Teoritin MF pills 4mg, 10pcs

Composition

Active ingredient: Benzhydrylpiperazinylbutylmethylxanthine succinate (Teoritin) in terms of 100% substance-4 mg, Excipients: Microcrystalline cellulose – 149.6 mg, Sodium Carboxymethyl Starch-4.8 mg, Calcium stearate-1.6 mg

Pharmacological action

Pharmacotherapy group: Anti-allergic agent-H1-histamine receptor blocker ATX code: R06axpharmacological properties

Pharmacodynamics

The drug Teoritin ® MF (3-methyl-7 – [4 – (4-benzhydrylpiperazinyl-1)butyl] xanthine succinate) is a purine derivative with pronounced anti-allergic activity associated with prolonged and selective blockade of H1-histamine receptors, the drug Teoritin® MF prevents the development and facilitates the course of allergic reactions. It has an antipruritic and antiexudative effect. It has weak m-holinoblokiruyuschey 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 in an experimental model of studying the effect of Teoritin® MF on the spasmogenic effect of histamine on the isolated ileum of guinea pigs. In terms of antiserotonin activity, which causes the presence of antipruritic effects in drugs of this group, Teoritin® MF is close to azelastine and significantly exceeds the rest of the above drugs.

Pharmacokinetics

Absorption rate

The drug Teoritin ® 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.

The drug Teoritin ® MF is most intensively distributed in well-vascularized organs (liver, spleen, lungs, kidneys), to a slightly lesser extent (2-3 times) in less vascularized organs (heart, brain, muscles, mesentery).

Metabolism and elimination. It has the effect of “first” passage through the liver. 0.23% and 0.33% of the administered dose are excreted unchanged in the urine and feces, respectively.

The elimination half-life is approximately 11±4.93 hours.

Indications

Symptomatic treatment of chronic idiopathic urticaria.

Use during pregnancy and lactation

The use of Teoritin ® MF is contraindicated during pregnancy and lactation.

Contraindications

• hypersensitivity to the Active ingredient or any other component of the drug.
• pregnancy and lactation;
• children under 18 years of age.
• renal or hepatic insufficiency

With caution:

• Angle-closure glaucoma, prostatic hyperplasia.
• Advanced age.

Side effects

Almost all of the adverse events identified in clinical trials were mild in severity. No cases of serious adverse events were reported, the identified adverse events were clinically insignificant and did not require any corrective measures.

The following adverse reactions were observed in clinical trials, indicating the frequency of their development according to the World Health Organization (WHO) classification: very common (≥1/10), common (≥1/100, <1/10), infrequent (≥1/1000, <1/100), rare (≥1/10000, <1/1000) and very rare ( Disorders of the cardiovascular system: very rare (isolated cases – – decreased heart rate( HR), increased heart rate.

Gastrointestinal disorders: often – dry mouth; very rarely (isolated case) – dyspepsia, abdominal pain.

Central nervous system disorders: often-headache; very rarely (isolated case) – dizziness, weakness.

Renal and urinary tract disorders: very rare (isolated case) – dysuria.

Influence on the results of laboratory and instrumental studies: often-increased activity of “hepatic” transaminases and bilirubin levels; rarely-bilirubinuria, proteinuria; very rarely-increased urine pH, changes in the level of glycemia (increase or decrease).

ECG: infrequently-violation of repolarization processes; very rarely – violation of conductivity.

If any of the side effects listed in the instructions get worse or you notice other side effects that are not listed in the instructions, be sure to tell your doctor!

Interaction

No clinically significant interactions with other drugs have been identified in clinical trials. Food intake does not affect the effectiveness of the drug Teoritin® MF.

How to take, course of use and dosage

Inside,4 mg 1 time a day. It is advisable to take the drug in the morning, at the same time. The duration of treatment is 14 days.

Overdose

No cases of overdose have been reported in clinical studies when taking 4 mg of the drug per day for 14 days.

Treatment: in case of overdose, consult a doctor. Symptomatic treatment, gastric lavage is recommended. There is no specific antidote.

Description

Tablets from white to white with a light brown tint of flat-cylindrical shape with a chamfer on both sides.

Special instructions

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

Form of production

Tablets 2 mg,4 mg.

10 tablets in a contour cell package made of polyvinyl chloride film and aluminum foil.

1,2,3,4,5 or 6 contour cell packages together with the instructions for use are placed in a pack of cardboard.

Storage conditions

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

Shelf

life is 3 years.

Active ingredient

Benzhydrylpiperazinylbutylmethylxanthine Succinate

Conditions of release from pharmacies

By prescription

Dosage form

Tablets