Mylan-Valsartan HCTZ

Brand Name

Mylan-Valsartan HCTZ

Common Name

valsartan-hydrochlorothiazide

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are any nutrients depleted by this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

This is a combination product that contains 2 medications: valsartan and hydrochlorothiazide. This combination medication is used to treat high blood pressure.

Valsartan belongs to the class of medications called angiotensin II receptor blockers and helps to lower blood pressure by relaxing blood vessels. Hydrochlorothiazide belongs to the class of medications called diuretics or "water pills" and helps control blood pressure by getting rid of excess salt and water. The full effects of this combination product are usually seen within about 4 weeks.

This medication is most often used when a person has taken valsartan and hydrochlorothiazide as separate medications without any problems.

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.

How should I use this medication?

Once the dose of each component (valsartan and hydrochlorothiazide) has been determined by your doctor, the appropriate dose of the combination tablets can be taken once daily. The usual adult dose of valsartan ranges from 80 mg to 160 mg once daily, with a maximum of 320 mg, while the usual adult dose of hydrochlorothiazide ranges from 12.5 mg to 25 mg once daily, with a maximum of 25 mg.

This medication may be taken with or without food, but it should be taken the same way each day.

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. 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 at room temperature, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Who should NOT take this medication?

Do not use valsartan-hydrochlorothiazide if you:

• are allergic to valsartan, hydrochlorothiazide, or any ingredients of this medication
• are allergic to other sulfonamide-derived medications (sulfa drugs, e.g., sulfamethoxazole)
• are pregnant or breast-feeding
• have anuria (inability to pass urine)
• have severe kidney disease
• have diabetes or kidney disease and are taking aliskiren
• have symptoms of gout or unusually high uric acid levels
• have untreated or treatment-resistant electrolyte abnormalities
• have galactose intolerance (a rare hereditary condition)

What side effects are possible with this medication?

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.

• altered sense of taste
• back, neck, or leg pain
• constipation
• cough
• decreased appetite
• decreased energy
• decreased interest in sexual activity
• decreased sexual ability
• diarrhea
• difficulty sleeping
• dizziness
• drowsiness
• dry mouth
• ear pain
• fatigue
• fever
• gas
• headache
• heartburn
• increased sensitivity of the skin to sunlight
• motion sickness
• nausea
• nosebleeds
• pins and needles sensation
• ringing in the ears
• sweating
• swollen glands (in mouth)
• trouble maintaining balance
• vomiting

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:

• abdominal pain
• anxiety
• inflamed blood vessels
• muscle pain, spasms, or weakness
• pain or swelling of the hands, arms, or feet
• pounding, rapid, or irregular heartbeat
• signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of bleeding (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of electrolyte changes (e.g., confusion, drowsiness, dry mouth, muscle fatigue, nausea, thirst, weakness)
• signs of gout (e.g., joint pain, swelling, and warm joints)
• signs of infections (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., decreased urination, nausea, vomiting, swelling of the feet and ankles)
• signs of liver damage (yellowing of skin or whites of eyes, abdominal pain, loss of appetite, brown urine, light-coloured stools, tiredness, or weakness)
• signs of low blood pressure such as dizziness, lightheadedness, or fainting
• signs of low potassium levels in the blood (e.g., weakness, fatigue, muscle cramps, irregular heartbeat)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• signs of non-melanoma skin cancer (e.g., lump or discoloured patch on skin, pink/red firm lumps, or flat and scaly patches)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of lung infection (e.g., difficulty breathing, cough)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
• unexplained muscle pain or weakness
• vision changes (e.g., sudden nearsightedness, blurred vision, blind spots, eye pain)
• worsening symptoms of lupus (e.g., fever, general feeling of being unwell, joint pain, confusion, muscle aches, skin rash)

Stop taking the medication and seek medical attention immediately if any of the following side effects occur:

• chest pain
• fainting
• signs of a serious allergic reaction (swelling of face or throat, hives, difficulty breathing)
• severe skin rash, including skin blistering and peeling (possibly with headache, fever, coughing, or aching before the rash begins)
• symptoms of acute respiratory distress syndrome (ARDS; e.g., sudden shortness of breath, fever, weakness, confusion)
• symptoms of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
• symptoms of increased pressure in the eyes (e.g., decreased or blurred vision, eye pain, red eye, swelling of the eye)

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.

