Nadolol and Bendroflumethiazide (Oral Route)

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure . High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

Nadolol is a beta-blocker. It works by affecting the response to some nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure . When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart .

Bendroflumethiazide is a diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure .

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

Appropriate studies have not been performed on the relationship of age to the effects of nadolol and bendroflumethiazide combination in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of nadolol and bendroflumethiazide combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment of dosage in patients receiving nadolol and bendroflumethiazide combination .

Pregnancy

Breastfeeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake .

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 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


• Albuterol


• Amiodarone


• Arformoterol


• Arsenic Trioxide


• Bambuterol


• Bepridil


• Bitolterol


• Broxaterol


• Clenbuterol


• Clonidine


• Colterol


• Deslanoside


• Digitalis


• Digitoxin


• Digoxin


• Diltiazem


• Dofetilide


• Dronedarone


• Droperidol


• Epinephrine


• Fenoldopam


• Fenoterol


• Fentanyl


• Flecainide


• Formoterol


• Hexoprenaline


• Isoetharine


• Ketanserin


• Levalbuterol


• Levomethadyl


• Lidocaine


• Lithium


• Metaproterenol


• Metildigoxin


• Pirbuterol


• Procaterol


• Reproterol


• Rimiterol


• Ritodrine


• Salmeterol


• Sotalol


• Terbutaline


• Tretoquinol


• Tulobuterol


• Verapamil

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.

• Acarbose


• Aceclofenac


• Acemetacin


• Acetohexamide


• Alacepril


• Alclofenac


• Alfuzosin


• Amlodipine


• Apazone


• Arbutamine


• Benazepril


• Benfluorex


• Benoxaprofen


• Bromfenac


• Bufexamac


• Bunazosin


• Captopril


• Carprofen


• Celecoxib


• Chlorpropamide


• Cilazapril


• Clometacin


• Clonixin


• Delapril


• Dexketoprofen


• Diclofenac


• Diflunisal


• Digoxin


• Dipyrone


• Doxazosin


• Droxicam


• Enalaprilat


• Enalapril Maleate


• Etodolac


• Etofenamate


• Felbinac


• Felodipine


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Fosinopril


• Ginkgo


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Gossypol


• Guar Gum


• Ibuprofen


• Imidapril


• Indomethacin


• Indoprofen


• Insulin


• Insulin Aspart, Recombinant


• Insulin Glulisine


• Insulin Lispro, Recombinant


• Isoxicam


• Ketoprofen


• Ketorolac


• Lacidipine


• Lercanidipine


• Licorice


• Lisinopril


• Lornoxicam


• Manidipine


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Metformin


• Mibefradil


• Miglitol


• Moexipril


• Moxisylyte


• Nabumetone


• Naproxen


• Nicardipine


• Nifedipine


• Niflumic Acid


• Nilvadipine


• Nimesulide


• Nimodipine


• Nisoldipine


• Nitrendipine


• Oxaprozin


• Oxyphenbutazone


• Pentopril


• Perindopril


• Phenelzine


• Phenoxybenzamine


• Phentolamine


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Pranidipine


• Prazosin


• Propyphenazone


• Proquazone


• Quinapril


• Ramipril


• Repaglinide


• Rofecoxib


• Spirapril


• St John`s Wort


• Sulindac


• Suprofen


• Tamsulosin


• Temocapril


• Tenidap


• Tenoxicam


• Terazosin


• Tiaprofenic Acid


• Ticrynafen


• Tolazamide


• Tolbutamide


• Tolmetin


• Trandolapril


• Trimazosin


• Troglitazone


• Urapidil


• 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:

• Angina (severe chest pain)a€”May provoke chest pain if stopped too quickly .

• Anuria (not able to form urine) or


• Asthma or


• Bradycardia (slow heartbeat) or


• Heart block or


• Heart failurea€”Should not use in patients with these conditions .

• Blood vessel disease (circulation problems) or


• Gout or


• Hyperuricemia (high uric acid in the blood) or


• Hypochloremia (low chloride in the blood) or


• Hypokalemia (low potassium in the blood) or


• Hypomagnesemia (low magnesium in the blood) or


• Hyponatremia (low sodium in the blood) or


• Parathyroid disease or


• Systemic lupus erythematosusa€”Use with caution. This medicine may make these conditions worse .

• Diabetes or


• Hyperthyroidism (overactive thyroid) or


• Hypoglycemia (low blood sugar)a€”May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .

• Kidney disease, severe or


• Liver diseasea€”Use with caution. The effects may be increased because of slower removal of the medicine from the body .

