Candesartan and hydrochlorothiazide

Candesartan and Hydrochlorothiazide is part of the drug class:

• Angiotensin II antagonists and diuretics

Tell your doctor if you are breastfeeding or plan to breastfeed.  

It is not known whether candesartan is excreted in human milk. Hydrochlorothiazide is excreted in human breast milk. Because many drugs are excreted into human milk and because of the potential for adverse reactions in nursing infants from candesartan and hydrochlorothiazide, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

candesartan and hydrochlorothiazide should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

In addition to the use of candesartan and hydrochlorothiazide, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that candesartan and hydrochlorothiazide will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

candesartan and hydrochlorothiazide works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day.

candesartan and hydrochlorothiazide may be taken with or without food.

Dosing

The dose of candesartan and hydrochlorothiazide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of candesartan and hydrochlorothiazide. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—1 tablet once or two times a day. Your doctor may increase your dose if needed.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of candesartan and hydrochlorothiazide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• This medicine can cause certain eye problems. If left untreated, this can lead to lasting eyesight loss. If eye problems happen, signs like change in eyesight or eye pain most often happen within hours to weeks of starting candesartan and hydrochlorothiazide. Call your doctor right away if you have these signs.

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 you have any side effects that bother you or do not go away.

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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take candesartan and hydrochlorothiazide or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to candesartan and hydrochlorothiazide. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

Reactions which follow have been reported with the combination product; see individual drug agents for additional adverse reactions that may be expected from each agent.

1% to 10%:

Central nervous system: Dizziness (3%), headache (3%, placebo 5%)

Neuromuscular & skeletal: Back pain (3%)

Respiratory: Upper respiratory tract infection (4%), flu-like symptoms (3%)

<1% (Limited to important or life-threatening): Agranulocytosis, angina pectoris, angioedema (<0.5%), arthritis, bradycardia, bronchitis, conjunctivitis, cystitis, depression, dermatitis, ECG abnormality, eczema, extrasystoles, gastritis, gastroenteritis, hematuria, hepatitis, hyperglycemia, hyperuricemia, hypoesthesia, hypokalemia, increased blood urea nitrogen, increased creatine phosphokinase, increased serum transaminases, increased susceptibility to infection, leukopenia, myocardial infarction (<0.5%), neutropenia, osteoarthritis, palpitations, peripheral edema, sciatica, tachycardia, urinary tract infection, viral infection

[US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected. Also see individual agents.

Candesartan 16 to 32 mg-Hydrochlorothiazide 12.5 to 50 mg orally daily in 1 to 2 divided doses

Comments:
-The recommended starting dose of candesartan is 16 mg orally once a day when used as monotherapy in patients who are not volume depleted; doses larger than 32 mg do not appear to have a greater blood pressure lowering effect.
-A patient whose blood pressure remains uncontrolled on candesartan 32 mg can expect an incremental effect from candesartan 32 mg-hydrochlorothiazide 12.5 mg
-A patient whose blood pressure remains uncontrolled on hydrochlorothiazide 25 mg can expect an incremental effect from candesartan 16 mg-hydrochlorothiazide 12.5 mg; a patient whose blood pressure is controlled on hydrochlorothiazide 25 mg but is experiencing decreases in serum potassium can expect the same or incremental blood pressure effects from candesartan 16 mg-hydrochlorothiazide 12.5 mg and serum potassium may improve.
-Maximal antihypertensive effect can be expected within 4 weeks of treatment initiation.

US BOXED WARNING:
-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.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.