Riboflavin-mononucleotide solution for injection 1%, 1ml No. 10

Riboflavin - a mononucleotide is used as directed by a doctor.

It is prescribed for adults and children with B2 hypo- and avitaminosis, as well as in the complex therapy of skin diseases (for itchy dermatoses, neurodermatitis, chronic eczema, photodermatosis, etc.)

Intramuscularly.

Adults are prescribed 10 mg (1 ml of 1% solution) 1 time per day.

The course of treatment is 10-20 days.

Children, depending on age, are prescribed 5 mg-10 mg (0.5-1 ml of 1% solution) for 3-5 days in a row, then 2-3 times a week.

active substance: sodium riboflavin phosphate - 10.0 mg;

excipients: chlorobutanol - 0.5 mg, sodium edetate - 0.3 mg, water for injection up to 1.0 ml.

- Increased sensitivity to the drug.

-Pregnancy.

-The period of breastfeeding.

Trade name: Riboflavin Mononucleotide

International non-proprietary or generic name: riboflavin

Dosage form: solution for intramuscular administration

Composition

For 1 ml:

active substance: sodium riboflavin phosphate - 10.0 mg;

excipients: chlorobutanol - 0.5 mg, sodium edetate - 0.3 mg, water for injection up to 1.0 ml.

Description

Transparent or slightly opalescent yellow-orange liquid

Pharmacotherapeutic group: vitamin

ATX code: A11HA04

Pharmacological properties

Pharmacodynamics

Vitamin B2 has a metabolic effect; interacts with ATP, forming coenzymes of flavin proteins - flavina adenine mononucleotide and flavina adenine dinucleotide, which are components of such enzymes as succinate dehydrogenase, cytochrome reductase, diaphorase, amino acid oxidases, etc. Regulating redox + reduction processes, hydrogen protein and fat metabolism, in maintaining normal visual function of the eye, the synthesis of hemoglobin and erythropoietin.

Riboflavin-activated pyridoxal kinase converts pyridoxine (vitamin B6) into the active form pyridoxal phosphate.

Promotes the conversion of tryptophan to niacin, maintaining the integrity of red blood cells. It is part of glutathione reductase, xanthine oxidase.

It is synthesized by normal intestinal microflora and itself is necessary for its maintenance.

Pharmacokinetics

Suction

It is rapidly absorbed from the injection site.

Distribution

Communication (mainly in the form of metabolites - flavin adenine mononucleotide and flavin adenine dinucleotide) with plasma proteins - 60%. Distributed to all organs and tissues, deposited in muscle tissue, liver, spleen, kidneys and myocardium. Penetrates through the placenta and into breast milk.

Metabolism

It is metabolized in the liver. The main metabolites are flavinadenine mononucleotide and flavinadenine dinucleotide.

Withdrawal

The half-life (T 1/2) is 66-84 minutes, the equilibrium volume of distribution is about 40 liters, the total clearance is about 0.3 l / min.

It is excreted from the body by the kidneys, almost completely in the form of metabolites, when taken in high doses - mostly unchanged. In small quantities, it is excreted through the intestines.

It is excreted by hemodialysis, but much slower than by renal excretion.

Indications for use

Riboflavin - a mononucleotide is used as directed by a doctor.

It is prescribed for adults and children with B2 hypo- and avitaminosis, as well as in the complex therapy of skin diseases (for itchy dermatoses, neurodermatitis, chronic eczema, photodermatosis, etc.)

Contraindications

- Increased sensitivity to the drug.

-Pregnancy.

-The period of breastfeeding.

Application during pregnancy and during breastfeeding

It is not recommended to take during pregnancy and during breastfeeding, due to the lack of clinical data on the effectiveness and safety of the drug during this period.

Method of administration and dosage

Intramuscularly.

Adults are prescribed 10 mg (1 ml of 1% solution) 1 time per day.

The course of treatment is 10-20 days.

Children, depending on age, are prescribed 5 mg-10 mg (0.5-1 ml of 1% solution) for 3-5 days in a row, then 2-3 times a week.

Side effect

To determine the incidence of side effects of the drug, the following classification is used: very often (? 1/10); often (? 1/100 and <1/10); infrequently (? 1/1000 and <1/100); rarely (? 1/10000 and <1/1000); very rare (<1/10000); the frequency is unknown (cannot be estimated from the available data).

From the respiratory system, chest and mediastinal organs:

frequency unknown: bronchospasm.

From the gastrointestinal tract:

frequency unknown: dyspeptic symptoms.

On the part of the skin and subcutaneous tissues:

frequency unknown : allergic reaction in the form of itching and rash, urticaria.

Overdose

Overdose cases were not observed.

Treatment: symptomatic therapy.

Interaction with other medicinal products

Reduces the activity of doxycycline, tetracycline, oxytetracycline, erythromycin and lincomycin. Incompatible with streptomycin.

Chlorpromazine, imipramine, amitriptyline, due to the blockade of flavinokinase, disrupt the incorporation of riboflavin into flavinadenine mononucleotide and flavinadenine dinucleotide and increase its excretion in the urine.

Thyroid hormones speed up the metabolism.

Reduces and prevents side effects of chloramphenicol (violation of hematopoiesis, optic neuritis).

Compatible with drugs that stimulate hematopoiesis, antihypoxants, anabolic steroids.

special instructions

It should be borne in mind that riboflavin is destroyed under the influence of the rays of the blue part of the solar spectrum (about 450 nm). Stains the urine light yellow.

The injections are somewhat painful.

Influence on the ability to drive vehicles, mechanisms

The use of the drug does not affect the ability to perform potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, the work of a dispatcher, an operator).

Release form

Solution for intramuscular injection, 10 mg / ml.

1 ml in ampoules made of colorless glass of I hydrolytic class.

A self-adhesive label is attached to each ampoule.

5 or 10 ampoules are placed in a blister strip made of polyvinyl chloride film and printed aluminum foil, varnished or without foil.

1 or 2 blister packs together with instructions for use are placed in a pack of imported cardboard.

1 ml in a polymer ampoule.

A self-adhesive label is attached to each ampoule.

5 ampoules are placed in a foil bag.

2 bags with instructions for use in a cardboard box.

Storage conditions

In its original packaging at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date.

Vacation conditions

Dispensed by prescription.

Manufacturer / organization accepting customer claims

Pharmstandard-UfaVITA OJSC,

450077, Ufa, st. Khudayberdin, 28,

telephone / fax (347) 272 92 85,

www.pharmstd.ru

Representative

OJSC 'Pharmstandard-UfaVITA'