Pharmacology
During scientific observations, it was found that the constituent substances change the degree of ligand-receptor interaction, endogenous stimulants with certain receptors.
The complex product not only has an antitussive effect, but also, thanks to its constituent components, helps achieve antiallergic, antispasmodic and anti-inflammatory effects.
Rengalin selectively stops the main components of the cough reflex, reduces the sensitivity of the cough center in the medulla oblongata region of the brain, and prevents the entry of painful signals to the brain.
Compared to analgesics that have a narcotic effect, Rengalin is not capable of leading to respiratory depression, the emergence of drug dependence, and does not cause drowsiness.
Effective for diseases such as bronchitis, pharyngitis and laryngitis. Can be used at any stage of disease development.
Combats systemic and local signs of allergy due to its effect on the synthesis and removal of histamine from mast cells.
Rengalin 100 ml solution for oral administration
APPROVED by the Order of the Chairman of the Pharmacy Committee of the Ministry of Health of the Republic of Kazakhstan Instructions for the medical use of the drug Rengalin Trade name Rengalin International nonproprietary name No Dosage form Oral solution Composition (per 100 ml) of the drug active substances: Affinity purified antibodies to bradykinin - 0.12 g* , Antibodies to histamine, affinity purified – 0.12 g*, Antibodies to morphine, affinity purified – 0.12 g*. * are administered as a mixture of three active aqueous dilutions of the substance, diluted 10012, 10030, 10050 times, respectively. Excipients: hypromellose 1.0 g, maltitol 6.0 g, glycerol 3.0 g, potassium sorbate 0.165 g, anhydrous citric acid 0.02 g, purified water up to 100 ml. Description Colorless or almost colorless transparent liquid. Pharmacotherapeutic group Respiratory system. Medicines used for coughs and colds. Antitussive drugs. Other antitussives. ATC code R05DB Pharmacological properties Pharmacokinetics The sensitivity of modern physicochemical methods of analysis (gas-liquid chromatography, high-performance liquid chromatography, gas chromatography-mass spectrometry) does not allow assessing the content of the active components of the drug Rengalin in biological fluids, organs and tissues, which makes it technically impossible to study pharmacokinetics. Pharmacodynamics It has been experimentally shown that the components of the drug modify the activity of the ligand-receptor interaction of endogenous regulators with the corresponding receptors: antibodies to morphine (a component of the drug) modify the activity of the ligand-receptor interaction of endogenous regulators with opiate receptors; antibodies to histamine – with H1 histamine receptors; antibodies to bradykinin – with bradykinin receptors; in this case, the combined use of the components leads to an increase in the antitussive effect. In addition to the antitussive effect, the complex drug, due to its constituent components, has anti-inflammatory, decongestant, antiallergic, antispasmodic (antibodies to histamine, antibodies to bradykinin) and analgesic effects (antibodies to morphine). The complex drug Rengalin, due to the modification of histamine-dependent activation of H1 receptors and bradykinin-dependent activation of B1 and B2 receptors, selectively reduces the excitability of the cough center of the medulla oblongata and inhibits the central parts of the cough reflex. By inhibiting pain sensitivity centers in the thalamus, it blocks the transmission of pain impulses to the cerebral cortex. Inhibits the flow of pain impulses from the periphery due to a decrease in the release of tissue and plasma algogens (histamine, bradykinin, prostaglandins, etc.). Unlike narcotic analgesics, it does not cause respiratory depression, drug dependence, and does not have a narcotic or hypnotic effect. Alleviates the manifestations of acute pharyngitis, laryngitis and bronchitis, reducing bronchospasm. Relieves systemic and local symptoms of allergic reactions by influencing the synthesis and release of histamine and bradykinin from mast cells. The drug Rengalin is homeopathic. Indications for use Acute and chronic diseases of the respiratory tract, accompanied by cough and bronchospasm. Productive and non-productive cough with influenza and ARVI, acute pharyngitis, laryngotracheitis, acute