Neginol 5 DHG treats dignity hypertension (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Nebivolol
Ingredient
| Composition information | Content |
| Nebivolol | 5mg |
Uses
indications
Neginol 5 drugs are indicated in the following cases:
ATC code: C07AB12.
Nebivolol is a mixture of two types of optical isomers, SRRR-nebivolol (or D-nebivolol) and RSSS-Nebivolol (or I-Nebivolol). The drug combines two pharmacological effects:
In the treatment dose, Nebivolol has no antagonistic effect on the alpha-adrenergic system.
Short and long -term treatment with Nebivolol for patients with hypertension, body resistance decreases.
Despite the decrease in heart rate, the heart amount when resting and when physical activity is not constantly changing due to increasing the volume of the squeeze. The clinical association of these hemodynamic differences compared to other beta 1 receptor antagonists has not been fully determined.
In patients with hypertension, Nebivolol increases the vascular dilatation response of NO intermediaries for acetylcholin whose parameters usually decrease in patients with endothelial dysfunction.
In a test of mortality, the rate of disease, a restraint with a placebo is performed on 2128 patients ≥ 70 years old (on average 75.2 years old) with chronic heart failure with stable stable or no decline in left ventricular blood loss (average LVEF: 36 ± 12.3%, with the following distribution as follows: LVEF is under 35% in 56% patients, LVEF from 45% to 25% and LVEF is larger than 45% and LVEF In 19% of patients) were monitored for an average of 20 months, Nebivolol, on therapy standards, significantly extended the death of death or hospitalized for cardiovascular reasons (the main ending point for efficiency) with relatively reduced risk of 14% (absolute reduction: 4.2%). The reduction of this risk develops after 6 months of treatment and is maintained during the treatment period (average time: 18 months). The effect of nebivolol does not depend on age, gender, or the left ventricular blood emulsion of the population in the study. Benefits on death due to all causes failing to achieve statistical significance compared to placebo (absolute reduction: 2.3%).
Suddenly reduced to be observed in patients with Nebivolol treatment (4.1%compared to 6.6%, relatively 38%decrease).
In vitro and in vivo tests on animals show that using Nebivolol does not have the same sympathetic effect.
In vitro and in vivo tests on animals show that using nebivolol in pharmacological dose is not stable.
In healthy volunteers, Nebivolol does not significantly affect the ability to exercise or endurance.
Clinical and preclinical evidence existing in patients with hypertension does not show that Nebivolol has an adverse effect on erectile function.
pharmacokinetics
Nebivolol optical isomers are absorbed quickly after drinking. The absorption of drugs is not affected by food, Nebivolol can be used or not with food.
Nebivolol is widely metabolized, partly into active hydroxy metabolites.
Nebivolol is metabolized through rings and aromatic hydroxylation hydroxylation, n-deckylation and glucuronide; In addition, glucuronid of hydroxy metabolites is formed. The metabolism of nebivolol by aromatic hydroxylation depends on the genetic oxidation property depends on CYP2D6. Oral bioavailability of Nebivolol averages 12% in fast metabolic people and almost entirely in slow metabolic people. In a stable state and at the same dose level, the peak concentration of Nebivolol's plasma does not change in the metabolic person about 23 times higher than the metabolic person. When considering the drug does not change, plus active metabolites, the difference in peak concentration in plasma is 1.3 to 1.4 times. Due to the change in metabolic speed, the dobivolol dose must always be adjusted according to the patient's personal requirements: Poor metabolic people may require lower dose.
In those who metabolize rapidly, the sale time of nebivolol optical substances is 10 hours. In those who metabolize slowly, longer 3-5 times. In fast metabolic people, RSSS-Enantiomer concentration in plasma is slightly higher than the SRRR-Enantiomer. In those who transform slowly, this difference is greater. In fast metabolic people, the disposal time for hydroxy metabolites of both optical substances is 24 hours, and is twice as long than those in slow metabolic people.
Plasma concentrations in a stable state in most subjects (rapid metabolaters) are achieved within 24 hours for nebivolol and within a few days for hydroxy metabolites.
Plasma concentrations proportional to the dose from 1 to 30 mg. Nebivolol's pharmacokinetics are not affected by age.
In plasma, both nebivolol optical substances are mainly linked to albumin.
Linking with plasma proteins is 98.1% for SRRR-Nebivolol and 97.9% for RSSS-Nebivolol.
