How does this medication work? What will it do for me?
This is a combination medication that contains aliskiren and hydrochlorothiazide. It is used to treat high blood pressure for people who have been taking at least one of these medications on its own.
Aliskiren belongs to a group of medications called direct renin inhibitors, which lower blood pressure by blocking the actions of renin (a chemical that causes blood vessels to tighten). Hydrochlorothiazide belongs to a group of medications called diuretics, which lower blood pressure by helping the kidneys get rid of excess salt and water.
This medication starts to work within a week, with full effect seen within 4 weeks.
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?
150 mg/12.5 mg
Each white, biconvex, ovaloid film-coated tablet imprinted with "LCI" on one side and "NVR" on the other contains 150 mg of aliskiren (as aliskiren fumarate) and 12.5 mg of hydrochlorothiazide. Nonmedicinal ingredients: cellulose, microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, and titanium dioxide (E 171).
150 mg/25 mg
Each pale yellow, biconvex, ovaloid film-coated tablet imprinted with "CLL" on one side and "NVR" on the other side contains 150 mg of aliskiren (as aliskiren fumarate) and 25 mg of hydrochlorothiazide. Nonmedicinal ingredients: cellulose, microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, iron oxide red (E 172) iron oxide yellow (E172), and titanium dioxide (E 171).
300 mg/12.5 mg
Each violet white, biconvex, ovaloid tablet imprinted with "CVI" on one side and "NVR" on the other side contains 300 mg of aliskiren (as aliskiren fumarate) and 12.5 mg of hydrochlorothiazide. Nonmedicinal ingredients: cellulose, microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, iron oxide black (E 172), iron oxide red (E 172), and titanium dioxide (E 171).
300 mg/25 mg
Each light yellow, biconvex, ovaloid tablet imprinted with "CVV" on one side and "NVR" on the other side contains 300 mg of aliskiren (as aliskiren fumarate) and 25 mg of hydrochlorothiazide. Nonmedicinal ingredients: cellulose, microcrystalline, crospovidone, lactose monohydrate, wheat starch, povidone, magnesium stearate, silica colloidal anhydrous, talc, hypromellose, macrogol, iron oxide red (E 172), iron oxide yellow (E172), and titanium dioxide (E 171).
How should I use this medication?
The usual recommended dose is one tablet daily, which can range from 150 mg to 300 mg of aliskiren and 12.5 mg to 25 mg of hydrochlorothiazide. The dose of aliskiren - hydrochlorothiazide is different for each person and depends on the dose(s) of aliskiren and hydrochlorothiazide you were taking before starting this combination medication.
Take this medication with or without food, but take it the same way each day and at the same time. Swallow the tablets whole with a small amount of water. Do not chew or crush the tablets.
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.
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 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 this medication if you:
- are allergic to aliskiren, hydrochlorothiazide, or any ingredients of this medication
- are allergic to sulfonamide medications (e.g., sulfamethoxazole)
- are pregnant
- are breast-feeding
- have anuria (difficulty making urine)
- 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)
- have gout symptoms and high levels of uric acid in the blood
- have hereditary angioedema or idiopathic angioedema (angioedema of unknown cause)
- have low sodium or potassium levels in your blood, or have high calcium levels in your blood despite being treated
- severe kidney disease that is worsening
- have galactose intolerance or glucose malabsorption (a rare hereditary disease)
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.
- decreased interest in sexual activity
- difficulty achieving or maintaining an erection
- feeling lightheaded
- reduced appetite
- sleep disturbances
- stomach pain
- swelling of the feet or lower legs
- swelling of the glands in the mouth
- tingling and numbness or pins and needles feeling in the legs
Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- irregular heartbeat
- severe diarrhea
- signs of blood vessel inflammation (e.g., rash, purplish-red spots, fever, itching)
- 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 heart beat)
- skin rash
- symptoms of anemia (e.g., tiredness, fast heart beat, paleness, shortness of breath)
- symptoms of depression (e.g., changes in weight or sleep patterns, lack of interest in activities, difficulty concentrating)
- 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 problems (e.g., increased urination at night, decreased urine production, blood in the urine, change of urine colour)
- 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)
- symptoms of high blood potassium levels (e.g., muscle weakness, muscle spasms, abnormal heart rhythm)
- symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
- symptoms of kidney failure (such as less or no urine being made by the body)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- signs and symptoms of a severe allergic reaction (e.g., hives; itchy skin; difficulty breathing or swallowing; swelling of the face, throat, or tongue)
- signs of lung problems (e.g., difficulty breathing with fever, coughing, wheezing, breathlessness)
- signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
- symptoms of a severe skin reaction (e.g., rash, red skin, blisters, peeling, fever)
- vision changes
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
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.
