propranolol and hydrochlorothiazide

proe-PRAN-oh-lol hye-droe-KLOR-ide, hye-droe-klor-oh-THYE-a-zide

Oral route(Tablet)

Following abrupt cessation of therapy with propranolol, exacerbations of angina pectoris and, in some cases, myocardial infarction have been reported. Even in the absence of overt angina pectoris, when discontinuing therapy, propranolol should not be withdrawn abruptly, and patients should be cautioned against interruption of therapy without the physician's advice .

Commonly used brand name(s)

In the U.S.

• Inderide

Available Dosage Forms:

• Capsule, Extended Release


• Tablet

Therapeutic Class: Beta-Adrenergic Blocker, Nonselective/Thiazide Combination

Pharmacologic Class: Propranolol

Chemical Class: Thiazide

Uses For propranolol and hydrochlorothiazide

Propranolol and hydrochlorothiazide combination is used to treat high blood pressure (hypertension). 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.

Propranolol 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.

Hydrochlorothiazide 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.

propranolol and hydrochlorothiazide is available only with your doctor's prescription.

Before Using propranolol and hydrochlorothiazide

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 propranolol and hydrochlorothiazide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to propranolol and hydrochlorothiazide 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 propranolol and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking propranolol and hydrochlorothiazide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using propranolol and hydrochlorothiazide 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


• Thioridazine

Using propranolol and hydrochlorothiazide 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


• Bitolterol


• Broxaterol


• Bupivacaine


• Clenbuterol


• Clonidine


• Colterol


• Deslanoside


• Diatrizoate


• Digitalis


• Digitoxin


• Digoxin


• Diltiazem


• Dronedarone


• Droperidol


• Epinephrine


• Fenoldopam


• Fenoterol


• Flecainide


• Formoterol


• Haloperidol


• Hexoprenaline


• Indacaterol


• Isoetharine


• Ketanserin


• Levalbuterol


• Levomethadyl


• Lidocaine


• Lithium


• Mefloquine


• Mepivacaine


• Metaproterenol


• Metildigoxin


• Ouabain


• Pirbuterol


• Prilocaine


• Procaterol


• Proscillaridin


• Reproterol


• Rimiterol


• Ritodrine


• Salmeterol


• Sotalol


• Terbutaline


• Tretoquinol


• Tulobuterol


• Verapamil

Using propranolol and hydrochlorothiazide 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


• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Amlodipine


• Apazone


• Arbutamine


• Aspirin


• Benazepril


• Benfluorex


• Benoxaprofen


• Bepridil


• Bromfenac


• Bufexamac


• Bunazosin


• Calcium Carbonate


• Captopril


• Carbamazepine


• Carprofen


• Celecoxib


• Chlorpromazine


• Chlorpropamide


• Cholestyramine


• Cilazapril


• Cimetidine


• Clometacin


• Clonixin


• Cyclophosphamide


• Delapril


• Dexketoprofen


• Diclofenac


• Diflunisal


• Digoxin


• Dihydroergotamine


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Dipyrone


• Disopyramide


• Doxazosin


• Droxicam


• Enalaprilat


• Enalapril Maleate


• Ergotamine


• Etodolac


• Etofenamate


• Felbinac


• Felodipine


• Fenbufen


• Fenoprofen


• Fentiazac


• Flecainide


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Fluvoxamine


• Fosinopril


• Ginkgo


• Gliclazide


• Glimepiride


• Glipizide


• Gliquidone


• Glyburide


• Gossypol


• Guar Gum


• Guggul


• Ibuprofen


• Ibuprofen Lysine


• Imidapril


• Indomethacin


• Indoprofen


• Insulin


• Insulin Aspart, Recombinant


• Insulin Glulisine


• Insulin Lispro, Recombinant


• Isoxicam


• Ketoprofen


• Ketorolac


• Lacidipine


• Lercanidipine


• Licorice


• Lisinopril


• Lornoxicam


• Magaldrate


• Magnesium Salicylate


• Manidipine


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Metformin


• Mibefradil


• Miglitol


• Moexipril


• Moxisylyte


• Nabumetone


• Naproxen


• Nepafenac


• Nicardipine


• Nifedipine


• Niflumic Acid


• Nilvadipine


• Nimesulide


• Nimodipine


• Nisoldipine


• Nitrendipine


• Oxaprozin


• Oxyphenbutazone


• Pentopril


• Perindopril


• Phenoxybenzamine


• Phentolamine


• Phenylbutazone


• Phenylephrine


• Piperine


• Pirazolac


• Piroxicam


• Pirprofen


• Pranidipine


• Prazosin


• Propoxyphene


• Propyphenazone


• Proquazone


• Quinapril


• Quinidine


• Ramipril


• Repaglinide


• Rifapentine


• Rizatriptan


• Salicylic Acid


• Salsalate


• Sertraline


• Spirapril


• St John's Wort


• Sulindac


• Suprofen


• Tamsulosin


• Temocapril


• Tenidap


• Tenoxicam


• Terazosin


• Tiaprofenic Acid


• Tolazamide


• Tolbutamide


• Tolmetin


• Topiramate


• Trandolapril


• Trimazosin


• Troglitazone


• Tubocurarine


• Urapidil


• Zileuton


• Zofenopril


• Zomepirac

Interactions with Food/Tobacco/Alcohol

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

• Angina (severe chest pain)—May provoke chest pain if stopped too quickly.

• Anuria (not able to form urine) or


• Asthma or


• Bradycardia (slow heartbeat) or


• Cardiogenic shock (shock caused by heart attack) or


• Congestive heart failure or


• Heart block or


• Sulfa drug allergy (e.g., sulfamethoxazole, Bactrim®, Septra®)—Should not be used in patients with these conditions.

• Diabetes or


• Hyperthyroidism (overactive thyroid) or


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

• Electrolyte imbalance (e.g., hypercalcemia, hypokalemia, hypomagnesemia, hyponatremia) or


• Gout or


• Hyperuricemia (high uric acid in the blood) or


• Liver disease or


• Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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

• Sympathectomy—Use with caution. The effects of propranolol and hydrochlorothiazide may be increased.

• Wolff-Parkinson-White syndrome (rare heart condition)—May cause very slow heartbeat in patients with this condition.

Proper Use of propranolol and hydrochlorothiazide

In addition to the use of propranolol 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. 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 propranolol and hydrochlorothiazide 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.

Dosing

The dose of propranolol 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 propranolol 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—One tablet two times a day. Your doctor may adjust your dose if needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of propranolol 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.

Precautions While Using propranolol and hydrochlorothiazide

It is very important that your doctor check your progress at regular visits to make sure propranolol and hydrochlorothiazide is working properly. Blood and urine tests may be needed to check for unwanted effects.

propranolol and hydrochlorothiazide may cause serious allergic reactions including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, lips, tongue, or throat while you are using propranolol and hydrochlorothiazide.

propranolol and hydrochlorothiazide 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.

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

propranolol and hydrochlorothiazide may cause changes in your blood sugar levels. Also, propranolol and hydrochlorothiazide 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 propranolol and hydrochlorothiazide. You may need to stop using propranolol and hydrochlorothiazide several days before having surgery or medical tests.

Serious skin reactions can occur during treatment with propranolol and hydrochlorothiazide. Check with your doctor right away if you start having skin itching, swelling, rash, or redness; blistering, peeling, or loosening of the skin; or any other unusual effects that may be caused by propranolol and hydrochlorothiazide.

Check with your doctor right away if you start having dry mouth, increased thirst, muscle cramps, nausea or vomiting, unusual tiredness or weakness, severe drowsiness or dizziness, seizures, a decrease in urine, or a fast heartbeat while you are using propranolol and hydrochlorothiazide. These may be symptoms of dehydration or mineral imbalance.

