abc
Search

EXFORGE AND EXFORGE HCT FAQs

Exforge Information

Exforge Dosage and Administration

Exforge Safety

SPECIAL/OTHER TOPICS

 

PRODUCT INFORMATION

What are the generic names of EXFORGE (X-PHORJ) and EXFORGE HCT (X-PHORJ HCT)?

  • The generic name of EXFORGE is amlodipine and valsartan tablets. The generic name of EXFORGE HCT is amlodipine, valsartan, and hydrochlorothiazide tablets.
  • Back to Top

What are EXFORGE and EXFORGE HCT?

  • EXFORGE contains two prescription medicines in a single, once-daily pill that work together in two different but complementary ways to lower blood pressure: amlodipine (the active ingredient in Norvasc®),* a dihydropyridine calcium channel blocker, and valsartan (the active ingredient in Diovan®), an angiotensin II receptor blocker. EXFORGE HCT contains amlodipine, valsartan, and hydrochlorothiazide, a diuretic (water pill).
  • * Norvasc is a registered trademark of Pfizer, Inc.
  • Back to Top

For what are EXFORGE and EXFORGE HCT indicated?

  • EXFORGE and EXFORGE HCT are prescription medications for the treatment of high blood pressure.
  • EXFORGE contains two prescription medicines: amlodipine, a calcium channel blocker (CCB), and valsartan, an angiotensin receptor blocker (ARB). EXFORGE may be used when any one of the following medicines to lower your high blood pressure is not enough: a dihydropyridine CCB or an ARB. It may also be used as the first medicine to lower high blood pressure if your doctor decides you are likely to need more than one medicine.
  • EXFORGE HCT contains three prescription medicines: amlodipine, valsartan, and hydrochlorothiazide (HCTZ), a diuretic, or “water pill.” EXFORGE HCT may be used to lower blood pressure in adults when any two of the following medicines to lower high blood pressure have been tried first: a CCB, an ARB, and a diuretic.
  • Back to Top

When were EXFORGE and EXFORGE HCT approved by the FDA?

  • The Food and Drug Administration approved EXFORGE on June 20, 2007. EXFORGE HCT was approved on May 5, 2009.
  • Back to Top

What type of medications are EXFORGE and EXFORGE HCT?

  • EXFORGE and EXFORGE HCT are pills containing two prescription medications, amlodipine and valsartan. Amlodipine is a dihydropyridine calcium channel blocker, otherwise known as a CCB. Valsartan is an angiotensin II receptor blocker, otherwise known as an ARB. EXFORGE HCT also contains hydrochlorothiazide, a diuretic (water pill).
  • Back to Top

How does EXFORGE or EXFORGE HCT work?

  • Blood is carried from the heart to all parts of the body in vessels called arteries. Blood pressure is created by the force of the blood pushing against the walls of the arteries as it circulates and the force of the arteries as they resist the blood flow. You have high blood pressure when the force is too much. EXFORGE works in two different but complementary ways to block substances in the body that can cause blood vessels to narrow, contributing to high blood pressure. EXFORGE can help your blood vessels relax so your blood pressure is lower.
    EXFORGE HCT also works to remove water from the body, which can help lower blood pressure.
  • Back to Top

In what strengths are EXFORGE and EXFORGE HCT available?

  • EXFORGE is available in 4 combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.
    (The first number refers to the number of milligrams of amlodipine. The second number refers to the number of milligrams of valsartan.)
  • EXFORGE HCT is available in 5 combinations: 5/160/12.5, 5/160/25, 10/160/12.5, 10/160/25, and 10/320/25.(The first number refers to the number of milligrams of amlodipine. The second number refers to the number of milligrams of valsartan. The third number refers to the number of milligrams of hydrochlorothiazide.)
  • Back to Top

What are the ingredients in EXFORGE and EXFORGE HCT?

  • The active ingredients in EXFORGE are amlodipine and valsartan. The active ingredients in EXFORGE HCT are amlodipine, valsartan, and hydrochlorothiazide
  • The inactive ingredients of all strengths of the tablets are colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. Additionally, the 5/320 mg and 10/320 mg strengths contain iron oxide yellow and sodium starch glycolate. The film coating contains hypromellose, iron oxides, polyethylene glycol, talc, and titanium dioxide.
  • Back to Top

What do EXFORGE and EXFORGE HCT look like?

