Atacand

Name: Atacand

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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Reviewed on 4/16/2014 References

Atacand Overview

Atacand is a prescription medication used to treat high blood pressure (hypertension) in adults and children and certain types of heart failure in adults. Atacand belongs to a group of drugs called angiotensin receptor blockers (ARBs), which prevent blood vessels from narrowing. This relieves the heart from excess strain and allows blood to pump smoothly.

This medication comes in tablet form and is taken once or twice a day, with or without food.

Common side effects of Atacand include back pain, sore throat, and nasal congestion.  Atacand can also cause dizziness. Do not drive or operate machinery until you know how Atacand will affect you.

Atacand Food Interactions

Medications can interact with certain foods. In some cases, they may be harmful and your doctor may advise you to avoid certain foods. While taking Atacand, do not use salt substitutes containing potassium without talking to your doctor. Atacand can cause increased potassium levels in your blood and high potassium levels can be dangerous.

Atacand and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Atacand falls into category D and 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 Atacand, tell your doctor right away and stop taking Atacand.

 

Atacand Overdose

If you take too much Atacand call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Atacand is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Atacand Pharmacokinetics

Absorption

Bioavailability

Candesartan cilexetil (prodrug) is rapidly and completely hydrolyzed to candesartan during absorption in the GI tract.1 2 3

Absolute bioavailability of candesartan is about 15%.1

Onset

Antihypertensive effect evident within 2 weeks, with maximum BP reduction after 4–6 weeks.1

Food

Food with high-fat content does not affect bioavailability.1

Special Populations

In patients with mild hepatic impairment (Child-Pugh class A), peak plasma concentration and AUC are increased by 56 and 30%, respectively,1 2 while in those with moderate hepatic insufficiency (Child-Pugh class B), peak plasma concentration and AUC are increased by 73 and 145%, respectively.1 2 Pharmacokinetics not studied in patients with severe hepatic impairment.1 2

In patients with severe renal impairment (Clcr <30 mL/min/1.73 m2), AUC and peak plasma concentration after repeated dosing are approximately double the values in patients with normal renal function.1

Distribution

Extent

Crosses the placenta and is distributed in the fetus in animals.

Crosses the blood-brain barrier poorly, if at all, in animals.1

Distributed into milk in rats; not known whether distributed into human milk.1 2

Plasma Protein Binding

>99%.1

Elimination

Metabolism

Undergoes minor hepatic metabolism by O-deethylation to an inactive metabolite.1

Elimination Route

Eliminated mainly as unchanged drug in urine and feces (via bile).1 2

Half-life

Approximately 9 hours.1

Special Populations

Not removed by hemodialysis.1 Pharmacokinetics in hypertensive patients undergoing hemodialysis are similar to those in hypertensive patients with severe renal impairment.1 (See Absorption: Special Populations, under Pharmacokinetics.)

Stability

Storage

Oral

Tablets

Tightly closed container at 25°C (may be exposed to 15–30°C).1 2

What are some things I need to know or do while I take Atacand?

  • Tell all of your health care providers that you take Atacand. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
  • To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
  • Have your blood pressure checked often. Talk with your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking Atacand with your other drugs.
  • It may take 4 to 6 weeks to see the full effect.
  • If you are taking a salt substitute that has potassium, potassium-sparing diuretics, or potassium, talk with your doctor.
  • If you are on a low-salt or salt-free diet, talk with your doctor.
  • If you are taking this medicine and have high blood pressure, talk with your doctor before using OTC products that may raise blood pressure. These include cough or cold drugs, diet pills, stimulants, ibuprofen or like products, and some natural products or aids.
  • Talk with your doctor before you drink alcohol.
  • Be careful in hot weather or while being active. Drink lots of fluids to stop fluid loss.
  • Tell your doctor if you have too much sweat, fluid loss, throwing up, or loose stools. This may lead to low blood pressure.
  • This medicine may not work as well in black patients. Talk with the doctor.
  • Do not give Atacand to a child younger than 1 year of age.
  • Do not give to a child who has kidney disease.

What are some other side effects of Atacand?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Dizziness.
  • Back pain.
  • Flu-like signs.
  • Sore throat.
  • Stuffy nose.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Indications and Usage for Atacand

Hypertension

Atacand is indicated for the treatment of hypertension in adults and in children 1 to <17 years of age, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Atacand may be used alone or in combination with other antihypertensive agents.

Heart Failure

Atacand is indicated for the treatment of heart failure (NYHA class II-IV) in adults with left ventricular systolic dysfunction (ejection fraction ≤ 40%) to reduce cardiovascular death and to reduce heart failure hospitalizations [see Clinical Studies (14.2)]. Atacand also has an added effect on these outcomes when used with an ACE inhibitor [see Drug Interactions (7.4)].

How Supplied/Storage and Handling

No. 3782 Tablets Atacand, 4 mg, are white to off-white, circular/biconvex-shaped, non-film-coated scored tablets, coded ACF on one side and 004 on the other. They are supplied as follows:

NDC 0186-0004-31 unit of use bottles of 30.

No. 3780 Tablets Atacand, 8 mg, are light pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACG on one side and 008 on the other. They are supplied as follows:

NDC 0186-0008-31 unit of use bottles of 30.

