Journal "Child's Health" 5 (32) 2011


Compound

Since the drug is produced in the form of a solution for injection, syrup for oral administration, as well as tablets, its chemical composition will depend, first of all, on one or another form of release of the drug.
Contains 1 ml. Riabal syrup includes 5 mg. Prifinia bromyl . One round, pink sugar-coated tablet contains 30 mg. of a similar active compound, and in 1 ml. solution for injection – 7.5 mg.

In addition, the tablet form of the drug contains such auxiliary components as: carmellose sodium salt, povidone, starch, talc, magnesium stearate, carnauba wax, silicon dioxide, as well as sucrose and titanium dioxide.

Analogs

In pharmacies you can buy many analogues of Riabal, which have a similar effect on the body. These include medications:

  • But-spasm;
  • Gastrofit;
  • Lactovit Forte;
  • Ranitidine;
  • Enzistal;
  • Domstal.

However, none of the drugs can completely replace the described medicine, since it contains a different set of active compounds, and also has different indications and contraindications.

Release form

Riabal syrup is packaged in bottles with a nominal volume of 50-60 ml, placed in a cardboard package and equipped with a pipette (0.4 ml volume) for ease of use.

Tablets (30 mg), coated with a specialized film coating, are packaged in blisters, usually 20 pcs. each, and then packed into a cardboard box (1 blister).

The solution for intravenous injection is produced in ampoules with a nominal volume of 2 ml. each, then placed in a cardboard package (6 ampoules).

Release form and composition

  • coated tablets: biconvex, round, sugar coated, pink (20 pcs. in blisters, 1 blister in a cardboard box);
  • solution for injection: colorless transparent liquid for parenteral administration (2 ml in dark glass ampoules, 6 ampoules in a cardboard box);
  • syrup: liquid of sweet caramel taste, orange color (60 ml in dark glass bottles complete with a measuring pipette, 1 set in a cardboard box).

1 tablet contains:

  • active ingredient: prifinium bromide – 30 mg;
  • auxiliary components: starch, lactose, povidone, magnesium stearate, colloidal silicon dioxide, croscarmellose sodium, gelatin, talc, titanium dioxide, paraffin paraffin, carnauba wax, sucrose, FD&C red dye No. 3.

1 ml of solution for injection contains:

  • active ingredient: prifinium bromide – 7.5 mg;
  • auxiliary components: sodium chloride, hydrochloric acid, water for injection.

1 ml of syrup contains:

  • active ingredient: prifinium bromide – 1.5 mg;
  • auxiliary components: glycerin, propylene glycol, sodium benzoate, sucrose, liquid sorbitol, sodium citrate, sodium saccharin, monoammonium glycyrrhizinate, liquid caramel flavor, dyes: FD&C yellow No. 6 and FD&C red No. 40, purified water.

Pharmacodynamics and pharmacokinetics

Since the medicinal substance that is part of the drug is classified as an M-anticholinergic blocker according to the scientific classification , experts include it in the group of quaternary ammonium compounds . Due to its distinctive properties, Riabal has a strong effect on M-cholinergic receptors , which are differently localized in the human body, for example, they can be found in the tissues of the stomach, intestinal tract , as well as the genitourinary and biliary tract.

Riabal affects M-cholinergic receptors , which as a result lose sensitivity to the effects of acetylcholine (a neurotransmitter that transmits neuromuscular impulses and plays a dominant role in the parasympathetic nervous system of the human body). As a result of this effect, the drug prevents the formation of spasms in the esophagus, uterus, bile ducts , and also in the ureters .

Riabal weakens peristalsis , and also reduces the tone of the smooth muscles of the gastrointestinal tract , reduces the activity of pancreatic secretion and the production of pepsin and HCI . In addition, the drug increases the motor activity of the digestive tract ( corrective effect ), and also promotes gastric emptying.

The active medicinal compound contained in the drug does not have a toxic effect on the human body, since it does not penetrate the natural blood-brain barrier . Thanks to this, Riabal can be used in the treatment of newborns, as well as during long-term therapeutic treatment, without fear of damaging effects on the circulatory system, liver , and kidneys .

