Candesartan and Hydrochlorothiazide (Oral Route)

Hydrochlorothiazide belongs to a class of medicines called thiazide diuretics. When these two medicines are combined, they are used to treat high blood pressure (hypertension).

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of candesartan and hydrochlorothiazide combination in children with use in other age groups.

Geriatric

This medicine has been tested in patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Dofetilide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetyldigoxin


• Arsenic Trioxide


• Deslanoside


• Digitalis


• Digitoxin


• Digoxin


• Droperidol


• Flecainide


• Ketanserin


• Levomethadyl


• Lithium


• Metildigoxin


• Ouabain


• Proscillaridin


• Sotalol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac


• Acemetacin


• Alacepril


• Alclofenac


• Apazone


• Benazepril


• Benoxaprofen


• Bepridil


• Bromfenac


• Bufexamac


• Calcium Carbonate


• Captopril


• Carbamazepine


• Carprofen


• Celecoxib


• Chlorpropamide


• Cholestyramine


• Cilazapril


• Clometacin


• Clonixin


• Cyclophosphamide


• Delapril


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Enalaprilat


• Enalapril Maleate


• Etodolac


• Etofenamate


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Fosinopril


• Ginkgo


• Glipizide


• Gossypol


• Ibuprofen


• Imidapril


• Indomethacin


• Indoprofen


• Isoxicam


• Ketoprofen


• Ketorolac


• Licorice


• Lisinopril


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Moexipril


• Nabumetone


• Naproxen


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Oxyphenbutazone


• Pentopril


• Perindopril


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Propyphenazone


• Proquazone


• Quinapril


• Ramipril


• Rofecoxib


• Spirapril


• Sulindac


• Suprofen


• Temocapril


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Ticrynafen


• Tolmetin


• Topiramate


• Trandolapril


• Valdecoxib


• Zofenopril


• Zomepirac

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy or


• Asthma, bronchiala€”May have an increased risk of allergic reaction to hydrochlorothiazide


• Congestive heart failure, severea€”Lowering of blood pressure by candesartan and hydrochlorothiazide combination may make this condition worse


• Diabetes mellitusa€” Insulin dosage may need to be adjusted.


• Fluid or electrolyte (e.g., potassium, chloride, sodium) imbalance (due to excessive perspiration, vomiting, diarrhea, etc.)a€”The side effects of candesartan and hydrochlorothiazide may be increased


• Kidney disease or


• Liver diseasea€”These conditions may be aggravated by candesartan and hydrochlorothiazide


• Sympathectomya€”Blood pressure-lowering effects may be increased


• Systemic lupus erythematosusa€”Candesartan and hydrochlorothiazide combination may trigger or worsen this condition.

Proper Use

Dosing

The dose of this medicine 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 this medicine. 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 patients taking this medicine for high blood pressure:

• This medicine 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.


• In addition to the use of the medicine your doctor has prescribed, treatment for your high blood pressure may include weight control and care in the types of foods you eat, especially foods high in sodium. 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 this medicine 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.


• This medicine may be taken with or without food.

• For oral dosage form (tablets):
  
  
  
  • For high blood pressure:
    
    
    
    • Adultsa€”1 tablet once a day. Your doctor may increase your dose if needed.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, 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.

Precautions

It is important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Check with your doctor immediately if you think that you may be pregnant . Candesartan and hydrochlorothiazide may cause birth defects or other problems in the baby if taken during pregnancy.

Do not take other medicines unless they have been discussed with your doctor . This especially includes potassium supplements or salt substitutes that contain potassium, since they may change your blood potassium levels, or over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure .

Dizziness or light-headedness may occur. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you experience these effects.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea and vomiting or diarrhea. These conditions may cause you to lose too much water and lead to low blood pressure .

Dizziness, light-headedness, or fainting also may occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure . Use extra care during exercise or hot weather.

Avoid alcoholic beverages until you have discussed their use with your doctor . Alcohol may make the low blood pressure effect worse and/or increase the possibility of dizziness or fainting.

For diabetic patients:

• Hydrochlorothiazide may raise blood sugar levels. Check with your doctor if any changes in your blood sugar levels occur.

Side Effects

Along with its needed effects, a medicine 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 as soon as possible if any of the following side effects occur:

Less frequent

• Cough


• Dizziness


• Dryness of mouth


• Fever


• Increased thirst


• Irregular heartbeat


• Light-headedness


• Muscle cramps


• Nausea


• Sore throat


• Unusual tiredness


• Vomiting


• Weak pulse


• Weakness

Rare

• Arm pain


• Chest pain


• Chest tightness


• Fast or irregular heartbeat


• Large, hive like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs


• Shortness of breath

Some side effects 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

• Back pain


• Chills


• Diarrhea


• Headache


• Joint pain


• Loss of appetite


• Muscle aches and pains


• Nausea


• Runny nose


• Sneezing


• Sweating


• Trouble sleeping


• Unusual tiredness


• Vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.