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eprosartan - hydrochlorothiazide
How does this medication work? What will it do for me?
Eprosartan – hydrochlorothiazide is a combination product that contains two medications to treat mild-to-moderate high blood pressure.
Eprosartan belongs to the class of medications called angiotensin II receptor blockers. These medications work by relaxing blood vessels. Angiotensin II is a chemical the body releases to cause the tightening of blood vessels. Eprosartan blocks angiotensin II, causing the blood vessels to relax. This relaxation causes the blood pressure to drop.
Hydrochlorothiazide belongs to the class of medications called thiazide diuretics or "water pills," which help control blood pressure by getting rid of excess salt and water.
This combination medication is prescribed when your doctor feels it is appropriate for you to be taking both medications. You should already be taking each medication individually before starting this combination medication. The full effects of eprosartan – hydrochlorothiazide are usually seen in about 2 to 3 weeks.
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 butterscotch-coloured, film-coated, capsule-shaped tablet, contains 600 mg of eprosartan and 12.5 mg of hydrochlorothiazide. Nonmedicinal ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized starch, crospovidone, magnesium stearate, macrogol 3350, polyvinyl alcohol, talc, titanium dioxide, iron oxide black, and iron oxide yellow.
How should I use this medication?
This combination medication is used to make dosing more convenient for people who are already taking both active ingredients (eprosartan and hydrochlorothiazide).
The recommended dose is one tablet taken once daily, with or without food. It is best to establish a routine with this medication with respect to time of day you take it and whether you take it with or without food. For example, if you take the medication with food in the morning, continue to take it with food in the morning.
Many things can affect the dose of 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, 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 and moisture, and keep it out of the reach of children. It should be left in the protective blisters until immediately before it is to be taken.
Who should NOT take this medication?
Do not use eprosartan – hydrochlorothiazide if you:
- are allergic to eprosartan, hydrochlorothiazide, or any ingredients of the medication
- are allergic to thiazides or sulfa medications (e.g., sulfamethoxazole)
- are breast-feeding
- are pregnant
- have anuria (unable to urinate) or severe kidney dysfunction
- have diabetes or kidney disease and are taking aliskiren
- have diabetes and are taking an angiotensin converting enzyme inhibitor (ACEI)
- have severe liver dysfunction
- have symptoms of gout or unusually high uric acid levels
- have untreated or treatment resistant electrolyte abnormalities
- have fructose intolerance (a rare hereditary condition)
- have galactose intolerance (a rare hereditary condition)
What side effects are possible with this medication?
- back or leg pain
- bleeding under the skin
- decreased appetite
- decreased interest in sexual activities
- dry mouth
- flu-like symptoms
- joint pain
- muscle spasms or cramps
- pins and needles sensation
- runny nose
- red patches on skin
- skin rash
- stomach pain
- trouble sleeping
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:
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
- signs of gout (e.g., joint pain, swelling and warmth of joints)
- signs of infections (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., decreased urination, nausea, vomiting, swelling of the feet and ankles)
- signs of liver problems (yellowing of skin or whites of eyes, abdominal pain, loss of appetite, brown urine, light-coloured stools, tiredness, or weakness)
- signs of low blood pressure such as dizziness, lightheadedness, or fainting
- signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heartbeat, lack of coordination, thirst, confusion)
- swelling legs, ankles, or hands
- symptoms of fluid build up in the lungs (e.g., shortness of breath with exercise, coughing, difficulty breathing)
- 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 lupus (e.g., fever, general feeling of being unwell, joint pain, confusion, muscle aches, skin rash)
- symptoms of muscle damage (e.g., unexplained muscle pain or weakness, brown or discoloured urine)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
- signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
- symptoms of a serious allergic reaction (such as hives; swelling of the face, eyes, and throat; and difficulty breathing)
- symptoms of increased pressure in the eyes (e.g., decreased or blurred vision, eye pain, red eye, swelling of the eye)
Are there any other precautions or warnings for this medication?
Are there any other precautions or warnings for this medication?
Before you begin taking 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 take 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.
Allergic reactions: Some people who are allergic to sulfonamide medications also experience allergic reactions to hydrochlorothiazide. Before you take this medication, inform your doctor about any previous adverse reactions you have had to medications, especially to sulfonamide antibiotics or diabetes medications. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing or swelling of the face and throat.
Cholesterol: Cholesterol and triglyceride levels may increase when taking hydrochlorothiazide. Talk to your doctor about whether you will need to have your cholesterol levels tested while you are taking this medication. If you have increased cholesterol or triglyceride levels, 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.
