Universal reference book for medicines
Name of the preparation: EHRANTIL ® (EBRANTIL ® )

Active substance: urapidil

Type: Alpha 1- blocker

Manufacturer: TAKEDA (Germany)
Composition, form of production and packaging

Capsules of prolonged action hard gelatinous, №4, with an opaque case and a lid of yellow color, with an inscription of black color "Ebr 30" on the body;
the contents of the capsules are yellow granules.
1 caps.

urapidil 30 mg

Auxiliary substances: sugar grits (sucrose, starch syrup) - 62.43 mg, methacrylic acid and methyl methacrylate copolymer (1: 2) - 0.62 mg, talc 1.18 mg, diethyl phthalate 0.06 mg, fumaric acid 8.88 mg, hypromellose 11.28 mg, ethylcellulose - 1.75 mg, stearic acid 0.47 mg, hypromellose phthalate 0.72 mg.

The composition of the capsule shell: gelatin - 32.707 mg, titanium dioxide - 1.2 mg, iron oxide, yellow oxide - 0.293 mg, water - 5.8 mg.

The composition of black ink: (shellac, iron oxide, black oxide, propylene glycol, ammonia water) - not more than 0.19 mg.

The composition of sugar grits (sucrose, starch syrup): sucrose - 80-91.5%, corn starch - 8.5-20%, water - max.
1.5%.
30 pcs.
- polyethylene bottles (1) - cardboard packs.
50 pcs.
- polyethylene bottles (1) - cardboard packs.
100 pieces.
- polyethylene bottles (1) - cardboard packs.
Capsules of prolonged action hard gelatinous, №2, with a transparent casing of light-blue color and an opaque lid of white color;
the contents of the capsules are yellow granules.
1 caps.

urapidil 60 mg

Auxiliary substances: sugar grits (sucrose, starch syrup) - 124.86 mg, methacrylic acid and methyl methacrylate copolymer (1: 2) 1.24 mg, talc 2.35 mg, diethyl phthalate 0.12 mg, fumaric acid 17.77 mg, hypromellose 22.55 mg, ethyl cellulose - 3.51 mg, stearic acid - 0.95 mg, hypromellose phthalate - 1.43 mg.

The composition of the capsule shell: gelatin - 53.33 mg, titanium dioxide - 0.504 mg, indigocarmine - 0.031 mg, water - 9.135 mg.

The composition of sugar grits (sucrose, starch syrup): sucrose - 80-91.5%, corn starch - 8.5-20%, water - max.
1.5%.
30 pcs.
- polyethylene bottles (1) - cardboard packs.
50 pcs.
- polyethylene bottles (1) - cardboard packs.
100 pieces.
- polyethylene bottles (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

Antihypertensive drug.
Urapidil has a central and peripheral mechanism of action. Blocks postsynaptic? 1- adrenoreceptors, which reduces the OPSS.
Regulates the central mechanism of maintaining vascular tone by stimulating the serotonin 5-HT1A receptors of the vasomotor center (prevents reflex increase in the tone of the sympathetic nervous system).
Heart rate, cardiac output does not change. Low cardiac output may be increased by lowering the OPSS.
Stimulates presynaptic?
2- adrenoreceptors.
Reduces systolic and diastolic blood pressure, does not cause reflex tachycardia.

Reduces pre- and afterload on the heart, increases the efficiency of cardiac contraction, thus (in the absence of arrhythmia) increases the reduced minute volume of the heart.

It does not affect the parameters of carbohydrate metabolism, the exchange of uric acid and does not cause a fluid retention in the body.

PHARMACOKINETICS

Suction

After oral administration, 80-90% of urapidil is absorbed from the digestive tract.
C max in blood plasma is achieved 4-6 hours after ingestion.
The relative bioavailability of prolonged-action capsules, compared with the solution of urapidil for oral administration, is 92 (83-103)%.

Distribution

Binding to plasma proteins is approximately 80%.
V d - 0.77 l / kg body weight.
It penetrates the GEB and the placental barrier.

Metabolism

Metabolized mainly in the liver.
The main metabolite is the hydroxylated derivative (in the 4-position of the benzene ring), which practically does not possess antihypertensive activity. O-demethylated metabolite is formed in very small amounts and almost as active as urapidil.
Excretion

T 1/2 is approximately 4.7 hours (3.3-7.6 hours).
50-70% of urapidil and its metabolites (15% as active substance) is excreted by the kidneys, the rest is excreted through the intestines in the form of metabolites (mainly in the form of inactive n-hydroxylated urapidil).
Pharmacokinetics in special clinical cases

In elderly patients and in patients with severe hepatic and / or renal insufficiency, V d and clearance are reduced, and T 1/2 is increased.

INDICATIONS

- severe arterial hypertension (in combination therapy).