A week after taking the drug, 38% of the dosage excreted through the urine (non -metabolic form under
Before taking Neginol 5 DHG treats dignity hypertension (3 blisters x 10 tablets)
How to use
oral tablets. Can be taken at meals.
Dosage
Hypertension
Adults: 1 tablet/day (5 mg), preferably oral at the same time per day.
Hypotension effect will be evident after 1-2 weeks of treatment. Sometimes, the maximum efficiency is only achieved after 4 weeks.
Coordinate with other anti -hypertension drugs
Beta blockers can be used for single or in combination with other blood pressure drugs. So far, the effectiveness of hypotension has been enhanced when combining Nebivolol 5mg with hydrochlorothiazid 12.5 - 25 mg.
Patients with renal failure
The starting dose is 2.5 mg/day. If necessary, the dose can be increased to 5 mg/day.
Patients with liver failure
data is limited. Therefore, contraindicated for these objects.
Elderly
In patients over 65 years old, the recommended starting dose is 2.5 mg/day. If necessary, the dose can be increased to 5 mg/day. However, there is little experience in treating patients over 75 years old, cautious and tightly controlled when taking the drug for this object.
Children
There is no data on the safety and effectiveness of Nebivolol in children and teenagers under 18 years old.
Do not recommend using this drug.
chronic heart failure
To treat chronic heart failure stable, the dose should be increased slowly until the optimal dose for each patient.
Patients with stable chronic heart failure are patients who do not suffer from acute heart failure occurred within 6 weeks. The treatment doctor must be experienced in the treatment of chronic heart failure.
For patients who are taking cardiovascular drugs (diuretics, digoxin, enzyme inhibitors, Angiotensin II antagonistic drugs), should maintain stable dose of these drugs for 2 weeks before starting treatment with Nebivolol.
Adjusting the dose increasing should be conducted in step by step, with the gap between the dose increases is 1-2 weeks depending on the response of the patient: 1.25 mg of Nebivolol, up to 2.5 mg x 1 time/day, then 5 mg x 1 time/day, then 10 mg x 1 time/day. The maximum dose is 10 mg x 1 time/day.
When starting to treat and each time increasing the dose should be monitored by the doctor with experience for at least 2 hours to ensure the clinical states remain stable (especially blood pressure, heart rate, conduction disorders, signs of worse heart failure).
The emergence of unwanted effects can cause patients to not be treated at maximum doses. If necessary, the maximum dose can also be reduced step by step and re -use the appropriate dose.
During the dose adjustment process, if the heart failure is worse or the patient is intolerant to the drug, the dose reduces or stops immediately if needed (when lowered with severe blood pressure, the more severe heart failure is accompanied by acute pulmonary edema, heart shock, symptomatic heart rate, atrial block).
Treatment of chronic heart failure with Nebivolol is often long -term treatment.
Do not stop nebivolol suddenly because it can make the heart failure more seriously. If stopping the drug is necessary, it is necessary to reduce the dose slowly every week.
Patients with renal failure
No dose adjustment for patients with mild to moderate renal impairment because the maximum increase is adjusted to each patient. There is no experience in treating patients with severe renal impairment (serum creatinine ≥250 mol/l). Nebivolol should not be used for these patients.
Patients with liver failure
data is limited. Contraindicated to use Mebivolol for these patients.
Elderly
No dose adjustment because the maximum tolerance has been adjusted for each patient.
Children
There is no data on the safety and effectiveness of Nebivolol in children and teenagers under 18 years old.
Do not recommend medication for this object.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when overdose?
Symptoms: slow heart rate, hypotension, bronchospasm and acute heart failure.
Treatment: In case of overdose or hypersensitivity, the patient must be closely monitored and treated at the Department of Positive Care. Should check blood sugar levels. Prevent the remaining drug absorption in the stomach by lavely and take active carbon or laxative. Artificial respiration can sometimes be required. Bradycardia or vagus reaction can be treated by using atropine or methylatropine. Hypotension and shock can be treated by plasma or plasma solutions and if it is possible to use catecholamine. The effect of beta blockers can be antagonistic by slow venous infusion isoprenalin hydrochloride at a dose of about 5 mcg/minute, or dobutamin with a dose of about 2.5 mcg/minute, until the requirements are reached. If it is still not achieved, it is possible to use isoprenalin with dopamine. If it is still not effective, it is possible to consider glucagon intravenously 50 - 100 mcg/kg. If needed, the injection is reminded for 1 hour, then, if necessary, the glucagon 70 mcg/kg/h intravenous can be transmitted. In a rare number of cases of anti -treatment heart rate, the pacemaker can be used.
