INHIBACE® 5mg Bottle of 100 Tabs

INHIBACE® 5mg Bottle of 100 Tabs

SKU: 6230410606859
DIN: 01911481
SIZE: 100 Tablets
INDICATIONS: INHIBACE® (cilazapril) is indicated in the treatment of mild to moderate essential hypertension. INHIBACE® is also indicated in the treatment of congestive heart failure as adjunctive therapy with digitalis and/or diuretics.
DIRECTIONS: Dosage of INHIBACE® (cilazapril) must be individualized..

Product Description

INDICATIONS AND CLINICAL USE

INHIBACE® (cilazapril) is indicated in the treatment of mild to moderate essential hypertension.
INHIBACE® may be used alone or in combination with thiazide-type diuretics. INHIBACE® is also indicated in the treatment of congestive heart failure as an adjunctive therapy with digitalis and/or diuretics.
In using INHIBACE® consideration should be given to the risk of angioedema

Hypertension
INHIBACE® should normally be used in those patients in whom treatment with a diuretic or a beta-blocker was found ineffective or has been associated with unacceptable adverse effects. INHIBACE® can also be tried as an initial agent in those patients in whom use of diuretics and/or
beta-blockers are contraindicated or in patients with medical conditions in which these drugs frequently cause serious adverse effects.
The safety and efficacy of INHIBACE® in renovascular hypertension has not been established and therefore, its use in this condition is not recommended.
The safety and efficacy of concomitant use of INHIBACE® with antihypertensive agents other than thiazide diuretics have not been established.

Congestive Heart Failure
INHIBACE® is indicated in the treatment of congestive heart failure as adjunctive therapy in patients who have not responded adequately to digitalis and/or diuretics. There is limited data on New York Heart Association Class IV patients. Treatment with INHIBACE® should be initiated in patients with congestive heart failure under close medical supervision.

Geriatrics:
Although clinical experience has not identified differences in response between the elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out. In elderly patients with congestive heart failure on high diuretic dosage, the recommended starting dose of
INHIBACE® 0.5 mg must be strictly followed.

Pediatrics:
The safety and effectiveness of the use of INHIBACE® in children have not been established. Therefore, use in this age group is not recommended.

CONTRAINDICATIONS

INHIBACE® (cilazapril) is contraindicated in:

  • Patients who are hypersensitive to cilazapril, any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the product monograph.
  • Patients with hereditary/idiopathic angioedema or a history of angioedema related to previous treatment with an angiotensin-converting enzyme inhibitor.
  • Patients with anuria
  • Patients with ascites
  • Women who are pregnant, intend to become pregnant, or of childbearing potential who are not using adequate contraception
  • Nursing Women
  • Combination with aliskiren-containing drugs in patients with:
    • diabetes mellitus (type 1 or type 2)
    • moderate to severe renal impairment (GFR < 60 ml/min/1.73 m2)
  • Patients with hereditary problems of galactose intolerance, glucose-galactose malabsorption, or the Lapp lactase deficiency as INHIBACE® contains lactose
  • Concomitant use with drug products containing a neprilysin inhibitor (e.g., sacubitril/valsartan). Do not administer INHIBACE® within 36 hours of switching to or from sacubitril/valsartan, a drug product containing a neprilysin inhibitor

WARNINGS

The use of INHIBACE® (cilazapril) is contraindicated during pregnancy. When used in pregnancy, angiotensin-converting enzyme (ACE) inhibitors can cause injury or even death of the developing fetus. Pregnant women should be informed of the potential hazards to the fetus and must not take INHIBACE® during pregnancy. Patients planning pregnancy should be changed to alternative antihypertensive treatments which
have an established safety profile for use in pregnancy. When pregnancy is detected, INHIBACE® should be discontinued as soon as possible and, if appropriate, alternative therapy should be started.

Please refer to the product monograph for a complete list of warnings and precautions

ADVERSE REACTIONS

Headache and dizziness were the most frequently reported events in patients taking INHIBACE® for hypertension. In chronic heart failure clinical trials, dizziness, and coughing were the most frequently reported events in patients taking INHIBACE®

The most frequent drug-attributable adverse events observed in patients taking ACE inhibitors are cough, skin rash, and renal dysfunction. Cough is more common in women and non-smokers.
Where the patient can tolerate the cough, it may be reasonable to continue treatment. In some cases, reducing the dose may help.
Treatment-related adverse events severe enough to stop treatment occur in less than 5% of patients receiving ACE inhibitors.
Hypotension and postural hypotension may occur when starting a treatment or increasing dose, especially in at-risk patients.
Renal impairment and acute renal failure are more likely in patients with severe heart failure, renal artery stenosis, pre-existing renal disorders or volume depletion.
Hyperkalemia is most likely to occur in patients with renal impairment and those taking potassium-sparing diuretics or potassium supplements.
The events of cerebral ischemia, transient ischemic attack, and ischemic stroke reported rarely in association with ACE inhibitors may be related to hypotension in patients with underlying cerebrovascular disease. Similarly, myocardial ischemia may be related to hypotension in patients with underlying ischemic heart disease.
Headache is a commonly reported adverse event, although the incidence of headache is greater in patients receiving placebo than in those receiving ACE inhibitors.

Please refer to the product monograph for a complete list of adverse reactions

ABOUT THE DISEASE

Hypertension:

Blood pressure is the pressure or force of blood against the walls of blood vessels as it circulates. Blood pressure is most commonly measured in the brachial artery of the arm, and it is expressed as two numbers. Systolic blood pressure (the top or higher number) is the pressure in the artery when the heart contracts and diastolic blood pressure (the bottom or lower number) is the pressure in the artery when the heart relaxes between beats. Blood pressure normally changes throughout the day, but when either systolic or diastolic pressure stays constantly high it is called high blood pressure (hypertension).

