Rengalin^® (Tablets, Solution) Instructions for Use

ATC Code

R05DB (Other antitussive drugs)

Clinical-Pharmacological Group

Antitussive, anti-inflammatory drug with antibronchoconstrictor action

Pharmacotherapeutic Group

Other antitussive drugs

Pharmacological Action

Experimental studies have shown that the active components of the drug – antibodies to morphine, histamine, and bradykinin – modify the ligand-receptor interaction of endogenous regulators with their corresponding receptors: opioid receptors, histamine receptors, and bradykinin receptors. The combined use of active components leads to an enhancement of the antitussive effect.

In addition to the antitussive effect, the combined drug Rengalin^®, due to its active components, exerts anti-inflammatory, anti-edematous, anti-allergic, antispasmodic (antibodies to histamine and bradykinin), and analgesic (antibodies to morphine) actions.

The combined drug Rengalin^®, by modifying the functional activity of histamine and bradykinin receptors, selectively reduces the excitability of the cough center in the medulla oblongata and inhibits the central links of the cough reflex. By suppressing the pain sensitivity centers in the thalamus, it blocks the transmission of pain impulses to the cerebral cortex. It inhibits the flow of pain impulses from the periphery due to a reduction 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 possess narcotic or hypnotic effects.

It alleviates the manifestations of acute pharyngitis, laryngitis, and bronchitis by reducing bronchospasm. It relieves systemic and local symptoms of allergic reactions by influencing the synthesis and release of histamine and bradykinin from mast cells.

Clinical Efficacy and Safety

The efficacy and safety of the drug Rengalin^® were demonstrated within the framework of a multicenter comparative randomized clinical study of the efficacy and safety of the drug Rengalin^® in the treatment of cough caused by acute viral respiratory tract infections.

The antitussive efficacy of the drug consisted of reducing the period of illness during which the patient was bothered by cough. The antitussive effect of the drug Rengalin^® in terms of the total duration of cough was comparable to the activity of the drug Codelac (p<0.025). The time to complete resolution of cough (daytime and nighttime) averaged 7.2±1.0 days (compared to 7.0±1.1 in the Codelac drug group).

The efficacy of the drug Rengalin^® was manifested by a pronounced reduction in cough intensity starting from the first day of treatment. After seven days of therapy, the severity of cough decreased by -3.1±0.9 points (compared to -3.1±1.0 points in the Codelac drug group, which was comparable; p<0.05), amounting to 0.2±0.5 points in both groups by the end of the treatment course. The antitussive effect of the drug Rengalin^® was confirmed by positive dynamics in the number of cough bouts throughout the entire therapy period (-10.7±14.5 per day; in the Codelac drug group -8.4±11.0).

As a result of treatment, non-productive dry frequent cough, which in 44% of patients disrupted their daily activity and sleep, was completely cured in 76% of patients; in the remaining study participants, it persisted as occasional (“residual cough”).

Positive changes in the condition of patients with cough due to acute respiratory infection were reflected in their quality of life and sleep. Assessment using the SF-36 questionnaire showed improvement in both physical and psychological health components after 7 days of treatment with the drug Rengalin^® by an average of 10%. The final positive dynamics of the sleep quality indicator over the week, as well as the dynamics of the total quality of life scores during treatment with the drug Rengalin^®, were comparable to the results of taking the drug Codelac (p<0.025).

Monitoring of adverse events and laboratory parameters confirmed the safety of the drug Rengalin^®. No serious adverse events were recorded during the study with the use of the drug. One adverse event in the form of a moderate increase in the number of eosinophils, according to the investigator, had an unlikely connection with the therapy.

The efficacy and safety of the drug Rengalin^® were demonstrated within the framework of a multicenter double-blind placebo-controlled randomized clinical study in parallel groups of the efficacy and safety of the drug Rengalin^® in the treatment of cough in patients with chronic obstructive pulmonary disease (COPD).

Data in brackets are for the Per Protocol (PP) sample.

The use of the drug Rengalin^® in addition to baseline therapy for 4 weeks led to a reduction in cough severity in a significantly greater percentage of patients, compared to the placebo group, where patients were treated only with baseline therapy drugs. The proportion of patients who responded to treatment with the drug Rengalin^® was 83.6 [85.7]% (compared to 72.6 [72.7]% in the placebo group; p=0.0422 [p=0.0163]). A twofold reduction in cough severity after 4 weeks of treatment was noted in 42.2 [43.8]% of patients in the Rengalin^® drug group (compared to 32.7 [32.7]% in the placebo group; p=0.1373 [p=0.0907]). Taking the drug Rengalin^® for 4 weeks significantly reduced the impact of COPD on patients’ lives: the total CAT score decreased by 3.3±4.2 [3.6±3.9] points (compared to 2.5±4.1 [2.5±4.2] in the placebo group), the difference between groups was 0.79±4.16 [1.04±4.02] points (p=0.0870 [p=0.0416]).