In case of emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double doses to compensate for missed dose.
Side Effects
When using Neginol 5 you may experience unwanted effects (ADR):
Unwanted effects are individually listed in case of hypertension and chronic heart failure due to the difference in background disease.
Hypertension
The unwanted effects are reported in most mild to medium -sized cases, classified by organ groups and arranged according to the following frequency: Common (≥ 1/100 to
immune system disorders
Mental disorders
Nervous system disorders
Eye disorders
Heart disorders
Vascular disorders
Gastrointestinal disorders
Skin and subcutaneous tissue disorders
Reproductive and breast disorders
chronic heart failure
Data on unwanted effects in patients with chronic heart failure available from a clinical trial with a placeborn with a placebo over 1067 patients using Nebivolol and 1061 patients to use placebo. In this study, a total of 449 patients Nebivolol (42.1%) reported at least there may be side effects related to the cause compared to 334 patients using placebo (31.5%). The most common reported reactions in patients using Nebivolol are slow and dizzy heart rate, both occur in about 11% of patients. The corresponding frequency between patients using placebo is about 2% and 7% respectively.
The following cases have been reported on unwanted effects (at least may be related to drugs) which are considered to be specific in the treatment of chronic heart failure:
Notify the physician with unwanted effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Neginol 5 contraindications in the following cases:
Be cautious when using
need to be very careful when taking the drug for patients in the following cases:
The following warnings and caution applies to beta blockers in general.
Anesthesia
Continuing to be treated with beta blockers reduces the risk of arrhythmia during anesthesia and intubation. If you stop taking beta blockers before surgery, it should be stopped at least 24 hours earlier. Be cautious when using some anesthetic because it can reduce myocardial strength. Atropin intravenous injection can help patients avoid vagus reactions.
cardiovascular
Do not use beta blockers for patients with congestive heart failure, unless untreated, unless the heart failure is stable.
Stop slowly (over 1-2 weeks) Beta blockers in patients with ischemia. If necessary, should start treating with other drugs at the time of stopping the drug to avoid overeating angina.
Beta blockers may slow down the heart rate. If the heart rate is below 50 - 55 BPM when resting and/or there are symptoms of slow heart rate, the dose should be reduced.
Beta blockers should be used carefully:
It is not recommended to combine Nebivolol with calcium blockers in Verapamil and Diltiazem, anti -arrhythmia group I, antihypertensive drugs acting on the central.
metabolism/endocrine
Nebivolol does not affect blood sugar in diabetes patients. However, it is necessary to be cautious because Nebivolol can cover some signs of hypoglycemia (fast heartbeat, chest drum).
Beta blockers can cover heart symptoms quickly in hyperthyroidism patients. Sudden stopping of the drug may increase symptoms.
Respiratory
In patients with chronic obstructive pulmonary disease, beta blockers can be used but must be cautious because it may increase respiratory spasms.
Other
Patients with a history of psoriasis can only use beta blockers when carefully considered.
Beta blockers can cause increased sensitivity to allergens and worsen hypersensitivity reactions.
Starting the treatment of chronic heart failure with Nebivolol needs regular monitoring. For dosage and usage, please refer to the usage, dosage. Do not suddenly stop pesticides when indicated clearly. For more information, please refer to the usage, dose.
related to excipients
This drug contains less than 1 mmol sodium (23 mg) each tablet, meaning "no sodium".
Lactose Monohydrate: Should not be used in patients with galactose tolerance, lactase deficiency or glucose - galactose absorption disorders.
The effect of drugs on driving and operating machinery
There has been no research on the effect of the drug on the ability to drive and operate machinery. Pharmacological studies show that Nebivolol 5 mg does not affect mental function. When driving and operating machinery, attention should be paid that dizziness and fatigue can sometimes occur.
Use drugs for women during pregnancy and lactation
Pregnant women
Nebivolol can be harmful to pregnancy, fetus/infant. In general, beta blockers reduce circulating flow through the placenta, underdeveloped the fetus, fetal death, miscarriage or early labor. Other unwanted side effects (hypoglycemia, slow heart rate) may occur for fetus/infant. If the treatment with beta inhibitors is necessary, it is advisable to use selective inhibitors on the beta receptor 1.