  • EXFORGE 5/160 mg Tablets–dark yellow, oval shaped, film-coated tablet with beveled edge, debossed with "NVR" on one side and "ECE" on the other side.
  • EXFORGE 10/160 mg Tablets–light yellow, oval shaped, film-coated tablet with beveled edge, debossed with "NVR" on one side and "UIC" on the other side.
  • EXFORGE 5/320 mg Tablets–very dark yellow, oval shaped, film-coated tablet with beveled edge, debossed with "NVR" on one side and "CSF" on the other side.
  • EXFORGE 10/320 mg Tablets–dark yellow, oval shaped, film-coated tablet with beveled edge, debossed with "NVR" on one side and "LUF" on the other side.
  • EXFORGE HCT 5/160/12.5 mg Tablets–white, oval, film-coated tablet imprinted with "NVR" and "VCL."
  • EXFORGE HCT 5/160/25 mg Tablets–yellow, oval, film-coated tablet imprinted with "NVR" and "VEL."
  • EXFORGE HCT 10/160/12.5 mg Tablets–light yellow, oval, film-coated tablet imprinted with "NVR" and "VDL."
  • EXFORGE HCT 10/160/25 mg Tablets–orange, oval, film-coated tablet imprinted with "NVR" and "VHL."
  • EXFORGE HCT 10/320/25 mg Tablets–orange, oval, film-coated tablet imprinted with "NVR" and "VFL."
  • Back to Top

Exforge Dosage and Information

How do I take EXFORGE or EXFORGE HCT?

  • Take EXFORGE or EXFORGE HCT exactly as your doctor or health care professional tells you.
  • Take it at the same time each day, with or without food.
  • If you miss a dose, take it as soon as you remember. If it is close to your next dose, wait and take your next dose at the regular time.
  • If you take too much of either, call your doctor or Poison Control Center, or go to the nearest hospital emergency room.
Back to Top

Can EXFORGE or EXFORGE HCT be taken with or without food?

  • You can take EXFORGE or EXFORGE HCT with or without food. Just remember to take it at approximately the same time every day.
  • Back to Top

When and how often should EXFORGE or EXFORGE HCT be taken?

  • Take EXFORGE or EXFORGE HCT exactly as your doctor prescribes. EXFORGE or EXFORGE HCT is usually taken once every day at the same time or as close to the same time as possible.
  • Back to Top

Can EXFORGE or EXFORGE HCT be cut or crushed?

  • No. EXFORGE and EXFORGE HCT should not be cut or crushed in any way. The tablet should be swallowed whole.
  • Back to Top

What should I do if I miss a dose?

  • If you miss a dose, take it as soon as you remember. If it is close to your next dose, wait and take your next dose at the regular time. As with any medication, EXFORGE or EXFORGE HCT should be taken exactly as directed by your doctor or health care professional. Do not double dose.
  • Back to Top

Can I take an extra dose?

  • No. Continue taking EXFORGE or EXFORGE HCT as directed by your doctor or health care professional.
  • Back to Top

How should EXFORGE or EXFORGE HCT be stored?

  • Store EXFORGE or EXFORGE HCT tablets at room temperature between 59oF and 86oF.
  • Keep EXFORGE or EXFORGE HCT in the original prescription bottle in a dry place.
  • Keep EXFORGE or EXFORGE HCT and all medications out of the reach of children.
Back to Top

How soon can I expect to see improvement?

  • Results will vary for each patient. EXFORGE and EXFORGE HCT have been shown to achieve significant blood pressure-lowering results in as soon as 2 weeks.
  • Back to Top

Can I stop taking EXFORGE or EXFORGE HCT if I feel better or if I get to my blood pressure goal?

  • No. Continue taking EXFORGE or EXFORGE HCT as directed by your physician. Some people stop taking their hypertension medication because they feel better and mistakenly believe that they no longer need the medication. Some stop because their blood pressure returns to normal with treatment and they mistakenly believe that they are "cured." Others stop taking their medication because they believe that it makes them feel worse or that it is too expensive.
  • Although there is no cure for hypertension, hypertension can be managed with medication. If you experience side effects from your medication or have other difficulties taking it as prescribed, contact your doctor or pharmacist to discuss the issue.
  • Back to Top

SAFETY

Has EXFORGE or EXFORGE HCT been studied in clinical trials?

