Lisinopril (Cobalt Pharmaceuticals): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

LISINOPRIL is the brand name of Cobalt Pharmaceuticals for the substance - lisinopril, available only on prescription from your physician. Lisinopril is one of a class of medicines known as angiotensin-converting enzyme (ACE) inhibitors.

LISINOPRIL is usually prescribed to:

• Reduce high blood pressure.
• Treat patients with heart failure

Remember - This medicine is prescribed for the particular condition that you have. Do not give this medicine to other people, nor use it for any other condition.

What it does:

LISINOPRIL belongs to a class of medicines known as angiotensin converting enzyme (ACE) inhibitors. ACE inhibitors work mainly by blocking an enzyme in the body that is necessary to produce angiotensin II, a substance that causes blood vessels to constrict (tighten). As a result, ACE inhibitors indirectly relax blood vessels which lowers blood pressure.

After taking a dose of LISINOPRIL, the blood pressure lowering effect will be seen after 1 hour, with peak reduction of blood pressure usually achieved by 6 hours after dosing. In some patients, achievement of optimal blood pressure reduction may require 2 to 4 weeks of therapy.

When it should not be used:

• If you have any allergies to lisinopril or to any other ingredients

  in LISINOPRIL. (See What the important nonmedicinal ingredients are).

• You have previously taken lisinopril or other medications of

  the same type - angiotensin-converting enzyme (ACE) inhibitors, and you were allergic or reacted badly to it, particulary if you experienced swelling of the face, lips, tongue, or throat, or had sudden difficulty breathing or swallowing. These drugs usually have names ending with ‘pril’ such as lisinopril, enalapril, captopril, etc. You should not take LISINOPRIL if you had these types of reactions without a known cause.

• If you have been diagnosed with angioedema, including

  laryngeal edema may occur, especially following the first dose

  of lisinopril. You should report immediately any signs of symptoms suggesting angioedema (swelling of face, extremities, eyes, lips, tongue, difficulty in breathing) and to take no more drug until you have been consulted with the prescribing physician.

  • If you have been diagnosed with hypotension, you should report light headedness especially during the first few days of therapy. If actual syncope occurs, you should discontinue the drug until you have been consulted with the prescribing physician.

  • If you are pregnant or breast-feeding.

  • If you impaired renal functions.

What the medicinal ingredient is:

Lisinopril dihydrate

What the important nonmedicinal ingredients are: Calcium hydrogen phosphate dihydrate, colloidal anhydrous silica, magnesium stearate, maize starch, mannitol, pregelatinized starch and red iron oxide.

What dosage forms it comes in:

LISINOPRIL are available as 5 mg, 10 mg and 20 mg tablets.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

• LISINOPRIL should not be used if you are already taking a blood pressure-lowering medicine that contains aliskiren (such as Rasilez) and you have diabetes or kidney disease.
• LISINOPRIL should not be used during pregnancy. If you discover that you are pregnant while taking LISINOPRIL, stop the medication and please contact your doctor as soon as possible.

This medicine may not be suitable for certain people. BEFORE you use LISINOPRIL talk to your doctor or pharmacist if:

• You have previously taken lisinopril or other ACE inhibitors and you were allergic or reacted badly to it.
• You are pregnant, breast-feeding or thinking of becoming pregnant. Taking LISINOPRIL during pregnancy can cause injury and even death to your developing baby. This medicine should not be used during pregnancy. If you become pregnant while taking LISINOPRIL, stop the medication and report to your physician as soon as possible. It is possible that LISINOPRIL passes into breast milk. You should not breast-feed while taking LISINOPRIL.

• You have any of these conditions:

  • diabetes
  • heart or blood vessel disease
  • liver disease
  • kidney disease and/or are on dialysis
  • a history of angioedema
• renal impairment

• You are taking any other medication, whether on prescription

  or otherwise.

• You are vomiting or have severe diarrhea.

• If you are taking a medicine that contains aliskiren, such as

  Rasilez, used to lower high blood pressure. The combination with LISINOPRIL is not recommended.

• If you are taking an angiotensin receptor blocker (ARB). You

  can recognized an ARB because its medicinal ingredient ends in “-SARTAN”.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with LISINOPRIL include:

• Blood pressure lowering durgs including diuretics (water

  pills), aliskiren-containing products (e.g. Rasilez), or angiotensin receptor blockers (ARBs).

• any other medicines to reduce blood pressure

• potassium supplement, potassium-sparing agents or

  potassium-containing salt substitutes

• Agents causing rennin release, e.g. diuretics
• lithium salts

• non-steroidal anti-inflammatory drug (NSAIDs), e.g.

  indomethacin

• Agents affecting sympathetic activity, e.g. ganglionic

  blocking agents or adrenergic neuron blocking agents and beta-adrenergic blocking drugs

• Gold injections, e.g. sodium aurothiomalate
• Antidiabetics

PROPER USE OF THIS MEDICATION

Usual dose:

Since absorption of LISINOPRIL tablets (lisinopril) is not affected by food, the tablets may be administered before, during or after meals. LISINOPRIL should be administered in a single daily dose. LISINOPRIL should be taken at the same time every day.

Dosage must be individualized and should be adjusted according to blood pressure response.

Overdose:

In case of an overdose, contact your doctor immediately so that medical attention may be given promptly. The most likely symptom of overdose include severe hypotension, electrolyte disturbances, and renal failure.

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss a dose of this medicine, take it as soon as possible. If it is almost time for the next dose, the missed dose should not be taken. Instead, the next scheduled dose should be taken. Do not take a double dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Along with its intended action, any medication, including lisinopril, may cause side effects. Most people do not experience any problem when taking this medicine; but if you notice any of the following, medical attention may be needed.

You may experience some side effects such as:

• Dizziness
• Cough
• Diarrhea
• Headache
• asthenia/fatigue
• Nausea
• Rash
• Vomiting

* Initial dose may cause a greater fall in blood pressure than will occur following continued treatment. You may notice this as faintness or dizziness and it may help to lie down.

** You should be aware that black patients are at increase risk of these types of reactions to ACE inhibitors.

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

HOW TO STORE IT

Store your tablets at 15°C-30°C, in a tightly closed container, away from heat and direct light, and out of damp places, such as the bathroom or kitchen.

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:

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• 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

This document plus the full product monograph, prepared for

health professionals can be found by contacting the sponsor, Cobalt Pharmaceuticals Company, at: 1-866-254-6111

Last revised: March 4, 2014.