When Riabal is taken orally, the active substance is absorbed rather slowly by the stomach . The maximum concentration of prifinium bromide (Cmax-7-15 ng/ml) when taking the drug orally is reached after a maximum of 2 hours. Most of Riabal is excreted from the body in the urine .

Journal "Child's Health" 5 (32) 2011

Relevance of the problem

Abdominal pain is a complex diagnostic and therapeutic problem in pediatrics and at the same time one of the common complaints of children and their parents, causing frequent visits to the doctor.
Most pediatricians believe that in 90–95% of children, abdominal pain is caused by functional pathology and only in 5–10% is associated with organic diseases of the digestive system [1, 2, 14, 19]. According to the Rome Consensus III (2006), functional disorders of the digestive system in newborns and children under 4 years of age include: infantile regurgitation, infantile rumination syndrome, cyclic vomiting syndrome, infantile colic, functional diarrhea, infantile difficult defecation and functional constipation [3, 4].

In children in the first months of life, abdominal pain manifests itself in the form of intestinal colic (from the Greek “kolikos”, meaning “pain in the colon”). The prevalence of infantile colic ranges from 5 to 19% among full-term infants and about 70% among premature infants [3, 4, 18].

To diagnose intestinal colic in infants, the so-called “rule of three” is used - crying for 3 or more hours a day, at least 3 days a week for 3 weeks in a row. The attack begins unexpectedly, against the background of complete well-being, more often during or shortly after feeding, accompanied by anxiety, crying, writhing legs, and regurgitation. Outside of an attack of intestinal colic, children have a good appetite, gain weight, and maintain a general positive emotional mood [7, 16].

There are a lot of theories and reasons explaining the occurrence of intestinal colic and regurgitation syndrome (regurgitation, vomiting) in children in the first year of life, but they are not fully understood. Most authors associate their appearance with impaired motor function of the intestine, accompanied by spastic contractions of smooth muscles and increased gas formation against the background of morphofunctional immaturity of the intestine and peripheral innervation, enzymatic failure of the gastrointestinal tract system, dysfunction of central regulation, and disturbances in the formation of intestinal microbiocenosis. A significant role is played by the nature of nutrition and the psycho-emotional state of the mother, as well as violations of breastfeeding techniques [3, 9, 15].

Treatment of intestinal colic in infants is gradual; it is individualized as much as possible and is aimed at normalizing the functions of the nervous system and gastrointestinal tract. Preference is given to routine, dietary, and psychotherapeutic recommendations. If there is no clinical effect, pharmacological correction is started [10, 13, 16, 17].

The motility of the intestinal muscles is regulated by peripheral and central mechanisms, in particular the parasympathetic system. Blockade of parasympathetic cholinergic influences makes it possible to prevent muscle spasms, intestinal hypermotility, hypersecretion of the stomach and pancreas [11, 12].

The most important requirements for modern drugs are high selectivity and minimization, as far as possible, of side effects and contraindications for use. In accordance with these requirements, selective M-anticholinergic blockers have been developed and are being widely introduced into modern clinical practice. The mechanism of their action is to selectively block peripheral M-cholinergic receptors in the digestive tract and biliary tract, which makes them insensitive to acetylcholine. The consequence of this is a decrease in the tone of the smooth muscles of the esophagus, stomach, intestines, gallbladder, and bile ducts [11, 16].

One of the modern selective M3 anticholinergic blockers of gastrointestinal smooth muscle cells is the drug Riabal (priphinium bromide), introduced in Ukraine. Riabal provides relief of abdominal pain syndrome, has a positive effect on the course of the disease, its prognosis and the quality of life of patients. A number of domestic pediatricians note the high effectiveness of Riabal in the treatment of various gastrointestinal disorders accompanied by vomiting and pain in children of different ages [5, 6, 8].