  • The blood pressure-lowering effects of EXFORGE and EXFORGE HCT have been studied in many clinical trials that included more than 5,000 patients with high blood pressure. The safety of both medications has been evaluated in more than 2,600 hypertensive patients; over 1,440 of these patients were treated for at least 6 months, and more than 540 of these patients were treated for at least 1 year.
  • Back to Top

What are the possible side effects of EXFORGE and EXFORGE HCT?

The most common side effects that occur more frequently with EXFORGE than placebo (sugar pill) are:
  • Swelling (edema) of the hands, ankles, or feet
  • Nasal congestion, sore throat, and discomfort when swallowing
  • Upper respiratory tract infection (head or chest cold)
  • Dizziness
The most common side effects with EXFORGE HCT include:
  • Dizziness
  • Swelling (edema) of the hands, ankles, or feet
  • Indigestion
  • Tiredness
  • Muscle spasms
  • Back pain
  • Nausea
  • Nasal congestion or sore throat

EXFORGE and EXFORGE HCT may cause serious side effects, including:

  • Harm or death to an unborn baby.
  • Low blood pressure (hypotension). Lie down if you feel faint or dizzy. Call your doctor right away.
  • More chest pain and heart attacks in people that already have severe heart problems. Get emergency help if you get worse chest pain or chest pain that does not go away.
  • Kidney problems that may become worse in people that already have kidney disease. Call your doctor if you get swelling in your feet, ankles, or hands or unexplained weight gain.
  • Allergic reactions.
  • Skin rash with EXFORGE HCT. Call your doctor right away if you get an unusual rash.
  • Eye problems with EXFORGE HCT. Call your doctor right away if you have eye pain or decrease in vision.
  • Tell your doctor if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of EXFORGE or EXFORGE HCT. For more information, ask your doctor or pharmacist.
  • Back to Top

Can I take EXFORGE or EXFORGE HCT with other medications?

EXFORGE or EXFORGE HCT can be taken with many other medications, but be sure to tell your doctor and pharmacist about all medications that you are taking or intend to take. Your doctor should decide whether you can take EXFORGE or EXFORGE HCT with other medications. These include:
  • Other medications that a doctor has prescribed
  • All medications that you buy yourself without a prescription
  • Any herbal remedies that you may be taking
Back to Top

Can I drink grapefruit juice while on EXFORGE or EXFORGE HCT?

  • The effect of grapefruit juice on EXFORGE and EXFORGE HCT has not been studied.
  • Back to Top

Does EXFORGE or EXFORGE HCT contain latex or gelatin?

  • EXFORGE and EXFORGE HCT do not contain latex or gelatin. Speak with your doctor if you have any questions or concerns.
  • Back to Top

Does EXFORGE or EXFORGE HCT contain gluten?

  • Novartis Pharmaceuticals Corporation does not knowingly or intentionally include gluten in its products. However, due to multisourcing of certain inactive ingredients, we cannot guarantee the absence of gluten from our products.
  • Back to Top

If I have lactose intolerance, can I take EXFORGE or EXFORGE HCT?

  • Yes. EXFORGE and EXFORGE HCT do not contain lactose.
  • Back to Top

Does EXFORGE or EXFORGE HCT contain dye?

  • No. EXFORGE and EXFORGE HCT do not contain dye. They do contain iron oxide–based colorants.
  • Back to Top

Does EXFORGE or EXFORGE HCT contain iodine?

  • No. EXFORGE and EXFORGE HCT do not contain iodine.
  • Back to Top

If I need to stop taking EXFORGE or EXFORGE HCT, do I need to titrate it (wean off it slowly)?

  • You should consult your doctor and follow their direction.
  • Back to Top

Who should not take EXFORGE or EXFORGE HCT?

  • EXFORGE and EXFORGE HCT can cause harm or death to an unborn baby. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant. If you get pregnant while taking EXFORGE or EXFORGE HCT, tell your doctor right away.
  • Do not take EXFORGE or EXFORGE HCT if you are allergic to any of its ingredients.
  • Back to Top

Can I take EXFORGE or EXFORGE HCT while pregnant or breast-feeding?

  • Pregnancy: EXFORGE and EXFORGE HCT should not be taken by women who are pregnant. Contact your physician immediately if you become pregnant. Both medicines should be discontinued as soon as pregnancy is detected because they may cause injury and even death to an unborn baby.
  • Breast-Feeding. EXFORGE and EXFORGE HCT may pass into your breast milk and can harm your baby. You should not take either and breast-feed.
  • If you are planning on becoming pregnant, discuss other treatment options with your doctor.
  • Back to Top

Are EXFORGE and EXFORGE HCT safe for use in children?

