Tarka (Abbott Laboratories): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

TARKA^® is used to treat hypertension (high blood pressure).

What it does:

TARKA^® contains two different types of medicines: a calcium channel blocker and an Angiotensin Converting Enzyme (ACE) inhibitor.

Calcium channel blockers change the amount of calcium getting into the muscle cells of your heart and blood vessels. This can change the strength and speed at which your heart beats. It also opens up the blood vessels so that blood can be pumped around your body more easily. This helps to lower your blood pressure.

ACE inhibitors also work by widening blood vessels, so helping to lower your blood pressure.

When it should not be used:

TARKA^® should not be used if:

• you are allergic to any component of TARKA^®, including

  active ingredients and non-active ingredients • you are pregnant or breast feeding or

• you have certain serious heart conditions.

Ask your doctor for advice.

What the medicinal ingredient is:

TARKA^® contains the ACE inhibitor trandolapril and the calcium channel blocker verapamil hydrochloride. The tablet consists of two layers, one layer containing trandolapril, and the other layer containing verapamil hydrochloride in a sustained-release matrix.

What the important non-medicinal ingredients are:

Corn starch, dioctyl sodium sulfosuccinate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, purified water, silicon dioxide, sodium alginate, sodium stearyl fumarate, synthetic iron oxides, talc, titanium dioxide.

What dosage forms it comes in:

TARKA is available as sustained-release tablets in the following strength combinations of trandolapril/verapamil hydrochloride:

1/180 mg; 2/180 mg; 1/240 mg; 2/240 mg; 4/240 mg.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

.

BEFORE you use TARKA^® talk to your doctor or pharmacist if:

• you have any heart disease
• you have kidney disease
• you are taking beta-blockers;
• you have neuromuscular disease (i.e. myasthenia gravis or Duchenne muscular dystrophy); • you have hepatic failure or elevated liver enzymes; • you have allergies to this drug or any of its ingredients.

INTERACTIONS WITH THIS MEDICATION Drugs that may interact with TARKA^® include:

• Drugs used for the treatment of high blood pressure

  (hypertension) such as beta-blockers (e.g. propranolol, metoprolol);

• Drugs used for the treatment of abnormal heartbeats

  (arrhythmia) such as procainamide, flecainide, prazosin, terazosin, digoxin;

• Water tablets (diuretics) (e.g. hydrochlorothiazide) and

  potassium supplements (e.g. potassium chloride); • Antibiotics such as erythromycin, telithromycin,

  rifampin;

• Some drugs used to treat diabetes (e.g. glyburide); • Some drugs used to treat migraine headaches (e.g.

  almotriptan);

• Some drugs used to treat epilepsy or other

  neurological conditions (e.g. carbamazepine, phenobarbital);

• Some drugs used to treat stomach ulcers (e.g.

  cimetidine);

• Some drugs used to treat certain forms of arthritis or

  gout (e.g. sulfinpyrazone);

• Some drugs used to treat lung conditions such as

  asthma (e.g. theophylline);

• Any of the group of medicines known as major

  tranquilizers, or antidepressants of the tricyclic group (e.g. lorazepam, imipramine);

• Some drugs used to treat mood disorders (e.g.

  lithium);

• Any of the group of medicines known as non-steroidal

  anti-inflammatory drugs (e.g. naproxen, aspirin); • Anti-cancer medications (e.g. cisplatin, doxorubicin); • Any medication that can affect your immune system

  (e.g. corticosteroids, cyclosporine);

• Any neuromuscular blocking agent (e.g. atracurium) • Some cholesterol lowering drugs (e.g., simvastatin,

  atorvastatin, lovastatin);

• Some HIV-antiviral medication (e.g. ritonavir); • Grapefruit juice;
• Alcohol;
• St. John’s Wort.

PROPER USE OF THIS MEDICATION

Usual dose:

Dosage must be individualized. The fixed combination is not for initial therapy. The dose of TARKA^® should be determined by titration of the individual components. TARKA^® should be taken once-a-day at the same time every day.

The usual adult dose for verapamil monotherapy is 180 to 240 mg/day.

The usual maintenance dose for trandolapril monotherapy is 1 to 2 mg once daily, as the recommended initial dose is 1 mg once daily.

Take TARKA^® with food to help it work better. TARKA^®

sustained-release tablets should not be divided, crushed or chewed.

Overdose:

If you or someone you know accidentally takes more than stated dose, contact your doctor immediately or go to the nearest hospital with the tablets. Tell your doctor or hospital how much was taken. Treat even small overdoses seriously.

Missed Dose:

If you forget to take one tablet, take another as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed tablet at all.

Never double-up on a missed dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its needed effects, a medicine may cause some unwanted effects. These are referred to as “side effects”. Although not all of these side effects may occur, if they do occur they may need medical attention.

The most common side effects with TARKA^® are dry cough, constipation and mild dizziness. Other less common side effects may include headaches, feeling sick (nausea), dry mouth, hair loss, nasal congestion, flushing of the face or neck, aches or pains in the joints of muscles, tiredness, swollen ankles, mild skin rash or itching, tingling or pickling of the skin, difficulty in sleeping, impotence, blurred vision, taste disturbance, anaemia or low numbers of white blood cells.

Check with your physician or pharmacist if you experience any unexpected effects, or are concerned by the above side effects.

SYMPTOMS OF SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM

Check with your pharmacist or doctor immediately, if you experience any of the above symptoms of the serious side effects.

HOW TO STORE IT

Keep TARKA^® and all other medicines out of reach of children.

TARKA^® sustained-release tablets should be stored at 15^BC to 25^BC, protected from light and moisture.

Do not take your tablets after the expiry date shown on the label.

It is important to keep the TARKA^® sustained-release tablets in the original package.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345 toll-free fax 866-678-6789

By email: cadrmp@hc-sc.gc.ca

By regular mail:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Health Canada

Address Locator: 0201C2

Ottawa, ON K1A 1B9

NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found at: http://www.abbott.ca or by contacting the sponsor, Abbott Laboratories, Limited, at: 1-800-361-7852

Last revised: February 13, 2007