Losartan and hydrochlorothiazide (Oral)

Losartan and hydrochlorothiazide combination is used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure increases the workload on the heart and arteries. If it lasts for a long time, the heart and arteries may not work properly. This can harm the blood vessels in the brain, heart, and kidneys, leading to a stroke, heart failure, or kidney failure. Lowering blood pressure may lower the risk of strokes and heart attacks.

Losartan and hydrochlorothiazide combination is also used to lower the risk of stroke in patients with high blood pressure and an enlarged heart.

Losartan is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that makes blood vessels tighten. Losartan relaxes the blood vessels and lowers blood pressure. A lower blood pressure increases blood and oxygen supply to the heart.

Hydrochlorothiazide is a thiazide diuretic (water pill). It decreases the amount of water in the body by increasing urine flow, which helps lower blood pressure.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby, especially in your second or third trimester. Use an effective form of birth control to avoid getting pregnant. If you think you have become pregnant while taking this medicine, tell your doctor right away. You may need to stop using this medicine.

This medicine may cause dizziness, lightheadedness, or fainting, especially when you get up suddenly from lying down or sitting. Make sure you know how you react to this medicine before you drive, operate machinery, or do anything else that could be dangerous if you feel dizzy. If you feel dizzy, lie down to prevent fainting. Then sit for a few moments before standing to avoid dizziness returning.

Contact your doctor right away if you become sick while taking this medicine, especially if you have severe or ongoing nausea or vomiting, or diarrhea that does not stop. These conditions may cause you to lose too much water and could lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Contact your doctor right away if you have bloody urine, a decrease in the frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These may be symptoms of a serious kidney problem.

Contact your doctor immediately if you experience blurred vision, difficulty reading, eye pain, or any other change in vision during or after treatment. This could indicate a serious eye problem. Your doctor may want an eye specialist to check your eyes.

This medicine may affect blood sugar levels. Diabetic patients may notice a change in the results of blood or urine glucose tests. Discuss any concerns with your doctor.

Ask your doctor before using medicines, supplements, or salt substitutes that contain potassium.

Drinking alcohol or taking narcotic pain relievers or sleeping pills with this medicine may increase feelings of lightheadedness, dizziness, or faintness. Inform your doctor if you are consuming alcohol or using pain relievers or sleeping pills.

This medicine may raise your risk of developing skin cancer (e.g., non-melanoma skin cancer). Avoid sun exposure. Use sunscreen when outdoors. Avoid sunlamps and tanning beds. Talk to your doctor if you are concerned about this risk.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus issues, and herbal or vitamin supplements.

In deciding to use a medication, the chances of taking the drug must be weighed against the beneficial it will do. This is a decision you and your doctor will make. For this medication, the following should be considered:

Allergies

Inform your clinician if you have ever had any unusual or allergic reaction to this medication or any other drugs. Additionally tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of losartan and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of losartan and hydrochlorothiazide combination in the elderly. Nevertheless, elderly patients are more likely to have unwanted side effects, which may require caution in patients receiving losartan and hydrochlorothiazide combination.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks prior to using this drug while breastfeeding.

Interactions with Medications

Although certain medications should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially essential that your healthcare professional know if you are using any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following drugs is not advised. Your clinician may decide not to treat you with this drug or change some of the other drugs you take.

• Aliskiren
• Dofetilide
• Sparsentan

Using this medication with any of the following medications is usually not recommended, but may be required in some cases. If both drugs are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Albuterol
• Alogliptin
• Amphetamine
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Benazepril
• Benzphetamine
• Bromfenac
• Bromocriptine
• Bufexamac
• Buprenorphine
• Canagliflozin
• Capecitabine
• Captopril
• Celecoxib
• Ceritinib
• Chlorpropamide
• Choline Salicylate
• Cilazapril
• Clarithromycin
• Clonixin
• Codeine
• Dapagliflozin
• Deslanoside
• Desmopressin
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Droperidol
• Droxicam
• Dulaglutide
• Empagliflozin
• Enalapril
• Enalaprilat
• Entacapone
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Formoterol
• Fosinopril
• Furosemide
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Indomethacin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Ketanserin
• Ketoprofen
• Ketorolac
• Levomethadyl
• Linagliptin
• Liraglutide
• Lisdexamfetamine
• Lisinopril
• Lithium
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Mavacamten
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Methamphetamine
• Methotrexate
• Metildigoxin
• Miglitol
• Moexipril
• Morniflumate
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Ouabain
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Perindopril
• Phenobarbital
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Porfimer
• Potassium Citrate
• Potassium Phosphate
• Pramlintide
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Quinapril
• Ramipril
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• Sotalol
• Spirapril
• Sulindac
• Tacrolimus
• Tapentadol
• Tenoxicam
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Trandolapril
• Trimethoprim
• Valdecoxib
• Vildagliptin
• Zofenopril

Using this drug with any of the following medications may cause an increased chance of certain adverse effects, but using both drugs may be the best therapy for you. If both medicines are prescribed together, your doctor may change the dose or how frequently you use one or both of the drugs.

