This combination product contains two medications: azilsartan and chlorthalidone. Azilsartan belongs to the class of medications called angiotensin II receptor blockers (ARBs). Chlorthalidone belongs to the class of medications called diuretics, or water pills. Both medications work in the kidney to reduce severe high blood pressure. This medication works to lower blood pressure within 1 to 2 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.

The usual adult starting dose of azilsartan - chlorthalidone is 40 mg of azilsartan, with 12.5 mg of chlorthalidone (40 mg/12.5 mg). This is taken once daily at the same time every day. Azilsartan-chlorthalidone may be taken with food or on an empty stomach.

After 2 to 4 weeks, your doctor may increase the dose, depending on how well the medication works for you.

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 to take this medication exactly as prescribed by your doctor. Continue to take the medication, even if you feel that it is not helping very much. High blood pressure does not have symptoms, so it can be hard for you to know if the medication is working.

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 in its original container at room temperature, protect it from light and moisture, and keep it out of the reach of children.

40 mg/12.5 mg
Each pale red, round, biconvex, film-coated tablet imprinted with "A/C" and "40/12.5" on one side contains 42.68 mg of azilsartan medoxomil potassium (equivalent to 40 mg of azilsartan) and 12.5 mg of chlorthalidone. Nonmedicinal ingredients: mannitol, microcrystalline cellulose, fumaric acid, sodium hydroxide, hydroxypropyl cellulose, crospovidone, magnesium stearate, hypromellose 2910, talc, titanium dioxide, ferric oxide red, polyethylene glycol 8000, and printing ink grey.

40 mg/25 mg
Each light red, round, biconvex, film-coated tablet imprinted with "A/C" and "40/25" on one side contains 42.68 mg of azilsartan medoxomil potassium (equivalent to 40 mg of azilsartan) and 25 mg of chlorthalidone. Nonmedicinal ingredients: mannitol, microcrystalline cellulose, fumaric acid, sodium hydroxide, hydroxypropyl cellulose, crospovidone, magnesium stearate, hypromellose 2910, talc, titanium dioxide, ferric oxide red, polyethylene glycol 8000, and printing ink grey.

Do not take azilsartan-chlorthalidone if you:

• are allergic to azilsartan, chlorthalidone, or any ingredients of the medication
• are allergic to sulfonamide medications (sulfa drugs)
• are breast-feeding
• are or are planning to become pregnant
• are producing very little urine
• are taking aliskiren and have diabetes or decreased kidney function
• have a low level of sodium in your blood that has not responded to treatment
• have difficulty urinating

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.

• abdominal pain or discomfort
• back or leg pain
• constipation
• decreased appetite
• decreased ability or interest in sexual activity
• diarrhea
• difficulty sleeping
• dizziness
• drowsiness
• dry mouth
• fatigue
• headache
• increased sensitivity to the sun – more likely to sunburn
• muscle cramps or spasms
• nausea
• red patches on the skin
• restlessness
• skin rash
• spinning sensation
• sweating
• upset stomach
• vomiting
• weakness

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:

• increased heart rate or irregular heart beat
• pins and needles feeling in your fingers
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of bleeding (e.g., nosebleeds, blood in urine, coughing blood, bleeding gums, unusual bruising or bleeding)
• signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heart beat)
• 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., changed frequency of urination, nausea, vomiting, swelling of hands, feet)
• 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 low blood pressure (e.g., dizziness when rising from sitting or lying, fainting)
• signs of muscle damage (e.g., unexplained muscle pain, tenderness or weakness, or brown or discoloured urine)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• swelling of the hands and feet, puffiness from fluid retention
• swollen glands in the mouth and neck
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• 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
• symptoms of eye problems (e.g., eye pain, blurred vision, sudden nearsightedness)

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.

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.

Allergy: Some people who are allergic to sulfa antibiotics (sulfonamides) also experience allergic reactions to chlorthalidone. Before you take azilsartan-chlorthalidone, inform your doctor about any previous adverse reactions you have had to medications, especially sulfa antibiotics. 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.

Drowsiness/reduced alertness: Azilsartan-chlorthalidone may cause drowsiness or dizziness, affecting mental and physical abilities needed to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.

Fluid and electrolyte balance: Azilsartan-chlorthalidone may cause the levels of electrolytes such as potassium, sodium, magnesium, chloride, and calcium in the blood to change while taking this medication. If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking this medication. Do not use potassium supplements or salt substitutes with potassium unless recommended by your doctor.

