Cilazapril

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 Cilazapril, cilazapril should be taken at the same time each day, and may be taken with or without food.

It is important that Cilazapril 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 Cilazapril 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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause unusual tiredness; it may alter your sense of taste; it may make your skin more sensitive to UV rays (e.g., sunlight, tanning lamps) - avoid exposure to UV rays as much as possible and protect yourself when out in the sun; on occasion, it may cause a dry cough - contact your pharmacist or doctor if it becomes bothersome. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

1 mg
Each yellow, oval-shaped, biconvex, film-coated tablet, with "CI" scoreline "1" on one side and "G" on the other, contains anhydrous cilazapril 1 mg as cilazapril monohydrate. Nonmedicinal ingredients: colloidal silicon dioxide, lactose, pregelatinized starch, sodium bicarbonate, and sodium stearyl fumarate; colorant mixture: hydroxypropyl methylcellulose, polydextrose, polyethylene glycol, titanium dioxide, triacetin, and yellow iron oxide.

2.5 mg
Each pinkish-brown, oval-shaped, biconvex, film-coated tablet, with "CI" scoreline "2.5" on one side and "G" on the other, contains anhydrous cilazapril 2.5 mg as cilazapril monohydrate. Nonmedicinal ingredients: colloidal silicon dioxide, lactose, pregelatinized starch, sodium bicarbonate, and sodium stearyl fumarate; colorant mixture: hydroxypropyl methylcellulose, polydextrose, polyethylene glycol, red iron oxide, titanium dioxide, triacetin, and yellow iron oxide.

5 mg
Each reddish-brown, oval-shaped, biconvex, film-coated tablet, with "CI" scoreline "5" on one side and "G" on the other, contains anhydrous cilazapril 5 mg as cilazapril monohydrate. Nonmedicinal ingredients: colloidal silicon dioxide, lactose, pregelatinized starch, sodium bicarbonate, and sodium stearyl fumarate; colorant mixture: D&C Yellow No. 10, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No. 6, polyethylene glycol, and titanium dioxide.

Do not take cilazapril if you:

• are allergic to cilazapril or any ingredients of Cilazapril
• 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)

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 (M.O.S. 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

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 Cilazapril. 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.

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 Cilazapril.

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 Cilazapril 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 Cilazapril. 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 Cilazapril.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Cilazapril may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Cilazapril, 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 Cilazapril affects you.

Fluid and electrolyte balance: Increases in blood levels of potassium occur for some people who take Cilazapril. 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 Cilazapril 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 Cilazapril 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 Cilazapril.

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 Cilazapril 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 Cilazapril.

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 Cilazapril, 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 Cilazapril.

This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. You should take this medication at approximately the same time each day. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. If you forget a dose, take it as soon as you remember -- unless it is almost time for your next dose. In that case, skip the missed dose. Do not double the next dose to catch up. This medication may be taken with or without food.