Betmiga tabs 50mg #30

Instruction for Betmiga

You can buy Betmiga here

Indications

Overactive bladder (GMF) with symptoms of urinary incontinence, frequent urination and urge to urinate.

Contraindications

- Hypersensitivity to the active substance or any of the excipients;
- children's age (lack of data on efficacy and safety);
- pregnancy and breastfeeding period;
- terminal stage of renal failure (eGFR <15 ml / min / 1.73 m2 or patients who are shown to undergo hemodialysis);
- severe stage of renal failure (eGFR 15-29 ml / min / 1.73 m2) with the simultaneous use of strong inhibitors of the isoenzyme CYP3A;
- severe stage of liver failure (Child-Pugh class C);
- moderate stage of liver failure (Child-Pugh class B) with simultaneous use of strong inhibitors of the CYP3A isoenzyme.

Carefully

Patients with renal and hepatic failure
Patients with severe renal failure should be treated with caution and the dose for them should not exceed 25 mg / day.
Patients with mild and moderate stage of renal failure, while taking strong inhibitors of the isoenzyme CYP3A, should be treated with caution and the dose for them should not exceed 25 mg / day.
Patients with moderate hepatic insufficiency should be treated with caution and the dose for them should not exceed 25 mg / day.
Patients with a mild stage of liver failure (Child-Pugh Class A), while taking strong inhibitors of the CYP3A isoenzyme, should be treated with caution and the dose for them should not exceed 25 mg / day.
Patients with uncontrolled severe arterial hypertension
Since there were no studies with Betmiga in patients with uncontrolled severe arterial hypertension (systolic blood pressure> 180 mm Hg and / or diastolic blood pressure> 110 mm Hg), therefore Betmiga is not recommended for use in this category of patients.
Only limited data are available regarding the use of the Betmiga drug in patients suffering from stage 2 hypertension (systolic blood pressure> 160 mm Hg. And / or diastolic blood pressure> 100 mm Hg).
Patients with congenital or acquired prolongation of the QT interval
Mirabegron at therapeutic doses did not demonstrate a clinically significant lengthening of the QT interval in the framework of the studies. However, since patients taking drugs that may provoke prolongation of the QT interval did not participate in these studies using Mirabegron, the effect on such categories of patients is not known. This category of patient needs to take Mirabegron with caution.
Mirabagron should be used with caution in combination with drugs with a narrow therapeutic index, and drugs that are largely metabolized by the CYP2D6 isoenzyme, for example, thioridazine, Type 1C drugs for treating arrhythmias , desipramine). Mirabegron should also be taken with caution when taken together with drugs that are metabolized by the CYP2D6 isoenzyme and the dose of which is subject to individual determination.

Use Betmiga during pregnancy and lactation

Pregnancy

There are limited data on the use of mirabegron during pregnancy. The results of animal reproductive toxicity studies do not indicate a direct or indirect negative effect of Miragegron. To prevent possible negative effects on the fetus, the use of the Betmiga drug should be avoided in pregnant women and in women of childbearing age and not using contraceptives.

Lactation period

In rodents, Mirabagron is excreted in breast milk, therefore, in humans there is also a risk of the drug Betmiga getting into breast milk. Studies on the effect of mirabegron on the production of breast milk, the allocation of miragegrone with breast milk and effects on the child are absent Mirabegron should not be used in women during lactation.

Fertility

In animal studies, the effect of mirabegron on fertility in non-lethal doses was not detected.
It is not established whether Mirabagron affects fertility in humans.

Application for violations of the liver

Patients with moderate hepatic insufficiency should be treated with caution and the dose for them should not exceed 25 mg / day.
Patients with a mild stage of liver failure (Child-Pugh Class A), while taking strong inhibitors of the CYP3A isoenzyme, should be treated with caution and the dose for them should not exceed 25 mg / day.

Application for violations of renal function

Patients with severe renal failure should be treated with caution and the dose for them should not exceed 25 mg / day.
Patients with mild and moderate stage of renal failure, while taking strong inhibitors of the isoenzyme CYP3A, should be treated with caution and the dose for them should not exceed 25 mg / day.

