Nebisam Uses

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What is Nebisam?

Nebisam 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.

Nebisam 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.

Nebisam is available only with your doctor's prescription.

Nebisam indications

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Nebisam is indicated for the treatment of hypertension. Nebisam may be used alone or in combination with other antihypertensive agents.

How should I use Nebisam?

Use Nebisam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Nebisam.

Uses of Nebisam in details

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Nebisam is used to treat high blood pressure and chronic heart failure.

Nebisam description

Each tablet contains Nebivolol HCl 5.45 mg equivalent to Nebisam 5 mg: 2.5 mg of d-Nebisam and 2.5 mg l-Nebisam. 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.

Nebisam dosage

Nebisam Dosage

Generic name: Nebisam

Dosage form: tablets

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

The dose of Nebisam 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. Nebisam 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. Nebisam 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.

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Nebisam interactions

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What other drugs will affect Nebisam?

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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 Nebisam.

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 Nebisam have not shown any clinical evidence of an interaction. Nebisam does not influence the kinetics of digoxin.

Insulin and

Oral Antidiabetic Drugs:

Although Nebisam 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 Nebisam.

Others: Concomitant use of NSAIDs had no effect on the blood pressure-lowering effect of Nebisam. Co-administration of cimetidine increased the plasma levels of Nebisam, without changing the clinical effect. Co-administration of ranitidine did not affect the pharmacokinetics of Nebisam. Provided Nebisam is taken with the meal, and an antacid between meals, the 2 treatments can be co-prescribed. Combining Nebisam 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 Nebisam. Nebisam 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 Nebisam 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.

Nebisam side effects

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What are the possible side effects of Nebisam?

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Adverse events are listed separately for hypertension and chronic heart failure because of differences in the background diseases.

Hypertension: The adverse reactions reported, which are in most of the cases of mild to moderate intensity, are tabulated, classified by system organ class and ordered by frequency. The following adverse reactions have also been reported with some β-adrenergic antagonists: Hallucinations, psychoses, confusion, cold/cyanotic extremities, Raynaud's phenomenon, dry eyes and oculo-mucocutaneous toxicity of the practolol type.

Chronic Heart Failure: Data on adverse reactions in chronic heart failure patients are available from 1 placebo-controlled clinical trial involving 1067 patients taking Nebisam and 1061 patients taking placebo. In this study, a total of 449 Nebisam patients (42.1%) reported at least possibly casually related adverse reactions compared to 334 placebo patients (31.5%). The most commonly reported adverse reactions in Nebisam patients were bradycardia and dizziness, both occurring in approximately 11% of patients. The corresponding frequencies among placebo patients were approximately 2% and 7%, respectively.

The following incidences were reported for adverse reactions (at least possibly drug-related) which are considered specifically relevant in the treatment of chronic heart failure: Aggravation of cardiac failure occurred in 5.8% of Nebisam patients compared to 5.2% of placebo patients; postural hypotension was reported in 2.1% of Nebisam patients compared to 1% of placebo patients; drug intolerance occurred in 1.6% of Nebisam patients compared to 0.8% of placebo patients; 1st-degree atrioventricular block occurred in 1.4% of Nebisam patients compared to 0.9% of placebo patients; edema of the lower limb were reported by 1% of Nebisam patients compared to 0.2% of placebo patients.

Nebisam contraindications

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What is the most important information I should know about Nebisam?

Hypersensitivity to Nebisam or to any of the excipients of Nebisam.

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 Nebisam 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, Nebisam should not be used during pregnancy.

Use in lactation: Most β-blockers, particularly lipophilic compounds eg, Nebisam and its active metabolites, pass into breast milk although to a variable extent. Since it is not known whether Nebisam is excreted into human milk, the use of Nebisam when breastfeeding is contraindicated. Animal studies have shown that Nebisam is excreted in breast milk.



Active ingredient matches for Nebisam:

Nebivolol in Latvia, Lithuania.