Gout: Chlorthalidone, like other diuretics, may increase the level of uric acid in the body. If you develop painful, warm, and swollen joints or difficulty with urination, contact your doctor as soon as possible.

If you have a history of 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: The use of azilsartan may affect the function of the kidneys, especially for those who already have kidney problems. Certain people have experienced changes in kidney function (e.g., people with narrowed blood vessels in their kidneys, diabetes, or severe congestive heart failure). The use of other 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 kidney disease or reduced kidney 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.

This medication should not be taken by people with severely decreased kidney function.

Liver function: If you have liver disease or 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. This medication is not recommended for people with severely reduced liver function.

Low blood pressure: Some people taking azilsartan-chlorthalidone 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. Low blood pressure is more likely to occur if you are dehydrated, are taking additional diuretics ("water pills"), are on a low-salt diet, or have diarrhea or vomiting. If you experience dizziness or lightheadedness, lie down until the symptoms go away and try getting up more slowly. If this continues, or if you faint, contact your doctor.

Systemic lupus erythematosus: People with systemic lupus erythematosus should be monitored by their doctor while taking chlorthalidone, as it may worsen this condition.

Vision problems: Although this is uncommon, chlorthalidone can cause sudden changes in vision, blurred vision, or increased pressure in the eyes. If you experience blurred vision, eye pain or sudden nearsightedness, contact your doctor immediately.

Pregnancy: Azilsartan, like other medications in this class, can cause severe harm and possibly death of the developing baby if it is taken during pregnancy. This medication 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 azilsartan-chlorthalidone passes into breast milk. If you are breast-feeding 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 using this medication have not been established for children.

Seniors: Seniors may be more sensitive to the effects of this medication. It may be necessary to take a lower dose.

There may be an interaction between azilsartan-chlorthalidone and any of the following:

• aclidinium
• alcohol
• aldesleukin
• aliskiren
• allopurinol
• alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
• alpha agonists (e.g., clonidine, methyldopa)
• amiodarone
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• angiotensin-converting enzyme inhibitors (ACEIs; e.g., captopril, ramipril)
• other angiotensin receptor blockers (ARBs; e.g., irbesartan, losartan)
• antihistamines (e.g., azelastine, bilastine, cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine, rupatadine)
• antipsychotics (e.g., cariprazine, chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• apomorphine
• atropine
• barbiturates (e.g., butalbital, phenobarbital)
• benztropine
• beta-2 agonists (e.g., formoterol, salbutamol, salmeterol, terbutaline)
• beta-blockers (e.g., atenolol, metoprolol, propranolol)
• bortezomib
• brimonidine
• bromocriptine
• buprenorphine
• calcipotriol
• calcium channel blockers (e.g., amlodipine, diltiazem, nicardipine, verapamil)
• calcium supplements
• carbamazepine
• caffeine
• cholestyramine
• clidinium
• colestipol
• conivaptan
• corticosteroids, including inhaled (e.g., budesonide, dexamethasone, fluticasone, prednisone)
• cyclobenzaprine
• cyclophosphamide
• darifenacin
• desmopressin
• dexmethylphenidate
• dextromethorphan
• diabetes medications (e.g., acarbose, canagliflozin, glyburide, insulin, lixisenatide, metformin, rosiglitazone, sitagliptin)
• digoxin
• dimenhydrinate
• disopyramide
• diuretics (water pills; e.g., amiloride, furosemide, hydrochlorothiazide)
• domperidone
• drospirenone
• duloxetine
• eplerenone
• fesoterodine
• flunarizine
• glycopyrrolate
• heparin
• hydralazine
• ipratropium
• ivabradine
• ketotifen
• levodopa
• lithium
• low-molecular-weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
• nabilone
• methadone
• methylphenidate
• metoclopramide
• minoxidil
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• multivitamins
• nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., celecoxib, ibuprofen, naproxen)
• opioid (narcotic) pain relievers (e.g., codeine, fentanyl, morphine, oxycodone, tapentadol, tramadol)
• orphenadrine
• oxcarbazepine
• oxybutynin
• pentoxifylline
• phosphodiesterase-5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
• potassium supplements
• riociguat
• ropinirole
• rotigotine
• sacubitril
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, escitalopram, fluoxetine, paroxetine, sertraline)
• sodium phosphates
• tacrolimus
• tiotropium
• tolterodine
• tolvaptan
• topiramate
• tretinoin
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
• trimethoprim
• umeclidinium
• vitamin D (e.g., calcitriol, cholecalciferol)
• 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 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.