Ebrantil solution d/iv 5 mg/ml 10 ml No. 5 (Urapidil)

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URAPIDIL J

The drug Urapidil J is administered intravenously as a bolus or by long-term intravenous infusion - in the supine position.

Hypertensive crisis, refractory and severe arterial hypertension

Intravenous bolus administration

The drug Urapidil J in a dose of 10-50 mg is administered intravenously, slowly, under constant monitoring of blood pressure. A decrease in blood pressure is expected within 5 minutes. after introduction. Depending on the therapeutic effect, repeated administration of the drug is possible.

Intravenous drip infusion or continuous infusion using a perfusion pump

Maintenance dose (on average) - 9 mg/h, i.e. 250 mg of Urapidil J (10 ampoules of 5 ml or 5 ampoules of 10 ml) are dissolved in 500 ml of solution for infusion (1 mg = 44 drops ~ 2.2 ml). The maximum permissible ratio is 4 mg of Urapidil J per 1 ml of solution for infusion. The maximum initial rate of administration is 2 mg/min (depending on blood pressure).

The rate of drip administration depends on the patient’s blood pressure.

A solution for drip infusion intended to maintain blood pressure is prepared as follows: usually 250 mg of the drug (10 ampoules of 5 ml or 5 ampoules of 10 ml) is added to 500 ml of solution for infusion, for example, 0.9% sodium chloride solution, 5 % or 10% dextrose (glucose) solution.

If a perfusion pump is used to administer a maintenance dose, then 100 mg of the drug (4 ampoules of 5 ml, or 2 ampoules of 10 ml, or 1 ampoule of 20 ml) is injected into the syringe of the perfusion pump and diluted to 50 ml with 0.9% sodium solution chloride, 5 or 10% dextrose (glucose) solution.

Managed hypotension during and/or after surgery
Continuous
infusion with a perfusion pump or drip infusion is used to maintain blood pressure at the level achieved with intravenous administration.

Notes.

If other antihypertensive drugs have previously been used, then Urapidil J can be administered only after a period of time sufficient for the previously administered drug(s) to take effect. The dose of Urapidil J should be adjusted accordingly.

The drug is administered intravenously as injections or infusions with the patient lying on his back. Administration of the drug can be single or multiple. Injection administration of the drug can be combined with subsequent drip infusion. Parenteral therapy can be repeated if there is a new increase in blood pressure.

Elderly patients

Caution must be exercised when using antihypertensive drugs in elderly patients. The initial dose should be reduced compared to the recommended one, since elderly patients often experience a change in sensitivity to drugs of this pharmacological class (volume of distribution is reduced and T1/2 is increased).

Patients with impaired liver and/or kidney function

In patients with impaired liver and/or kidney function, a reduction in the initial dose of the drug may be required compared to the recommended doses.

Duration of therapy

Therapy for 7 days is safe, but, as a rule, when administering antihypertensive drugs parenterally, this period should not be exceeded.

If blood pressure rises again, parenteral therapy may be resumed. It is possible to initiate continuous therapy with oral antihypertensive drugs at the same time as emergency parenteral therapy. If other antihypertensive drugs have previously been used, then Urapidil J can be administered only after a period of time sufficient for the previously administered drug(s) to take effect. The dose of Urapidil J should be adjusted accordingly.

Special precautions for handling

Before administration, the ampoule should be inspected for the presence of suspended particles and discoloration. Only a clear, colorless solution should be injected.

The drug Urapidil J cannot be mixed with alkaline solutions for injections and infusions (it can lead to turbidity and the formation of a flocculent sediment).

The drug should not be mixed with other drugs with the exception of: 0.9% sodium chloride solution for infusion, 5% or 10% dextrose (glucose) solution. After opening the ampoule, the drug solution should be administered immediately.

Instructions for use TACHYBEN®

Urapidil is administered intravenously as an injection or infusion to patients in the supine position. The dose can be administered as one or more injections or as a slow IV infusion. Injections can be combined with subsequent slow infusion.

