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 for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each yellow, oval-shaped, biconvex, film-coated tablet, engraved with "N|N" on one side and "1" on the other side, contains anhydrous cilazapril 1 mg as cilazapril monohydrate. Nonmedicinal ingredients: lactose, cornstarch, microcrystalline cellulose, talc, sodium stearyl fumarate, hypromellose, titanium dioxide, macrogol, iron oxide yellow, and polysorbate.
Each pinkish-brown, oval-shaped, biconvex, film-coated tablet, engraved with "N|N" on one side and "2.5" on the other side, contains anhydrous cilazapril 2.5 mg as cilazapril monohydrate. Nonmedicinal ingredients: lactose, cornstarch, microcrystalline cellulose, talc, sodium stearyl fumarate, hypromellose, titanium dioxide, macrogol, and iron oxide red.
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 which 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)
- dry mouth
- runny or stuffed-up nose
- unusual tiredness
- weakness (loss of energy)
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- chest pain
- dizziness, lightheadedness, or fainting (signs of low blood pressure)
- increased or irregular heartbeat
- joint pain
- muscle cramps
- signs of anemia (low red blood cells; e.g., pale skin, unusual tiredness, or weakness)
- signs of breathing problems (e.g., pain when breathing, shortness of breath, troubled breathing, wheezing, tightness in chest, fast or irregular breathing)
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
- signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heartbeat)
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- signs of kidney or urinary tract problems (e.g., difficulty urinating, pain when urinating, decreased amount of urine passed)
- signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
- signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
- skin rash (with or without itching, fever, or joint pain)
- symptoms of lupus (e.g., fatigue, joint pain, butterfly-shaped rash on face, headaches, memory loss)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- difficulty swallowing or breathing (sudden)
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
- signs of angioedema (e.g., swelling of face, mouth, hands, or feet)
- signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
- signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
- signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
- signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
- symptoms of too much potassium in the body (e.g., muscle fatigue, weakness, difficulty moving, abnormal heart rhythms, nausea)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you.
Are there any other precautions or warnings for this medication?
HEALTH CANADA ADVISORY
February 4, 2014
Health Canada has issued new restrictions concerning the use of cilazapril. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Angioedema: Angioedema is a serious allergic reaction that causes the area around the face, throat, and tongue to swell. It may occur with use of cilazapril. If you experience swelling of the face, tongue, or throat, stop taking cilazapril at once and get immediate medical attention. Do not take other ACE inhibitors in the future. If you have had angioedema caused by other substances, you may be at increased risk of angioedema while receiving cilazapril.
Cough: ACE inhibitors such as this medication may cause you to develop a dry, persistent cough within hours of the first dose to weeks or months after starting therapy. The cough usually resolves within 4 weeks of stopping this medication. Talk to your doctor if you develop a persistent, intolerable cough.
Diabetes: Cilazapril may cause a decrease in blood sugar levels and increased effects from medications used to reduce blood glucose. You may find it necessary to monitor your blood sugar more frequently while using this medication.
If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Drowsiness/reduced alertness: Cilazapril may cause drowsiness or dizziness, especially at the beginning of treatment or after a dose increase. This can affect your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.
Fluid and electrolyte balance: Increases in blood levels of potassium occur for some people who take this medication. This rarely causes problems, but potassium levels should be monitored by your doctor. If you have kidney disease or diabetes, there is a higher risk of having increased blood potassium while taking cilazapril. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Infection: Cilazapril can reduce the number of cells that fight infection in the body (white blood cells). This makes you more likely to experience infections.
Tell your doctor if you notice frequent signs of infection such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor should do blood tests periodically, to monitor the number of specific types of blood cells in your blood.
Kidney function: Changes in kidney function have been noticed in people with narrowed blood vessels in their kidneys, or those with severe congestive heart failure. The use of diuretics (water pills), non-steroidal anti-inflammatory drugs (NSAIDs), or aliskiren, may further increase risk of kidney problems in those at risk for this problem. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you have kidney function impairment you may require lower doses of this medication.
Let your doctor know if you notice any decreases in urine output or increases in the swelling of lower limbs, suggesting accumulation of fluid due to decreased urination.
Liver function: This medication may worsen liver disease or cause reduced liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
If you have liver disease or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Low blood pressure: Occasionally, blood pressure drops too low after taking cilazapril. This usually happens after the first or second dose, or when the dose is increased. It is more likely to occur for people who take water pills or the medication aliskiren, have a salt-restricted diet, are on dialysis, are suffering from diarrhea or vomiting, or have been sweating excessively and not drinking enough liquids. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.
To reduce the risk of dizziness, get up slowly from a lying or sitting position. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.
Surgery: Cilazapril may interact with medications used during surgery. If you are scheduled for surgery, let your doctor know that you are taking this medication.
Pregnancy: Like other ACE inhibitors, cilazapril may cause severe harm or death to an unborn baby and should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if cilazapril passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of cilazapril have not been established for children. Its use by this age group is not recommended.
Seniors: People over the age of 65 are more likely to experience the side effects of cilazapril. If you are over the age of 65, your doctor may prescribe a lower dose of this medication.
What other drugs could interact with this medication?
There may be an interaction between cilazapril and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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