Are any nutrients depleted by this medication?

Some medications can affect vitamin and nutrient levels in the body. Below is a list of nutrient depletions associated with this medication. Talk to your doctor or pharmacist about whether taking a supplement is recommended or if you have any questions or concerns.

Are there any other precautions or warnings for this medication?

Before you begin taking 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 take this medication.

Allergic reaction: Some people who are allergic to sulfonamide medications also experience allergic reactions to hydrochlorothiazide. Before you take this medication, inform your doctor about any previous adverse reactions you have had to medications, especially to sulfonamide antibiotics or diabetes medications. 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.

Angioedema: This medication may cause a serious allergic reaction called angioedema, which may be fatal if not treated quickly. If you have difficulty breathing or notice hives or swelling of the face, lips, tongue, or throat, stop taking this medication and get emergency medical help immediately. You should not take other angiotensin II receptor antagonists in the future. People who have had angioedema caused by other substances may be at increased risk of angioedema while taking this medication.

Breathing: Rarely, people taking hydrochlorothiazide-containing medications experience sudden difficulty breathing, caused by swelling in the lungs. This is called acute respiratory distress syndrome (ARDS) and usually occurs soon after taking the medication. If you experience shortness of breath, worsening difficulty breathing, fever, light-headedness or dizziness, seek immediate medical attention, as this condition can become life-threatening.

Cholesterol: Increases in cholesterol and triglyceride levels may occur when taking hydrochlorothiazide. At doses used in valsartan – hydrochlorothiazide, this rarely causes problems. However, if you have increased cholesterol or triglyceride levels, 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.

Diabetes:  Hydrochlorothiazide may make it more difficult for people with diabetes to control their blood sugar levels. High blood sugar may occur, glucose tolerance may change, and diabetes may worsen. A dose adjustment of diabetes medications, including insulin, may be required. If you have diabetes, 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.

Drowsiness/dizziness: Valsartan – hydrochlorothiazide may cause drowsiness or dizziness, affecting your ability to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how you are affected by this medication.

Electrolytes: The levels of electrolytes such as potassium, sodium, magnesium, and chloride can be reduced, and the levels of calcium can be increased by the use of hydrochlorothiazide. Your doctor will periodically check to see if these levels are in balance. Warning signs or symptoms of fluid and electrolyte imbalance include:

• decreased urination
• drowsiness
• dryness of mouth
• lethargy
• low blood pressure
• muscle pains or cramps
• muscular fatigue
• nausea and vomiting
• racing heartbeat
• restlessness
• thirst
• weakness

Gout: Some people taking valsartan–hydrochlorothiazide may experience an acute gout attack as a result of high levels of uric acid in the blood. Symptoms of an acute gout attack include sudden pain, swelling, and stiffness in the affected joint, often the big toe. You may also experience a fever. If this is your first attack, seek medical attention as soon as possible. If you have had gout attacks before, follow your doctor's instructions for dealing with the attack.

Kidney problems: Valsartan can cause changes to kidney function that may result in decreased kidney function, kidney failure, or possibly death. Certain people have experienced changes in kidney function (e.g., people with narrowed blood vessels in their kidneys, or those with severe congestive heart failure). The use of 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 reduced kidney function, renal artery stenosis (narrowing of blood vessels in the kidneys), or congestive heart failure, 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. If you have reduced kidney function, you may require lower doses of this medication.

Liver problems: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have reduced liver function or liver disease, 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 severe liver impairment.

This medication may also cause a decrease in liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Low blood pressure: Occasionally, a greater-than-expected drop in blood pressure occurs after taking this medication. In some cases, this happens after the first dose. This is more likely to occur if you have a reduced salt intake, are on dialysis, are experiencing diarrhea or vomiting, or take diuretics (water pills) or the medication aliskiren. Your doctor may recommend that you have your blood pressure tested more often in these situations. If you have low blood pressure or are just starting to take this medication, move slowly from a reclined to an upright position to reduce the risk of dizziness.

Lupus: There have been reports of worsening or activation of lupus in people taking hydrochlorothiazide. If you have lupus, 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.