In case of hypertensive crisis, severe and very severe arterial hypertension, arterial hypertension resistant to therapy,

urapidil in a dose of 10-50 mg is administered intravenously, slowly, with constant monitoring of blood pressure. A decrease in blood pressure should be expected within 5 minutes after administration of the drug. Administration of urapidil at a dose of 10-50 mg can be repeated depending on the blood pressure response.

To maintain blood pressure achieved after intravenous administration of the drug, an intravenous infusion or infusion is performed using a syringe infusion pump.

The maximum allowable amount is 4 mg of urapidil per 1 ml of solution for infusion. The rate of infusion depends on the patient's blood pressure. The recommended initial maximum infusion rate is 2 mg/min.

The average maintenance dose is 9 mg/hour, taking into account that when diluting 250 mg of urapidil in 500 ml of solution for infusion, 1 mg = 44 drops = 2.2 ml.

Controlled reduction of blood pressure in patients with arterial hypertension during and/or after surgery

IV infusion or infusion using a syringe infusion pump is used to maintain blood pressure achieved after IV administration.

Dosage regimen

Urapidil is administered intravenously at a dose of 25 mg (= 5 ml solution for injection). If after 2 minutes the blood pressure decreases, then the blood pressure is stabilized with an infusion; if there are no changes in blood pressure after 2 minutes, urapidil is re-introduced intravenously at a dose of 25 mg (= 5 ml of solution for injection), if after 2 minutes blood pressure decreases, urapidil is continued to be administered at an initial rate of up to 6 mg for 1-2 minutes, then speed is reduced. If, after repeated administration of urapidil, blood pressure does not decrease after 2 minutes, urapidil is administered slowly intravenously at a dose of 50 mg (=5 ml of solution for injection). When blood pressure decreases after 2 minutes, further administration of the drug is continued at an initial rate of up to 6 mg for 1-2 minutes, then the rate is reduced.

Duration of therapy

Therapy lasting 7 days has been shown to be safe from a toxicological point of view; As a rule, when administering antihypertensive drugs parenterally, this period should not be exceeded. If blood pressure increases again, parenteral therapy may be resumed.

It is possible to initiate chronic treatment with oral antihypertensive agents simultaneously with emergency parenteral therapy.

In elderly patients

Antihypertensive drugs should be used with caution and started in small doses, since such patients often experience changes in sensitivity to drugs of this pharmacotherapeutic class.

In patients with impaired renal and/or liver function

A dose reduction of urapidil may be required.

Safety and effectiveness of urapidil when administered intravenously in children and adolescents aged 0 to 18 years

not installed. There are no dosage recommendations.

Instructions for use, handling and disposal

100 mg ampoules can only be used for infusion to stabilize blood pressure. For initial therapy, the drug is available in ampoules containing 25 mg and 50 mg of urapidil. After dilution, these ampoules can also be used for intravenous infusion.

The drug is diluted under aseptic conditions.

Before administration, the solution should be inspected for the presence of suspended particles or color changes. Only clear solution should be used.

Preparation of a diluted solution:

- for intravenous infusion:
• add 250 mg of urapidil (2 ampoules of 100 mg of urapidil + 1 ampoule of 50 mg of urapidil) to 500 ml of one of the compatible solvents.

— for a syringe infusion pump:

• 100 mg of urapidil is drawn into a syringe infusion pump and diluted to a volume of 50 ml with one of the compatible solvents.

Compatible solvents for dilution:

• sodium chloride solution 9 mg/ml (0.9%) for infusion;
• dextrose solution 50 mg/ml (5%), dextrose solution 100 mg/ml (10%).

Unused solution and packaging material should be disposed of in accordance with local regulations.