HEALTH CANADA ADVISORY
January 31, 2019
Health Canada has issued new restrictions concerning the use of hydrochlorothiazide. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
Blood electrolytes (salts): This medication may cause changes in electrolyte (e.g., potassium, sodium, chloride) levels in the blood. If you are taking other medications that affect electrolyte levels such as potassium supplements, certain diuretics (e.g., amiloride, triamterene), or salt substitutes containing potassium, 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. A high level of potassium in the blood is more likely to occur when aliskiren is taken with a medication from either the angiotensin converting enzyme inhibitor (ACEI) family or the angiotensin receptor blocker (ARB) family. Contact your doctor if you experience symptoms of electrolyte imbalance such as dry mouth, muscle pain or cramps, tired muscles, low blood pressure, decreased urine production, fast heart rate, or nausea or vomiting while taking this medication.
Blood sugar: Hydrochlorothiazide can change blood glucose (sugar) levels in some people. If you have diabetes and are taking this medication, monitor your blood sugar levels closely and report any changes to your doctor.
Calcium: Hydrochlorothiazide can increase calcium levels in the blood. Your doctor will check your calcium levels regularly while you are taking this medication.
Cholesterol and triglycerides: Hydrochlorothiazide may increase cholesterol and triglyceride levels. Your doctor will monitor for this with blood tests.
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 - hydrochlorothiazide (see the "Who should not take this medication?" section). Talk to your doctor for more information.
Diarrhea: If you experience severe and persistent diarrhea while taking this medication, stop taking it and contact your doctor.
Glaucoma: Hydrochlorothiazide may cause a sudden reaction leading to glaucoma in some people. If you experience a sudden decrease in vision or pain in the eyes (usually within hours to a week of starting the medication), stop taking the medication and contact your doctor immediately.
Kidney problems: Aliskiren - hydrochlorothiazide can cause changes in kidney function. If you have reduced kidney function or a history of dialysis or other kidney problems (e.g., nephrotic syndrome), 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. People with severely reduced kidney function should not take this medication.
Liver function: This medication can cause changes in the amount of fluid and certain chemicals in the body. For people who have reduced liver function, these changes can cause severe problems for the liver. If you have reduced 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. People with severely reduced liver function should not take this medication.
Low blood pressure: Some people taking aliskiren - hydrochlorothiazide may experience sudden blood pressure drops when getting up from a sitting or lying position. These blood pressure drops could lead to dizziness, lightheadedness, and falls and may be more commonly experienced by 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.
Lupus: Hydrochlorothiazide can trigger or worsen lupus. If you experience symptoms such as fever, facial rash, or joint pain, or your lupus symptoms worsen while taking this medication, 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.
Uric acid and gout: Hydrochlorothiazide may increase uric acid levels in the blood and cause gout. If you experience symptoms of gout such as a swollen, red, painful joint, contact your doctor immediately.
Pregnancy: This medication should not be used during pregnancy as it may cause serious birth defects or death for the developing baby, if it is taken by the mother during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: Hydrochlorothiazide passes into breast milk. It is not known if aliskiren passes into breast milk. If you are a breast-feeding mother and are taking aliskiren - hydrochlorothiazide, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication are unknown for children under 18 years of age.
Seniors: Seniors may be more sensitive to the effects of this medication.
What other drugs could interact with this medication?
There may be an interaction between aliskiren - hydrochlorothiazide and any of the following:
- abiraterone acetate
- alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
- alpha agonists (e.g., clonidine, methyldopa)
- amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
- amphotericin B
- angiotensin-converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
- angiotensin receptor blockers (ARBs; e.g., candasartan, irbesartan, losartan)
- antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- barbiturates (e.g., phenobarbital, butalbital)
- beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
- beta-2 agonists (e.g., salbutamol, formoterol, terbutaline)
- calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
- calcium supplements (e.g., calcium carbonate, calcium citrate)
- diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- grapefruit juice
- HIV protease inhibitors (e.g., darunavir, nelfinavir, ritonavir, saquinavir)
- inhaled corticosteroids (e.g., budesonide, ciclesonide, fluticasone)
- low-molecular-weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
- macrolide antibiotics (e.g., clarithromycin, erythromycin)
- monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, rasagiline, selegiline, tranylcypromine)
- multivitamin with mineral supplements
- narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
- nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
- nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen, ketoprofen, ketorolac, diclofenac)
- oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
- phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
- potassium supplements (e.g., potassium chloride, potassium citrate)
- St. John's wort
- salt substitutes containing potassium
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, duloxetine, fluoxetine, paroxetine, sertraline)
- sodium phosphates
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
- vitamin D forms (e.g., alfacalcidol, calcitriol, cholecalciferol)
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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