Release form, composition and packing Betac
Tablets, coated in white or almost white, round, biconvex, with Valium on one side on a break - the core of a white or nearly white. 1 tab. betaxolol (as hydrochloride) 20 mg. Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica colloidal anhydrous, magnesium stearate, hydroxypropyl methylcellulose, titanium oxide, polyethylene glycol 400.
Clinico-pharmacological group: Beta1-blocker.
Pharmacological action
Cardioselective beta1-blocker without intrinsic sympathomimetic activity. Has a weak membrane stabilizing activity. Exerts antihypertensive effects due to reduced cardiac output and a decrease in sympathetic stimulation of peripheral vessels.
When used in therapeutic doses of drug has not expressed cardiodepressive action does not affect the exchange of glucose, does not diminish bronhorasshiryayuschego-acting beta-agonists, does not cause retention of sodium and water in the body.
Effect of the drug begins after 1-2 h, duration - 24 hours antihypertensive effect occurs within 2-5 days, maximum effect develops in 1-2 months.
Pharmacokinetics
Suction
After oral administration is completely absorbed from the gastrointestinal tract (100%). Bioavailability is 90%. Cmax achieved within 2-4 hours
Distribution
Associated with blood proteins by 55%. Vd - from 4.9 to 9.8 L / kg. Slightly penetrates the blood-brain barrier and placental barrier, little is excreted in breast milk.
Breeding
T1 / 2 of 14-22 hours is excreted in urine (15% unchanged). Ground clearance is 4.7 ml / min, clearance increases with age.
Statement
hypertension;
Coronary heart disease: angina and rest myocardial infarction (combined therapy);
hypertrophic cardiomyopathy;
cardiac arrhythmias (sinus tachycardia, supraventricular and ventricular tachyarrhythmia and beats, arrhythmia, combined mitral valve prolapse, hyperthyroidism).
Dosing regimen
Betacam take 1 time per day, regardless of the meal, washed down with water. Hypertension the initial dose is 5-10 mg / day. 1-2 weeks if necessary it was increased to 20 mg.
Side effect
Cardio-vascular system: bradycardia, AV-block, heart failure, orthostatic hypotension, deterioration of peripheral circulation (cold extremities, paresthesias, Raynaud's syndrome).
With the respiratory system: bronchospasm. Allergic reactions: skin rash, urticaria.
CNS: fatigue, depression, fatigue, drowsiness, confusion, hallucinations, dizziness, headache.
From the digestive system: nausea, rarely - vomiting, diarrhea or constipation, cholestasis.
By the authority of: dry eyes.
From the hemopoietic system: leucopenia, thrombocytopenia.
Other: exacerbation of psoriasis, impotency.
Contraindications
chronic heart failure II-III stage;
cardiogenic shock;
AV-block II or III degree;
sinoatrial block;
bradycardia;
Prinzmetal angina;
cardiomegaly;
hypotension (systolic blood pressure less than 100 mm Hg);
diabetes mellitus;
myasthenia gravis;
psoriasis;
Raynaud's syndrome;
endarteritis obliterans;
marked renal dysfunction;
bronchial asthma;
emphysema;
chronic obstructive bronchitis;
increased sensitivity to betaxolol and other ingredients.
Pregnancy and lactation
Use of the drug Betacam during pregnancy and lactation (breastfeeding) is possible with caution and only when the potential benefits of its application to the mother justifies the potential risk to the fetus.
Use in renal impairment
The drug is contraindicated in marked renal impairment.
Cautions
Precautions should be used in the preparation for pheochromocytoma. In the case of the need for routine surgical treatment of the abolition of the preparation is carried out for 48 hours before general anesthesia. Should take into account the possibility of heart failure in the first days of treatment with Betacam in patients with an appropriate disposition. Betaxolol may mask symptoms of hypoglycemia (eg, tachycardia), so that when applied to patients with diabetes should regularly monitor blood glucose levels.
Betacam drug use under control of HR. With the development of bradycardia dose reduce or cancel the product. Upon the termination of therapy with Betacam recommend a gradual reduction in dose (5 mg every 3-4 days) for 1-2 weeks in order to avoid withdrawal symptoms. The drug is not recommended concurrently with MAO inhibitors.