Use in children

It is forbidden to use Betmiga in children, because no data on efficacy and safety.
Active ingredient: Mirabegron.
Product form: Extended-release tablets, film-coated 50mg №30.

Adults (over 18 years old), incl. the elderly

At 50 mg once a day inside, with a liquid, regardless of the time of meals.
The tablet must be taken whole, it can not be chewed, because This may affect the prolonged release of the active substance.

Patients with renal and hepatic failure

The following table shows the recommended daily doses for patients suffering from renal or hepatic insufficiency, with or without inhibitors of the CYP3A isoenzyme.
Strong inhibitors of isoenzyme CYP3A
Without inhibitor With inhibitor
Renal impairment * Easy stage 50 mg 25 mg
Moderate stage 50 mg 25 mg
Severe stage 25 mg Not recommended
Hepatic insufficiency ** Easy stage 50 mg 25 mg
Moderate stage 25 mg 11s recommended
* easy stage: eGFR 60 - 89 ml / min / 1.73 m2; moderate stage: eGFR 30–59 ml / min / 1.73 m2; severe stage: eGF 15–29 ml / min / 1.73 m2
** easy stage: class A on the Child-Pugh scale; moderate stage: class B on the Child-Pugh scale

Interactions

In vitro research data
Mirabegron is a moderate inhibitor with a time-dependent CYP2D6 isoenzyme and a weak inhibitor of the CYP3A isoenzyme. In high concentrations, Mirabagron inhibited the transport of drugs through P-glycoprotein.
In vivo research data
CYP2D6 isoenzyme polymorphism
The genetic polymorphism of the CYP2D6 isoenzyme has a minimal effect on the average plasma concentration of Miragegron. Although the interaction of miragegron with inhibitors of the CYP2D6 isoenzyme has not been studied, in theory it is not expected. In patients taking CYP2D6 isoenzyme inhibitors, as well as in patients with a slower metabolism of substrates of CYP2D6 isoenzyme, there is no need for dose adjustment of mirabegron.
Drug Interactions
Most of the drug-free interactions have been studied using 100 mg of mirabegron in the form of controlled-release tablets (OKAS). In the study of the interactions of Mirabegron with metoprolol and mstformin, Mirabegron was used with an immediate release (IR) in a dose of 160 mg. Clinically significant interactions between mirabagron and drugs that inhibit, activate or are the substrate of one of the CYP isoenzymes or carriers are not expected, except for the inhibitory effect of Mirabagron on the metabolism of the CYP2D6 isoenzyme substrates.
Effect on enzyme inhibitors
The concentration of Mirabagron (AUC) increased 1.8 times under the influence of a strong inhibitor of isoenzymes CYP3A / P-gp ketoconazole in healthy volunteers. Mirabagron dose adjustment is not required when taken together with CYP3A or P-gp isoenzyme inhibitors. However, in patients with mild or moderate renal insufficiency (eGFR 30–89 ml / min / 1.73 m2) or mild hepatic insufficiency (Child-Pugh class A), taking such strong inhibitors of the CYP3A isoenzymes as itraconazole, ketoconazole, ritonavir and clarithromycin, the recommended daily dose of Mirabegron is 25 mg, regardless of the meal.
Effect on enzyme inducers
Substances that induce isoenzymes CYP3A or P-gp, reduce the concentration of Mirabogron in plasma. Dose adjustment is not required when taking Mirabegron along with therapeutic doses of rifampicin or other inducers of CYP3A or P-gp isoenzymes.
The effect of Mirabegron on drugs metabolized by the CYP2D6 isoenzyme
In healthy volunteers, Mirabagron moderately and inhibits the CYP2D6 isoenzyme, whose activity is restored 15 days after the cessation of Mirabegron administration. Daily use of Mirabegron led to an increase in Cmax by 90% and PEP by 229% for a single dose of metoprolol. Daily use of Mirabegron led to an increase in Cmax by 79% and PEP by 241% for a single dose of desipramine. It should be carefully prescribed Mirabagron in combination with drugs with a narrow therapeutic index, and drugs that are largely metabolized by the CYP2D6 isoenzyme, for example, thioridazine, drugs for treating arrhythmias type 1C (for example, flecine, propafenone) and tricyclic antidepressants (for example, imipramine , desipramine). Mirabegron should also be taken with caution when taken together with drugs that are metabolized by the CYP2D6 isoenzyme and the dose of which is subject to individual determination.
The effect of Mirabegron on drugs transported by the carrier protein (P-gp)
Mirabegron is a weak inhibitor of the protein P-gp. Mirabegron contributed to an increase in Cmax and AUC by 29% and 27%, respectively, when taken with digoxin by healthy volunteers. For patients who are starting to take Mirabagron and Digoxin at the same time, Digoxin should be taken at the lowest dose. At the same time, it is necessary to monitor the concentration of digoxin in the blood plasma and to select a further effective dose of digoxin according to the results of control tests. The potential for inhibition of P-gp protein by mirabegron should be taken into account when prescribing mirabegron in conjunction with preparations transported by P-gp proteins, for example, dabigatran.
Other forms of interaction
There were no clinically significant interactions when co-administering Mirabegron with Solifenacin, Tamsulosin, Warfarin, Metformin or combined oral contraceptives containing Ethinyl Estradiol and Levonogestrel. Dose adjustment is not required.
Strengthening the effect of mirabegron when combined with other drugs is reflected in an increase in the pulse rate.