obstructive laryngitis, chronic bronchitis and other infectious-inflammatory and allergic diseases of the upper and lower respiratory tract. Directions for use and dosage: Inside. For one dose – 1-2 teaspoons (5-10 ml) – outside meals. It is advisable to keep the solution in the mouth before swallowing for maximum effect of the drug. Use 1-2 teaspoons 3 times a day. Depending on the severity of the condition in the first three days, the frequency of administration can be increased to 4-6 times a day. The duration of therapy depends on the severity of the disease and is determined by the attending physician. Side effects Reactions of increased individual sensitivity to the components of the drug are possible. If these side effects get worse, or you notice any other side effects not listed in the instructions, tell your doctor. Contraindications - children under 3 years of age - increased individual sensitivity to the components of the drug - hereditary fructose intolerance (due to the presence of maltitol in the composition). With caution: diabetes mellitus. Drug interactions During the clinical studies conducted, no data were obtained on the interaction of the drug Rengalin with drugs used as concomitant therapy. Special instructions For diseases accompanied by a dry (non-productive) cough, it promotes its transition to a wet (productive) cough. If necessary, combination with mucolytics is possible. Patients with diabetes should remember that each teaspoon (5 ml) of the drug contains 0.3 g of maltitol, which corresponds to 0.02 bread units (XU). Insulin is required for the metabolism of maltitol, although due to slow hydrolysis and absorption in the gastrointestinal tract, the need for insulin is low. The energy value of maltitol is 10 kJ or 2.4 kcal/g, which is significantly less than that of sucrose. The energy value of one teaspoon of the drug is approximately 5.7 kJ (1.37 kcal). Use during pregnancy and breastfeeding The safety of Rengalin in pregnant women and during breastfeeding has not been studied. During pregnancy and breastfeeding, the drug is used only if the expected benefit to the mother outweighs the potential risk to the fetus and child. The benefit/risk ratio is determined by the attending physician. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms Rengalin does not affect the ability to drive vehicles or other potentially dangerous mechanisms. Overdose In case of overdose, dyspeptic symptoms (nausea, vomiting, diarrhea) are possible due to the fillers included in the drug (maltitol, glycerol). Treatment is symptomatic. Release form Solution for oral administration. 100 ml in bottles made of OS grade glass or in bottles made of painted glass (type III for hydrolytic stability), sealed with tamper evident caps, with a polyethylene dropper. Each bottle, along with instructions for medical use in the state and Russian languages, is placed in a cardboard pack. Storage conditions: At a temperature not exceeding 25 °C. Keep out of the reach of children. Do not freeze. Shelf life 2 years. Do not use after the expiration date. The storage period after the first opening of the package is 35 days at a temperature not exceeding 25°C. Conditions for dispensing from pharmacies Without a prescription Manufacturer/Packager NPF MATERIA MEDICA HOLDING LLC; Russia, 127473, Moscow, 3rd Samotechny lane, 9. Tel./fax. Address of the place of production of the drug Russia, 454139, Chelyabinsk, st. Buguruslanskaya, 54. Registration certificate holder of NPF MATERIA MEDICA HOLDING LLC, Russia. Name, address and contact details (telephone, fax, e-mail) of the organization on the territory of the Republic of Kazakhstan that accepts claims (suggestions) on the quality of medicines from consumers and is responsible for post-registration monitoring of the safety of medicines Representative office of NPF MATERIA MEDICA HOLDING LLC in RK Almaty, st. Seifullina 498. Tel./fax: 2734713 E-mail
Dosage
The drug in the form of a solution is intended for oral administration. You can take no more than 2 tsp at one time. 2 hours before or after meals. It is best to hold the solution in your mouth for as long as possible and only then swallow. This will achieve the greatest effect. You can take no more than 3 times, 1-2 tsp. per day. Depending on the condition of the patient, in the first 72 hours you can take the medicine 6 times a day.