The neurotropic selective antispasmodic Riabal has a number of advantageous distinctive features. It selectively blocks M-cholinergic receptors of the abdominal and pelvic organs, corrects gastrointestinal motility and has virtually no effect on M-cholinergic receptors of other organs. When administered enterally, it has good bioavailability and is quickly excreted in the urine and partially in bile. By relieving spasms, Riabal eliminates pain, regurgitation, flatulence, vomiting, and stool disorders. Being a quaternary ammonium compound, it does not penetrate the blood-brain barrier. Riabal is available in several dosage forms - parenteral (solution for injection), tablets and syrup for young children. To ensure accurate dosing of the drug, the syrup form is equipped with a dispenser pipette. Riabal is approved for use in children from the first days of life.

The daily dose of the drug, divided into 3 doses, is 1 mg/kg body weight. The course of treatment for functional digestive disorders ranges from several days to 2 weeks.

The purpose of this study was to study the clinical effectiveness and safety of the use of the drug Riabal in the complex treatment of children in the first months of life with intestinal colic and regurgitation syndrome.

Materials and research methods

The study was carried out on 45 children aged from 3 weeks to 6 months - 28 (62.2%) boys and 17 (37.8%) girls. Regurgitation syndrome in combination with intestinal colic occurred in 32 (71.1%) children, isolated intestinal colic - in 13 (28.9%). The patients were divided into two groups: in the first group (main), consisting of 30 children, complex treatment included dietary and regimen measures, as well as the drug Riabal. The second (control) group consisted of 15 children, who were managed exclusively with routine measures and feeding recommendations. Dietary and routine recommendations included proper latching of the baby to the breast, feeding the baby on demand, reducing the intervals between feedings, creating a certain position for the baby after feeding, and the correct selection of formula for artificial feeding. In both groups, conversations were held with mothers and relatives to create a positive psychological climate around the child. All patients were randomized by age, gender and severity of the disease (Table 1).

The examination complex included: a clinical-anamnestic method, which has a verbal assessment of the leading clinical symptoms per day (pain, regurgitation (vomiting), anxiety associated with feeding, flatulence, sleep disturbance), recording the presence or absence of a symptom, general clinical laboratory tests of blood, urine, coprogram. According to indications, the microbial composition of the intestine was studied (stool culture for enteropathogenic and opportunistic bacterial flora), ultrasound examination of the abdominal organs and kidneys, and determination of the enzymatic activity of the digestive tract.

All children in the main group were prescribed Riabal orally 20 minutes before meals in recommended age-specific doses - 1 mg/kg/day in 3 divided doses. The duration of treatment was determined individually and averaged 14 days.

The effectiveness of treatment was assessed by the dynamics of complaints and objective data on the 3rd, 7th and 14th days of treatment.

The results obtained were processed using generally accepted mathematical methods of variation statistics.

Research results and discussion

When collecting anamnesis and analyzing documentation (histories of children's development), the following aggravating factors were identified in the medical history of the observed children: risk factors for perinatal lesions (early and late gestosis, anemia, placental dysfunction, ante- and intrapartum hypoxia), prematurity, artificial feeding.

28 (62.2%) children were breastfed, 5 (11.1%) were mixed-fed, and 12 (26.7%) were bottle-fed.

Most often, intestinal colic and regurgitation syndrome were observed among children in the first two months of life - in 27 babies (60%), among whom boys predominated - 17 (63%).

The clinical effectiveness of the drug Riabal in comparison with the control group is presented in table. 2.

Observations showed that relief of symptoms of intestinal colic and regurgitation syndrome occurred faster in the group of children whose complex therapy included Riabal. In children in the main group, the average duration of abdominal pain was significantly shorter than in the control group (7.46 ± 0.28 and 13.26 ± 0.24 days, respectively) (p Ј 0.001). According to the results of a survey of parents, children taking Riabal became calm on average on the 6th day of treatment (6.11 ± 0.22); in the control group, anxiety persisted for more than 11 days (11.46 ± 0.23). Similar dynamics were observed with regurgitation syndrome. Relief of regurgitation (vomiting) was noted on the 7th (6.86 ± 0.21) day of Riabal therapy versus 11.41 ± 0.22 days. in children in the comparison group (p Ј 0.001). A statistically significant better effect in the treatment of flatulence was also obtained in children of the main group. Intestinal bloating stopped much earlier with Riabal - in the main group by 7.46 ± 0.28 days, in the control group - by 10.12 ± 0.25 days. (p Ј 0.05). Reducing intestinal colic and flatulence contributed to the normalization of sleep in the children studied. In the main group, sleep was restored by 5.06 ± 0.15 days, which was significantly earlier than in the comparison group (9.25 ± 0.21 days) (p Ј 0.05).

