How does this medication work? What will it do for me?
Aliskiren belongs to a group of medications known as direct renin inhibitors. These medications reduce blood pressure by blocking the actions of a chemical (renin) that causes blood vessels to tighten.
Aliskiren is used treat mild to moderate high blood pressure. It may be used alone or in combination with other blood-pressure-lowering medications. You may notice an effect on your blood pressure within 2 weeks of starting the medication.
What form(s) does this medication come in?
Each light-pink, biconvex, round, film-coated tablet, imprinted with "NVR" on one side and "IL" on the other side, contains aliskiren 150 mg. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide colorants, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.
Each light-red, biconvex, ovaloid, film-coated tablet, imprinted with "NVR" on one side and "IU" on the other side, contains aliskiren 300 mg. Nonmedicinal ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide colorants, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.
How should I use this medication?
The usual starting dose of aliskiren is 150 mg taken by mouth once daily. The usual dose ranges from 150 mg to 300 mg taken by mouth once daily. Aliskiren may be taken with or without food. Swallow the tablets whole with a small amount of water. Do not chew or crush the tablets.
It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and go back to 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 moisture, and keep it out of the reach of children.
Who should NOT take this medication?
Do not take aliskiren if you:
- are allergic to aliskiren or any ingredients of this medication
- have angioedema, a condition that causes swelling of the mouth, tongue, throat, and lips
- have diabetes or reduced kidney function and are also taking high blood pressure medications belonging to the ACE inhibitors family (e.g., lisinopril, ramipril) or the ARB family (e.g., candesartan, losartan)
- have experienced swelling (e.g. around the eyes or lips, hands or feet) while taking aliskiren or medications belonging to the ACE inhibitors family (e.g. lisinopril, ramipril) or ARB family (e.g., candesartan, losartan)
What side effects are possible with this medication?
- back pain
- feeling tired
- flu or cold (e.g., cough, sore throat or stuffy nose)
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:
- dizziness, lightheadedness, or fainting
- low blood pressure
- swelling of the feet, ankles, or hands
- symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine)
- symptoms of too much potassium in the blood (e.g., irregular heartbeat, muscle weakness, general feeling of being unwell)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- severe diarrhea
- symptoms of a serious allergic reaction (such as swelling of the face or throat, skin rash, hives, or difficulty breathing)
- symptoms of a severe skin reaction (e.g., rash, redness, blistering, peeling, fever)
- symptoms of kidney failure (such as a smaller or no amount of urine being made by the body)
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 aliskiren. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Diabetes: People with type 2 diabetes may be at higher risk of side effects such as kidney problems, stroke, high potassium levels in the blood, and blood pressure that's too low. If you have type 2 diabetes, discuss with your doctor how this medication may affect your medical condition and whether any special monitoring is needed. If you have type 2 diabetes and are also taking certain high blood pressure-lowering medications, you should not take aliskiren (see the "Who should not take this medication?" section). Talk to your doctor for more information.
Diarrhea: Stop taking this medication and contact your doctor if you experience severe and persistent diarrhea.
Kidney problems: This medication may cause reduced kidney function. 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. Aliskiren is not recommended for people with severely reduced kidney function.
Liver problems: Aliskiren may caused 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.
Low blood pressure: This medication can cause low blood pressure, especially for people who are taking other diuretics (water pills), are receiving dialysis, or have lost fluid from diarrhea and vomiting. If you feel dizzy and lightheaded while taking this medication, lie down until these symptoms go away and contact your doctor.
Other blood pressure medications: When combined with blood pressure medications in the angiotensin converting enzyme inhibitor (ACEI) family or the angiotensin receptor blocker (ARB) family, aliskiren has been linked to stroke, severely low blood pressure and decreased kidney function. If you are taking a medication in either of these families, avoid taking aliskiren until you speak with your doctor or pharmacist.
Pregnancy: Aliskiren may cause harm to the developing baby if this medication is taken by the mother while pregnant. It 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 aliskiren 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 or taking this medication.
Children: The safety and effectiveness of using this medication are unknown for children under the age of 18.
What other drugs could interact with this medication?
There may be an interaction between aliskiren and any of the following:
- ACE inhibitors (e.g. lisinopril, ramipril)
- alpha agonists (e.g., clonidine, methyldopa)
- amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
- ARBs (e.g., candesartan, irbesartan, losartan)
- barbiturates (e.g., butalbital, phenobarbital)
- beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- grapefruit juice
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
- monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
- nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, diclofenac, naproxen, celecoxib)
- phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
- potassium-containing products
- potassium-sparing diuretics (e.g., spironolactone, eplerenone)
- St. John's wort
- 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.
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