Atacand HCT

DRUG DESCRIPTION

ATACAND HCT (candesartan cilexetil-hydrochlorothiazide) combines an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide.

Candesartan cilexetil, a nonpeptide, is chemically described as ()-1-Hydroxyethyl 2-ethoxy-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]-7-benzimidazolecarboxylate, cyclohexyl carbonate (ester).

Its empirical formula is C33H34N6O6, and its structural formula is

Candesartan cilexetil Structural Formula Illustration

Candesartan cilexetil is a white to off-white powder with a molecular weight of 610.67. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2H-1,2,4- benzothiadiazine-7-sulfonamide 1,1-dioxide. Its empirical formula is C7H8ClN3O4S2 and its structural formula is

Hydrochlorothiazide is a white, or practically white, crystalline powder with a molecular weight of 297.72, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.

ATACAND HCT (candesartan cilexetil-hydrochlorothiazide) is available for oral administration in three tablet strengths of candesartan cilexetil and hydrochlorothiazide.

ATACAND HCT (candesartan cilexetil-hydrochlorothiazide) 16-12.5 contains 16 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide. ATACAND HCT (candesartan cilexetil-hydrochlorothiazide) 32-12.5 contains 32 mg of candesartan cilexetil and 12.5 mg of hydrochlorothiazide. ATACAND HCT (candesartan cilexetil-hydrochlorothiazide) 32-25 contains 32 mg of candesartan cilexetil and 25 mg of hydrochlorothiazide. The inactive ingredients of the tablets are carboxymethylcellulose calcium, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, corn starch, polyethylene glycol 8000, and ferric oxide (yellow). Ferric oxide (reddish brown) is also added to the 16-12.5 mg and 32-25 mg tablets as colorant.

What are the possible side effects of hydrochlorothiazide and candesartan (Atacand HCT)?

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, hydrochlorothiazide and candesartan 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...

Read All Potential Side Effects and See Pictures of Atacand HCT

What are the precautions when taking candesartan cilexetil-hydrochlorothiazide (Atacand HCT)?

Before taking this medication, tell your doctor or pharmacist if you are allergic to candesartan or hydrochlorothiazide; or to ACE inhibitors (e.g., captopril, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an inability to make urine.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, severe loss of body fluids (dehydration through too much sweating/vomiting/diarrhea), mineral/electrolyte problems (e.g.,...

Read All Potential Precautions of Atacand HCT


Atacand HCT Consumer (continued)

SIDE EFFECTS: See also How to Use section.

You may experience dizziness, lightheadedness, and blurred vision as your body adjusts to the medication. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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: signs of loss of too much body water and minerals (e.g., unusual thirst, muscle cramps, weakness, confusion, fast/irregular heartbeat, fainting, seizures), decreased sexual ability, decrease in vision, eye pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: unusual change in the amount of urine (not including the normal increase in urine when you first start this drug), stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes or skin, dark urine, unusual tiredness, muscle pain.

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 medication, tell your doctor or pharmacist if you are allergic to candesartan or hydrochlorothiazide; or to ACE inhibitors (e.g., captopril, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: an inability to make urine.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, severe loss of body fluids (dehydration through too much sweating/vomiting/diarrhea), mineral/electrolyte problems (e.g., imbalance of sodium/potassium/magnesium/calcium), gout, lupus, high levels of fats in the blood (high cholesterol or triglycerides), asthma.

If you have diabetes, this medication may affect your blood sugar levels. Your doctor may need to adjust the dosage of your medications used to treat diabetes (e.g., insulin, glipizide). Monitor your blood sugar levels as instructed and tell your doctor immediately if you develop signs of high blood sugar (e.g., increased thirst, vision changes, fruity breath odor).

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.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

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

Hydrochlorothiazide may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for dizziness while using this drug.

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.)

This drug passes into breast milk. Consult your doctor before breast-feeding.


Atacand HCT Patient Information Including Side Effects

Brand Names: Atacand

Generic Name: candesartan (Pronunciation: kan de SAR tan)

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

What is candesartan (Atacand HCT)?

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

Candesartan is used to treat high blood pressure (hypertension). It is sometimes given together with other blood pressure medications.

Candesartan is also used to treat kidney problems caused by type 2 (not insulin-dependent) diabetes.

Candesartan may also be used for other purposes not listed in this medication guide.

What are the possible side effects of candesartan (Atacand HCT)?

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, candesartan 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 effect, such as:

  • feeling like you might pass out;
  • chest pain;
  • swelling in your hands or feet; or
  • slow heart rate, weak pulse, tingly feeling.

Less serious side effects may include:

  • runny or stuffy nose, sore throat, cough;
  • back pain;
  • joint pain;
  • stomach pain, diarrhea;
  • headache, dizziness; or
  • tired feeling.

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 candesartan (Atacand HCT)?

Do not use this medication without telling your doctor if you are pregnant. Candesartan 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.

You should not use this medication if you are allergic to candesartan.

Avoid drinking alcohol. It can lower your blood pressure and may increase some of the side effects of candesartan.

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

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. Do not miss any scheduled appointments.

Keep using this medication even if you feel fine. High blood pressure often has no symptoms.

In rare cases, candesartan 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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