Nevilob is used alone or together with other medicines 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.
Nevilob is a beta-blocker. It works by affecting the response to 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.
Nevilob is available only with your doctor's prescription.
Nevilob indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Nevilob is indicated for the treatment of hypertension. Nevilob may be used alone or in combination with other antihypertensive agents.
How should I use Nevilob?
Use Nevilob as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Take Nevilob by mouth with or without food.
Take Nevilob on a regular schedule to get the most benefit from it. Taking Nevilob at the same time each day will help you remember to take it.
Continue to take Nevilob even if you fell well. Do not miss any doses.
Do not suddenly stop taking Nevilob without first talking with your doctor. You may have an increased risk of side effects (eg, chest pain, irregular heartbeat). If you need to stop Nevilob or add a new medicine, your doctor may need to gradually lower your dose.
If you miss a dose of Nevilob, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Nevilob.
Uses of Nevilob in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Nevilob is used to treat high blood pressure and chronic heart failure.
Nevilob description
Each tablet contains Nebivolol HCl 5.45 mg equivalent to Nevilob 5 mg: 2.5 mg of d-Nevilob and 2.5 mg l-Nevilob. It also contains the following excipients: Lactose monohydrate, polysorbate 80 (E433), hypromellose (E464), maize starch, croscarmellose sodium (E468), microcrystalline cellulose (E460), anhydrous colloidal silica (E551), magnesium stearate (E572).
The tablets can be divided in equal quarters.
Nevilob dosage
Nevilob Dosage
Generic name: Nevilob
Dosage form: tablets
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
The dose of Nevilob should be individualized to the needs of the patient. For most patients, the recommended starting dose is 5 mg once daily, with or without food, as monotherapy or in combination with other agents. For patients requiring further reduction in blood pressure, the dose can be increased at 2-week intervals up to 40 mg. A more frequent dosing regimen is unlikely to be beneficial.
Renal Impairment
In patients with severe renal impairment (ClCr less than 30 mL/min) the recommended initial dose is 2.5 mg once daily; upward titration should be performed cautiously if needed. Nevilob has not been studied in patients receiving dialysis.
Hepatic Impairment
In patients with moderate hepatic impairment, the recommended initial dose is 2.5 mg once daily; upward titration should be performed cautiously if needed. Nevilob has not been studied in patients with severe hepatic impairment and therefore it is not recommended in that population.
Geriatric Patients
It is not necessary to adjust the dose in the elderly.
CYP2D6 Polymorphism
No dose adjustments are necessary for patients who are CYP2D6 poor metabolizers. The clinical effect and safety profile observed in poor metabolizers were similar to those of extensive metabolizers.
The following interactions apply to β-adrenergic antagonists in general: Calcium Antagonists: Care should be exercised when administering β-adrenergic antagonists with calcium antagonists of the verapamil or diltiazem type, because of their negative effect on contractility and AV conduction. IV verapamil is contraindicated in patients on Nevilob.
Antiarrhythmics: Caution should be exercised when administering β-adrenergic antagonists in association with Class I antiarrhythmic drugs and amiodarone, as their effect on atrial conduction time and their negative inotropic effect may be potentiated.
Clonidine: β-adrenergic antagonists increase the risk of rebound hypertension after sudden withdrawal of chronic clonidine treatment.
Digitalis: Digitalis glycosides associated with β-adrenergic antagonists may increase AV conduction time. Clinical trials with Nevilob have not shown any clinical evidence of an interaction. Nevilob does not influence the kinetics of digoxin.
Insulin and
Oral Antidiabetic Drugs:
Although Nevilob does not affect glucose levels, certain symptoms of hypoglycaemia (palpitations, tachycardia) may be masked.
Anaesthetics: Concomitant use of β-adrenergic antagonists and anaesthetics may attenuate reflex tachycardia and increase the risk of hypotension. The anaesthesiologist should be informed when the patient is receiving Nevilob.
Others: Concomitant use of NSAIDs had no effect on the blood pressure-lowering effect of Nevilob. Co-administration of cimetidine increased the plasma levels of Nevilob, without changing the clinical effect. Co-administration of ranitidine did not affect the pharmacokinetics of Nevilob. Provided Nevilob is taken with the meal, and an antacid between meals, the 2 treatments can be co-prescribed. Combining Nevilob with nicardipine slightly increased the plasma levels of both drugs, without changing the clinical effect. Co-administration of alcohol, furosemide or hydrochlorothiazide did not affect the pharmacokinetics of Nevilob. Nevilob does not affect the pharmacokinetics and pharmacodynamics of warfarin. Sympathicomimetic agents may counteract the effect of β-adrenergic antagonists. β-adrenergic agents may lead to unopposed α-adrenergic activity of sympathicomimetic agents with both α- and β-adrenergic effects (risk of hypertension, severe bradycardia and heart block). Concomitant administration of tricyclic antidepressants, barbiturates and phenothiazines may increase the blood-pressure lowering effect. As Nevilob metabolism involves the CYP2D6 isoenzyme, concomitant administration of serotonin reuptake inhibitors, dextrometorphan or other compounds predominantly metabolised via this pathway, may make extensive metabolisers resemble poor metabolisers.
