Theoritin MF tablets 4mg, No. 10

Symptomatic treatment of chronic idiopathic urticaria.

Inside, 4 mg once a day. It is advisable to take the drug in the morning, at the same time.
The duration of the course of treatment is 14 days.

Active ingredient: Benzhydrylpiperazinylbutylmethylxanthine

Succinate - 4 mg;

Excipients:

microcrystalline cellulose 149.6 mg;

sodium carboxymethyl starch - 4.8 mg;

calcium stearate - 1.6 mg

• hypersensitivity to the active substance or any other component of the drug.

• pregnancy and the period of breastfeeding;

• children under 18 years of age.

• renal, hepatic failure

Carefully

Angle-closure glaucoma, prostatic hyperplasia.
Elderly age.

Trade name:

TheoritinЃ MF

International non-proprietary or group name:

Benzhydrylpiperazinylbutylmethylxanthine succinate

Dosage form:

pills

Composition:

Active ingredient: Benzhydrylpiperazinylbutylmethylxanthine

Succinate - 4 mg;

Excipients:

microcrystalline cellulose 149.6 mg;

sodium carboxymethyl starch - 4.8 mg;

calcium stearate - 1.6 mg

Description:

Tablets from white to white with a light brown shade of color, flat-cylindrical, beveled on both sides.

Pharmacotherapeutic group:

Antiallergic agent - H1-histamine receptor blocker

Pharmacological properties

Pharmacodynamics
TheoritinЃ MF drug (3-methyl-7- [4- (4-benzhydrylpiperazinyl-1) butyl] xanthine succinate) is a purine derivative with pronounced antiallergic activity associated with long-term and selective blockade of H1-histamine receptors, TheoritinЃ MF drug prevents the development and facilitates the course of allergic reactions. It has antipruritic and antiexudative action. It has weak m-anticholinergic and antiserotonin activity. It does not have sedative properties and does not affect the speed of psychomotor reactions. In terms of activity and duration of antihistamine action, it surpasses both H1-histamine blockers of the first generation - diphenhydramine, hifenadine and azelastine, and the second - cetirizine, loratadine, fexofenadine,which was shown on an experimental model of studying the effect of TheoritinЃ MF on the spasmogenic effect of histamine on the isolated ileum of guinea pigs. In terms of antiserotonin activity, which determines the presence of antipruritic action in drugs of this group, TheoritinЃ MF drug is close to azelastine and significantly surpasses the rest of the above drugs.

Pharmacokinetics
Absorption
TheoritinЃ MF is almost completely absorbed in the gastrointestinal tract, the relative bioavailability is about 95% after taking 5 mg of the drug. The maximum concentration (Cmax) in blood plasma is reached after 3 ± 1.3 hours and is 2.04 ± 0.89 ng / ml. The area under the concentration-time curve (AUC0-?) Is 26.56 ± 13.06 ng * h / ml.
Distribution. TheoritinЃ MF drug is most intensively distributed in well-vascularized organs (liver, spleen, lungs, kidneys), to a lesser extent (2-3 times) in less vascularized organs (heart, brain, muscles, mesentery).
Metabolism and excretion.Has the effect of 'first' passage through the liver. Unchanged with urine and feces is excreted, respectively, 0.23% and 0.33% of the administered dose.
The half-life is about 11 ± 4.93 hours.

Indications for use

Symptomatic treatment of chronic idiopathic urticaria.

Contraindications

• hypersensitivity to the active substance or any other component of the drug.

• pregnancy and the period of breastfeeding;

• children under 18 years of age.

• renal, hepatic failure

Carefully

Angle-closure glaucoma, prostatic hyperplasia.
Elderly age.

Application during pregnancy and during breastfeeding

The use of TheoritinЃ MF is contraindicated during pregnancy and during breastfeeding.

Method of administration and dosage

Inside, 4 mg once a day. It is advisable to take the drug in the morning, at the same time.
The duration of the course of treatment is 14 days.

Side effect

In accordance with the classification of the World Health Organization (WHO), adverse reactions observed in clinical trials are presented by an indication of the frequency of their development: very often (? 1/10); often (? 1/100, <1/10), infrequently (? 1/1000, <1/100), rarely (? 1/10000, <1/1000) and very rarely (<1/10000), frequency unknown - according to the available data, it was not possible to establish the frequency of occurrence.
In the course of the conducted clinical studies, not a single case of the development of a serious adverse event was recorded.
The most common adverse events were changes in laboratory parameters (clinical and biochemical blood tests, general urinalysis), in the overwhelming majority of cases these deviations had no connection or had a doubtful connection with the use of the drug.
Laboratory indicators:
Clinical and biochemical blood test: often - monocytosis, increased activity of alanine aminotransferase (ALT), increased activity of aspartate aminotransferase (ACT), hyperbilirubinemia, lymphocytosis, leukopenia, hypoproteinemia, infrequently - basophilia, neutrophilia, neutrophilia, neutrophilia, hypoglycemia, leukemia , rarely - hyperproteinemia, lymphopenia, decreased urea concentration, thrombocytopenia, eosinophilia.
ECG:often - a violation of the processes of repolarization, rarely - a violation of conduction.
General urine analysis: often - a change in the specific gravity of urine, a decrease in the transparency of urine, infrequently - alkalization of urine, proteinuria, erythrocytosis, bilirubinuria.
Violations of the cardiovascular system: often bradycardia, infrequently - tachycardia.
Disorders from the gastrointestinal tract: often - dry mouth, infrequently - dyspepsia, abdominal pain.
Central nervous system disorders: often - headache, infrequently - dizziness, weakness.
Renal and urinary tract disorders: infrequently - dysuria.

Overdose

In clinical studies, when taking 4 mg of the drug per day for 14 days, cases of overdose have not been described.
Treatment: in case of overdose, consult a doctor. Symptomatic treatment, gastric lavage is recommended. There is no specific antidote.

Interaction with other medicinal products

In the course of clinical studies, no clinically significant interactions with other drugs have been identified. Food intake does not affect the effectiveness of TheoritinЃ MF drug.

special instructions

Care should be taken when using the drug in elderly patients, patients with angle-closure glaucoma and prostatic hyperplasia.

Influence on the ability to drive vehicles and work with mechanisms

Studies on the effect of TheoritinЃ MF on the ability to drive vehicles, mechanisms have not been conducted. Patients should be warned about the possibility of developing adverse events from the nervous system, including dizziness (see the section 'Side Effects'), which may adversely affect the ability to drive vehicles and mechanisms. If the described adverse events occur, you should refrain from performing these activities.

Release form:

Tablets 2 mg, 4 mg.
10 tablets in a blister made of polyvinyl chloride film and aluminum foil.
1, 2, 3, 4, 5 or 6 blister packs, together with instructions for use, are placed in a cardboard box.

Storage conditions:

In its original packaging, at a temperature not exceeding 30 ? C.
Keep out of the reach of children.

Expiration date: 3 years

Do not use after the expiration date.

Vacation conditions:

Dispensed by prescription.