Ebrantil solution d/iv 5 mg/ml 10 ml No. 5 (Urapidil)

Full description

[RU]

Tradename

Ebrantil®

International nonproprietary name

Urapidil

Dosage form

Modified release capsules 30 mg, 60 mg

C leaving

One capsule contains

active substance - urapidil 30 mg, 60 mg,

excipients: granulated sugar; methacrylic acid and metal acrylate copolymer; talc; diethyl phthalate; fumaric acid; hypromellose; ethylcellulose; stearic acid; hypromellose phthalate

capsule shell composition (30 mg): gelatin, titanium dioxide (E 171), iron (III) yellow oxide (E 172); purified water; purified black ink,

composition of the capsule cap (60 mg): titanium dioxide (E 171); gelatin,

capsule shell composition (60 mg): indigo carmine (E 132); gelatin.

Description

Capsules, 30 mg

Hard gelatin capsules size No. 4 with an opaque body and yellow cap and black marking “Ebr30”. The contents of the capsules are yellow granules.

Capsules, 60 mg

Hard gelatin capsules size No. 2 with a transparent light blue body and an opaque white cap. The contents of the capsules are yellow granules.

Pharmacotherapeutic group

Antihypertensive drugs. Peripheral antiadrenergic drugs. Alpha adrenergic blockers. Urapidil.

ATX C02CA06

Pharmacological properties

Pharmacokinetics

Suction

After oral administration, up to 80-90% of urapidil is absorbed in the gastrointestinal tract. The maximum plasma concentration of long-acting forms is achieved 4-6 hours after administration; The plasma half-life is approximately 4.7 hours (3.3-7.6 hours). The absolute bioavailability of sustained-release capsules compared to intravenous administration is 72 (63-80)%. The relative bioavailability of extended-release capsules compared to the orally administered solution is 92 (83-103)%.

Distribution

The binding of urapidil to plasma proteins is 80%. The volume of distribution is 0.77 l/kg body weight. The substance passes through the blood-brain barrier and penetrates the placenta.

Metabolism

Urapidil is predominantly metabolized in the liver. The main metabolite is urapidil, hydroxylated at the 4th position of the phenyl ring, which has virtually no antihypertensive activity. The O-demethylated metabolite of urapidil is as biologically active as urapidil, but is present in very small quantities.

Excretion and excretion

The elimination of urapidil and its metabolites in humans by 50-70% occurs through the kidneys, of which about 15% of the administered dose is pharmacologically active urapidil; the rest, mainly in the form of non-antihypertensive p-hydroxylated urapidyl, are excreted via the fecal route.

Special patient groups

In the elderly and in patients with severe hepatic and/or renal impairment, volumes of distribution and clearance are reduced and the plasma half-life is longer.

Pharmacodynamics

Urapidil causes a decrease in systolic and diastolic blood pressure by reducing peripheral vascular resistance. The heart rate remains unchanged in most cases. Cardiac output does not change; cardiac output, which is reduced by increased afterload, may increase.

Urapidil has a central and peripheral zone of action. Peripheral action - urapidil blocks predominantly postsynaptic alpha-1 receptors and thus prevents the vasoconstrictor effect of catecholamines. With central action, urapidil reduces the activity of circulatory-regulatory centers; this prevents a reflex increase in sympathetic tone or decreases sympathetic tone.

Indications for use

• arterial hypertension

Directions for use and doses

Recommended dosage:

To gradually lower blood pressure, treatment begins with taking Ebrantil® 30 mg twice a day (corresponding to 30 mg urapidil × 2 times a day).

If a more rapid reduction in blood pressure is required, it is recommended to take Ebrantil® at a dose of 60 mg twice a day (corresponding to 60 mg urapidil × 2 times a day).

The dose can be gradually adapted based on the individual needs of the patient. The maintenance dose is 60-180 mg of urapidil per day, the total amount is divided into two separate doses.

Mode of application:

Modified-release capsules should be taken with morning and evening meals, swallowed whole with a small amount of liquid.

Modified-release urapidil capsules are suitable for long-term use. Treatment of hypertension with this drug requires regular medical supervision.