Sensitivity to sunlight: This medication may increase the sensitivity of the skin to sunlight, increasing the risk of sunburn. Avoid exposure to sunlight for long periods of time, particularly between the hours of 10 am and 2 pm, while you are taking this medication. Wear a broad-spectrum sunscreen with an SPF of 30 or greater. If you notice any unusual skin rash or peeling, contact your doctor immediately.

Skin cancer: Recent studies of hydrochlorothiazide have suggested that long-term use of hydrochlorothiazide may be associated with an increased risk of developing non-melanoma skin cancer. Regularly check your skin for new moles or lesions or changes to any existing ones and report any concerns you have to your doctor.

Vision changes: Hydrochlorothiazide occasionally causes vision changes including increased eye pressure and myopia (nearsightedness). If you experience any eye symptoms, such as pain or change in vision, contact your doctor as soon as possible.

Pregnancy: This medication may cause harm to a developing baby if it is taken during pregnancy. Pregnant people should not take this medication. If you become pregnant while taking this medication, stop taking it immediately and call your doctor.

Breast-feeding: It is not known if valsartan passes into breast milk. Hydrochlorothiazide passes into breast milk. If you are breast-feeding and are taking this medication, it may affect your baby. Do not breast-feed while you are taking this medication.

Children: The safety and effectiveness of using this medication have not been established for children. This medication is not recommended for children.

What other drugs could interact with this medication?

There may be an interaction between valsartan-hydrochlorothiazide and any of the following:

• aclidinium
• alcohol
• aldesleukin
• aldosterone antagonists (e.g., eplerenone, finerenone, spironolactone)
• aliskiren
• allopurinol
• alpha-agonists (e.g., clonidine, methyldopa)
• alpha-adrenergic blocking agents (e.g., alfuzosin, terazosin)
• aminolevulinic acid
• amiodarone
• amphetamines (e.g., dextroamphetamine, lisdexamfetamine)
• angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
• other angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• antihistamines (e.g., azelastine, 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-blockers (e.g., atenolol, carvedilol, propranolol)
• beta-2 agonists (e.g., formoterol, indacaterol, salbutamol, salmeterol, terbutaline)
• bortezomib
• brigatinib
• brimonidine
• bromocriptine
• buprenorphine
• butorphanol
• calcium carbonate, calcium citrate
• calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
• cholestyramine
• clidinium
• colesevelam
• colestipol
• oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• cyclobenzaprine
• cyclophosphamide
• darifenacin
• darolutamide
• desmopressin
• diabetes medications (e.g., acarbose, canagliflozin, dulaglutide, gliclazide, insulin, metformin, sitagliptin)
• diazoxide
• digoxin
• dimenhydrinate
• disopyramide
• diuretics (water pills; e.g., amiloride, furosemide, triamterene)
• drospirenone
• duloxetine
• eltrombopag
• encorafenib
• ethopropazine
• fesoterodine
• flunarizine
• gemfibrozil
• general anesthetics (medications used to put people to sleep before surgery)
• glycopyrrolate
• heparin
• ipratropium
• ivabradine
• ketotifen
• leflunomide
• levodopa
• licorice
• lithium
• low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
• medications that increase blood levels of potassium (e.g., potassium chloride, salt substitutes containing potassium)
• methadone
• methylphenidate
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• multivitamins/minerals
• nabilone
• narcotic pain relievers (e.g., codeine, fentanyl, morphine, tapentadol, tramadol)
• nitrates (e.g., nitroglycerin, isosorbide dinitrate, isosorbide mononitrate)
• nonsteroidal anti-inflammatory drugs (NSAIDs; e.g., celecoxib, ibuprofen, naproxen)
• obinutuzumab
• oxybutynin
• orphenadrine
• pentoxifylline
• pergolide
• phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
• pizotifen
• pramipexole
• propiverine
• primidone
• riociguat
• ropinirole
• rotigotine
• sacubitril
• scopolamine
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline, vortioxetine)
• sodium phosphates
• solifenacin
• tacrolimus
• teriflunomide
• tizanidine
• tolterodine
• tolvaptan
• topiramate
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
• trihexyphenidyl
• trimethoprim
• trospium
• vitamin D analogues (e.g., alfacalcidol, 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 that 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.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Mylan-Valsartan-HCTZ