Valsartan and hydrochlorothiazide (Oral)

Valsartan and hydrochlorothiazide combination is used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure increases the workload of 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 can lower the risk of strokes and heart attacks.

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

Hydrochlorothiazide is a thiazide diuretic (water pill). It lowers the amount of water in the body by increasing urine flow. This helps to 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 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 might be pregnant while using 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 this medicine affects you before you drive, use machines, 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 up to avoid dizziness returning. If you faint, call your doctor right away.

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

Check with your doctor right away 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 doctor to examine your eyes.

This medicine may affect blood sugar levels. Diabetic patients may notice changes in their blood or urine glucose test results. Talk to your doctor if you have any questions.

Hyperkalemia (high potassium in the blood) may occur while using this medicine. Check with your doctor right away if you have stomach pain, confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, trouble breathing, or weakness or heaviness in the legs. Do not use medicines, supplements, or salt substitutes containing potassium without first checking with your doctor.

This medicine may increase 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 have concerns about this risk.

Alcohol, narcotic pain relievers, or sleeping pills may make you feel more lightheaded, dizzy, or faint when used with this medicine. Tell your doctor if you are drinking alcohol or using pain relievers or sleeping pills.

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 problems, as well as herbal or vitamin supplements.

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

Allergies

Inform your physician if you have ever had any unusual or allergic reaction to this medication or any other medicines. Also inform 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 valsartan 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 problems that would limit the usefulness of valsartan and hydrochlorothiazide combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

Breast Feeding

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

Interactions with Medicines

Although certain drugs 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 physician may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially essential that your healthcare professional know if you are taking any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Aliskiren
• Dofetilide
• Sparsentan

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

• Acarbose
• Aceclofenac
• Acemetacin
• Acetyldigoxin
• Albiglutide
• Albuterol
• Alogliptin
• Amphetamine
• Amtolmetin Guacil
• Arsenic Trioxide
• Aspirin
• Benazepril
• Benzphetamine
• Bromfenac
• Bromocriptine
• Bufexamac
• Buprenorphine
• Canagliflozin
• Captopril
• Celecoxib
• Chlorpropamide
• Choline Salicylate
• Cilazapril
• Clonixin
• Codeine
• Dapagliflozin
• Deslanoside
• Desmopressin
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Dipyrone
• Droperidol
• Droxicam
• Dulaglutide
• Empagliflozin
• Enalapril
• Enalaprilat
• 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
• 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
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Porfimer
• Potassium Citrate
• Potassium Phosphate
• Pramlintide
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Quinapril
• Ramipril
• Repaglinide
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Simeprevir
• Sitagliptin
• Sodium Salicylate
• Sotalol
• Spirapril
• Sulindac
• Tacrolimus
• Tapentadol
• Tenoxicam
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Trandolapril
• Trimethoprim
• Valdecoxib
• Vildagliptin
• Zofenopril

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

• Aceclofenac
• Acemetacin
• Aminolevulinic Acid
• Amtolmetin Guacil
• Bepridil
• Bromfenac
• Bufexamac
• Carbamazepine
• Celecoxib
• Cholestyramine
• Choline Salicylate
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Eltrombopag
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• 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
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Valdecoxib

Interactions with Food/Tobacco/Alcohol

Certain medications 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 also cause interactions to occur. Discuss with your healthcare professional the use of your medication with food, alcohol, or tobacco.

Other Medical Problems

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

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

• Anuria (not capable to create urine) or
• Diabetic patients who are also using aliskiren (Tekturna®) or
• Sulfa drug allergy, history of—Should not be used in patients with these conditions.

• Asthma, 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
• Gallstones, or history of or
• Glaucoma, angle-closure or
• Gout or
• Hypercholesterolemia (high cholesterol in the blood) or
• Hypertriglyceridemia (high triglycerides or fats in the blood) or
• Kidney disease, severe or
• Myopia (changes in the eyeball causing vision issues) or
• Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

Less common

• Cold or flu-like symptoms
• Difficulty with swallowing
• Sore throat
• Tender or swollen lymph nodes in the neck
• Unusual tiredness or weakness

Rare

• Bloating or stomach pain
• Blurred vision
• Chills
• Eye pain
• Fainting
• Fever
• Flushing
• Itching, pain, redness, or swelling of the eye or eyelid
• Joint stiffness or swelling, especially if sudden
• Nausea
• Skin rash or hives
• Trouble breathing
• Vomiting
• Watering of the eyes
• Yellow eyes or skin

Incidence not known

• Confusion
• Dark urine
• Decreased urine output
• Dizziness
• Drowsiness
• Dry mouth
• Fast or irregular heartbeat
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Light-colored stools
• Lightheadedness
• Muscle cramps, spasms, pain, or stiffness
• Nervousness
• Numbness or tingling in the hands, feet, or lips
• Persistent non-healing sore
• Pink growth
• Reddish patch or irritated area
• Seizures
• Shiny bump
• Thirst
• Weakness or heaviness of the legs
• White, yellow or waxy scar-like area

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:

Less common

• Cough
• Diarrhea (mild)
• Headache

Rare

• Anxiety
• Increased sensitivity to sunlight
• Increased sweating
• Redness of the face or neck
• Reduced sexual performance or drive

Incidence not known

• Hair loss or thinning of the hair

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.

• Diovan HCT

Available Dosage Forms:

• Tablet

Therapeutic Class: Angiotensin II Receptor Antagonist/Thiazide Combination

Pharmacologic Class: Angiotensin II Receptor Antagonist

Chemical Class: Thiazide

In addition to using this medicine, 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.

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 might 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, strokes, or kidney disease.

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

Swallow the tablet whole. Do not break, crush, or chew it. You may take this medicine with or without food.

If you also use cholestyramine or colestipol, take these at least 4 to 6 hours before or 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—One tablet once a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than valsartan 320 milligrams (mg) and hydrochlorothiazide 25 mg per day. 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.