At the end of the 2nd week of therapy with Riabal, all children (100%) of the main group achieved complete elimination of all clinical manifestations of gastrointestinal disorders. In the control group, clinical success by the end of the treatment course was achieved in only 11 (73.3%) infants.

During treatment with Riabal, not a single case of complications or side effects of the drug was reported.

conclusions

1. Riabal effectively and quickly relieves the syndrome of intestinal colic and regurgitation in newborns and children in the first months of life.

2. Riabal is a safe drug and meets the requirements for first-choice drugs in pediatrics.

Indications for use

The drug suppresses pain caused by spasms in diseases such as:

  • chronic gastritis;
  • enterocolitis;
  • acute gastritis;
  • dyskinesia;
  • calculous cholecystitis;
  • stomach and duodenal ulcers;
  • diseases of the large intestine , for example, intestinal obstruction or flatulence ;
  • urolithiasis disease;
  • cystitis;
  • inflammation of the pancreas;
  • bloating and colic in newborns;
  • algomenorrhea.

This drug is used in preparatory activities before examination of the gastrointestinal tract , as well as before x-ray examinations and after radiation therapy . In addition, Riabal is included in the program of complex therapeutic treatment for such organic diseases of the gastrointestinal tract as: gastroenteritis, hypertension, hyperthermia.

Side effects

It is extremely rare that when using the drug, side effects such as:

  • allergic reaction;
  • dry mouth;
  • weakness;
  • hives;
  • headache;
  • increased intraocular and blood pressure ;
  • constipation;
  • Quincke's edema;
  • drowsiness;
  • nausea;
  • redness and itching of the skin.

Instructions for Riabal (Method and dosage)

In accordance with the instructions for use, Riabal syrup is used in the treatment of children under 6 years of age. The dosage and schedule for taking the syrup depends on the age of the child, his state of health, as well as the nature and type of the disease.

The recommended daily dose of Riabal for newborns and children under 3 months of age is 6 mg, from 3 to 6 months – 6-12 mg, from six months and one year – 12 mg, from one year to 6 - 3 years – 30-60 mg. As a rule, the drug is taken 3 times a day for two weeks.

Riabal tablets are prescribed to children over the age of 6 years at a dose of 60-90 mg. per day, adults – 90-180 mg. The drug is also taken for two weeks three times a day. The initial single dosage of the medicinal solution for intravenous and intramuscular administration is 1-2 ml, it can be increased to a maximum of 30 mg.

On average, no more than 45 mg should be administered intravenously per day to the patient. active compound. It is worth noting that when using Riabal for injection, the solution is administered slowly (about one minute). If the above rule is not followed when taking the drug, patients may experience a sharp rise in blood pressure , which will lead to a state of shock.

Often, to enhance the medicinal effect, Riabal is mixed with a 0.9% solution of sodium chloride (NaCl) .

Directions for use and dosage

Film-coated tablets Riabal tablets are taken orally.

Recommended dosage regimen depending on the patient’s age:

  • children 6-12 years old – 1 pc. (30 mg) 2-3 times a day;
  • children over 12 years old and adults – 1-2 pcs. (30-60 mg) 3 times a day.

If necessary (to relieve severe acute pain), adults are allowed to take 3 tablets (90 mg) at a time.

Solution for injection Solution for injection Riabal is administered subcutaneously (SC), intravenously (IV) or intramuscularly (IM), depending on the indications.

