Bisoprolol and hydrochlorothiazide (oral route)


    Brand Name

    US Brand Name

    Ziac


    Description

    Bisoprolol 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.

    Bisoprolol 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 thiazide 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 bisoprolol 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 bisoprolol and hydrochlorothiazide combination in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults and more likely to have age-related liver, heart, or kidney problems, which may require caution and an adjustment in the dose for patients receiving bisoprolol and hydrochlorothiazide combination.

    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

    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 this medicine, 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 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.

    • Acarbose
    • Aceclofenac
    • Acemetacin
    • Acetyldigoxin
    • Albiglutide
    • Albuterol
    • Alogliptin
    • Amphetamine
    • Amtolmetin Guacil
    • Arsenic Trioxide
    • Aspirin
    • Benzhydrocodone
    • Benzphetamine
    • Bromfenac
    • Bromocriptine
    • Bufexamac
    • Buprenorphine
    • Canagliflozin
    • Cefepime
    • Celecoxib
    • Ceritinib
    • Chlorpropamide
    • Choline Salicylate
    • Clonidine
    • Clonixin
    • Codeine
    • Crizotinib
    • Dapagliflozin
    • Darunavir
    • Deslanoside
    • Desmopressin
    • Dexibuprofen
    • Dexketoprofen
    • Dextroamphetamine
    • Diclofenac
    • Diflunisal
    • Digitalis
    • Digitoxin
    • Digoxin
    • Dihydrocodeine

    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
    • Acetyldigoxin
    • Albiglutide
    • Alfuzosin
    • Alogliptin
    • Aminolevulinic Acid
    • Amtolmetin Guacil
    • Aspirin
    • Bepridil
    • Bromfenac
    • Bufexamac
    • Bunazosin
    • Canagliflozin
    • Carbamazepine
    • Celecoxib
    • Chlorpropamide
    • Cholestyramine
    • Choline Salicylate
    • Clonixin
    • Dapagliflozin
    • Deslanoside
    • Dexibuprofen
    • Dexketoprofen
    • Diclofenac
    • Diflunisal
    • Digitoxin
    • Digoxin
    • Dipyrone
    • Doxazosin
    • Droxicam
    • Dulaglutide
    • Empagliflozin
    • Ertugliflozin
    • Etodolac
    • Etofenamate
    • Etoricoxib
    • Exenatide
    • Felbinac

    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)—May provoke chest pain if stopped too quickly.
    • Anuria (not able to form urine) or
    • Bradycardia (slow heartbeat) or
    • Cardiogenic shock (shock caused by heart attack) or
    • Heart block or
    • Heart failure or
    • Sulfa drug allergy (eg, sulfamethoxazole, Bactrim®, Septra®)—Should not be used in patients with these conditions.
    • Blood vessel disease or circulation problems (eg, coronary artery disease) or
    • Electrolyte imbalance (eg, high calcium or low magnesium, potassium, sodium in the blood) or
    • Glaucoma, acute angle-closure or
    • Gout or
    • Hyperuricemia (high uric acid in the blood) or
    • Myopia (changes in the eyeball causing vision problems), acute or
    • Systemic lupus erythematosus (SLE)—Use with caution. May make these conditions worse.
    • 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.
    • Kidney disease or
    • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
    • Lung disease (eg, asthma, bronchitis, emphysema)—Use with caution. May cause difficulty with breathing in patients with this condition.
    • Patients who are fasting (eg, surgery, not eating regularly, vomiting)—May increase risk of hypoglycemia (low blood sugar).
    • Sympathectomy (a surgical procedure where certain nerves are removed)—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 (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 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.

    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:
        • Adults—One or two tablets per day, given as a single dose or in divided doses. 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 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. Blood and urine tests may be needed to check for unwanted effects.

    This medicine may cause or worsen heart failure in some patients. Check with your doctor right away if you have chest pain or discomfort, dilated neck veins, irregular breathing, an irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, weight gain, or unusual tiredness or weakness.