  • We refer to optimal blood pressure if systolic blood pressure is below 120 mmHg and diastolic blood pressure is below 80 mmHg.
  • Normal blood pressure is systolic blood pressure less than 130 mmHg and diastolic blood pressure less than 85 mmHg.
  • Normal-high blood pressure is defined as systolic blood pressure 130-139 mmHg and/or diastolic blood pressure 85-89 mmHg.
  • High blood pressure is systolic blood pressure at or above 140 mmHg or diastolic blood pressure at or above 90 mmHg. Individuals with high blood pressure have hypertension. When measured at home, blood pressure above 135 mmHg systolic or 85 mmHg diastolic pressure is considered high
  • Hypertension for individuals with diabetes or chronic kidney disease is defined as blood pressure over 130 mmHg systolic or over 80 mmHg diastolic.

Congestive Heart Failure

Heart failure, sometimes known as congestive heart failure, occurs when your heart muscle doesn’t pump blood as well as it should. Certain conditions, such as narrowed arteries in your heart (coronary artery disease) or high blood pressure, gradually leave your heart too weak or stiff to fill and pump efficiently.

Not all conditions that lead to heart failure can be reversed, but treatments can improve the signs and symptoms of heart failure and help you live longer. Lifestyle changes — such as exercising, reducing sodium in your diet, managing stress, and losing weight — can improve your quality of life.

One way to prevent heart failure is to prevent and control conditions that cause heart failures, such as coronary artery disease, high blood pressure, diabetes, or obesity.

Diagnosis:

  • Blood test
  • X-rays
  • Magnetic Resonance Imaging (MRI)
  • Echocardiogram
  • Electrocardiogram (ECG)
  • Ejection fraction
  • Stress test
  • Cardiac catheterization

CLINICAL TRIALS

Please check back later

RESOURCES

PRODUCT MONOGRAPH

Click here to download the Product Monograph

 

 

PRESCRIBING INFORMATION

Click here to download Prescribing Information

 

 

FREQUENTLY ASKED QUESTIONS

How does this medication work? What will it do for me?

Cilazapril belongs to the family of medications known as angiotensin converting enzyme (ACE) inhibitors. It is used to treat mild-to-moderate high blood pressure and congestive heart failure (CHF). Cilazapril controls blood pressure and reduces symptoms of congestive heart failure by relaxing blood vessels and making the heart pump more efficiently.

To treat high blood pressure, cilazapril may be used alone or in combination with diuretics (water pills) known as thiazide diuretics (e.g., hydrochlorothiazide) when one medication has not been found to sufficiently control blood pressure.

Cilazapril is used in addition to digoxin, thiazide diuretics, or both for the treatment of CHF when these medications have not produced enough of a response.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful to people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

5 mg cilazapril – reddish-brown, oval-shaped, single scored biconvex tablets, imprinted CIL
5. Available in bottles of 100 tablets.

How should I use this medication?

The usual recommended dose depends on the condition being treated as well as your kidney and liver function.

The dose range for treatment of high blood pressure is 1 mg to 5 mg once daily.

The dose range for congestive heart failure is 0.5 mg to 2.5 mg once daily.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

For the greatest benefit of this medication, cilazapril should be taken at the same time each day, and may be taken with or without food.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take cilazapril if you:

  • are allergic to cilazapril or any ingredients of this medication
  • are allergic to any other angiotensin converting enzyme inhibitor (e.g., captopril, lisinopril, ramipril)
  • are pregnant or plan to become pregnant
  • are breast-feeding
  • have a history of angioedema (a serious allergic reaction that causes the area around the throat and tongue to swell) after taking any ACE inhibitors
  • have ascites (swollen abdomen due to liver problems)
  • are taking aliskiren and
    • have diabetes
    • have kidney disease
    • are taking a medication in the class of angiotensin receptor blockers (e.g., irbesartan, losartan, valsartan)
    • are taking another angiotensin converting enzyme inhibitor (e.g., captopril, lisinopril, ramipril)

have galactose intolerance (a rare hereditary condition)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • cough (dry, persistent)
  • diarrhea
  • dizziness
  • drowsiness
  • dry mouth
  • headache
  • nausea
  • runny or stuffed-up nose
  • unusual tiredness
  • vomiting
  • weakness (loss of energy)

What other drugs could interact with this medication?

There may be an interaction between cilazapril and any of the following:

  • aldesleukin
  • aliskiren
  • allopurinol
  • alpha agonists (e.g., clonidine, methyldopa)
  • alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
  • amifostine
  • angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
  • angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
  • antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide, sodium bicarbonate)
  • azathioprine
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • beta-blockers (e.g., propranolol, metoprolol, sotalol)
  • brimonidine
  • calcium channel blockers (e.g., amlodipine, nifedipine, verapamil)
  • cyclosporine
  • diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
  • dipyridamole
  • diuretics (e.g., hydrochlorothiazide, furosemide, spironolactone, triamterene)
  • eplerenone
  • everolimus
  • ginger
  • ginseng
  • grass pollen extract
  • heparin
  • iron dextran complex
  • isosorbide dinitrate, isosorbide mononitrate
  • licorice
  • lithium
  • low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • methylphenidate
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • nonsteroidal anti-inflammatory medications (NSAIDs; e.g., ibuprofen, indomethacin, naproxen)
  • phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • potassium supplements
  • quetiapine
  • quinine
  • rituximab
  • salt substitutes that contain potassium
  • sirolimus
  • sodium phosphates
  • temsirolimus
  • tizanidine
  • tolvaptan
  • trimethoprim
  • yohimbine