Recommended average doses for adults:

  • single dose – 15-30 mg (1-2 ampoules), maximum single dose – 90 mg (6 ampoules);
  • daily – 45-90 mg (3-6 ampoules), maximum daily – 90 mg (6 ampoules);
  • course - 450 mg (30 ampoules), maximum course - 900 mg (60 ampoules).

For children, Riabal injection solution can be administered from birth at 1 mg/kg body weight per day (s.c., i.v., i.m.).

The duration of therapy ranges from 7 to 15 days.

The IV solution should be administered slowly over 1 minute, because rapid administration of prifinium bromide can provoke a sharp drop in blood pressure and cause the development of a state of shock.

Riabal can be used intravenously in an isotonic aqueous solution of 0.9% sodium chloride.

Syrup Riabal syrup is taken orally.

Children over 12 years of age and adults are recommended to take 20-40 ml of syrup 3 times a day.

Recommended average doses for children over 12 years of age and adults:

  • single dose – 15-30 mg, maximum single dose – 90 mg;
  • daily – 45-90 mg, maximum daily – 90 mg;
  • course - 450 mg, maximum course - 900 mg.

Recommended dosage regimen for children with a dosage frequency of 1 time every 6-8 hours:

  • up to 3 months – 1 ml;
  • 3-6 months – 1-2 ml;
  • 6-12 months – 2 ml;
  • 1-2 years – 5 ml;
  • 2-6 years – 5-10 ml;
  • 6-12 years – 10-20 ml.

The duration of therapy with Riabal syrup is from 7 to 15 days.

Overdose

Overdose as a result of the use of this medicinal compound can occur if the recommended average daily dose is exceeded by 10 times. In case of an overdose of the drug, symptoms such as weakness, tachycardia, dizziness, hypotension and hallucinations appear.

To eliminate the negative effects of Riabal in case of overdose, artificial ventilation of the lungs , as well as gastric lavage, . If necessary, patients are prescribed laxatives , Proserin, and Physostigmine .

special instructions

With special attention, the drug should be used in the treatment of patients with diseases of the respiratory, cardiovascular and digestive systems , with reflux esophagitis and thyrotoxicosis, liver failure, myasthenia gravis, preeclampsia, cerebral palsy and Down syndrome, since side effects of Riabal may occur, for example, tachycardia , atrial fibrillation, heart failure, bleeding, hypertension, stenosis, coronary artery disease, fever, esophageal achalasia and others.

Riabal's analogs

Level 4 ATX code matches:
Spasmomen

Among the main structural analogues of Riabal, the following drugs, similar in chemical composition and medicinal effects, can be distinguished:

  • Bebinos;
  • Bromocriptine;
  • Ganaton;
  • Bimaral;
  • Gaviscon;
  • Digestal;
  • Halidor;
  • Domperidone;
  • Gastenorm forte;
  • Itomed;
  • Carbopect;
  • Gestid;
  • Marcalact;
  • Disflatil;
  • Mezim forte;
  • Iberogast;
  • Methovit;
  • Yogulact;
  • Milk of Magnesia;
  • Maalox;
  • Motonium;
  • Metamol;
  • No-shpa forte;
  • Metoclopramide;
  • Panzinorm Forte;
  • Motilak;
  • Penzital;
  • Pancreatin;
  • Rennie;
  • Perinorm;
  • Simikol;
  • Sub simplex;
  • Spasmonet;
  • Smecta;
  • Festal;
  • Trimedat;
  • Holenzym;
  • Hilak forte;
  • Zeolate;
  • Chophytol;
  • Unienzyme;
  • Espumisan.

Riabal price, where to buy

The price of Riabal varies depending on the region, as well as the form of release of the drug.

Since the drug has not passed the re-registration procedure established by law, it is currently not possible to buy Riabal syrup in Moscow, as well as throughout Russia, either in a regular pharmacy or via the Internet.

Syrup for newborns Riabal (60 mg bottle with pipette) can be bought in Kyiv, Kharkov, Dnepropetrovsk, Donetsk and other large Ukrainian cities at an average cost of 40-50 UAH.

