Candesartan

What is Candesartan?

• Candesartan (Atacand) an angiotensin II receptor blocker (ARB) used to treat high blood pressure.
• Candesartan is also used alone or in combination with other medications to treat congestive heart failure.

Candesartan

Candesartancilexetil Structural Formulae V.1

Candesartan cilexetil

What are the uses of this medicine?

• Candesartan (Atacand) is a prescription medicine called an angiotensin receptor blocker (ARB).

Candesartan cilexetil tablets are used to:

• treat high blood pressure in adults and children, 1 to 17 years of age.
• treat certain types of heart failure in adults, to reduce death and hospitalization for heart damage and heart failure.

• Heart failure is a condition where the heart does not pump blood as well as it should.

• High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys, and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure.

How does this medicine work?

• A synthetic, benzimidazole-derived angiotensin II receptor antagonist prodrug with antihypertensive activity.
• After hydrolysis of candesartan cilexetil to candesartan during gastrointestinal absorption, candesartan selectively competes with angiotensin II for the binding of the angiotensin II receptor subtype 1 (AT1) in vascular smooth muscle, blocking angiotensin II-mediated vasoconstriction and inducing vasodilatation.
• In addition, antagonism of AT1 in the adrenal gland inhibits angiotensin II-stimulated aldosterone synthesis and secretion by the adrenal cortex; sodium and water excretion increase, followed by a reduction in plasma volume and blood pressure.
• Candesartan blocks the effect of the hormone angiotensin II, causing the blood vessels to relax.
• This helps lower blood pressure.
• Medicines that lower your blood pressure lower your chance of having a stroke or heart attack.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• allergic to any of the ingredients in candesartan cilexetil tablets.
• are diabetic and taking aliskiren.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• lithium carbonate (Lithobid) or lithium citrate, medicines used in some types of depression
• other medicines for high blood pressure, especially water pills (diuretics)
• potassium supplements
• salt substitutes
• angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten, in Capozide), enalapril (Vasotec), fosinopril, lisinopril (in Prinzide, in Zestoretic), moexipril (Univasc, in Uniretic), perindopril, (Aceon), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka)
• aspirin
• nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• diuretics ('water pills') including spironolactone (Aldactone, in Aldactazide);
• medications for diabetes

Is this medicine FDA approved?

• Candesartan was approved for use in the United States in 1998 and is available in 4, 8, 16 and 32 mg tablets generically and under the trade name Atacand.

How should this medicine be used?

Recommended dosage: Adult Hypertension:

• Dosage must be individualized.
• Blood pressure response is dose related over the range of 2 to 32 mg.
• The usual recommended starting dose of candesartan cilexetil tablets is 16 mg once daily when it is used as monotherapy in patients who are not volume depleted.
• Candesartan cilexetil tablets can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg.

Pediatric Hypertension 1 to <17 Years of Age: Children 1 to <6 years of age:

• The dose range is 0.05 to 0.4 mg/kg per day. The recommended starting dose is 0.20 mg/kg (oral suspension).

Children 6 to <17 years of age:

• For those less than 50 kg, the dose range is 2 to 16 mg per day. The recommended starting dose is 4 to 8 mg.
• For those greater than 50 kg, the dose range is 4 to 32 mg per day. The recommended starting dose is 8 to 16 mg.

• Children <1 year of age must not receive candesartan cilexetil tablets for hypertension.

Adult Heart Failure:

• The recommended initial dose for treating heart failure is 4 mg once daily.
• The target dose is 32 mg once daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by the patient.

Administration:

• Candesartan comes as a tablet to take by mouth.
• It is usually taken once or twice a day with or without food.
• Your doctor will probably start you on a low dose of candesartan and gradually increase your dose not more than once every 2 weeks.
• Take candesartan cilexetil tablets exactly as prescribed by your doctor.
• Do not change your dose or stop candesartan cilexetil tablets without talking to your doctor, even if you are feeling well.
• If your child cannot swallow tablets, or if tablets are not available in the prescribed strength, your pharmacist will prepare candesartan cilexetil as a liquid suspension for your child. If your child switches between taking the tablet and the suspension, your doctor will change the dose as needed. Shake the bottle of suspension well before each dose.
• If you miss a dose of candesartan cilexetil tablets, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Take the next dose on time. Do not take 2 doses at one time. If you are not sure about your dosing call your doctor or pharmacist.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets 4 mg, 8 mg, 16 mg, 32 mg

This medicine is available in fallowing brand namesː

• Atacand

What side effects can this medication cause?

