Azor

DRUG DESCRIPTION

Azor provided as a tablet for oral administration, is a combination of the calcium channel blocker (CCB) amlodipine besylate and the angiotensin II receptor blocker (ARB) olmesartan medoxomil.

The amlodipine besylate component of Azor is chemically described as 3-ethyl-5methyl ()-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5pyridinedicarboxylate, monobenzenesulphonate. Its empirical formula is C20H25ClN2O5C6H6O3S.

Olmesartan medoxomil, a prodrug, is hydrolyzed to olmesartan during absorption from the gastrointestinal tract.

The olmesartan medoxomil component of Azor is chemically described as 2,3dihydroxy-2-butenyl 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[p-(o-1H-tetrazol-5ylphenyl)benzyl]imidazole-5-carboxylate, cyclic 2,3-carbonate. Its empirical formula is C29H30N6O6.

The structural formula for amlodipine besylate is:

AZOR (amlodipine and olmesartan medoxomil) Structural Formula Illustration

The structural formula for olmesartan medoxomil is:

Azor contains amlodipine besylate, a white to off-white crystalline powder, and olmesartan medoxomil, a white to light yellowish-white powder or crystalline powder. The molecular weights of amlodipine besylate and olmesartan medoxomil are 567.1 and 558.59, respectively. Amlodipine besylate is slightly soluble in water and sparingly soluble in ethanol. Olmesartan medoxomil is practically insoluble in water and sparingly soluble in methanol.

Each tablet of Azor also contains the following inactive ingredients: silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, and magnesium stearate. The color coatings contain polyvinyl alcohol, macrogol/ polyethylene glycol 3350, titanium dioxide, talc, iron oxide yellow (5/40 mg, 10/20 mg, 10/40 mg tablets), iron oxide red (10/20 mg and 10/40 mg tablets), and iron oxide black (10/20 mg tablets).

What are the possible side effects of amlodipine and olmesartan (Azor)?

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 olmesartan 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 Azor

What are the precautions when taking amlodipine and olmesartan medoxomil tablets (Azor)?

Before taking this product, tell your doctor or pharmacist if you are allergic to either amlodipine or olmesartan; 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, 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...

Read All Potential Precautions of Azor


Azor Consumer (continued)

SIDE EFFECTS: Dizziness or lightheadedness may occur as your body adjusts to the medication. Swelling hands/ankles/feet 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: fainting, muscle weakness, fast/pounding heartbeat.

Tell your doctor immediately if any of these rare but very serious side effects occur: unusual change in the amount of urine, unusual muscle pain/tenderness, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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 olmesartan; 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, 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.


Azor Patient Information Including Side Effects

Brand Names: Azor

Generic Name: amlodipine and olmesartan (Pronunciation: am LOE de peen ol me SAR tan)

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

What is amlodipine and olmesartan (Azor)?

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

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

The combination of amlodipine and olmesartan is used to treat high blood pressure (hypertension).

Amlodipine and olmesartan may also be used for other purposes not listed in this medication guide.

What are the possible side effects of amlodipine and olmesartan (Azor)?

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 olmesartan 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;
  • urinating less than usual or not at all;
  • 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 include:

  • dizziness, drowsiness;
  • warmth, redness, or tingly feeling under your skin;
  • hair loss; or
  • mild skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about amlodipine and olmesartan (Azor)?

Do not use this medication without telling your doctor if you are pregnant. Olmesartan 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 olmesartan, 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 olmesartan 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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