No. 3781 Tablets Atacand, 16 mg, are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACH on one side and 016 on the other. They are supplied as follows:

NDC 0186-0016-31 unit of use bottles of 30

NDC 0186-0016-54 unit of use bottles of 90

No. 3791 Tablets Atacand, 32 mg, are pink, circular/biconvex-shaped, non-film-coated scored tablets, coded ACL on one side and 032 on the other. They are supplied as follows:

NDC 0186-0032-31 unit of use bottles of 30

NDC 0186-0032-54 unit of use bottles of 90

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.

Patient Counseling Information

Advise patient to read FDA-approved patient labeling (Patient Information).

Pregnancy

Advise female patients of childbearing age about the consequences of exposure to Atacand during pregnancy. Discuss treatment options with women planning to become pregnant. Tell patients to report pregnancies to their physicians as soon as possible.

Manufactured under the license

from Takeda Pharmaceutical Company, Ltd.

by: AstraZeneca AB, SE-151 85 Södertälje, Sweden

for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

Atacand is a registered trademark of the AstraZeneca group of companies.

©AstraZeneca 2016

PRINCIPAL DISPLAY PANEL – 16 mg

NDC 0186-0016-31

30 tablets

Atacand®

candesartan cilexetil

16 mg tablets

Rx only

Manufactured for:

AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850

By: AstraZeneca AB, SE-151 85

Södertälje, Sweden Product of Japan

AstraZeneca

What is candesartan (atacand)?

Candesartan is an angiotensin II receptor antagonist. 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 diabetes.

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

What is Atacand?

Atacand (candesartan) is an angiotensin II receptor antagonist. Candesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Atacand is used to treat high blood pressure (hypertension) in adults and children who are at least 1 year old. Lowering blood pressure can reduce the risk of stroke, heart attack, or other heart complications.

Atacand is also used in adults with certain types of heart failure, to reduce serious complications or death due to heart damage.

Atacand dosing information

Usual Adult Dose of Atacand for Hypertension:

Initial dose: 16 mg orally once a day
Maintenance dose: 8 to 32 mg/day orally in 1 to 2 divided doses
Maximum dose: 32 mg/day

Comments:
-Consider administration of a lower initial dose in volume depleted patients.
-Most of the antihypertensive effect is present within 2 weeks; maximum blood pressure reduction at a given dose is generally observed within 4 to 6 weeks of starting that dose.

Usual Adult Dose of Atacand for Congestive Heart Failure:

Initial dose: 4 mg orally once a day; double dose every 2 weeks, as tolerated, to target dose of 32 mg orally once a day

Use: Treatment of New York Heart Association (NYHA) class II through IV heart failure

Usual Pediatric Dose of Atacand for Hypertension:

1 TO LESS THAN 6 YEARS:
Initial dose: 0.2 mg/kg/day orally in 1 to 2 divided doses
Maintenance dose: 0.05 to 0.4 mg/kg/day orally in 1 to 2 divided doses

6 TO LESS THAN 17 YEARS:
Less than 50 kg:
-Initial dose: 4 to 8 mg/day orally in 1 to 2 divided doses
-Maintenance dose: 2 to 16 mg/day orally in 1 to 2 divided doses
Greater than 50 kg:
-Initial dose: 8 to 16 mg/day orally in 1 to 2 divided doses
-Maintenance dose: 4 to 32 mg/day orally in 1 to 2 divided doses

Comments:
-For patients with possible intravascular volume depletion (e.g., patients treated with diuretics, especially those with renal impairment), initiate this drug under close supervision and consider administration of a lower dose.
-Antihypertensive effect is present within 2 weeks; maximum blood pressure reduction at a given dose is generally observed within 4 weeks of starting that dose.
-For children unable to swallow tablets, an extemporaneous suspension may be used instead.

For the Consumer

Applies to candesartan: oral tablet

Along with its needed effects, candesartan (the active ingredient contained in Atacand) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking candesartan:

Rare
  • Arm, back, or jaw pain
  • bleeding gums
  • chest pain or discomfort
  • chest tightness or heaviness
  • chills
  • cough or hoarseness
  • dizziness
  • fainting
  • fast or irregular heartbeat
  • fever
  • joint pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lightheadedness
  • lower back or side pain
  • nausea
  • nosebleeds
  • pain or discomfort in the arms, jaw, back, or neck
  • painful or difficult urination
  • shortness of breath
  • sweating
  • swelling of the feet or lower legs
  • vomiting
Incidence not known
  • Abdominal or stomach pain
  • black, tarry stools
  • bloody urine
  • coma
  • confusion
  • convulsions
  • dark urine
  • decreased urine output
  • difficult or troubled breathing
  • general feeling of tiredness or weakness
  • headache
  • hives or welts
  • increased blood pressure
  • increased thirst
  • itching
  • light-colored stools
  • loss of appetite
  • muscle pain or cramps
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pale skin
  • redness of the skin
  • skin rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the face, ankles, or hands
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • weakness or heaviness of the legs
  • weight gain
  • yellow eyes or skin

Some side effects of candesartan may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Ear congestion or pain
  • head congestion
  • runny or stuffy nose
  • sneezing

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