Stop using propranolol and hydrochlorothiazide and check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).

Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

propranolol and hydrochlorothiazide 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:

Incidence not known

• Abdominal or stomach pain, usually after eating a meal


• abdominal or stomach tenderness


• black, tarry stools


• bleeding gums


• blistering, peeling, or loosening of the skin


• bloating


• blood in the urine


• bloody nose


• bloody stools


• blurred or loss of vision


• body aches or pain


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


• chest pain or discomfort


• clay-colored stools


• cold sweats


• confusion about identity, place, and time


• congestion


• constipation


• cough


• coughing up blood


• cracks in the skin


• crying


• darkened urine


• decreased awareness or responsiveness


• decreased urine output


• depersonalization


• diarrhea


• difficulty with breathing or swallowing


• dilated neck veins


• disturbed color perception


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


• double vision


• dry mouth


• dryness or soreness of the throat


• dysphoria


• euphoria


• extreme fatigue


• fast, pounding, slow, or irregular heartbeat


• fever or chills


• flushing or redness of the skin


• fruit-like breath odor


• general feeling of discomfort or illness


• general feeling of tiredness or weakness


• hair loss


• halos around lights


• headaches


• heavier menstrual periods


• hives or welts


• hoarseness


• increased hunger


• increased sensitivity of the skin to sunlight


• increased thirst


• increased urination


• indigestion


• irregular breathing


• irregular heartbeat


• itching


• joint pain, stiffness, or swelling


• lightheadedness, dizziness, or fainting


• loss of appetite


• loss of heat from the body


• loss of strength or energy


• lower back or side pain


• mental depression


• mimicry of speech or movements


• muscle pain or weakness


• mutism


• nausea or vomiting


• negativism


• night blindness


• noisy breathing


• overbright appearance of lights


• painful or difficult urination


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


• paleness or cold feeling in the fingertips and toes


• paranoia


• peculiar postures or movements, mannerisms or grimacing


• pinpoint red or purple spots on the skin


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


• quick to react or overreact emotionally


• rapidly changing moods


• rectal bleeding


• red skin lesions, often with a purple center


• red, irritated eyes


• red, swollen skin


• reddening of the skin, especially around the ears


• runny nose


• scaly skin


• seeing, hearing, or feeling things that are not there


• severe sleepiness


• severe sunburn


• short-term memory loss


• shortness of breath


• skin irritation or rash, including rash that looks like psoriasis


• sleeplessness


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• sugar in the urine


• sweating


• swelling of the eyes, face, or inside of the nose


• swelling of the fingers, feet, or lower legs


• tender, swollen, or painful glands in the neck


• tenderness of salivary glands


• tenderness, burning, or peeling of the skin


• thickening of bronchial secretions


• tightness in the chest


• tingling or pain in the fingers or toes when exposed to cold


• trouble with sleeping


• trouble with swallowing


• troubled breathing


• tunnel vision


• unable to sleep


• unpleasant breath odor


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight loss


• unusually warm skin


• voice changes


• vomiting of blood


• weight gain


• wheezing


• 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


• fast, slow, or shallow breathing


• gas


• heartburn


• increase in heart rate


• increased sweating


• indigestion


• loss of consciousness


• low blood pressure


• muscle cramps


• pale or blue lips, fingernails, or skin


• rapid breathing


• seizures


• sunken eyes


• unusual drowsiness, dullness, or feeling of sluggishness


• unusual paleness


• weakness and heaviness of the 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:

Incidence not known

• Decreased interest in sexual intercourse


• dry eyes


• feeling of constant movement of self or surroundings


• inability to have or keep an erection


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


• muscle spasm


• pain of the penis on erection


• pain or discomfort in the chest, upper stomach, or throat


• restlessness


• sensation of spinning


• stomach cramps


• thinning of the hair


• vivid dreams

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.

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