  • EXFORGE and EXFORGE HCT have not been studied in children under 18 years of age.
  • Back to Top

Why do EXFORGE and EXFORGE HCT have a black box warning?

  • Drugs that act on the renin angiotensin system–including angiotensin receptor blockers and angiotensin-converting enzyme inhibitors–should not be used in pregnant women due to the risk of injury and even death to the developing fetus. If you get pregnant, stop taking EXFORGE or EXFORGE HCT and call your doctor right away. Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
  • Back to Top

SPECIAL/OTHER TOPICS

What should I tell my doctor before taking EXFORGE or EXFORGE HCT?

Tell all your doctors and dentist you are taking EXFORGE or EXFORGE HCT if you:
  • Are going to have surgery or dental surgery
  • Go for kidney dialysis
  • Are hospitalized for any reason
Tell your doctor about all your medical conditions, including if you:
  • Are pregnant or plan to become pregnant
  • Have a heart condition
  • Have liver problems
  • Have kidney problems
  • Are vomiting or having a lot of diarrhea
  • Have or have had gallstones
  • Have lupus
  • Are breast-feeding or plan to breast-feed. EXFORGE and EXFORGE HCT may pass into your milk and can harm your baby. You should not take EXFORGE or EXFORGE HCT and breast-feed.
Tell your doctor about any of the following signs and symptoms of fluid and electrolyte problems with
EXFORGE HCT:
  • Dry mouth
  • Thirst
  • Weakness
  • Lack of energy (lethargy)
  • Drowsiness
  • Restlessness
  • Confusion
  • Seizures
  • Muscle pains or cramps
  • Muscle fatigue
  • Low blood pressure
  • Very low urine output
  • Fast heartbeat
  • Nausea and vomiting
Some of your other medications and EXFORGE or EXFORGE HCT could affect each other, causing serious side effects. Especially tell your doctor if you take:
  • Other medicines for high blood pressure or a heart problem
  • Water pills (diuretics)
  • Potassium supplements
  • Salt substitutes containing potassium
  • Aspirin
  • Other medicines called non-steroidal anti-inflammatory drugs (NSAIDs, like ibuprofen or naproxen)
If you are taking EXFORGE HCT, also tell your doctor if you take:
  • Diabetes medicine including insulin
  • Narcotic pain medicines
  • Sleeping pills and anti-seizure medicines called barbiturates
  • Lithium, a medicine used to treat some types of depression
  • Steroids
  • Cholesterol lowering medicine
  • Alcohol
  • If you are taking a beta-blocker medication and your doctor tells you to stop taking it while you are taking EXFORGE or EXFORGE HCT, follow your doctor's instructions very carefully to slowly and safely stop the beta-blocker medication. Stopping beta-blocker medications too quickly can cause chest pain, heart attack, abnormal heart rhythm, or high blood pressure. Taking EXFORGE or EXFORGE HCT does not help to prevent these effects. If you do not know if you take a beta-blocker medication, contact your doctor or pharmacist.
  • Keep a list of your medications with you, including vitamins and natural or herbal remedies, to show your doctor or pharmacist. Some of your other medications and EXFORGE or EXFORGE HCT could affect each other, causing serious side effects. Your doctor or pharmacist will know what medications are safe to take together.
  • Back to Top

How much do EXFORGE and EXFORGE HCT cost?

  • There is usually quite a bit of variability on prices from one pharmacy to another. It is best to check the price with your pharmacy of choice.
  • Back to Top

Is there a patient assistance program for patients who cannot afford EXFORGE or EXFORGE HCT?

  • Novartis provides a Patient Assistance Program for individuals that cannot afford certain Novartis medications. Novartis is also a sponsor of the Together Rx Access Card.* To find out if you qualify, please call the Novartis Savings Network at 1-800-245-5356.
  • * Together RX Access is a registered trademark of Together RX Access, LLC.
  • Back to Top
Exforge $4 co pay Exforge coupon
Exforge get on track patient support program get started with Exforge get on track patient support program
Novartis patient assistance

isi-home www.fda.gov/medwatch prescribe info patient info prescribe info patient info download