CANDESTAN ( TABLET ) ( 4 mg )

Hypertension

Adult Dose

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.

Pediatric Dose

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.

Usual Adult Dose 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

Renal Dose Adjustments

Adult: No adjustment recommended

Pediatric:

GFR 30 mL/min/1.73 m2 or greater: Data not available

GFR less than 30 mL/min/1.73 m2: Not recommended

Liver Dose Adjustments

Adult:

Mild liver dysfunction (Child-Pugh A): No adjustment recommended

Moderate liver dysfunction (Child-Pugh B): Initial dose: 8 mg orally once a day

Severe liver dysfunction (Child-Pugh C): Data not available

Candesartan is prescribed for high blood pressure (hypertension) and congestive heart failure (a condition when the heart cannot pump enough blood to the other parts of the body).It blocks the action of certain chemicals that tighten the blood vessels, so blood flows more smoothly. High blood pressure reduction helps prevent strokes, heart attacks, and kidney problems.

When it is not to be taken

patients with anuria (absence of urination) and hypersensitivity.

Check with your physician/doctor immediately, if any of the following side effects observed

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 may not need any medical attention, these side effects may disappear once your body gets used to the medicine. Your physician may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue.

Less common

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

FETAL TOXICITY: If pregnancy is detected, discontinue this drug as soon as possible. Drugs that act directly on the renin angiotensin system (RAS) can cause injury and death to the developing fetus.

AU TGA pregnancy category: D

US FDA pregnancy category: D

AU (Australia): Use is contraindicated.

UK: Use is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters.

US: This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus.

Comments: Adequate methods of contraception should be encouraged.

Animal studies have revealed evidence of reduced survival and increased incidence of hydronephrosis in the offspring. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.