DOSING MODE

The drug is taken inside, in the morning and in the evening, while eating, squeezed a small amount of water.

The dose of the drug must be selected individually.

Assign to 30 mg 2 times / day.
If necessary, the dose of Egrantil ® can be increased to 120 mg (2 capsules 30 mg or 1 capsule 60 mg 2 times / day).
The maximum daily dose is 180 mg in 2 divided doses.

In elderly patients , as well as patients with impaired liver function and / or renal insufficiency of moderate and severe degree with the use of the drug Egrantil®, a dose reduction may be required depending on the indices of blood pressure and laboratory indicators of liver and / or kidney function.

SIDE EFFECT

Determination of the frequency of adverse reactions: very often (> 1/10), often (> 1/100 and <1/10), infrequently (> 1/1000 and <1/100), rarely (> 1/10 000 and <1 / 1000), very rarely (<1/10 000), the frequency is unknown (the frequency can not be determined from the available data).

Often Infrequently Very rarely Frequency unknown

From the side of the cardiovascular system

Heart palpitations, tachycardia, bradycardia, a feeling of constriction or chest pain (symptoms typical for angina attack), orthostatic hypotension

From the digestive system

Nausea Vomiting, diarrhea, dryness of the oral mucosa

Laboratory indicators

Reversible increase in hepatic enzyme activity, thrombocytopenia *

From the nervous system

Dizziness, headache Increased fatigue, sleep disturbances Dysphoria

From the side of the reproductive system

Priapism

From the urinary system

Increased urination and increased incontinence

From the skin and subcutaneous tissues

Dryness of the skin

Allergic reactions

Skin itching, exanthema, redness of the skin Angioedema, urticaria

From the respiratory system

Nasal congestion

General reactions

Generalized edema

* In very rare cases thrombocytopenia was observed during the period of using the drug Ebrantil ® , although a causal relationship with the treatment administered by the preparation through, for example, immunological tests, is not established.

The patient should inform the doctor of any of the above side effects or any other side effects.

CONTRAINDICATIONS

- age under 18 years (effectiveness and safety not established);

- Pregnancy;

- the period of lactation (breastfeeding);

- fructose intolerance and glucose / galactose absorption disorder or sugarase / isomaltase deficiency;

- Hypersensitivity to the components of the drug.

With caution:
impaired liver function, patients with moderate and severe renal insufficiency, chronic heart failure, stenosis of the aortic and mitral valve, pulmonary embolism, violation of myocardial contractility due to pericardial disease (eg, tamponade, chronic pericarditis), with simultaneous application with cimetidine, .
PREGNANCY AND LACTATION

Ebrantil ® should not be used during pregnancy and during breastfeeding due to the lack of clinical data on use.

APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with moderate and severe renal insufficiency , using Ebrantil ® may require a dose reduction depending on the indices of blood pressure and laboratory indicators of liver and / or kidney function.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In patients with impaired liver function of medium and severe degree with the use of the drug Egrantil ®, a dose reduction may be required depending on the indices of blood pressure and laboratory indicators of liver and / or kidney function.

APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 18 years.

APPLICATION IN ELDERLY PATIENTS

In elderly patients with the use of the drug Ebrantil ®, a dose reduction may be required depending on the indices of blood pressure and laboratory indicators of liver and / or kidney function.

SPECIAL INSTRUCTIONS

There are cases of development of prolonged erection and priapism against the background of therapy with alpha 1- adrenoblockers.
If the erection persists for more than 4 hours, you should immediately seek medical help. If priapism therapy has not been carried out immediately, it can lead to damage to the tissues of the penis and an irreversible loss of potency.
Impact on the ability to drive vehicles and manage mechanisms

During the period of therapy with the drug Egrantil ® , care must be taken when driving vehicles and engaging in other potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

This is especially true at the beginning of treatment, with an increase in the dose of the drug or the replacement of the drug, as well as the use of alcohol during the treatment period.

OVERDOSE

Symptoms: marked decrease in blood pressure, dizziness, increased fatigue, retardation, collapse.

Treatment: during the first 4 hours after an overdose it is possible to wash the stomach and use activated carbon.
In the case of a marked decrease in blood pressure, the patient should be given a horizontal position, and the legs should be raised; to carry out measures to increase bcc, symptomatic therapy.
DRUG INTERACTION

The antihypertensive effect of urapidil can be enhanced by joint admission with alpha-adrenoblockers, vasodilators or other antihypertensive agents, as well as in conditions associated with a decrease in body fluid (diarrhea, vomiting) and with the intake of ethanol (alcohol).

With simultaneous administration of cimetidine C max, urapidil in blood plasma can increase by 15%.

It is not recommended to use with ACE inhibitors, because data on such a combination is not enough.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life - 2 years. Do not use after the expiration date printed on the package.
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