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Valsartan and hydrochlorothiazide (Oral route)

Pronunciation:

val-SAR-tan, hye-droe-klor-oh-THYE-a-zide

Brand Names:

  • Diovan HCT

Dosage Forms:

  • Tablet

Warnings:

Oral route(Tablet)

Drugs with direct action on the renin-angiotensin system can cause injury or death to the developing fetus. Discontinue valsartan/hydrochlorothiazide therapy as soon as possible when pregnancy occurs .

Classifications:

Therapeutic—

Angiotensin II Receptor Antagonist/Thiazide Combination

Pharmacologic—

Angiotensin II Receptor Antagonist

Chemical—

Thiazide

Uses of This Medicine:

Valsartan and hydrochlorothiazide combination is used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce 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 the blood vessels to tighten. Valsartan relaxes the blood vessels and lowers blood pressure. A lower blood pressure will increase the supply of blood and oxygen to the heart.

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

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

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also 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.

Children—

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.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of valsartan and hydrochlorothiazide combination in the elderly.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

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

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines 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 taking this medicine, it is especially important that your healthcare professional know if you are taking 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 medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Aliskiren
  • Dofetilide

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

  • Acetyldigoxin
  • Arsenic Trioxide
  • Benazepril
  • Captopril
  • Cyclophosphamide
  • Deslanoside
  • Digitalis
  • Digitoxin
  • Digoxin
  • Droperidol
  • Enalapril
  • Enalaprilat
  • Flecainide
  • Fosinopril
  • Ketanserin
  • Levomethadyl
  • Lisinopril
  • Lithium
  • Methotrexate
  • Metildigoxin
  • Moexipril
  • Ouabain
  • Perindopril Erbumine
  • Proscillaridin
  • Quinapril
  • Ramipril
  • Sotalol
  • Trandolapril

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

  • Aceclofenac
  • Acemetacin
  • Alacepril
  • Amtolmetin Guacil
  • Aspirin
  • Benazepril
  • Bepridil
  • Bromfenac
  • Bufexamac
  • Captopril
  • Carbamazepine
  • Celecoxib
  • Chlorpropamide
  • Cholestyramine
  • Choline Salicylate
  • Cilazapril
  • Clonixin
  • Delapril
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Dipyrone
  • Enalaprilat
  • Enalapril Maleate
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Fosinopril
  • Ginkgo
  • Glipizide
  • Gossypol
  • Ibuprofen
  • Ibuprofen Lysine
  • Imidapril
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Licorice
  • Lisinopril
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Moexipril
  • Morniflumate
  • Nabumetone
  • Naproxen
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Pentopril
  • Perindopril
  • Phenylbutazone
  • Piketoprofen
  • Piroxicam
  • Pranoprofen
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Quinapril
  • Ramipril
  • Rofecoxib
  • Salicylic Acid
  • Salsalate
  • Sodium Salicylate
  • Spirapril
  • Sulindac
  • Temocapril
  • Tenoxicam
  • Tiaprofenic Acid
  • Tolfenamic Acid
  • Tolmetin
  • Topiramate
  • Trandolapril
  • Valdecoxib
  • Zofenopril

Other interactions—

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 medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

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

  • Angioedema (an allergic reaction) with other blood pressure medicines (e.g., benazepril, enalapril, lisinopril, Lotrel®, Vasotec®, Zestoretic®, Zestril®), history of—Use may cause this condition to reoccur.
  • Anuria (not able to create urine) or
  • Diabetic patients who are also taking aliskiren (Tekturna®) or
  • Sulfa drug allergy, history of—Should not be used in patients with these conditions.
  • Asthma, history of—May increase likelihood of having an allergic reaction.
  • Congestive heart failure, severe—Use may lead to kidney problems.
  • Diabetes or
  • Electrolyte imbalances (e.g., 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 problems) or
  • Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

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.

You may take this medicine with or without food.

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.

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure 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. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may cause dizziness, lightheadedness, or fainting, especially when you get up suddenly from a lying or sitting position. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning. If you faint, call your doctor right away.

Check with your doctor right away 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 blurred vision, difficulty with reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor may want an eye doctor 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. Talk to your doctor if you have any questions.

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

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

Side Effects of This Medicine:

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

Check with your doctor immediately 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 with breathing or wheezing
vomiting
watering of the eyes
yellow eyes or skin
Incidence not known
Confusion
convulsions (seizures)
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 or spasms
muscle pain or stiffness
nervousness
numbness or tingling in the hands, feet, or lips
thirst
weakness or heaviness of the legs

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.


Last Updated: 11/4/2014

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