• Lung disease (e.g., bronchitis, emphysema)a€”May cause difficulty with breathing in patients with this condition .

• Sympathectomya€”Use with caution. The effects of this medicine may be increased .

Proper Use

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes 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. 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 .

Do not interrupt or stop taking this medicine without first checking with your doctor . Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. Some conditions may become worse when the medicine is stopped suddenly, which can be dangerous .

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 oral dosage form (tablets):
  
  
  
  • For high blood pressure:
    
    
    
    • Adultsa€”One tablet once a day. Your doctor may adjust 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.

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

Precautions

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

This medicine may cause heart failure in some patients. Check with your doctor right away if you are having chest pain or discomfort; dilated neck veins; extreme fatigue; irregular breathing; an irregular heartbeat; shortness of breath; swelling of the face, fingers, feet, or lower legs; weight gain; or wheezing .

This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, such as a rapid pulse rate . Check with your doctor if you have these problems or if you notice a change in the results of your blood or urine sugar tests .

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests .

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 immediately if any of the following side effects occur:

Less common

• Blurred vision


• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• Chest pain or discomfort


• Confusion


• Cough


• Difficulty breathing


• Dilated neck veins


• Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• Extreme fatigue


• Irregular breathing


• Lightheadedness, dizziness, or fainting


• Noisy breathing


• Paleness or cold feeling in fingertips and toes


• Shortness of breath


• Slow or irregular heartbeat


• Slurred speech


• Sweating


• Swelling of face, fingers, feet, or lower legs


• Tightness in chest


• Tingling or pain in fingers or toes when exposed to cold


• Unusual tiredness or weakness


• Weight gain


• Wheezing

Incidence not determined

• Back or leg pains


• Black, tarry stools


• Bleeding gums


• Bloating


• Blood in urine or stools


• Chills


• Clay-colored stools


• Cloudy urine


• Cold sweats


• Constipation


• Coughing up blood


• Dark urine


• Difficulty swallowing


• Drowsiness


• Dry mouth


• Fast heartbeat


• Fever


• Flushed, dry skin


• Fruit-like breath odor


• General body swelling


• General feeling of discomfort or illness


• General tiredness and weakness


• Headache


• Hives


• Hoarseness


• Increased hunger


• Increased thirst


• Increased urination


• Indigestion


• Joint pain, stiffness, or swelling


• Light-colored stools


• Loss of appetite


• Lower back or side pain


• Muscle tremors


• Nausea and vomiting


• Nosebleeds


• Pain in muscles


• Painful or difficult urination


• Pains in stomach, side, or abdomen, possibly radiating to the back


• Pale skin


• Pinpoint red spots on skin


• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• Rapid, deep breathing


• Rash


• Redness, soreness, or itching skin


• Restlessness


• Skin rash


• Sore throat


• Sores, ulcers, or white spots on lips or in mouth


• Sores, welting or blisters


• Stomach cramps


• Sugar in the urine


• Swollen or painful glands


• Tenderness of salivary glands


• Thickening of bronchial secretions


• Troubled breathing


• Unpleasant breath odor


• Unusual bleeding or bruising


• Unusual weight loss


• Upper right abdominal pain


• Vomiting of blood


• Yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Change in consciousness


• Decreased urination


• Diarrhea


• Fast, slow, or shallow breathing


• Gas


• Heartburn


• Increase in heart rate


• Increased sweating


• Indigestion


• Loss of consciousness


• Low blood pressure


• Muscle cramps


• Numbness, tingling, pain, or weakness in hands or feet


• Pale or blue lips, fingernails, or skin


• Seizures


• Sunken eyes


• Trembling


• Unusual drowsiness, dullness, or feeling of sluggishness


• Unusual paleness


• Weakness and heaviness of legs


• Wrinkled skin

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

• Change in behavior


• Continuing ringing or buzzing or other unexplained noise in ears


• Decreased interest in sexual intercourse


• Dry eyes or skin


• Excess air or gas in stomach or intestines


• Hair loss, thinning of hair


• Hearing loss


• Inability to have or keep an erection


• Loss in sexual ability, desire, drive, or performance


• Relaxed and calm


• Sleepiness


• Stomach soreness or discomfort


• Stuffy nose


• Weight loss

Incidence not determined

• Cracks in the skin


• Discoloration of skin


• Feeling of constant movement of self or surroundings


• Increased sensitivity of skin to sunlight


• Large, flat, blue or purplish patches in the skin


• Loss of heat from the body


• Muscle spasm, weakness, or restlessness


• Scaly skin


• Sensation of spinning


• Severe sunburn

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.