Use in pediatrics
It is not recommended to use the drug in children.
Effects on ability to drive vehicles and management mechanisms
Precautions should be administered to patients whose activities require increased attention and rapid psychomotor reactions.
Overdose
Symptoms: bradycardia, AV-block, falling blood pressure, fainting, heart failure, bronchospasm, seizures.
Treatment: symptomatic. When AV-blockade was shown to intravenous atropine alupenta or epinephrine (adrenaline), a temporary pacemaker. In arterial hypotension, if there are no signs of pulmonary edema, we recommend IV drip infusion of plasma substitutes, and inefficiency - epinephrine (adrenaline), dopamine, dobutamine. In the event of bronchospasm - an inhaled beta 2-adrenoceptor agonists, with cramps - diazepam.
Drug Interactions
In an application with Betacam amiodarone, calcium channel blockers (verapamil, diltiazem) and beta-blockers, used as eye drops for glaucoma, may increase the inhibitory effect of betaxolol on cardiac contractility and cardiac conduction.
In an application with Betacam cardiac glycosides increase the probability of AV-block. Antihypertensive drugs in a joint application with Betacam enhance its hypotensive action.
While the application Betacam with preparations for inhalation anesthesia increases the risk of depression of the myocardium and the development of arterial hypotension. Duration of action of nondepolarizing muscle relaxants may be increased against the background of the simultaneous reception of Betacam. NSAIDs, while the application weaken the hypotensive effect Betacam by retention of sodium and water and inhibition of prostaglandin synthesis in the kidneys. Estrogen also reduces the hypotensive effect Betacam (due to sodium retention). Cocaine, while the application may reduce the therapeutic effects of betaxolol.
The combined use of Betacam and agonists or xanthine their therapeutic effects are relatively weaker. Concomitant use of phenothiazines with Betacam leads to increased concentrations of each drug in blood plasma. Betaxolol slows the excretion of lidocaine and theophylline. Sulfasalazine improves betaxolol in blood serum.
Conditions and terms of
The drug should be stored in a dry place, protected from light and away from children at or above 25 ° C. Shelf life - 2 years.
Tablets, coated in white or almost white, round, biconvex, with Valium on one side on a break - the core of a white or nearly white. 1 tab. betaxolol (as hydrochloride) 20 mg. Excipients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, silica colloidal anhydrous, magnesium stearate, hydroxypropyl methylcellulose, titanium oxide, polyethylene glycol 400.
Clinico-pharmacological group: Beta1-blocker.
Pharmacological action
Cardioselective beta1-blocker without intrinsic sympathomimetic activity. Has a weak membrane stabilizing activity. Exerts antihypertensive effects due to reduced cardiac output and a decrease in sympathetic stimulation of peripheral vessels.
When used in therapeutic doses of drug has not expressed cardiodepressive action does not affect the exchange of glucose, does not diminish bronhorasshiryayuschego-acting beta-agonists, does not cause retention of sodium and water in the body.
Effect of the drug begins after 1-2 h, duration - 24 hours antihypertensive effect occurs within 2-5 days, maximum effect develops in 1-2 months.
Pharmacokinetics
Suction
After oral administration is completely absorbed from the gastrointestinal tract (100%). Bioavailability is 90%. Cmax achieved within 2-4 hours
Distribution
Associated with blood proteins by 55%. Vd - from 4.9 to 9.8 L / kg. Slightly penetrates the blood-brain barrier and placental barrier, little is excreted in breast milk.
Breeding
T1 / 2 of 14-22 hours is excreted in urine (15% unchanged). Ground clearance is 4.7 ml / min, clearance increases with age.
Statement
hypertension;
Coronary heart disease: angina and rest myocardial infarction (combined therapy);
hypertrophic cardiomyopathy;
cardiac arrhythmias (sinus tachycardia, supraventricular and ventricular tachyarrhythmia and beats, arrhythmia, combined mitral valve prolapse, hyperthyroidism).
Dosing regimen
Betacam take 1 time per day, regardless of the meal, washed down with water. Hypertension the initial dose is 5-10 mg / day. 1-2 weeks if necessary it was increased to 20 mg.
