Exforge

DRUG DESCRIPTION

Exforge is a fixed combination of amlodipine and valsartan.

Exforge contains the besylate salt of amlodipine, a dihydropyridine calcium-channel blocker (CCB). Amlodipine besylate is a white to pale yellow crystalline powder, slightly soluble in water and sparingly soluble in ethanol. Amlodipine besylate's chemical name is 3-Ethyl-5-methyl(4RS)-2-[(2-aminoethoxy)methyl]-4-(2chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate benzenesulphonate; its structural formula is

Amlodipine besylate Structural Formula Illustration

Its empirical formula is C20H25ClN2O5C6H6O3S and its molecular weight is 567.1.

Valsartan is a nonpeptide, orally active, and specific angiotensin II antagonist acting on the AT1 receptor subtype. Valsartan is a white to practically white fine powder, soluble in ethanol and methanol and slightly soluble in water. Valsartan's chemical name is N-(1-oxopentyl)-N-[[2'-(1H-tetrazol-5-yl) [1,1'-biphenyl]-4yl]methyl]-L-valine; its structural formula is

Its empirical formula is C24H29N5O3 and its molecular weight is 435.5.

Exforge tablets are formulated in four strengths for oral administration with a combination of amlodipine besylate, equivalent to 5 mg or 10 mg of amlodipine free-base, with 160 mg, or 320 mg of valsartan providing for the following available combinations: 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg.

The inactive ingredients for 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.

What are the possible side effects of amlodipine and valsartan (Exforge)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, amlodipine and valsartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Call your doctor at once if you have any other serious side...

Read All Potential Side Effects and See Pictures of Exforge

What are the precautions when taking amlodipine and valsartan (Exforge)?

Before taking this product, tell your doctor or pharmacist if you are allergic to either amlodipine or valsartan; or to other calcium channel blockers (e.g., nifedipine); or to other angiotensin receptor blockers (e.g., losartan); or to ACE inhibitors (e.g., lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (e.g., renal artery stenosis), liver disease, bile duct blockage, heart/blood vessel disease (e.g., heart attack, heart failure, aortic stenosis), high levels of potassium in the blood (hyperkalemia), loss of too much body...

Read All Potential Precautions of Exforge


Exforge Consumer (continued)

SIDE EFFECTS: Dizziness or lightheadedness may occur as your body adjusts to the medication. Runny/stuffy nose or flushing may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling hands/ankles/feet, muscle weakness, fainting, fast/slow/irregular heartbeat.

Tell your doctor immediately if any of these rare but very serious side effects occur: unusual change in the amount of urine, muscle pain/tenderness, unusual tiredness, signs of infection (e.g., fever, chills, persistent sore throat), easy bruising/bleeding, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking this product, tell your doctor or pharmacist if you are allergic to either amlodipine or valsartan; or to other calcium channel blockers (e.g., nifedipine); or to other angiotensin receptor blockers (e.g., losartan); or to ACE inhibitors (e.g., lisinopril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease (e.g., renal artery stenosis), liver disease, bile duct blockage, heart/blood vessel disease (e.g., heart attack, heart failure, aortic stenosis), high levels of potassium in the blood (hyperkalemia), loss of too much body water (dehydration).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Too much sweating, diarrhea, or vomiting may cause you to feel lightheaded. Report prolonged diarrhea or vomiting to your doctor.

Before having surgery, tell your doctor or dentist that you are taking this medication.

This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

Older adults may be more sensitive to the effects of this product, especially dizziness.

This medication is not recommended for use during pregnancy due to the risk for harm to an unborn baby. Consult your doctor for more details. (See also Warning section.)

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Exforge Patient Information Including Side Effects

Brand Names: Exforge

Generic Name: amlodipine and valsartan (Pronunciation: am LOE de peen val SAR tan)

  • What is amlodipine and valsartan (Exforge)?
  • What are the possible side effects of amlodipine and valsartan (Exforge)?
  • What is the most important information I should know about amlodipine and valsartan (Exforge)?
  • What should I discuss with my healthcare provider before taking amlodipine and valsartan (Exforge)?
  • How should I take amlodipine and valsartan (Exforge)?
  • What happens if I miss a dose (Exforge)?
  • What happens if I overdose (Exforge)?
  • What should I avoid while taking amlodipine and valsartan (Exforge)?
  • What other drugs will affect amlodipine and valsartan (Exforge)?
  • Where can I get more information?

What is amlodipine and valsartan (Exforge)?

Amlodipine is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.

Amlodipine and valsartan is in a group of drugs called angiotensin II receptor antagonists. Amlodipine and valsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

The combination of amlodipine and valsartan is used to treat high blood pressure (hypertension). This medication is usually given after others have been tried without successful treatment of hypertension.

Amlodipine and valsartan may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of amlodipine and valsartan (Exforge)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, amlodipine and valsartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

Call your doctor at once if you have any other serious side effects, such as:

  • feeling like you might pass out;
  • swelling in your hands or feet, rapid weight gain;
  • fast or pounding heartbeats;
  • jaundice (yellowing of the skin or eyes); or
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling.

Less serious side effects may include:

  • dizziness, spinning sensation;
  • runny or stuffy nose, sore throat, cough;
  • warmth, redness, or tingly feeling under your skin;
  • diarrhea, constipation, stomach pain;
  • dry mouth, loss of appetite;
  • joint pain; or
  • anxiety, sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about amlodipine and valsartan (Exforge)?

Do not use this medication without telling your doctor if you are pregnant. Valsartan may cause injury and even death to the unborn baby if you take it during the second and third trimesters of pregnancy. Use an effective form of birth control. Stop using this medication and tell your doctor right away if you become pregnant during treatment.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Do not use potassium supplements or salt substitutes while you are taking amlodipine and valsartan, unless your doctor has told you to.

Call your doctor at once if you have swelling in your hands or feet, rapid weight gain, fast or pounding heartbeats, jaundice (yellowing of the skin or eyes), chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling, or if you feel like you might pass out.

In rare cases, amlodipine and valsartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.

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