Diabetes: Hydrochlorothiazide may make it more difficult for people with diabetes to control their blood sugar levels. High blood sugar may occur, glucose tolerance may change, and diabetes may worsen. A dose adjustment of diabetes medications, including insulin, may be required. If you have 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: Blood pressure medications may cause drowsiness or dizziness. Avoid driving or operating machinery until you know how this medication affects you.
Electrolytes: Your levels of electrolytes such as potassium, sodium, magnesium, and chloride may change with the use of this medication. Your doctor will periodically check that these are in balance and a potassium supplement may be necessary when taking this medication. If you experience symptoms such as muscle pains or cramps; dryness of mouth; numbness in hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible
Gout: Some people taking hydrochlorothiazide may experience high levels of uric acid in the blood or gout. Symptoms of an acute attack of gout include sudden swelling, redness, and pain in a joint, usually the big toe. You may also experience a fever. If this is your first attack, seek medical attention as soon as possible. If you have gout, 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.
Kidney function: Eprosartan – hydrochlorothiazide can cause changes to kidney function that may result in decreased kidney function, kidney failure, or possibly death. Certain people have experienced changes in kidney function (e.g., people with narrowed blood vessels in their kidneys, or those with severe congestive heart failure). The use of diuretics (water pills), nonsteroidal anti-inflammatory drugs (NSAIDs), or aliskiren may further increase risk of kidney problems for people already at risk for this problem. If you have reduced kidney function, renal artery stenosis (narrowing of blood vessels in the kidneys), or congestive heart failure, 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 reduced kidney function, you may require lower doses of this medication.
Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. People with reduced liver function may need a lower-than-normal dose of eprosartan; therefore, it may be necessary to use the components of the combination product separately. If you have reduced liver function or liver 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. This medication is not recommended for people with severe liver impairment.
This medication may also cause a decrease in 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: Occasionally, a larger-than-expected decrease in blood pressure occurs after taking eprosartan – hydrochlorothiazide. In some cases, this happens after the first dose. It is more likely to occur if you are taking additional diuretics (water pills), or aliskiren, have a reduced salt intake, are on dialysis, or are experiencing diarrhea or vomiting.
Blood pressure should be monitored more often in these situations. To reduce the risk of dizziness, those with low blood pressure or those just starting to take this medication should stand or sit up slowly when getting up from a lying down or sitting position.
If low blood pressure causes you to faint or feel lightheaded, contact your doctor.
Excessive sweating and lack of fluid intake may lead to an excessive fall in blood pressure because of reduced fluid in your blood vessels. Vomiting or diarrhea may also lead to a fall in blood pressure. Consult your doctor if you feel your blood pressure is too low.
Lupus: There have been reports of a worsening or activation of lupus in people taking hydrochlorothiazide. If you have lupus, 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.
Vision changes: Hydrochlorothiazide occasionally causes vision changes including increased eye pressure and myopia (nearsightedness). If you experience any eye symptoms, such as pain or change in vision, contact your doctor as soon as possible.
Pregnancy: Eprosartan may cause harm or death to an unborn baby if the medication is taken by the mother during pregnancy. If you become pregnant while taking this medication, stop taking the medication and contact your doctor immediately. Women taking eprosartan – hydrochlorothiazide who are planning or trying to become pregnant should discuss other, more appropriate medications to control blood pressure with their doctor.
Breast-feeding: It is not known if eprosartan passes into breast milk. Hydrochlorothiazide passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Do not breast-feed while you are taking this medication.
Children: The safety and effectiveness of using this medication have not been established for children. This medication is not recommended for children.
What other drugs could interact with this medication?
There may be an interaction between eprosartan – hydrochlorothiazide and any of the following:
- alpha-adrenergic blocking agents (e.g., clonidine, doxazosin, prazosin, terazosin)
- alpha agonists (e.g., clonidine, methyldopa)
- amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
- angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
- other angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
- antiarrhythmic medications (e.g., amiodarone, disopyramide, dofetilide, quinidine)
- antihistamines (e.g,. cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
- antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
- barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
- beta-blockers (e.g., atenolol, carvedilol, propranolol)
- 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)
- corticosteroids (e.g., budesonide, ciclesonide, dexamethasone, hydrocortisone, prednisone)
- diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, rosiglitazone)
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
- low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
- medications that increase blood levels of potassium (e.g., potassium chloride, salt substitutes containing potassium)
- multivitamins/minerals with ADE
- narcotic pain relievers (e.g., codeine, fentanyl, morphine)
- nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
- nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen)
- phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
- selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
- sodium phosphates
- tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
- vitamin D analogues (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 that 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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