continues for a long time, damage to the blood vessels of the brain, heart, and kidneys can occur, and may eventually result in a stroke, heart failure or kidney failure. High blood pressure also increases the risk of heart attacks. Reducing your blood pressure decreases your risk of developing these illnesses.

What it does:

The valsartan ingredient in Ava-Valsartan HCT lowers blood pressure by specifically blocking angiotensin II. Angiotensin II is a natural hormone produced in the body to keep blood pressure at normal levels. One function of angiotensin II is to increase blood pressure, usually when it becomes too low. Valsartan works by blocking the effect of angiotensin II. As a result, blood pressure is lowered. The hydrochlorothiazide ingredient in Ava-Valsartan HCT works by making your kidneys pass more water and salt. Together valsartan and hydrochlorothiazide lower blood pressure.

When it should not be used:

You should not take Ava-Valsartan HCT if you:

• are allergic to valsartan, hydrochlorothiazide or to any other

  component of this product;

• are allergic to any sulfonamide-derived drugs (ask your

  physician or pharmacist if you are not sure what sulfonamide-derived drugs are);

• suffer from severe kidney disease with being unable to produce

  urine (anuria)

• suffer from severe liver disease with destruction of the small

  bile ducts within the liver (biliary cirrhosis) leading to the builds up bile in the liver (cholestasis)

• are pregnant or planning to become pregnant (See

  WARNINGS AND PRECAUTIONS below);

• have serious kidney disease;

• have a too low level of potassium or sodium or if you have a

  too high level of calcium in your blood despite treatment;

• have uric acid crystals in the joints (gout);
• are pregnant;
• are under 18 years old.

What the medicinal ingredients are:

Valsartan and hydrochlorothiazide.

What the nonmedicinal ingredients are:

Ava-Valsartan HCT 80/12.5 mg tablets: Colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, hydroxypropyl methylcellulose, polyethylene glycol, red iron oxide, talc, titanium dioxide and yellow iron oxide.

The other strengths also contain:

Ava-Valsartan HCT 160/25 mg: Black iron oxide

Ava-Valsartan HCT 320/12.5 mg: Black iron oxide

If you are on a special diet, or if you are allergic to any substance, ask your doctor or pharmacist whether any of these ingredients may cause a problem.

What dosage forms it comes in:

Tablet; valsartan/hydrochlorothiazide 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg, 320 mg/12.5 mg, 320 mg/25 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions Ava-Valsartan HCT should not be used during pregnancy. If you discover that you are pregnant while taking Ava-Valsartan HCT, stop the medication and please contact your physician.

BEFORE you use Ava-Valsartan HCT talk to your doctor or pharmacist if you:

• suffer from liver or kidney disorders;
• suffer from diabetes (high blood sugar in your blood);
• have fever, rash, and joint pain, which may be signs of lupus erythematosus (or a history of this disease);
• have low levels of potassium in your blood (with or without symptoms such as muscle weakness, muscle spasms, abnormal heart rhythm);
• have low levels of sodium in your blood (with or without symptoms such as tiredness, confusion, muscle twitching, convulsions);
• have high levels of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching);
• have high levels of uric acid in the blood;
• are suffering from allergy or asthma
• have high levels of cholesterol or triglycerides in your blood;
• are suffering from vomiting or diarrhoea, or taking high doses of a diuretic (water pill);
• experience a decrease in vision or eye pain. These could be symptoms of an increase of pressure in your eye and can happen within hours to weeks of taking Ava-Valsartan HCT. This can lead to permanent vision impairment, if not treated.

You should have regular blood tests before and during treatment with Ava-Valsartan HCT. These will monitor the amount of

electrolytes (such as potassium, sodium, calcium or magnesium) in your blood and may also monitor your kidney function

You are pregnant, breast-feeding or thinking of becoming pregnant?

Taking Ava-Valsartan HCT during pregnancy can cause injury and even death to your baby. This medicine should not be used during pregnancy. If you are planning to become pregnant while taking Ava-Valsartan HCT, contact immediately your doctor.

It is also advisable not to take Ava-Valsartan HCT during breast-feeding. The diuretic component of Ava-Valsartan HCT passes into the breast milk and may also reduce your milk supply. If you are breast-feeding, avoid using Ava-Valsartan HCT unless recommended by your doctor.

Similar medicines were associated with serious harm to fetuses when they were taken during pregnancy. It is therefore important to tell your doctor immediately if you think you may have become pregnant, or planning to become pregnant. Your doctor will discuss with you the potential risk of taking Ava-Valsartan HCT during pregnancy.

Like many other medicines used to treat high blood pressure, Ava-Valsartan HCT may rarely cause effects such as dizziness or fainting in some patients. So before you drive a vehicle, use machinery, or do other things that need concentration, make sure you know how you react to the effects of Ava-Valsartan HCT.

INTERACTIONS WITH THIS MEDICATION

Tell your doctor or pharmacist about any medicines you are taking or have recently taken, including prescription medications, over-the-counter medications or natural health products (herbal medicines).

Certain medicines tend to increase your blood pressure, for example, non prescription preparations for appetite control, asthma, colds, coughs, hay fever and sinus problems.

Before surgery and general anesthesia (even at the dentist’s office), tell the physician or dentist that you are taking Ava-Valsartan HCT, as there may be a sudden drop in blood pressure associated with general anesthesia.