The drug Rengalin^® did not have a negative effect on patients’ vital signs, including heart rate, respiratory rate, systolic and diastolic blood pressure. The number of patients with adverse events, classified under various MedDRA codes, did not show significant differences between the two groups (Rengalin^® drug group, placebo group). The frequency distribution of adverse events by severity (p=1.00) and certainty of causal relationship with the drug (p=1.00) also did not differ between the two groups. No adverse events with a certain connection to the investigational drug were recorded.

No cases of interaction of the drug Rengalin^® with baseline COPD therapy drugs (anticholinergics, short- and long-acting β₂-adrenergic receptor agonists, inhaled corticosteroids) and concomitant therapy drugs, including angiotensin receptor antagonists, calcium channel blockers, beta-blockers, diuretics, imidazoline receptor agonists, statins, antiplatelet agents, oral hypoglycemic drugs, nitrates and nitrate-like agents, alpha-blockers, correctors of cerebral circulation disorders, nootropic drugs, combined oral contraceptives, were identified. The treatment was well tolerated by patients and had a high compliance rate.

Preclinical Safety Data

Preclinical safety studies on sexually mature and immature animals, including assessment of toxicity after single and repeated administration, genotoxicity, reproductive toxicity, as well as sensitizing and local irritant properties, did not reveal the presence of toxic or potentially hazardous effects of the drug Rengalin^® for humans.

Pharmacokinetics

Pharmacokinetic studies are impossible due to the complex composition of the drug.

Indications

The drug Rengalin^® is indicated for use in adults and children from 3 years of age

• Productive and non-productive cough in influenza and ARVI, acute pharyngitis, laryngotracheitis, acute obstructive laryngitis, chronic bronchitis, chronic obstructive pulmonary disease and other infectious-inflammatory and allergic diseases of the upper and lower respiratory tract.

ICD codes

Dosage Regimen

Tablets

The score line is not intended for dividing the tablet into parts.

Orally, not during meals. The tablet should be held in the mouth, without swallowing, until completely dissolved.

The recommended dose for adults is 1-2 tablets per dose.

Take 1-2 tablets 3 times/day. Depending on the severity of the condition, the frequency of administration may be increased to 4-6 times/day during the first 3 days.

Children

The dosage regimen for children aged 3 years to 18 years does not differ from the dosage regimen for adults.

The safety and efficacy of the drug Rengalin^® in children aged 0 to 3 years have not been established to date. Data are not available.

Solution

The drug is taken orally, not during meals. It is advisable to hold the solution in the mouth before swallowing for the maximum effect of the drug.

The recommended dose for adults is 1-2 teaspoons (5-10 ml) per dose.

Take 1-2 teaspoons 3 times/day. Depending on the severity of the condition, the frequency of administration may be increased to 4-6 times/day during the first 3 days.

Special Patient Groups

Dose adjustment in elderly patients is not required.

Dose adjustment in patients with impaired renal function is not required.

Dose adjustment in patients with impaired hepatic function is not required.

The dosage regimen for children aged 3 years to 18 years does not differ from the dosage regimen for adults.

The safety and efficacy of the drug Rengalin^® in children aged 0 to 3 years have not been established to date. Data are not available.

Adverse Reactions

Possible reactions of increased individual sensitivity to the components of the drug.

Contraindications

• Hypersensitivity to the active substance or to any of the excipients included in the drug;
• Children under 3 years of age.

Use in Pregnancy and Lactation

Pregnancy

The safety of using the drug Rengalin^® in pregnant women has not been studied. During pregnancy, the drug is used only if the intended benefit to the mother outweighs the potential risk to the fetus. The “benefit-risk” ratio is determined by the attending physician.

Breastfeeding Period

The safety of using the drug Rengalin^® during lactation has not been studied. During lactation, the drug is used only if the intended benefit to the mother outweighs the potential risk to the child. The “benefit-risk” ratio is determined by the attending physician.

Pediatric Use

The use of the drug is contraindicated in children under 3 years of age (due to insufficient data on efficacy and safety).

Special Precautions

Excipients

Patients with rare hereditary fructose intolerance should not take this drug.

Effect on Ability to Drive Vehicles and Operate Machinery

No negative effect of the drug Rengalin^® on the ability to drive vehicles (including bicycles, scooters, etc.) and other potentially dangerous machinery has been identified.

Overdose

In case of overdose, dyspeptic phenomena are possible, caused by the excipients included in the drug.

Treatment is symptomatic.

Drug Interactions

No cases of incompatibility with other medicinal products have been reported to date.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.