Special patient groups

Dosage for liver failure

Patients with liver failure may require a reduction in the dose of urapidil.

Dosage for renal failure

Patients with moderate to severe renal impairment may require a dose reduction during long-term treatment with urapidil modified-release capsules.

Dosage for elderly people

Elderly patients on long-term treatment with modified-release urapidil capsules may require a dose reduction.

Use in pediatrics

There is insufficient experience with children and adolescents under 18 years of age.

Side effects

Adverse side reactions are distributed in the following order, taking into account the frequency of occurrence: very often (≥1/10); often (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000); very rare (<1/10000), unknown (cannot be estimated based on available data).

* In very rare cases, there is a decrease in the number of platelets along the development time coinciding with the use of urapidil, however, in such cases, immunological studies refute the connection of thrombocytopenia with the use of urapidil.

Reports of suspected adverse reactions

Providing reports of suspected adverse reactions during the post-marketing period of a drug is important because it allows for continuous monitoring of the benefit/risk balance of the drug. Healthcare professionals are asked to report any suspected adverse reactions.

Contraindications

• hypersensitivity (allergy) to any of the components of the drug
• pregnancy and lactation
• children and adolescents up to 18 years of age (for a dosage of 60 mg)

Drug interactions

The antihypertensive effect of urapidil can be enhanced by the use of alpha-adrenergic receptor blockers, vasodilators and other antihypertensive drugs simultaneously, as well as in cases of dehydration (diarrhea, vomiting) and alcohol consumption.

Concomitant use of cimetidine may cause serum urapidil levels to increase by up to 15%.

Since there is still no complete information on combination treatment with angiotensin-converting enzyme inhibitors (ACEIs), such treatment is not recommended at this time.

special instructions

Particular caution is required when urapidil is used:

• in case of heart failure, the cause of which is a functional disorder of a mechanical nature (for example, stenosis of the aortic or mitral valves), with pulmonary embolism or deterioration of myocardial function due to pericardial disease;
• in the treatment of patients with liver dysfunction;
• in patients with moderate to severe renal dysfunction;
• in elderly patients;
• in the treatment of patients who are simultaneously receiving cimetidine

Use in pediatrics

The drug should not be used in children and adolescents under 18 years of age, as no clinical studies have been conducted in children.

Patients with rare hereditary disorders such as fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency should not use urapidil.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms.

During therapy with Ebrantil®, care must be taken when operating machines or potentially dangerous mechanisms. This is especially important after starting treatment, when changing medications, or when taking alcohol.

Overdose

Symptoms

• circulatory symptoms: dizziness, orthostatic hypotension, collapse;
• symptoms from the central nervous system: fatigue, decreased reaction speed.

Treatment

Excessive drops in blood pressure can be reduced by elevating the legs as well as replenishing blood volume. If these measures are ineffective, vasoconstrictor drugs may be administered slowly intravenously with constant monitoring of blood pressure.

In very rare cases, intravenous administration of adrenaline, 0.5-1.0 mg, diluted in 10 ml of isotonic sodium chloride solution is necessary.

Release form and packaging

30 capsules are placed in polyethylene bottles, sealed with screw-on polyethylene caps with a cavity containing silica gel, and equipped with a ring to control the first opening.

1 bottle, along with instructions for medical use in the state and Russian languages, is placed in a cardboard box.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf life

2 years

Do not use after expiration date.

Conditions for dispensing from pharmacies

On prescription

Manufacturer

Takeda GmbH, Oranienburg, Germany.

Name and country of the marketing authorization holder

Takeda GmbH, Germany

Address of the organization that receives claims from consumers on the quality of products (goods) in the territory of the Republic of Kazakhstan and is responsible for post-registration monitoring of the safety of the medicinal product

Takeda Kazakhstan LLP

Almaty, st. Shashkina 44

Phone number (727) 2444004

Fax number (727) 2444005

E-mail address