Generic Name: amlodipine/valsartan/hydrochlorothiazide (am-LOE-di-peen/val-SAR-tan/HYE-droe-KLOR-oh-THYE-a-zide)
Brand Name: Exforge HCT
Exforge HCT may cause birth defects or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. If you are planning to become pregnant, talk with your doctor about other treatment options.
Exforge HCT is used for:
Treating high blood pressure. It may also be used for other conditions as determined by your doctor.
Exforge HCT is a calcium channel blocker, angiotensin II receptor blocker, and thiazide diuretic combination. It works by relaxing the blood vessels and helping the kidneys remove fluid from the body.
Do NOT use Exforge HCT if:
- you are allergic to any ingredient in Exforge HCT or to any other sulfonamide (sulfa) medicine (eg, sulfamethoxazole)
- you are pregnant
- you have severe liver problems or severe kidney problems, or you are unable to urinate
- you are taking a medicine that contains aliskiren and you also have diabetes or kidney problems. Check with your doctor or pharmacist if you are not sure if a medicine you take contains aliskiren
- you are taking dofetilide or ketanserin
Contact your doctor or health care provider right away if any of these apply to you.
Before using Exforge HCT:
Some medical conditions may interact with Exforge HCT. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are able to become pregnant
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of angioedema (eg, swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; hoarseness), including angioedema caused by treatment with another angiotensin II receptor blocker (eg, losartan) or an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril)
- if you are dehydrated, are on a low-salt (sodium) diet, or have high or low blood electrolyte levels (eg, sodium, magnesium, potassium, calcium)
- if you have a history of gallbladder or liver problems, kidney problems (eg, renal artery stenosis), stroke, heart attack, asthma, gout or high blood levels of uric acid, lupus, parathyroid gland problems, low blood pressure, blood vessel problems, diabetes, swelling or fluid retention, heart problems (eg, heart failure, angina, narrowing of heart blood vessels), or high blood cholesterol or lipid levels
- if you are on dialysis, will be having surgery, or have recently had a certain type of nerve surgery (sympathectomy)
- you drink alcohol
- if you are taking another medicine for high blood pressure or heart problems
- if you have never taken another medicine for high blood pressure
Some MEDICINES MAY INTERACT with Exforge HCT. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Dofetilide or ketanserin because the risk of irregular heartbeat may be increased
- Potassium-sparing diuretics (eg, amiloride, spironolactone, triamterene) or potassium supplements because the risk of high blood potassium levels may be increased
- ACE inhibitors (eg, ramipril) or aliskiren because the risk of certain side effects (eg, kidney problems, high blood potassium levels, low blood pressure) may be increased
- Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, celecoxib, ibuprofen, naproxen) because they may decrease Exforge HCT's effectiveness and the risk of serious kidney problems may be increased
- Adrenocorticotropic hormone (ACTH), azole antifungals (eg, itraconazole, ketoconazole), barbiturates (eg, phenobarbital), cobicistat, conivaptan, corticosteroids (eg, prednisone), cyclosporine, diuretics (eg, furosemide), macrolide antibiotics (eg, clarithromycin), narcotic pain relievers (eg, morphine), protease inhibitors (eg, ritonavir, telaprevir), rifamycins (eg, rifampin), sildenafil, or telithromycin because they may increase the risk of Exforge HCT's side effects
- Aspirin, cholestyramine, or colestipol because they may decrease Exforge HCT's effectiveness
- Carbamazepine, cyclophosphamide, diazoxide, digoxin, lithium, methotrexate, simvastatin, or tacrolimus because the risk of their side effects may be increased by Exforge HCT
- Insulin or other diabetes medicines (eg, glipizide, metformin) because their effectiveness may be decreased by Exforge HCT
This may not be a complete list of all interactions that may occur. Ask your health care provider if Exforge HCT may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Exforge HCT:
Use Exforge HCT as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Exforge HCT. Talk to your pharmacist if you have questions about this information.
- Take Exforge HCT by mouth with or without food.
- Exforge HCT may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.
- If you take cholestyramine or colestipol, ask your doctor or pharmacist how to take it with Exforge HCT.
- Take Exforge HCT on a regular schedule to get the most benefit from it. Taking Exforge HCT at the same time each day will help you remember to take it.
- Continue to take Exforge HCT even if you feel well. Do not miss any doses.
- If you miss a dose of Exforge HCT, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Exforge HCT.
Important safety information:
- Exforge HCT may cause dizziness, light-headedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use Exforge HCT with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Exforge HCT may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
- It may take up to 2 weeks or more for Exforge HCT to work fully. Do not stop using Exforge HCT or change your dose of Exforge HCT without checking with your doctor.
- Exforge HCT contains hydrochlorothiazide, a sulfonamide, which can cause certain eye problems (myopia, angle-closure glaucoma). Your risk may be increased if you are allergic to sulfonamide medicines (eg, sulfamethoxazole) or to penicillin antibiotics (eg, amoxicillin). Untreated angle-closure glaucoma can lead to permanent vision loss. If these eye problems occur, symptoms usually occur within hours to weeks of starting Exforge HCT. Contact your doctor immediately if you experience symptoms such as vision changes (eg, decrease in vision) or eye pain.
- Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
- If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have questions or concerns.
- Check with your doctor before you use a salt substitute or a product that has potassium in it.
- If vomiting, diarrhea, or excessive sweating occur, you will need to take care not to become dehydrated. This could increase your risk for low blood pressure. Contact your doctor for instructions.
- Exforge HCT may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Exforge HCT. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Exforge HCT may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Diabetes patients - Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Tell your doctor or dentist that you take Exforge HCT before you receive any medical or dental care, emergency care, or surgery.
- Although rare, a component of Exforge HCT (amlodipine) has been known to increase chest pain and increase the risk of a heart attack, mainly in patients with severe heart disease.
- Exforge HCT may interfere with certain lab tests, including parathyroid function. Be sure your doctor and lab personnel know you are taking Exforge HCT.
- Lab tests, including blood pressure, kidney function, and blood electrolyte levels, may be performed while you use Exforge HCT. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Exforge HCT with caution in the ELDERLY; they may be more sensitive to its effects.
- Exforge HCT should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Exforge HCT may cause birth defects, or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. Exforge HCT is found breast milk. Do not breast-feed while taking Exforge HCT.
Possible side effects of Exforge HCT:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Dizziness; headache; indigestion; mild back pain; mild sore throat or discomfort when swallowing; muscle spasms; nausea; stuffy nose; tiredness; upset stomach.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blurred vision or other vision changes (eg, decrease in vision); burning, numbness, or tingling; change in the amount of urine produced; chest, jaw, or arm pain; confusion; eye pain; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; increased thirst; joint pain, swelling, warmth, or redness (especially of the big toe joint); mental or mood changes (eg, depression); red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent dizziness or light-headedness; severe or persistent dry mouth; severe or persistent muscle pain, tenderness, or cramps; severe or persistent nausea, vomiting, or stomach or back pain; shortness of breath; sluggishness; stiff muscles, tremors, or muscle movements that are not normal; sudden, unexplained weight gain; swelling of the feet, ankles, or hands; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe or persistent stomach pain, yellowing of the eyes or skin); unusual bruising or bleeding; unusual sweating, tiredness, or weakness; worsening of angina pain (eg, longer, more often, more severe).
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Exforge HCT:
Store Exforge HCT at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Exforge HCT out of the reach of children and away from pets.
- If you have any questions about Exforge HCT, please talk with your doctor, pharmacist, or other health care provider.
- Exforge HCT is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Exforge HCT or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Exforge HCT. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Exforge HCT. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Exforge HCT.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.