List of Nebisam substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
NEBISAINT tab 5 mg x 10's (Saint)
NEBISTAR Capsule/ Tablet / 5mg / 10 units (Pinnacle (Lupin Laboratories Ltd.))$ 0.93
NEBISTAR Capsule/ Tablet / 2.5mg / 10 units (Pinnacle (Lupin Laboratories Ltd.))$ 0.57
Nebistar 2.5mg TAB / 100 (Pinnacle (Lupin Laboratories Ltd.))$ 3.86
Nebistar 5mg TAB / 100 (Pinnacle (Lupin Laboratories Ltd.))$ 6.63
2.5 mg x 100's (Pinnacle (Lupin Laboratories Ltd.))$ 3.86
5 mg x 100's (Pinnacle (Lupin Laboratories Ltd.))$ 6.63
Nebistar 10 mg Tablet (Pinnacle (Lupin Laboratories Ltd.))$ 0.14
Nebistar 5 mg Tablet (Pinnacle (Lupin Laboratories Ltd.))$ 0.08
Nebistar 2.5 mg Tablet (Pinnacle (Lupin Laboratories Ltd.))$ 0.06
NEBISTAR - 10 TABLET 1 strip / 10 tablets each (Pinnacle (Lupin Laboratories Ltd.))$ 1.90
NEBISTAR - 2.5 TABLET 1 strip / 10 tablets each (Pinnacle (Lupin Laboratories Ltd.))$ 0.63
NEBISTAR - 5 TABLET 1 strip / 10 tablets each (Pinnacle (Lupin Laboratories Ltd.))$ 1.11
NEBISTAR tab 2.5 mg x 10's (Pinnacle (Lupin Laboratories Ltd.))$ 0.63
NEBISTAR tab 5 mg x 10's (Pinnacle (Lupin Laboratories Ltd.))$ 1.11
NEBISTAR tab 10 mg x 10's (Pinnacle (Lupin Laboratories Ltd.))$ 1.90
Nebistar 2.5mg TAB / 100 (Pinnacle (Lupin Laboratories Ltd.))$ 3.86
Nebistar 5mg TAB / 100 (Pinnacle (Lupin Laboratories Ltd.))$ 6.63
Nebistar 10mg Tablet (Pinnacle (Lupin Laboratories Ltd.))$ 0.19
Nebistar 2.5mg Tablet (Pinnacle (Lupin Laboratories Ltd.))$ 0.07
Nebistar 5mg Tablet (Pinnacle (Lupin Laboratories Ltd.))$ 0.11
NEBISTOL 10 MG TABLET 1 strip / 10 tablets each (Eris Life Sciences Pvt Ltd)$ 1.57
NEBISTOL 2.5 MG TABLET 1 strip / 10 tablets each (Eris Life Sciences Pvt Ltd)$ 0.61
NEBISTOL 5 MG TABLET 1 strip / 10 tablets each (Eris Life Sciences Pvt Ltd)$ 1.02
2.5 mg x 10's (Rhine Biogenics Pvt Ltd)$ 0.47
5 mg x 10's (Rhine Biogenics Pvt Ltd)$ 0.80
Nebitab 2.5mg TAB / 10 (Rhine Biogenics Pvt Ltd)$ 0.47
Nebitab 5mg TAB / 10 (Rhine Biogenics Pvt Ltd)$ 0.80
Nebitab 2.5 mg Tablet (Rhine Biogenics Pvt Ltd)$ 0.05
Nebitab 5 mg Tablet (Rhine Biogenics Pvt Ltd)$ 0.08
NEBITAB tab 2.5 mg x 10's (Rhine Biogenics Pvt Ltd)$ 0.47
NEBITAB tab 5 mg x 10's (Rhine Biogenics Pvt Ltd)$ 0.80
Nebitab 2.5mg TAB / 10 (Rhine Biogenics Pvt Ltd)$ 0.47
Nebitab 5mg TAB / 10 (Rhine Biogenics Pvt Ltd)$ 0.80
2.5 mg x 10's (Anthus Pharmaceuticals Pvt. Ltd.)$ 0.45
5 mg x 10's (Anthus Pharmaceuticals Pvt. Ltd.)$ 0.71

References

  1. PubChem. "Nebivolol". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "Nebivolol". http://www.drugbank.ca/drugs/DB04861 (accessed September 17, 2018).
  3. MeSH. "Adrenergic beta-1 Receptor Agonists". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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