The drug in tablet form is taken as follows: 1 tablet is enough for 1 dose. It should not be swallowed immediately, but should be held in the mouth until it completely dissolves. You can take 3-4 tablets a day a few hours before or after meals. On average, the course of treatment is 6-8 days. The duration of treatment is determined by the severity of the disease and is determined by a specialist.
Already one day after administration, an improvement in the condition can be noted; a pronounced clinical effect is achieved on the 3rd day of therapy.
If 3 days after the start of therapy the cough begins to intensify, then you should come for an examination to a doctor.
Compound
One tablet contains (active ingredients):
- antibodies to bradykinin, affinity purified: a mixture of homeopathic dilutions C12, C30 and C50 - 6 mg;
- affinity purified antibodies to histamine: a mixture of homeopathic dilutions C12, C30 and C50 - 6 mg;
- affinity purified antibodies to morphine: a mixture of homeopathic dilutions C12, C30 and C50 - 6 mg.
Excipients: isomalt, microcrystalline cellulose, magnesium stearate, anhydrous citric acid, aspartame (E 951), sodium saccharin.
Note!
Description of the drug Rengalin table. No. 20 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
What we are treated with: Rengalin
In another study, the authors did not neglect the comparison group: Ambroxol and Sinekod competed in curing cough in children with Rengalin. However, in the middle of the article there is an advertisement for Rengalin (for which the magazine was clearly paid), it was financed by the manufacturer, and there was no blinding in it. This means that when conducting the test, doctors knew who would get what, and could subjectively interpret or deliberately manipulate the result. Therefore, you should not trust it, although according to some formal indicators (p-value < 0.05) it looks decent.
An article in the journal Antibiotics and Chemotherapy describes a trial on 139 participants. Rengalin is compared here with Codelac and found to be comparable in effectiveness. True, problems with blinding do not go away. Moreover, the study included patients with a nonproductive cough that lasted at least 12 hours and no more than seven days! Thus, doctors could simply assign more people who had been coughing for a long time to the Rengalin group and receive a “magic” healing.
The fourth study did not go much further: at the conclusion of the article there is an advertisement for Rengalin. Despite the fact that the study is double-blind this time, it inspires little hope. “Over seven days of treatment, the severity of daytime cough decreased to 1.0±0.9 points in the Rengalin group and 1.2±0.9 points in the placebo group; night to 0.1±0.4 points and 0.3±0.5 points in groups, respectively” - such results cannot be called success. And if you look at the tables with these scores, you will find out that for some reason the placebo group has lower average scores, especially at first, but those who took Rengalin have huge standard deviations.
Indicator.Ru does not recommend: this is ordinary homeopathy
Rengalin is another creation that discredits the title of the work of Carl Linnaeus. For many, this information will already be a signal to stop reading and choose such a remedy for treatment. There is practically no active ingredient in tablets and solutions of this drug. At the same time, even if it existed, it could make it worse: treating a cough by suppressing the work of histamine, bradykinin and morphine is a pointless undertaking.
Despite registration and clinical trials, the drug has not proven its medicinal properties. Four articles about this medicine, published in low-rated Russian publications, are cheerfully interspersed with advertisements for Rengalin. Despite all the arguments of the authors and sometimes (but not always) beautiful numbers in statistics, it becomes clear why decent journals did not publish their work. We will not blame the manufacturers; let the reader draw the conclusions himself (or perhaps the investigative committee, as in Belarus).
Our recommendations cannot be equated with a doctor's prescription. Before you start taking this or that drug, be sure to consult a specialist.
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At what age can Rengalin be given to children?
Rengalin is available in two forms - oral solution and lozenges. Both dosage forms can be given to a child from three years of age*. Rengalin solution is more suitable for children (it is convenient to drink from a spoon); older children can be offered cough tablets that need to be dissolved without drinking water.
Before use, be sure to consult with your doctor and read the instructions for the drug.
* Geppe N.A. et al. Antibiotics and Chemotherapy, 2014; 59(7-8), pp. 16-24
