Expiration date: 01/2025

Release form and composition:

Tablets, coated white or almost white, round, lenticular, scored on one side on a break - kernel white, or almost white.

1 tablet contains:

betaxolol (hydrochloride) 20 mg

Excipients: lactose monohydrate, cellulose microcrystalline, sodium starch of glycolate, silica colloidal anhydrous, magnesium stearate, hydroxypropyl methylcellulose, titanium oxide, polyethylene glycol 400.

10 PCs. - packaging sells contoured (3) - packs cardboard.

Pharmacological action:

Cardioselective beta1-blocker without intrinsic sympathomimetic activity. Has weak membrane-stabilizing activity.

It has antihypertensive effect due to a decrease in minute volume of the heart and a decrease in sympathetic stimulation of peripheral vessels.

When used in therapeutic doses the drug has not expressed cardiodepressivne action does not affect glucose metabolism, does not reduce the bronchodilator action of beta-agonists, does not cause a delay of sodium and water in the body.

Drug action begins in 1-2 h, duration – 24 h

The antihypertensive effect occurs within 2-5 days, the maximum effect develops after 1-2 months.

Pharmacokinetics:

Suction

After intake of fully absorbed from the gastrointestinal tract (100%). Bioavailability is 90%. Cmax achieved within 2-4 hours.

Distribution

Of proteins associated with blood by 55%. Vd - from 4.9 to 9.8 l/kg.

Slightly penetrates the GEB and placental barrier, slightly out of breast milk.

Excretion

T1/2 is 14-22 hours Excreted in urine (15% unchanged). Ground clearance is 4.7 ml/min, with age, the clearance increases.

Indications:

• arterial hypertension
• IHD: exertional angina and rest, myocardial infarction (in the complex therapy)
• hypertrophic cardiomyopathy
• cardiac arrhythmias (sinus tachycardia, supraventricular and ventricular tachyarrhythmia and arrhythmia, arrhythmia on the background of mitral valve prolapse, hyperthyroidism).

Dosing regimen:

The Betacam is taken 1 time/day, regardless of meals, squeezed water.

When hypertension the initial dose is 5-10 mg/day. After 1-2 weeks if necessary, increase it to 20 mg.

Side effects:

From the side of cardiovascular system: bradycardia, AV-blockade, heart failure, orthostatic hypotension, worsening of peripheral circulation (cold extremities, paresthesia, Raynaud's syndrome).

The respiratory system: bronchospasm.

Allergic reactions: skin rash, urticaria.

CNS: asthenia, depression, fatigue, drowsiness, confusion, hallucinations, dizziness, and headache.

From the digestive system: nausea, rarely – vomiting, diarrhea or constipation, cholestasis.

On the part of the organ of vision: dry eye.

With the hematopoietic system: leukopenia, thrombocytopenia.

Other: exacerbation of psoriasis, impotence.

Contraindications:

• chronic heart failure II-III stage
• cardiogenic shock
• AV blockade II or III extent
• sinoatrial block
• bradycardia
• Prinzmetal's angina
• cardiomegaly
• hypotension (systolic BP less than 100 mm Hg.St.)
• diabetes
• myasthenia gravis
• psoriasis
• Raynaud's syndrome
• occlusive disease
• expressed violation of the kidney
• bronchial asthma
• emphysema
• chronic obstructive bronchitis
• hypersensitivity to betaxolol and other components of the drug.

Pregnancy and lactation:

The drug of Betacam during pregnancy and lactation (breastfeeding) perhaps with caution and only when potential benefits of its use for the mother outweighs the potential risk to the fetus.

Special instructions:

With caution should use the drug in pheochromocytoma.

In case of the need for planned surgical treatment elimination of the drug is carried out for 48 h before General anesthesia.

Keep in mind the possibility of development of heart failure in the first days of treatment of Betacam in patients with the appropriate predisposition.

Betaxolol may mask the symptoms of hypoglycemia (e.g., tachycardia), so when using it in patients with diabetes should regularly monitor glucose levels in the blood.

Drug Betacam is used by the heart rate. With the development of bradycardia, reduce dose or cancel the drug.

Upon termination of therapy with a medication Betacam recommended gradual dose reduction (5 mg every 3-4 days) for 1-2 weeks to avoid withdrawal syndrome.

The drug is not recommended to prescribe concurrently with MAO inhibitors.

Use in Pediatrics

Not recommended the use of the drug in children.

Effects on ability to drive vehicles and management mechanisms

With caution should appoint drug patients whose activity requires increased attention and rapid psychomotor reactions.

Overdose:

Symptoms: bradycardia, AV-blockade, a drop in blood pressure, fainting, heart failure, bronchospasm, seizures.

Treatment: symptomatic. At AV-blockade is shown in/with the introduction of atropine, epinephrine, or alupent (adrenaline), a temporary pacemaker. Hypotension, if no signs of pulmonary edema, it is recommended in/in drip infusion of plasma substitutes, in case of inefficiency – epinephrine (adrenaline), dopamine, dobutamine. In the case of bronchospasm - inhaled beta2-agonists in convulsions - diazepam.

Drug interactions:

While the use of Betac amiodarone, calcium channel blockers (verapamil, diltiazem) and beta-blockers used as eye drops for glaucoma, can enhance the inhibitory effect betaxolol on myocardial contractility and cardiac conduction.

While the use of Betac cardiac glycosides increases the risk of AV-blockade.

Antihypertensive agents combined with Betac enhance its hypotensive effect.

While the use of Bataka of drugs for inhalation anesthesia increases the risk of depression of myocardial function and hypotension. The duration of action of non-depolarizing muscle relaxants may increase while simultaneously receiving Betake.

NSAIDs, while the application weakens the hypotensive action Betake due to the delay of sodium and water and inhibiting the synthesis of prostaglandins in the kidneys. Estrogens reduce gipotenzivny effect Bataka (due to sodium).

Cocaine with simultaneous use may decrease therapeutic effects betaxolol.

With the combined use of Bataka and agonists or xantinov their therapeutic effects are mutually attenuated.

Concurrent use of phenothiazines with Betac leads to increased concentration of each of the drugs in plasma.

Betaxolol slows down the excretion of lidocaine and theophylline.

Sulfasalazine increases the level betaxolol in the serum.

Terms and conditions of storage:

The drug should be stored in a dry, protected from light and inaccessible to children at temperature not exceeding 25°C. shelf Life – 2 years.