Side effect
Cardio-vascular system: bradycardia, AV-block, heart failure, orthostatic hypotension, deterioration of peripheral circulation (cold extremities, paresthesias, Raynaud's syndrome).
With the respiratory system: bronchospasm. Allergic reactions: skin rash, urticaria.
CNS: fatigue, depression, fatigue, drowsiness, confusion, hallucinations, dizziness, headache.
From the digestive system: nausea, rarely - vomiting, diarrhea or constipation, cholestasis.
By the authority of: dry eyes.
From the hemopoietic system: leucopenia, thrombocytopenia.
Other: exacerbation of psoriasis, impotency.
Contraindications
chronic heart failure II-III stage;
cardiogenic shock;
AV-block II or III degree;
sinoatrial block;
bradycardia;
Prinzmetal angina;
cardiomegaly;
hypotension (systolic blood pressure less than 100 mm Hg);
diabetes mellitus;
myasthenia gravis;
psoriasis;
Raynaud's syndrome;
endarteritis obliterans;
marked renal dysfunction;
bronchial asthma;
emphysema;
chronic obstructive bronchitis;
increased sensitivity to betaxolol and other ingredients.
Pregnancy and lactation
Use of the drug Betacam during pregnancy and lactation (breastfeeding) is possible with caution and only when the potential benefits of its application to the mother justifies the potential risk to the fetus.
Use in renal impairment
The drug is contraindicated in marked renal impairment.
Cautions
Precautions should be used in the preparation for pheochromocytoma. In the case of the need for routine surgical treatment of the abolition of the preparation is carried out for 48 hours before general anesthesia. Should take into account the possibility of heart failure in the first days of treatment with Betacam in patients with an appropriate disposition. Betaxolol may mask symptoms of hypoglycemia (eg, tachycardia), so that when applied to patients with diabetes should regularly monitor blood glucose levels.
Betacam drug use under control of HR. With the development of bradycardia dose reduce or cancel the product. Upon the termination of therapy with Betacam recommend a gradual reduction in dose (5 mg every 3-4 days) for 1-2 weeks in order to avoid withdrawal symptoms. The drug is not recommended concurrently with MAO inhibitors.
Use in pediatrics
It is not recommended to use the drug in children.
Effects on ability to drive vehicles and management mechanisms
Precautions should be administered to patients whose activities require increased attention and rapid psychomotor reactions.
Overdose
Symptoms: bradycardia, AV-block, falling blood pressure, fainting, heart failure, bronchospasm, seizures.
Treatment: symptomatic. When AV-blockade was shown to intravenous atropine alupenta or epinephrine (adrenaline), a temporary pacemaker. In arterial hypotension, if there are no signs of pulmonary edema, we recommend IV drip infusion of plasma substitutes, and inefficiency - epinephrine (adrenaline), dopamine, dobutamine. In the event of bronchospasm - an inhaled beta 2-adrenoceptor agonists, with cramps - diazepam.
Drug Interactions
In an application with Betacam amiodarone, calcium channel blockers (verapamil, diltiazem) and beta-blockers, used as eye drops for glaucoma, may increase the inhibitory effect of betaxolol on cardiac contractility and cardiac conduction.
In an application with Betacam cardiac glycosides increase the probability of AV-block. Antihypertensive drugs in a joint application with Betacam enhance its hypotensive action.
While the application Betacam with preparations for inhalation anesthesia increases the risk of depression of the myocardium and the development of arterial hypotension. Duration of action of nondepolarizing muscle relaxants may be increased against the background of the simultaneous reception of Betacam. NSAIDs, while the application weaken the hypotensive effect Betacam by retention of sodium and water and inhibition of prostaglandin synthesis in the kidneys. Estrogen also reduces the hypotensive effect Betacam (due to sodium retention). Cocaine, while the application may reduce the therapeutic effects of betaxolol.
The combined use of Betacam and agonists or xanthine their therapeutic effects are relatively weaker. Concomitant use of phenothiazines with Betacam leads to increased concentrations of each drug in blood plasma. Betaxolol slows the excretion of lidocaine and theophylline. Sulfasalazine improves betaxolol in blood serum.
Conditions and terms of
The drug should be stored in a dry place, protected from light and away from children at or above 25 ° C. Shelf life - 2 years.
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