Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children. Do not dispose of medications in wastewater e. Ask your pharmacist how to dispose of medications that are no longer needed or have expired. Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication.
If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor. Many of these side effects can be managed, and some may go away on their own over time. Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects. Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.
Stop taking the medication and seek immediate medical attention if any of the following occur:. Some people may experience side effects other than those listed.
Check with your doctor if you notice any symptom that worries you while you are taking this medication. Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health.
These factors may affect how you should use this medication. Breathing conditions: In general, people who have asthma and certain other breathing problems or chronic lung disease should use nebivolol cautiously, as it can also have the effect of causing breathing difficulty. Low doses of nebivolol may be taken with caution by those with asthma who do not respond to or cannot tolerate alternative treatment.
If you have breathing problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. It may be necessary to monitor your blood glucose levels more often when you are taking this medication. Blood pressure is the force in your blood vessels when your heart beats and when your heart rests.
You have high blood pressure when the force is too great. High blood pressure makes the heart work harder to pump blood through the body and causes damage to the blood vessels. Medicines that lower your blood pressure lower your chance of having a stroke or heart attack. The active ingredient is nebivolol. Before starting BYSTOLIC, tell your healthcare provider about all of your medical conditions, including if you: Have asthma or other lung problems such as bronchitis or emphysema Have problems with blood flow in your feet and legs peripheral vascular disease.
Have diabetes and take medicine to control blood sugar Have thyroid problems Have liver or kidney problems Have had allergic reactions to medications or have allergies Have a condition called pheochromocytoma rare adrenal gland tumor Are pregnant or trying to become pregnant.
Talk with your doctor about the best way to treat your high blood pressure while you are pregnant. Oral administration of nebivolol to pregnant rats during organogenesis resulted in embryofetal and perinatal lethality at doses approximately equivalent to the maximum recommended human dose MRHD.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U. Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications e.
Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Pregnant women with hypertension should be carefully monitored and managed accordingly. Neonates of women with hypertension, who are treated with beta-blockers during the third trimester of pregnancy, may be at increased risk for hypotension, bradycardia, hypoglycemia, and respiratory depression. Observe newborns for symptoms of hypotension, bradycardia, hypoglycemia and respiratory depression and manage accordingly.
Nebivolol was shown to increase embryo-fetal and perinatal lethality in rats at approximately 1. Decreased pup body weights occurred at 1. These events occurred only when nebivolol was given during the perinatal period late gestation, parturition and lactation.
There is no information regarding the presence of nebivolol in human milk, the effects on the breastfed infant, or the effects on milk production. Nebivolol is present in rat milk [see Data]. In lactating rats, maximum milk levels of unchanged nebivolol were observed at 4 hours after single and repeat doses of 2. Safety and effectiveness in pediatric patients have not been established. Pediatric studies in ages newborn to 18 years old have not been conducted because of incomplete characterization of developmental toxicity and possible adverse effects on long-term fertility [see Nonclinical Toxicology Daily oral doses of nebivolol to juvenile rats from post-natal day 14 to post-natal day 27 showed sudden unexplained death at exposures equal to those in human poor metabolizers given a single dose of 10 mg.
No mortality was seen at half the adult human exposure. In surviving rats, cardiomyopathy was seen at exposures greater than or equal to the human exposure. Male rat pups exposed to twice the human exposure showed decreases in total sperm count as well as decreases in the total and percentage of motile sperm.
Of the patients in the U. No overall differences in efficacy or in the incidence of adverse events were observed between older and younger patients. In a placebo-controlled trial of patients BYSTOLIC, placebo over 70 years of age with chronic heart failure receiving a maximum dose of 10 mg per day for a median of 20 months, no worsening of heart failure was reported with nebivolol compared to placebo.
The patient experienced hyperhydrosis, pallor, depressed level of consciousness, hypokinesia, hypotension, sinus bradycardia, hypoglycemia, hypokalemia, respiratory failure and vomiting. The patient recovered. Because of extensive drug binding to plasma proteins, hemodialysis is not expected to enhance nebivolol clearance.
If overdose occurs, provide general supportive and specific symptomatic treatment. Bradycardia: Administer IV atropine. If the response is inadequate, isoproterenol or another agent with positive chronotropic properties may be given cautiously. Under some circumstances, transthoracic or transvenous pacemaker placement may be necessary. Hypotension: Administer IV fluids and vasopressors.
Intravenous glucagon may be useful. Heart Block second or third degree : Monitor and treat with isoproterenol infusion. Congestive Heart Failure: Initiate therapy with digitalis glycoside and diuretics. In certain cases, consider the use of inotropic and vasodilating agents. Hypoglycemia: Administer IV glucose. Repeated doses of IV glucose or possibly glucagon may be required.
Supportive measures should continue until clinical stability is achieved. The half-life of low doses of nebivolol is hours. Nebivolol hydrochloride is a white to almost white powder that is soluble in methanol, dimethylsulfoxide, and N,N-dimethylformamide, sparingly soluble in ethanol, propylene glycol, and polyethylene glycol, and very slightly soluble in hexane, dichloromethane, and methylbenzene. Nebivolol lacks intrinsic sympathomimetic and membrane stabilizing activity at therapeutically relevant concentrations.
Possible factors that may be involved include: 1 decreased heart rate, 2 decreased myocardial contractility, 3 diminution of tonic sympathetic outflow to the periphery from cerebral vasomotor centers, 4 suppression of renin activity and 5 vasodilation and decreased peripheral vascular resistance.
Nebivolol is metabolized by a number of routes, including glucuronidation and hydroxylation by CYP2D6. The active isomer d-nebivolol has an effective half-life of about 12 hours in CYP2D6 extensive metabolizers most people , and 19 hours in poor metabolizers and exposure to d-nebivolol is substantially increased in poor metabolizers.
Plasma levels of d—nebivolol increase in proportion to dose in EMs and PMs for doses up to 20mg. The absolute bioavailability has not been determined. Mean peak plasma nebivolol concentrations occur approximately 1. Food does not alter the pharmacokinetics of nebivolol.
However, having high blood pressure during pregnancy may cause complications such as diabetes or eclampsia dangerously high blood pressure that can lead to medical problems in both mother and baby. The benefit of treating hypertension may outweigh any risks to the baby. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. This is not a complete list of side effects and others may occur.
Call your doctor for medical advice about side effects. Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Use Bystolic Nebivolol exactly as directed on the label, or as prescribed by your doctor.
Do not use in larger or smaller amounts or for longer than recommended. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
0コメント