Pronunciation:

bis-oh-PROE-lol FUE-ma-rate, hye-droe-klor-oh-THYE-a-zide

Brand Names:

• Ziac

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Beta-Adrenergic Blocker, Cardioselective/Thiazide Combination

Pharmacologic—

Bisoprolol

Chemical—

Thiazide

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

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.

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.

Other 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 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
• Benzphetamine
• Bromfenac
• Bromocriptine
• Bufexamac
• Buprenorphine
• Canagliflozin
• Celecoxib
• Ceritinib
• Chlorpropamide
• Choline Salicylate
• Clonidine
• Clonixin
• Codeine
• Crizotinib
• Dapagliflozin
• Darunavir
• Deslanoside
• Desmopressin
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digitalis
• Digitoxin
• Digoxin
• Diltiazem
• Dipyrone
• Dronedarone
• Droperidol
• Droxicam
• Dulaglutide
• Empagliflozin
• Etodolac
• Etofenamate
• Etoricoxib
• Exenatide
• Felbinac
• Fenoldopam
• Fenoprofen
• Fepradinol
• Feprazone
• Fexinidazole
• Fingolimod
• Flecainide
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Formoterol
• Glimepiride
• Glipizide
• Glyburide
• Ibuprofen
• Indacaterol
• Indomethacin
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Iohexol
• Ketanserin
• Ketoprofen
• Ketorolac
• Lacosamide
• Levalbuterol
• Levomethadyl
• Linagliptin
• Liraglutide
• Lisdexamfetamine
• Lithium
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Methamphetamine
• Methotrexate
• Metildigoxin
• Miglitol
• Morniflumate
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Olodaterol
• Ouabain
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Ponesimod
• Porfimer
• Pramlintide
• Proglumetacin
• Propyphenazone
• Proquazone
• Proscillaridin
• Repaglinide
• Rivastigmine
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salmeterol
• Salsalate
• Saxagliptin
• Siponimod
• Sitagliptin
• Sodium Salicylate
• Sotalol
• Sulindac
• Tapentadol
• Tenoxicam
• Terbutaline
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Topiramate
• Valdecoxib
• Verapamil
• Vilanterol
• Vildagliptin

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
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Ginkgo
• Glimepiride
• Glipizide
• Glyburide
• Gossypol
• Ibuprofen
• Indomethacin
• Insulin Aspart, Recombinant
• Insulin Degludec
• Insulin Detemir
• Insulin Glargine, Recombinant
• Insulin Glulisine
• Insulin Human Inhaled
• Insulin Human Isophane (NPH)
• Insulin Human Regular
• Insulin Lispro, Recombinant
• Ketoprofen
• Ketorolac
• Licorice
• Linagliptin
• Liraglutide
• Lixisenatide
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Metformin
• Methyldopa
• Metildigoxin
• Miglitol
• Morniflumate
• Moxisylyte
• Nabumetone
• Naproxen
• Nateglinide
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenoxybenzamine
• Phentolamine
• Phenylbutazone
• Piketoprofen
• Pioglitazone
• Piroxicam
• Pramlintide
• Pranoprofen
• Prazosin
• Proglumetacin
• Propyphenazone
• Proquazone
• Repaglinide
• Rifapentine
• Rofecoxib
• Rosiglitazone
• Salicylic Acid
• Salsalate
• Saxagliptin
• Sitagliptin
• Sodium Salicylate
• St John's Wort
• Sulindac
• Tamsulosin
• Tenoxicam
• Terazosin
• Tiaprofenic Acid
• Tolazamide
• Tolbutamide
• Tolfenamic Acid
• Tolmetin
• Trimazosin
• Urapidil
• Valdecoxib
• Vildagliptin

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 body) 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.

• Sympathectomy (a surgical procedure where certain nerves are removed)—Use with caution. The effects of this medicine may be increased.

Proper Use of This Medicine:

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 While Using This Medicine:

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, 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.

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 of This Medicine:

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

Persistent non-healing sore

pink growth

reddish patch or irritated area

shiny bump

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.