The most common side effects of this medicine include:

• back pain
• dizziness
• cold or flu symptoms (upper respiratory tract infection)
• sore throat (pharyngitis)
• nasal congestion and stuffiness (rhinitis)

Candesartan cilexetil tablets may cause serious side effects, including:

• Injury or death to your unborn baby
• hypotension
• Worsening kidney problems
• Increased potassium in your blood
• allergic reaction

What special precautions should I follow?

• Candesartan cilexetil tablets can cause you to feel dizzy or tired. Do not drive, operate machinery, or do other dangerous activities until you know how candesartan cilexetil tablets affect you.
• Children <1 year of age must not receive candesartan cilexetil for hypertension. Drugs that act directly on the renin-angiotensin system (RAS) can have effects on the development of immature kidneys.
• Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. When pregnancy is detected, discontinue candesartan cilexetil as soon as possible.
• Candesartan cilexetil can cause symptomatic hypotension. Monitoring of blood pressure is recommended during dose escalation and periodically thereafter.
• Hypotension may occur during major surgery and anesthesia in patients treated with angiotensin II receptor antagonists, including candesartan cilexetil. tell the doctor or dentist that you are taking candesartan.
• candesartan may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking candesartan. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• Monitor renal function periodically in patients treated with candesartan cilexetil.
• Drugs that inhibit the renin-angiotensin system can cause hyperkalemia. Concomitant use of candesartan cilexetil with drugs that may increase potassium levels may increase the risk of hyperkalemia. Monitor serum potassium periodically.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• hypotension, dizziness, and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation.

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• If symptomatic hypotension should occur, supportive treatment should be instituted.
• Candesartan cannot be removed by hemodialysis.
• In managing overdose, consider the possibilities of multiple-drug overdoses, drug-drug interactions, and altered pharmacokinetics in your patient.

Can this medicine be used in pregnancy?

• Pregnancy Category D.
• Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
• When pregnancy is detected, discontinue candesartan cilexetil as soon as possible.

Can this medicine be used in children?

• Candesartan cilexetil tablets must not be used in children less than 1 year of age for high blood pressure.

What are the active and inactive ingredients in this medicine?

Active ingredient: candesartan cilexetil, USP. Inactive ingredients in candesartan cilexetil tablets and candesartan cilexetil oral suspension are: hydroxypropyl cellulose, lactose monohydrate, maize starch, carboxymethylcellulose calcium, glyceryl stearate and magnesium stearate. The 8 mg, 16 mg, and 32 mg tablets contain red iron oxide as a colorant.

Who manufactures and distributes this medicine?

Manufactured by:

• Mylan Laboratories Limited
• Hyderabad, India for
• Sandoz Inc., Princeton, NJ

What should I know about storage and disposal of this medication?

• Do not keep medicine that is out of date or that you no longer need.
• Store candesartan cilexetil tablets at 68º to 77ºF (20º to 25ºC).
• Store candesartan cilexetil oral suspension at room temperature below 86°F (30°C).
• Use the oral suspension within 30 days after first opening the bottle. Do not use after the expiration date stated on the bottle.
• Do not freeze.
• Keep the container of candesartan cilexetil tablets closed tightly.

The common ARBS are the following:

• Azilsartan
• Candesartan
• Eprosartan
• Irbesartan
• Losartan
• Olmesartan
• Telmisartan
• Valsartan

Common ACE inhibitors include the following:

• Benazepril
• Captopril
• Enalapril
• Fosinopril
• Lisinopril
• Moexipril
• Perindopril
• Quinapril
• Ramipril
• Trandolapril

• Dailymed label info on Candesartan
• FDA Candesartan

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