  • Online pharmacies in RussiaRussia
  • Online pharmacies in UkraineUkraine

LuxPharma* special offer

  • Riabal tablets 30 mg No. 20
    RUB 2,890 order
  • Riabal (Prifinia bromide) syrup 60ml

    RUR 3,290 order

show more

Pharmacy24

  • Riabal 30 mg N20 tablets Al-Hikma Pharmaceuticals, Jordan/Ze Arab Pharmaceutical Menufacturing Co. Ltd., Jordan
    119 UAH.order
  • Riabal 7.5 mg/5 ml 60 ml syrup Ze Arab Pharmaceutical Menufecturing Co. Ltd., Jordan

    158 UAH order

RIABAL: ridding your baby of colic

Intestinal colic is one of the most common causes of concern for parents of young children. According to various studies, from 20 to 80% of all visits to the pediatrician are related to intestinal colic (Saavedra MA et al., 2003; Iacono G. et al., 2005). What is infantile intestinal colic? To diagnose intestinal colic in infants, the so-called rule of three is used: crying for 3 or more hours a day, at least 3 days a week, for 3 weeks in a row (Roberts DM et al., 2004). Typically, children experience normal weight gain, a general positive emotional mood, good appetite, and normal bowel movements.

Therapy for intestinal colic includes several stages. First of all, it is necessary to pay attention to the psycho-emotional state of the mother and surrounding relatives. Often, colic is a child’s reaction to an unfavorable psycho-emotional environment in the family (Raiha H. et al., 1996). Therefore, it is very important to have a conversation with relatives surrounding the mother and child, to explain how important the psychological climate is for the proper development of the little person. It is also necessary to normalize the mother's diet - exclude whole cow's milk (at the same time, fermented milk products must be included in the diet), limit the consumption of foods that cause excess gas formation. When artificial feeding, mixtures containing short-chain triglycerides as a fat component are recommended; for severe colic, it is possible to use a mixture with partially hydrolyzed protein (Forsyth BW, 1989).

However, it should be understood that in most cases, normalization of the psycho-emotional environment and diet therapy are not enough for successful treatment. Drug therapy for intestinal colic should be aimed at normalizing intestinal motility and relieving spasms. The choice of medications for the treatment of children with intestinal colic should be approached very responsibly. Preference should be given to drugs that are approved for use in early childhood and have a release form created specifically for the youngest patients.

From the point of view of the pathogenesis of intestinal colic and taking into account the necessary safety profile, the use of the drug RIABAL (prifinium bromide) produced in Jordan is justified. The exclusive distributor of the drug in Ukraine is. The mechanism of action of the drug RIABAL is the selective blocking of peripheral M-cholinergic receptors in the digestive tract, biliary and urinary tracts. As is known, activation of the parasympathetic part of the autonomic nervous system leads to contraction of smooth muscles, increased peristalsis and secretion of the digestive tract. By selectively blocking M-cholinergic receptors, RIABAL makes them insensitive to acetylcholine. The consequence of this is a decrease in the tone of the smooth muscles of the esophagus, stomach, intestines, gallbladder, bile ducts and urinary tract, as well as a decrease in the secretion of hydrochloric acid, pepsin, and a decrease in the exocrine activity of the pancreas. Unlike mixed-type M-anticholinergic blockers, the peripheral M-anticholinergic blocker RIABAL does not cause side effects such as paralysis of accommodation, increased heart rate, and drowsiness.

The drug RIABAL is well known both to a wide range of doctors and pharmacists, and to consumers, primarily in its tablet form. Since 2006, it began selling the drug RIABAL in the form of a caramel-flavored syrup, approved for use in children from the first days of life. For children under 3 months of age, RIABAL is prescribed 1 ml 3-4 times a day. The package contains an additional cap with a pipette, which allows you to accurately measure the required dose of the drug, which is very important for the effective and safe treatment of a small patient.

The use of the drug RIABAL in the form of syrup will improve the well-being of a baby with intestinal colic. This will reduce the level of anxiety and worries of parents, and therefore increase the number of grateful regular customers of your pharmacy.

Press service of “APTEKA Weekly”

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