The data described below reflect worldwide clinical trial exposure to Nevilob in 6545 patients, including 5038 patients treated for hypertension and the remaining 1507 subjects treated for other cardiovascular diseases. Doses ranged from 0.5 mg to 40 mg. Patients received Nevilob for up to 24 months, with over 1900 patients treated for at least 6 months, and approximately 1300 patients for more than one year. In placebo-controlled clinical trials comparing Nevilob with placebo, discontinuation of therapy due to adverse events was reported in 2.8% of patients treated with Nevilob and 2.2% of patients given placebo. The most common adverse events that led to discontinuation of Nevilob were headache (0.4%), nausea (0.2%) and bradycardia (0.2%).
Adverse Reactions in Controlled Trials
Table 2 lists treatment-emergent signs and symptoms that were reported in three 12-week, placebo-controlled monotherapy trials involving 1597 hypertensive patients treated with either 5 mg, 10 mg or 20-40 mg of Nevilob and 205 patients given placebo and for which the rate of occurrence was at least 1% of patients treated with Nevilob and greater than the rate for those treated with placebo in at least one dose group.
Table 2. Treatment-Emergent Adverse Events with an Incidence (over 6 weeks) ≥ 1% in Nevilob-Treated Patients and at a Higher Frequency than Placebo-Treated Patients
Placebo
(n = 205)
(%)
Nevilob
5 mg
(n = 459)
(%)
Nevilob
10 mg
(n = 461)
(%)
Nevilob
20-40 mg
(n = 677)
(%)
Headache
6
9
6
7
Fatigue
1
2
2
5
Dizziness
2
2
3
4
Diarrhea
2
2
2
3
Nausea
0
1
3
2
Insomnia
0
1
1
1
Chest pain
0
0
1
1
Bradycardia
0
0
0
1
Dyspnea
0
0
1
1
Rash
0
0
1
1
Peripheral edema
0
1
1
1
Other Adverse Events Observed During Worldwide Clinical Trials
Listed below are other reported adverse events with an incidence of at least 1% in the more than 5300 patients treated with Nevilob in controlled or open-label trials, whether or not attributed to treatment, except for those already appearing in Table 2, terms too general to be informative, minor symptoms, or events unlikely to be attributable to drug because they are common in the population. These adverse events were in most cases observed at a similar frequency in placebo-treated patients in the controlled studies.
Body as a whole: asthenia.
Gastrointestinal System Disorders: abdominal pain
Metabolic and Nutritional Disorders: hypercholesterolemia and hyperuricemia
Nervous System Disorders: paraesthesia
Laboratory
In controlled monotherapy trials, Nevilob was associated with an increase in BUN, uric acid, triglycerides and a decrease in HDL cholesterol and platelet count.
Events Identified from Spontaneous Reports of Nevilob Received Worldwide
The following adverse events have been identified from spontaneous reports of Nevilob received worldwide and have not been listed elsewhere. These adverse events have been chosen for inclusion due to a combination of seriousness, frequency of reporting or potential causal connection to Nevilob. Events common in the population have generally been omitted. Because these events were reported voluntarily from a population of uncertain size, it is not possible to estimate their frequency or establish a causal relationship to Nevilob exposure: abnormal hepatic function (including increased AST, ALT and bilirubin), acute pulmonary edema, acute renal failure, atrioventricular block (both second and third degree), bronchospasm, erectile dysfunction, hypersensitivity (including urticaria, allergic vasculitis and rare reports of angioedema), myocardial infarction, pruritus, psoriasis, Raynaud's phenomenon, peripheral ischemia/claudication, somnolence, syncope, thrombocytopenia, various rashes and skin disorders, vertigo, and vomiting.
Hypersensitivity to Nevilob or to any of the excipients of Nevilob.
Liver insufficiency or liver function impairment.
β-adrenergic antagonists are contraindicated in the following conditions: Cardiogenic shock; uncontrolled heart failure; sick sinus syndrome, including sino-atrial block; 2nd and 3rd degree heart block; history of bronchospasm and bronchial asthma; untreated phaeochromocytoma; metabolic acidosis; bradycardia (heart rate <50 bpm); hypotension; severe peripheral circulatory disturbances.
Use in pregnancy: Insufficient data exist on the use of Nevilob in human pregnancy to determine its potential harmfulness. Animal studies have not shown any indication of harmful effects, other than on the basis of its pharmacological properties. β-blockers reduce placental perfusion, which may result in intrauterine fetal death and in immature and premature delivery. In addition, adverse effects (hypoglycaemia and bradycardia) may occur in the fetus and the neonate. There is an increased risk of cardiac and pulmonary complications in the neonate in the postnatal period. Therefore, Nevilob should not be used during pregnancy.
Use in lactation: Most β-blockers, particularly lipophilic compounds eg, Nevilob and its active metabolites, pass into breast milk although to a variable extent. Since it is not known whether Nevilob is excreted into human milk, the use of Nevilob when breastfeeding is contraindicated. Animal studies have shown that Nevilob is excreted in breast milk.
The results of a survey conducted on ndrugs.com for Nevilob are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Nevilob. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
User reports
Consumer reported useful
No survey data has been collected yet
Consumer reported price estimates
No survey data has been collected yet
Consumer reported time for results
No survey data has been collected yet
3 consumers reported age
Users
%
> 60
1
33.3%
46-60
1
33.3%
6-15
1
33.3%
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