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What is Zebeta (bisoprolol)?
Zebeta prevents the neurotransmitters norepinephrine and epinephrine (adrenaline) from binding to beta receptors on nerves. By blocking the effect of norepinephrine and epinephrine on the nerves reaching the heart and blood vessels, beta-blockers reduce heart rate and the force with which the heart contracts and reduce blood pressure by dilating blood vessels but may constrict air passages by stimulating the muscles that surround the air passages.
Angina occurs when the heart’s need for oxygen exceeds the supply of oxygen-carrying blood. By slowing heart rate and decreasing the force with which the heart muscle contracts, Zebeta reduces the work of the heart and the demand of the heart for oxygen.
Common side effects of Zebeta include:
- abdominal cramps,
- slow heart rate,
- low blood pressure,
- cold extremities,
- sore throat,
- shortness of breath,
- wheezing, and
- increased asthma symptoms.
Serious side effects of Zebeta include cardiac failure.
Drug interactions of Zebeta include rifampin, which when taken with Zebeta may make Zebeta less effective. Other beta-blockers when taken with Zebeta may produce excessive reduction of sympathetic activity.
The use of digoxin with Zebeta also may cause an excessive reduction in heart rate.
What are the important side effects of Zebeta (bisoprolol)?
Bisoprolol is generally well-tolerated, and side effects are mild and transient.
Side effects include:
- abdominal cramps,
- slow heart rate,
- low blood pressure,
- cold extremities,
- sore throat, and
- shortness of breath or
Patients with asthma may have symptoms increase.
Zebeta (bisoprolol) side effects list for healthcare professionals
Safety data are available in more than 30,000 patients or volunteers. Frequency estimates and rates of withdrawal of therapy for adverse events were derived from two U.S. placebo-controlled studies.
In Study A, doses of 5, 10, and 20 mg bisoprolol fumarate were administered for 4 weeks. In Study B, doses of 2.5, 10, and 40 mg of bisoprolol fumarate were administered for 12 weeks. A total of 273 patients were treated with 5-20 mg of bisoprolol fumarate; 132 received placebo.
Withdrawal of therapy for adverse events was 3.3% for patients receiving bisoprolol fumarate and 6.8% for patients on placebo. Withdrawals were less than 1% for either bradycardia or fatigue/lack of energy.
The following table presents adverse experiences, whether or not considered drug related, reported in at least 1% of patients in these studies, for all patients studied in placebo-controlled clinical trials (2.5- 40 mg), as well as for a subgroup that was treated with doses within the recommended dosage range (5- 20 mg). Of the adverse events listed in the table, bradycardia, diarrhea, asthenia, fatigue, and sinusitis appear to be dose related.
|All Adverse Experiences (% )|
|Central Nervous System|
|Autonomic Nervous System|
|Body as a Whole|
|*percentage of patients with event|
The following is a comprehensive list of adverse experiences reported with bisoprolol fumarate in worldwide studies, or in postmarketing experience (in italics):
Central Nervous System
Autonomic Nervous System
In addition, a variety of adverse effects have been reported with other beta-adrenergic blocking agents and should be considered potential adverse effects of Zebeta:
Central Nervous System
Agranulocytosis, thrombocytopenia, thrombocytopenic purpura.
Mesenteric arterial thrombosis, ischemic colitis.
The oculomucocutaneous syndrome associated with the beta-blocker practolol has not been reported with Zebeta (bisoprolol fumarate) during investigational use or extensive foreign marketing experience.
In clinical trials, the most frequently reported laboratory change was an increase in serum triglycerides, but this was not a consistent finding.
Sporadic liver test abnormalities have been reported. In the U.S. controlled trials experience with bisoprolol fumarate treatment for 4-12 weeks, the incidence of concomitant elevations in SGOT and SGPT from 1 to 2 times normal was 3.9%, compared to 2.5% for placebo. No patient had concomitant elevations greater than twice normal.
In the long-term, uncontrolled experience with bisoprolol fumarate treatment for 6-18 months, the incidence of one or more concomitant elevations in SGOT and SGPT from 1 to 2 times normal was 6.2%. The incidence of multiple occurrences was 1.9%. For concomitant elevations in SGOT and SGPT of greater than twice normal, the incidence was 1.5%. The incidence of multiple occurrences was 0.3%. In many cases these elevations were attributed to underlying disorders, or resolved during continued treatment with bisoprolol fumarate.
Other laboratory changes included small increases in uric acid, creatinine, BUN, serum potassium, glucose, and phosphorus and decreases in WBC and platelets. These were generally not of clinical importance and rarely resulted in discontinuation of bisoprolol fumarate.
As with other beta-blockers, ANA conversions have also been reported on bisoprolol fumarate. About 15% of patients in long-term studies converted to a positive titer, although about one-third of these patients subsequently reconverted to a negative titer while on continued therapy.
What drugs interact with Zebeta (bisoprolol)?
Zebeta should not be combined with other beta-blocking agents. Patients receiving catecholaminedepleting drugs, such as reserpine or guanethidine, should be closely monitored, because the added beta-adrenergic blocking action of Zebeta may produce excessive reduction of sympathetic activity. In patients receiving concurrent therapy with clonidine, if therapy is to be discontinued, it is suggested that Zebeta be discontinued for several days before the withdrawal of clonidine.