It is especially important for your physician and pharmacist to know if you are taking other drugs, such as:

• digoxin or other digitalis glycosides (a heart medicine),
• other diuretics (water pills),

• pressor amines such as epinephrine (substances that raise

  blood pressure),

• other medicines used to lower blood pressure,
• potassium-sparing agents,

• potassium supplement or salt substitutes containing potassium.

  Your doctor may monitor the levels of potassium in your blood,

• vitamin D and calcium salts,

• amantadine (medicine to treat Parkinson's disease and also

  used to treat or prevent certain illnesses caused by viruses),

  • certain cancer medicines,
  • anticholonergic agents (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia),
  • lithium, antidepressants, antipsychotics, medicines used to treat some mental conditions,
  • antiepileptics, such as carbamazepine (medicines used to treat convulsions),
  • medicines used to relieve pain or inflammation, especially non-steroidal anti-inflammatory agents (NSAIDS) including Cox-2 selective inhibitors,
  • cortisone-like medicines, steroids, carbenoxolone (a medicine used to treat ulceration and inflammation), antibiotics such as penicillin G, amphothericine, antiarrhythmics (medicines used to treat heart problems),
  • steroids,
  • cholestyramine, colestipol or other resins (medicines used mainly to treat high levels of lipids in the blood),
  • insulin or antidiabetic medicines taken by mouth (medicines used to treat high levels of sugar in your blood),
  • muscle relaxant drugs (medicines used during operations),
  • allopurinol (medicine used to treat gout),
  • cyclosporine (a medicine used in transplantation and in autoimmune disorders),
  • barbiturates, narcotics (medicines with sleep-inducing properties) and alcohol,
  • warfarin (medicine to prevent blood clot),
  • diazoxide (medicine to increase blood glucose level).

Taking carbamazepine with hydrochlorothiazide (a medicinal ingredient in Ava-Valsartan HCT) may cause a low sodium level in the blood. Symptoms of low sodium level in the blood may include: nausea, vomiting, headache, muscular cramps or weakness, and general uneasiness. As it worsens, confusion, decreased consciousness, convulsions (fits), or coma may occur. Tell your doctor if this happens to you.

Sedatives, tranquilizers, narcotics, alcohol and analgesics may increase the blood-pressure lowering effect of Ava-Valsartan HCT, so tell your physician or pharmacist if you are taking any of these.

PROPER USE OF THIS MEDICATION

Patients who have high blood pressure often do not notice any signs or symptoms of this condition. So even though you are feeling well, your health may be getting worse. This makes it all the more important for you to continue your treatment program and to keep your appointments with your doctor.

Remember that this medicine does not cure your high blood pressure; it only may help to control it. Therefore, if you want to lower your blood pressure and keep it down, you must continue to take Ava-Valsartan HCT as directed.

Usual dose:

Take Ava-Valsartan HCT as directed. Dosage must be individualized. Ava-Valsartan HCT is not for initial therapy. Once you are stabilized on both individual components of Ava-

Valsartan HCT the usual dosage is one 80 mg/12.5mg tablet once a day. In some cases, your doctor may prescribe a higher dose (e.g., the 160mg/12.5mg, 160 mg/25 mg, 320mg/12.5mg or the 320mg/25mg tablet).

You can take Ava-Valsartan HCT with or without food, but it should be taken the same way each day.

Overdose:

If you experience severe dizziness and/or fainting, contact your doctor immediately so that medical attention may be given promptly.

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Missed Dose:

Try to take your dose at the same time each day, preferably in the morning. However, if you have completely forgotten to take your dose during the day, carry on with the next one at the usual time. Do not double doses.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medicines, Ava-Valsartan HCT may cause unwanted reactions, or side effects. Most patients do not experience side effects from Ava-Valsartan HCT, however, some patients may experience dizziness.

Possible side effects are:

Headache; dizziness or light-headedness when getting up from a lying or sitting position; fainting; stomach upset; unusual tiredness or weakness (sometimes sign of potassium loss), loss of appetite; skin rash or itching; increased sensitivity of the skin to sunlight, muscle pain; difficulty in achieving erection or loss of interest in sex, vomiting; nausea; diarrhea; pain in the back or stomach; constipation; pain in the joints; cold and flu-like symptoms, dry cough; vertigo (feeling of spinning); rash; sleep disturbance.; blurred vision, blistering rash.

If any of these affect you severely, tell your doctor.

Other possible side effects from spontaneous reporting are:

Muscle spasm, fever (pyrexia), weakness (asthenia)

If any of these affect you severely, tell your doctor.

If you notice any other effects not listed above, check with your doctor.

This is not a complete list of side effects. For any unexpected effects while taking Ava-Valsartan HCT, contact your doctor or pharmacist.

HOW TO STORE IT

Store your Ava-Valsartan HCT tablets in a dry place at room temperature (15-30°C).

Do not take Ava-Valsartan HCT past the expiry date shown on the pack.

Always remember

This medicine has been prescribed to you for your current medical problem only. Do not give it to other people.

It is very important that you take this medicine exactly as your doctor tells you in order to get the best results and reduce the chance of side effects.

Keep this medicine out of the reach and sight of children.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

---------------------------------------------------------------------

• Report online at www.healthcanada.gc.ca/medeffect
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to: Canada Vigilance Program Health Canada

    Postal Locator 0701E

    Ottawa, Ontario

    K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

Please consult your doctor or pharmacist with any questions or concerns you may have regarding your individual condition.

This document plus the full Product Monograph, prepared for health professionals can be obtained by contacting the sponsor, Avanstra Inc., at 1-855-708-3678.

or by e-mail, at :

medinfo@avanstra.com

Last revised: June 12, 2012