• Aceclofenac
• Acemetacin
• Aminolevulinic Acid
• Amtolmetin Guacil
• Bepridil
• Bromfenac
• Bufexamac
• Carbamazepine
• Celecoxib
• Cholestyramine
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Flurbiprofen
• Ginkgo
• Gossypol
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Licorice
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Rifampin
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medications may as well cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical issues may affect the use of this medicine. Make sure you inform your physician if you have any other medical problems, especially:

• Angioedema (an allergic reaction) with other blood pressure medicines (eg, benazepril, enalapril, lisinopril, Lotrel®, Vasotec®, Zestoretic®, Zestril®), history of—Use may cause this condition to reoccur.

• Anuria (not capable to form urine) or
• Diabetic patients who are as well using aliskiren (Tekturna®) or
• Patients with kidney disease who are as well taking aliskiren (Tekturna®)—Should not be used in patients with these conditions.

• Asthma, or history of—May raise likelihood of having an allergic reaction.

• Congestive heart failure, serious—Use may lead to kidney problems.

• Diabetes or
• Electrolyte imbalances (eg, high or low calcium, magnesium, potassium, or sodium in the body) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Glaucoma, secondary angle closure or
• Gout or
• Hypercholesterolemia (high cholesterol in the blood) or
• Hypertriglyceridemia (high triglycerides or fats in the blood) or
• Kidney disease or
• Liver disease (such as cirrhosis) or
• Myopia (changes in the eyeball causing vision problems), acute or
• Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse.

• Sympathectomy—Blood pressure–lowering effects of this medication may be increased.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

• Black, tarry stools
• Blood in the urine or stools
• Cough or hoarseness accompanied by chills or fever, lower back or side pain, or painful or difficult urination
• Fainting
• Pinpoint red spots on the skin
• Pounding heartbeat
• Severe stomach pain, nausea, and vomiting
• Skin rash
• Swelling of the feet or lower legs
• Unusual bleeding or bruising

Incidence not known

• Bleeding gums
• Blistering, peeling, loosening of the skin
• Blurred vision
• Chest pain or tightness
• Chills
• Coma
• Confusion
• Cough
• Dark-colored urine
• Decreased frequency of urine
• Decreased urine output
• Diarrhea
• Difficulty swallowing
• Dizziness
• Dry mouth
• Fast, irregular, pounding, or racing heartbeat or pulse
• Fever
• Hives, itching skin, rash
• Increased sensitivity of the skin to sunlight
• Increased thirst
• Irritability
• Joint or muscle pain
• Large, flat, blue, or purplish patches in the skin
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Light-colored stools
• Loss of appetite
• Lower back or side pain
• Muscle cramps, pain, spasms, stiffness, or twitching
• Nausea or vomiting
• Numbness or tingling in the hands, feet, or lips
• Painful knees and ankles
• Persistent non-healing sore
• Pink growth
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Raised red swellings on the skin, the buttocks, legs, or ankles
• Red, irritated eyes
• Red skin lesions, often with a purple center
• Reddish patch or irritated area
• Redness or other discoloration of the skin
• Restlessness
• Seizures
• Severe sunburn
• Shiny bump
• Sore throat
• Sores, ulcers, or white spots in the mouth or on the lips
• Swelling of the face, ankles, or hands
• Trouble breathing
• Upper right abdominal or stomach pain
• Unusual tiredness or weakness
• Weak or irregular heartbeat
• Weight gain
• White, yellow or waxy scar-like area
• Yellow eyes and skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Body aches or pain
• Headache
• Loss of voice
• Sneezing
• Sore throat
• Stuffy or runny nose

Rare

• Dry cough

Incidence not known

• Acid or sour stomach
• Belching
• Change or loss of taste
• Difficulty having a bowel movement (stool)
• General feeling of discomfort or illness
• Heartburn
• Inability to have or keep an erection
• Indigestion
• Loss in sexual ability, desire, drive, or performance
• Trouble sleeping
• Weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Hyzaar

Available Dosage Forms:

• Tablet

Therapeutic Class: Angiotensin II Receptor Antagonist/Thiazide Combination

Pharmacologic Class: Losartan

Chemical Class: Thiazide

In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these is most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not break, crush, or chew it. This medicine may be taken with or without food.

If you also use cholestyramine or colestipol, take these at least 4 hours after you take this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): For high blood pressure: Adults—At first, one tablet once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 100 mg of losartan and 25 mg of hydrochlorothiazide per day. Children—Use and dose must be determined by your doctor. For lowering risk of stroke in patients with high blood pressure and enlargement of the heart: Adults—At first, one tablet once a day. Your doctor may increase your dose as needed. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.