Side effects of Betmiga

The most frequent adverse reactions reported during 12-week double-blind, placebo-controlled trials of phase 3 in patients receiving Mirabegron at a dose of 50 mg are tachycardia and urinary tract infections.
In patients receiving Mirabagron in a dose of 50 mg, the frequency of tachycardia reached 1.2%. In 0.1% of patients receiving Mirabegron in a dose of 50 mg, the development of tachycardia caused the early termination of participation in the study.
In patients receiving Mirabagron 50 mg, the incidence of urinary tract infections reached 2.9%. The development of urinary tract infections did not cause an early termination of participation in the study in any of the patients receiving Mirabegron at a dose of 50 mg.
Serious adverse reactions included atrial fibrillation (0.2%). In the course of a long-term (1 year) study with active control (control drug-m-cholinoblocker), adverse reactions were recorded, similar in appearance and frequency to those recorded during 12-week double-blind, placebo-controlled studies of 3 phases.

Adverse Reactions Table

The following table summarizes the adverse reactions reported during Mirabegron treatment in three 12-week double-blind, placebo-controlled, phase 3 studies.
The frequency of adverse reactions is determined as follows: very often (<1/10): often (<1/100 - <1/10), infrequently (<1/1000 - <1/100), rarely (<1/10000 - < 1/1000), very rarely (<1/10000). Within each group, the reactions are listed as the degree of severity decreases.
Infections and invasions:
Often (<1/100 - <1/10) - urinary tract infection
Infrequently (<1/1000 - <1/100) - vaginal infection, cystitis
Violations by the organ of vision:
Rarely (<1/10000 - <1/1000) - eyelid edema
Violations of the cardiovascular system:
Often (<1/100 - <1/10) - tachycardia
Infrequently (<1/1000 - <1/100) - rapid heart beat, atrial fibrillation
Disorders of the gastrointestinal tract:
Infrequently (<1/1000 - <1/100) - dyspepsia, gastritis
Rarely (<1/10000 - <1/1000) - lip swelling
Violations of the skin and subcutaneous tissue:
Infrequently (<1/1000 - <1/100) - urticaria, macular rash, papular rash, rash, itching
Rarely (<1/10000 - <1/1000) - leukocytostoclastic vasculitis, purpura
Disorders of the musculoskeletal system and connective tissue:
Infrequently (<1/1000 - <1/100) - inflammation of the joints
Disorders of the reproductive system and the breast:
Infrequently (<1/1000 - <1/100) - vulvovaginal itching
Abnormalities identified in laboratory studies:
Infrequently (<1/1000 - <1/100) - high blood pressure, increased GGT activity, increased AST activity, increased ALT activity

special instructions

The drug Betmiga does not have a clinically significant effect on the ability to drive vehicles and mechanisms.

Storage conditions

Store at a temperature not higher than 30 ° С

Terms of sell

You can buy Betmiga without a prescription.