Amlodipine, Nebivolol
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Clinical Pharmacology
Nebilong AM is a III generation cardioselective beta-blocker with vasodilating properties. The active substance is a racemate consisting of two enantiomers: D-nebivolol and L-nebivolol. Nebivolol is a competitive and selective blocker of β1-adrenoreceptors (affinity for β1-adrenoreceptors is 288 times higher than for β2-adrenoreceptors), in addition, it has a mild vasodilating effect by modulating the release of the relaxing factor (NO) from the vascular endothelium. Nebivolol reduces heart rate and blood pressure at rest and under load, reduces the end diastolic pressure of the left ventricle, lowers the round neck, improves the diastolic function of the heart (decreases the filling pressure), increases the ejection fraction; causes an antianginal effect in IHD patients. Optimal hypotensive effect occurs after 1-2 weeks of treatment. In some cases, the maximum effect is achieved after 4 weeks.
Indications
Essential (primary) arterial hypertension, ischemic heart disease.
Composition
1 tablet contains:
Active substances: Amlodipine 5 mg; Nebivolol 5 mg.
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Dosage and Administration
Orally, at the same time of day, without chewing, squeezed with a sufficient amount of water, during or after a meal - 5 mg 1 time per day. Patients with renal insufficiency or patients over 65 years old - 2.5 mg / day. The maximum daily dose is 10 mg.
Adverse reactions
From the side of the central nervous system and peripheral nervous system: headache, dizziness, fatigue, paresthesia, depression, decreased concentration, drowsiness, insomnia, nightmares, hallucinations.
From the digestive system: nausea, constipation, diarrhea, dry mouth.
Since the cardiovascular system: bradycardia, orthostatic hypotension, dyspnea, edema, heart failure, AV-blockade, heart rhythm disturbances, Raynaud's syndrome, cardialgia.
Allergic reactions: skin rash.
Other: bronchospasm (including in the absence of obstructive pulmonary disease in history), photodermatosis, hyperhidrosis, rhinitis.
Contraindications
Bronchial asthma, chronic heart failure in the stage of decompensation, untreated pheochromocytoma, severe impaired liver function, depression, angiospastic stenocardia (Prinzmetal's angina), peripheral vascular obliterating diseases (syndrome of intermittent claudication), arterial hypotension, cardiogenic vascular disease (chirosphoric syndrome), arterial hypotension, cardiogenic vascular disease (chromosity syndrome), arterial hypotension, cardiogenic vascular disease (syndrome intermittent claudication), arterial hypotension, cardiogenic vascular diseases / min), SSSU, AV block II and III degrees, myasthenia gravis, muscle weakness, children and adolescents under 18 years of age, hypersensitivity to nebivolol.
Drug interactions
Calcium channel blockers increase the blockade of AV conduction, class I antiarrhythmics and amiodarone lengthen the time of excitation in the atria. Anesthetic agents (cyclopropane, diethyl ether, trichloroethylene), tricyclic antidepressants, barbiturates, phenothiazine derivatives potentiate hypotension, cimetidine and nicardipine increase plasma concentrations, and sympathomimetics level activity.
Pregnancy and Lactation
Use during pregnancy is possible only under strict indications (due to the possible development of newborn bradycardia, arterial hypotension, hypoglycemia and respiratory paralysis). Reception of nebivolol must be stopped 48-72 hours before delivery. In cases where this is not possible, strict monitoring of newborns should be ensured within 48-72 hours after delivery.
Special instructions
It is necessary to stop therapy gradually (within 1–2 weeks). Decrease in heart rate to 55 beats / min requires dose reduction. Against the background of diabetes, it is possible to mask signs of hypoglycemia, with hyperfunction of the thyroid gland - tachycardia. May exacerbate reactions to pollen and other allergens. It should be canceled 24 hours before surgery using general anesthesia (including surgical dentistry) or choose an anesthetic with the least negative inotropic effect. If necessary, the simultaneous appointment of antacids nebivolol taken during meals and antacids - between meals. Be careful when using vehicle drivers and people whose profession is related to increased concentration of attention. At the time of treatment is recommended to exclude alcohol intake.
Overdosage
Symptoms: bradycardia, arterial hypotension, bronchospasm, acute heart failure.
Treatment: gastric lavage, taking Activated charcoal, the appointment of laxatives; possible IVL and the introduction of atropine (with bradycardia and increased vagotonia), plasma or plasma substitutes, if necessary, catecholamines. For edema beta-adrenergic blocking action - isoprenaline hydrochloride (slowly, IV, in the initial dose of 5 mcg / min to achieve the desired effect), dobutamine (in the initial dose - 2.5 mcg / min), in the absence of effect - glucagon ( (in 50–100 mcg / kg, again after 1 h - 70 mcg / kg / h by infusion). When AV blockade - transvenous stimulation.
- Brand name: Neilong AM
- Active ingredient: Amlodipine, Nebivolol
- Dosage form: Pills
- Manufacturer: Micro Labs Ltd
- Country of Origin: India
Studies and clinical trials of Amlodipine, Nebivolol (Click to expand)
- RP-LC Simultaneous Determination of Nebivolol Hydrochloride and Amlodipine Besilate in Bi-Layer Tablets
- A randomized, open-label, blinded-endpoint, active-comparator, forced-titration study to compare nebivolol versus metoprolol as dual therapy with amlodipine in patients with hypertension: results of the tandem study
- Nebivolol vs Amlodipine as First-line Treatment of Essential Arterial Hypertension in the Elderly
- Second-derivative synchronous spectrofluorimetric determination of nebivolol hydrochloride and amlodipine besylate in their combined dosage form
- Combination therapy with nebivolol/amlodipine is superior to metoprolol/amlodipine in the control of cuff and 24-hr ambulatory blood pressure
- Novel bio analytical method development, validation and application for simultaneous determination of nebivolol and S-amlodipine in human plasma using ultra performance liquid chromatography-tandem mass spectrometry
- Effects of nebivolol combined with ramipril vs nebivolol associated amlodipine and ramipril on biomarker of endothelial dysfunction in pacients with angina pectoris and essential hypertension
- Effect of Amlodipine/Valsartan Versus Nebivolol/Valsartan Fixed Dose Combinations on Peripheral and Central Blood Pressure