Azilsartan Medoxomil/Chlorthalidone, Oral

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KEY POINTS

• This medicine is taken by mouth to treat and control high blood pressure. Take it exactly as directed.
• You should not take this medicine if you are pregnant.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antihypertensive; angiotensin receptor blocker/diuretic

Generic and brand names: azilsartan medoxomil/chlorthalidone, oral; Edarbyclor

What is this medicine used for?

This medicine is taken by mouth to treat and control high blood pressure.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before you take this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Diabetes
• Gout
• Heart problems
• High cholesterol
• Imbalances of potassium, calcium, or sodium in your blood
• Kidney or liver problems
• Lupus
• Trouble urinating or an enlarged prostate gland

Also, tell your healthcare provider if you are on a low-sodium diet.

Females of childbearing age: Tell your healthcare provider if you are pregnant, plan to become pregnant, or are breast-feeding. Do not take this medicine if you are pregnant. It can cause severe harm, or even death, to an unborn child. If you become pregnant while taking this medicine, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

How do I take it?

Check the label on the medicine for directions about your specific dose. Take this medicine every day exactly as your healthcare provider prescribes, even if you start to feel better. Take the medicine at the same time each day to help you remember to take it. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach.

Your healthcare provider may increase or decrease your dosage depending on your response.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: fast or slow heartbeat, lightheadedness, dizziness, fainting, weakness, confusion, nausea, vomiting, dry mouth.

What should I watch out for?

You will need to have lab tests regularly to see how this medicine affects you. You should check your blood pressure regularly while taking this medicine. Keep all appointments.

This medicine may make you feel tired or dizzy when you first start taking it. Do not drive or operate machinery if you are dizzy or are not fully alert.

This medicine may make your skin more sensitive to the sun and may cause you to sunburn more easily. While you are taking this medicine, avoid long exposure to the sun. While you are in the sun, wear protective clothing and a sunscreen lotion that is SPF15 or higher until you know how you will react to the sun. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help. Also, drinking alcohol may make it worse. Do not drink alcohol unless your healthcare provider approves.

Dizziness may get worse if you lose too much water from your body. You can lose water if you sweat a lot, vomit, or have diarrhea. Be careful when exercising, especially in hot weather, and drink plenty of water as instructed by your healthcare provider. If you feel faint, lie down until the reaction passes. Talk with your healthcare provider if this happens often.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

Talk with your healthcare provider about potassium in your diet. Do not use potassium supplements or salt substitutes that contain potassium without your healthcare provider's approval. Follow the diet and exercise program your healthcare provider recommends.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Chest pain; fast or irregular heartbeat; severe tiredness or weakness; fainting or severe dizziness; swelling in hands, ankles, or feet; severe nausea, vomiting, constipation, or diarrhea; decreased or trouble urinating; dry mouth or thirst; muscle pain; joint pain or swelling; confusion; seizures.

Other: Cough, mild dizziness, tiredness, nausea.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), and ramipril (Altace)
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Allopurinol (Aloprim, Zyloprim)
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), and terazosin
• Amifostine (Ethyol)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), sertraline (Zoloft), and venlafaxine (Effexor)
• Antipsychotic medicines such as asenapine (Saphris), clozapine (Clozaril, FazaClo), iloperidone (Fanapt), paliperidone (Invega), quetiapine (Seroquel), and ziprasidone (Geodon)
• Aspirin and other salicylates
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol and sotalol (Betapace, Sorine)
• Blood pressure medicines such as hydralazine, methyldopa, minoxidil, and reserpine
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Calcium supplements
• Carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
• Carbonic anhydrase inhibitors such as acetazolamide (Diamox) and methazolamide (Neptazane)
• Cholesterol-lowering medicines such as cholestyramine (Prevalite), colesevelam (Welchol), and colestipol (Colestid)
• Clonidine (Catapres, Kapvay)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Diabetes medicines such as acarbose (Precose), chlorpropamide, glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), miglitol (Glyset), nateglinide (Starlix), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), and tolbutamide
• Diazoxide (Proglycem)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Heart medicines such as digoxin (Lanoxin) and dofetilide (Tikosyn)
• Lithium (Lithobid)
• Narcotic pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and oxycodone/acetaminophen (Percocet, Roxicet)
• Natural remedies such as bayberry, black cohosh, blue cohosh, California poppy, coleus, dong quai, ephedra, ginger, ginseng, goldenseal, hawthorn, horse chestnut, natural licorice, St. John's wort, and yohimbe
• Nitrate medicines such as isosorbide (Dilatrate, Isordil, Monoket) and nitroglycerin (Minitran, Nitro-Dur, Nitrostat)
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), diflunisal, etodolac, ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Other diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), chlorthalidone, eplerenone (Inspra), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Potassium supplements or salt substitutes that contain potassium
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• Sulfamethoxazole/trimethoprim (Bactrim, Septra) or trimethoprim (Primsol)
• Topiramate (Qudexy, Topamax, Trokendi)

Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the original container at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.