Zebeta should be used with care when myocardial depressants or inhibitors of AV conduction, such as certain calcium antagonists (particularly of the phenylalkylamine [verapamil] and benzothiazepine [diltiazem] classes), or antiarrhythmic agents, such as disopyramide, are used concurrently.
Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Concurrent use of rifampin increases the metabolic clearance of Zebeta, resulting in a shortened elimination half-life of Zebeta. However, initial dose modification is generally not necessary. Pharmacokinetic studies document no clinically relevant interactions with other agents given concomitantly, including thiazide diuretics and cimetidine. There was no effect of Zebeta on prothrombin time in patients on stable doses of warfarin.
Zebeta (bisoprolol) is a beta-adrenergic receptor blocking agents (beta-blocker) to treat high blood pressure and heart pain (angina). Common side effects of Zebeta include abdominal cramps, diarrhea, dizziness, fatigue, depression, headache, nausea, impotence, slow heart rate, low blood pressure, numbness,tingling, cold extremities, sore throat, shortness of breath, wheezing, and increased asthma symptoms. Serious side effects of Zebeta include cardiac failure. It is unknown if Zebeta is secreted in breast milk.
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Related Disease Conditions
High Blood Pressure (Hypertension) Signs, Causes, Diet, and Treatment
High blood pressure (hypertension) is a disease in which pressure within the arteries of the body is elevated. About 75 million people in the US have hypertension (1 in 3 adults), and only half of them are able to manage it. Many people do not know that they have high blood pressure because it often has no has no warning signs or symptoms. Systolic and diastolic are the two readings in which blood pressure is measured. The American College of Cardiology released new guidelines for high blood pressure in 2017. The guidelines now state that blood normal blood pressure is 120/80 mmHg. If either one of those numbers is higher, you have high blood pressure. The American Academy of Cardiology defines high blood pressure slightly differently. The AAC considers 130/80 mm Hg. or greater (either number) stage 1 hypertension. Stage 2 hypertension is considered 140/90 mm Hg. or greater. If you have high blood pressure you are at risk of developing life threatening diseases like stroke and heart attack.REFERENCE: CDC. High Blood Pressure. Updated: Nov 13, 2017.
Herpangina is a contagious illness often seen in children. It is caused by a Coxsackievirus or an enterovirus. Symptoms and signs include mouth sores, fever, and sore throat. Treatment focuses on alleviating fever and pain with acetaminophen and ibuprofen. It is important for children to stay well hydrated, as children may be resistant to eating or drinking.
Angina is chest pain due to inadequate blood supply to the heart. Angina symptoms may include chest tightness, burning, squeezing, and aching. Coronary artery disease is the main cause of angina but there are other causes. Angina is diagnosed by taking the patient's medical history and performing tests such as an electrocardiogram (EKG), blood test, stress test, echocardiogram, cardiac CT scan, and heart catheterization. Treatment of angina usually includes lifestyle modification, medication, and sometimes, surgery. The risk of angina can be reduced by following a heart healthy lifestyle.
Pulmonary hypertension is elevated pressure in the pulmonary arteries that carry blood from the lungs to the heart. The most common symptoms are fatigue and difficulty breathing. If the condition goes undiagnosed, more severe symptoms may occur. As pulmonary hypertension worsens, some people with the condition have difficulty performing any activities that require physical exertion. While there is no cure for pulmonary hypertension, it can be managed and treated with medications and supplemental oxygen to increase blood oxygen levels.
Hypertension-Related Kidney Disease
Second Source WebMD Medical Reference
Portal hypertension is most commonly caused by cirrhosis, a disease that results from scarring of the liver. Other causes of portal hypertension include blood clots in the portal vein, blockages of the veins that carry the blood from the liver to the heart, and a parasitic infection called schistosomiasis. Symptoms of portal hypertension include varices (enlarged veins), vomiting blood, blood in the stool, black and tarry stool, ascites (abnormal fluid collection within the peritoneum, the sac that contains the intestines within the abdominal cavity), confusion and lethargy, splenomegaly or enlargement of the spleen, and decreased white blood cell counts.
Hypertensive Kidney Disease
High blood pressure can damage the kidneys and is one of the leading causes of kidney failure (end-stage renal kidney disease). Kidney damage, like hypertension, can be unnoticeable and detected only through medical tests. If you have kidney disease, you should control your blood pressure. Other treatment options include prescription medications.
Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Pseudotumor Cerebri (intracranial hypertension) is a condition where there is an increase in pressure of fluid surrounding the brain and spinal cord (cerebrospinal fluid or CSF) mimicing a brain tumor. The cause is unknown. The most common symptom is headache but also include eye-pain, vision loss and double vision. Pseudotumor cerebri is diagnosed with MRI or CAT scans and treated by discontinuing offending medications (if applicable), weight loss and diuretic medications. The condition can also be helped by repeated drainage of spinal fluid using the lumbar puncture.
Preeclampsia (Pregnancy Induced Hypertension)
Preeclampsia is related to increased blood pressure and protein in the mother's urine. Preeclampsia typically begins after the 20th week of pregnancy. When preeclampsia causes seizures, it is termed "eclampsia" and is the second leading cause of maternal death of in the US. Preeclampsia is the leading cause of fetal complications. Risk factors for preeclampsia include high blood pressure, obesity, multiple births, and women with preexisting medical conditions such as diabetes, kidney disease, rheumatoid arthritis, lupus, or scleroderma. Pregnancy planning and lifestyle changes may reduce the risk of preeclampsia during pregnancy.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.