Do not use nebivolol during pregnancy unless really necessary. If the treatment with Nebivolol is necessary, it is necessary to closely monitor the blood flow to the uterus - the placenta and the development of the fetus. If it is harmful to the mother and the fetus, it is advisable to consider using other drugs. Babies must be closely monitored. Symptoms of hypoglycemia and slow heart rate often occur in the first 3 days.
breastfeeding women
In animal in vivo studies show that Nebivolol is excreted through milk. On the body, it is not known whether this drug will excrete in the mother's milk or not. Most beta blockers (especially fat -soluble preparations such as Nebivolol and active metabolites) excrete in breast milk, although different levels. Do not breastfeed when using nebivolol.
Drug interaction
Pharmacological interaction
The following interactions apply to beta-adrenergic antagonists in general.
Unreasonable combinations
Group I anti -arrhyths (quinidin, hydroquinidin, cibenzolin, flecainid, disopyramid, lidocaine, mexiletin, propafenon): slow down the atrial transmission time and reduce myocardial contraction.
Verapamil/diltiazem calcium blockers: reduce myocardial contraction and inhibit atrial transmission. Verapamil intravenous injection for patients being treated with beta inhibitors can lead to excessive hypotension and atrial block.
Coordinate with hypotension effects on the central level (Clonidin, Guanfacin, Moxonidin, Methyldopa, Rilmenidin) can seriously cause heart failure due to reducing central sympathetic nerves (reduced heart rate and cardiac supply, blood vessels). Stop the drug suddenly, especially if it has previously stopped using beta blockers, which can increase the risk of "hypertension bound back".
Precautions when combining
Anti -arrhythmia group III (amiodaron): affects the time of the atrial transmission.
Me - Halogen is volatile: Concomitance of beta and anesthetic blockers can reduce reflected tachycardia and increase the risk of hypotension. According to the general principle, avoid stopping the sudden beta blockers. Anesthesia doctor should be informed when the patient is taking Nebivolol.
insulin and diabetic oral medications: Although Nebivolol does not affect blood sugar levels, the use of simultaneously can hide some symptoms of hypoglycemia (brushing chest, tachycardia).
Baclofen (muscle relaxants), amifostin (anti -cancer support drugs): Concomitant use with hypertension treatment can cause increased blood pressure effect, so the dose of hypertension medication should be adjusted accordingly.
The combination should be considered
cardiac glycosides: simultaneously use it may increase the time of the atrial transmission. Clinical trials with Nebivolol do not show any clinical evidence of interaction. Nebivolol does not affect Digoxin's dynamics.
Calcium blockers of dihydropyridin group (amlodipin, felodipin, lacidipin, nifedipine, nicardipine, nimodipine, nitrendipine): simultaneously can increase the risk of lowering blood pressure, impaired pumping of ventricular pump function in patients with heart failure.
Anti -psychotic drugs, antidepressants (three rounds, barbiturates, phenothiazin): simultaneous use can increase the lowering effect of beta blockers (copper effects).
Non -steroid anti -inflammatory (NSAID): does not affect the hypotension effect of Nebivolol.
Sympathetic drugs: simultaneous use may lose the effect of beta blockers. Beta blockers can stimulate Alpha adrenergic effects of sympathetic drugs with both alpha and beta - adrenergic (risk of hypertension, bradycardia and heart block).
pharmacokinetic interaction
The metabolism of Nebivolol is related to CYP2D6, so the simultaneous use of these enzyme inhibitors, (especially paroxetin, fluoxetin, thioridazin, quinidin) can increase the concentration of nebivolol in plasma, increase the risk of excessive slow heart rate and other unwanted effects.Nebivolol combination with cimetidine increases the concentration of nebivolol in plasma but does not change the clinical effect. Collaborate with ranitidin does not affect the pharmacokinetics of Nebivolol. As long as taking Nebivolol at a meal, or using antacids between meals, these two drugs can be used together.
Nebivolol combination with nicardipine increases the concentration of both drugs in plasma but does not change the clinical effect. Using drugs with alcohol, Furosemid or hydrochlorothiazid does not affect the pharmacokinetics of Nebivolol. Nebivolol does not affect the pharmacokinetics and pharmacology of Warfarin.
Storage
Leave a cool place, avoid light, temperatures below 30⁰C.
To be out of reach of children, read the instructions carefully before use.
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