    This medicine may cause serious allergic reactions, including anaphylaxis, which 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 this medicine.

    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.

    This medicine may cause changes in your blood sugar levels. Also, this medicine may cover up signs of low blood sugar, including fast heartbeat and increase the risk for serious or prolonged hypoglycemia (low blood sugar). Check with your doctor if you notice a change in your normal symptoms or a change in the results of your blood or urine sugar tests. Call your doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness.

    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.

    Check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. This could be a signs of a serious eye problem. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).

    Check with your doctor right away if you have 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 this medicine. These may be symptoms of dehydration or mineral imbalance.

    This medicine may cause some people to become less alert than they are normally. If this side effect occurs, do not drive, use machines, or do anything else that could be dangerous if you are not alert while taking this medicine.

    This medicine may increase your risk of getting skin cancer (eg, non-melanoma skin cancer). Avoid sun exposure. Be sure to apply sunscreen before going outside, and wear protective clothing and a hat. Avoid sunlamps and tanning beds. Talk to your doctor if you have concerns about this risk.

    Alcohol, narcotic pain relievers, or sleeping pills may cause you to feel more lightheaded, dizzy, or faint when used with this medicine. Tell your doctor if you are drinking alcohol or using pain relievers or sleeping pills.

    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.


    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

    • Bloating or swelling of the face, arms, hands, lower legs, or feet
    • chest pain or discomfort
    • lightheadedness, dizziness, or fainting
    • rapid weight gain
    • slow or irregular heartbeat
    • tingling of the hands or feet
    • trouble breathing
    • unusual tiredness or weakness
    • unusual weight gain or loss

    Incidence not known

    • Anxiety
    • blurred vision
    • chills
    • cold sweats
    • coma
    • confusion
    • cool, pale skin
    • depression
    • fast heartbeat
    • headache
    • increased hunger
    • nausea
    • nervousness
    • nightmares
    • persistent non-healing sore
    • pink growth
    • reddish patch or irritated area
    • seizures
    • shakiness
    • shiny bump
    • slurred speech
    • white, yellow or waxy scar-like area

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

    Symptoms of overdose

    • Anxiety
    • blurred vision
    • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
    • change in consciousness
    • chills
    • cold, clammy skin
    • cold sweats
    • confusion as to time, place, or person
    • cool, pale skin
    • cough
    • decrease in amount of urine
    • depression
    • dilated neck veins
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • drowsiness
    • dry mouth
    • fast or pounding heartbeat or pulse
    • fast, weak pulse
    • frequent urination
    • holding false beliefs that cannot be changed by fact
    • increased hunger
    • increased thirst
    • increased volume of pale, dilute urine
    • irregular breathing
    • irritability
    • loss of appetite
    • loss of consciousness
    • mood changes
    • muscle pain or cramps
    • nausea or vomiting
    • nervousness
    • nightmares
    • no breathing
    • noisy breathing
    • not able to pass urine
    • numbness or tingling in the hands, feet, or lips
    • pain or aching in the lower legs
    • seeing, hearing, or feeling things that are not there
    • seizures
    • shakiness
    • slurred speech
    • sweating
    • swelling of the face, hands, fingers, feet, ankles, or lower legs
    • tightness in the chest
    • trembling
    • unconsciousness
    • unusual drowsiness, dullness, or feeling of sluggishness
    • unusual excitement, nervousness, or restlessness
    • very drowsy or sleepy
    • weakness and heaviness of legs
    • weight gain

    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

    • Acid or sour stomach
    • belching
    • decreased interest in sexual intercourse
    • diarrhea
    • difficulty with moving
    • heartburn
    • inability to have or keep an erection
    • indigestion
    • joint pain
    • loss in sexual ability, desire, drive, or performance
    • muscle aching or stiffness
    • sleepiness
    • stomach discomfort, upset, or pain
    • swollen joints

    Rare

    • Runny or stuffy nose
    • sneezing

    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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