Composition and release form
GELOMYRTOL
caps. enteric-sol. 120 mg blister, No. 10, No. 20
1 capsule contains standardized myrtol 120 mg.
Other Ingredients: Medium Chain Triglycerides;
shell: gelatin, glycerin 85%, dried substance of liquid sorbitol 70%, hydrochloric acid 13% (obtained from hydrochloric acid 25% and purified water), hypromellose phthalate, dibutyl phthalate.
GELOMIRTOL FORTE
caps. enteric-sol. 300 mg blister, No. 10, No. 20
1 capsule contains standardized myrtol 300 mg.
Other ingredients: refined rapeseed oil; shell: gelatin, glycerin 85%, dried substance of liquid sorbitol 70%, hydrochloric acid 13% (obtained from hydrochloric acid 25% and purified water), hypromellose phthalate, dibutyl phthalate.
Pharmaceutical action
expectorant. Gelomyrtol contains as an active substance an essential oil of plant origin - standardized myrtol.
Myrtol standardized has secretomotor and secretolytic effects, which contribute to the liquefaction of sputum, activation of the mucociliary epithelium and, as a result, intensive production of sputum. When used in high doses, standardized myrtol also has antimicrobial, immunomodulatory, antispasmodic and vasodilatory effects.
Pharmacokinetics have not been studied.
Improving the tactics of drug treatment of patients with acute rhinosinusitis (ARS) continues to worry otolaryngologists, despite the large arsenal of pharmaceutical drugs at their disposal. This is due to the widespread and steady growth of this pathology, the difficulty of obtaining adequate material to establish the etiology of the disease, the growing resistance of pathogens due to irrational treatment and many other factors [1–4].
Currently, large-scale consensus documents have been created - EPOS-2007 and -2012, which analyze the entire world experience in the diagnosis and treatment of rhinosinusitis [1, 4]. As a result of the analysis, experts concluded that the symptoms of ARS in many cases are well eliminated with the use of antibiotics.
At the same time, given the fairly high effectiveness of placebo, one can expect good effectiveness from symptomatic therapy without the use of antibiotics, especially with regard to the mild form of ARS, the criteria for which in the EPOS recommendations are determined on the basis of a subjective assessment of the severity of symptoms using a visual analogue scale (0–10 cm):
- 0–3 – mild form;
- 4–7 – moderate severity;
- 8–10 – pronounced form.
Among the numerous groups of medications that are used in the treatment of patients with ARS, herbal medicines have become very popular among doctors and patients in the last decade, which is primarily due to their relative safety. Regarding the effectiveness of this treatment method, according to EPOS-2012 [4], in most existing studies, the active substance of herbal medicines is not standardized and, accordingly, the mechanism of its action from the standpoint of pharmacokinetics and pharmacodynamics is not clear. The relatively small array of randomized placebo-controlled trials of herbal medicines with an established mechanism of action of the active component is not representative for the evaluation of herbal medicine for ARS, which emphasizes the need for further research in this direction. One of the successful experiences with the use of herbal medicine in patients with ARS is reflected in the results of a double-blind, placebo-controlled, multicenter study with level of evidence Ib (evidence obtained in at least one randomized trial), in which standardized myrtol (MS; 300 mg, 4 capsules per day) was used within 6 ± 2 days). The study included 331 patients. Analysis of the results demonstrated significant differences in the sum of scores for the severity of clinical symptoms compared to the group receiving placebo. Moreover, the need for additional antibiotic use in the main group was 23% versus 40% in the placebo group [5]. These results made it possible to include myrtol standardized in the EPOS 2012 recommendations for the treatment of acute rhinosinusitis in adults (grade A recommendation, for viral and post-viral ARS) [6].
The pharmacodynamic profile of mucoactive drugs is usually considered in close relationship with their mucosecretolytic properties. While most mucoactive drugs have one specific mode of action, MS exhibits secretolytic, mucolytic and secretomotor properties. In addition, the drug has a noticeable anti-inflammatory effect, neutralizing aggressive oxygen free radicals and reducing the concentration of leukotrienes and prostaglandin E2. Antimicrobial properties have also been identified in MS, primarily against pathogens that are most often found in inflammatory diseases of the respiratory tract - Streptococcus pneumoniae and Haemophilus influenzae. Another advantage of this drug is the release form - the drugs GeloMyrtol® and GeloMyrtol® forte, containing standardized myrtol as an active substance, are offered in the form of enteric capsules, which leads to the release of the active substance only in the small intestine and significantly increases the bioavailability of MS, bringing it closer to 100%.
This distinguishes these drugs from the experimentally created form, which was absorbed in the stomach [7].
Thus, the pharmacokinetic and pharmacodynamic properties of the active substance, standardized myrtol, allow us to regard the drug not only as a means of versatile influence on mucociliary transport, but also as an effective antioxidant, as well as an anti-inflammatory and antibacterial agent.
Due to the presence of so many points of clinical application of MS, of great interest is the comparison of the effectiveness of GeloMyrtol®/GeloMyrtol® forte and other plant secretolytics, conducted in a prospective comparative study by Wittig T. (1998) with the participation of 569 patients with ARS, divided into 2 groups. Patients of group 1 (n = 284; 156 women, 128 men) received GeloMyrtol® forte; patients of group 2 (n = 285; 168 women, 117 men) received an alternative herbal secretolytic. The duration of treatment was about 2 weeks. A significantly higher effectiveness of GeloMyrtol® forte was noted in all forms of ARS compared to the comparison drug, which was effective only in mild forms of ARS. Among the clinical symptoms, the most pronounced differences were noted in the dynamics of pain when pressing on the area of the paranasal sinuses, which correlated with the data of the ultrasound picture when scanning them. The final efficacy, as assessed by patients, when using GeloMyrtol® forte was 95% versus 83% when treated with an alternative drug. The need to prescribe antibiotics in group 1 was lower than in group 2 (19.0% versus 23.9%) [8].
Material and methods
Taking into account the above, at the Department of Otorhinolaryngology of Moscow State Medical University named after. A.I. Evdokimov conducted an open controlled study of the effectiveness and tolerability of the drug GeloMyrtol® forte in the treatment of ARS and exacerbation of mild chronic rhinosinusitis (ACRS).
A preliminary (input) examination of patients in order to decide on the possibility of including them in the research program included the collection of complaints and medical history, assessment by the attending physician of subjective and objective data on the patient’s condition (standard ENT examination), X-ray examination, study of mucociliary transport using a saccharin test .
A control assessment of the patient’s condition was carried out on the 1st (1st visit), 3rd (2nd visit), 5th (3rd visit) and 7th day (4th visit) from the start of treatment (in the absence of cure at earlier stages). A control assessment of mucociliary transport was performed during the initial examination, during the second and fourth visits (in the absence of recovery by the third visit). X-ray examination of the paranasal sinuses was carried out before and after treatment (twice).
The study patients were randomized into two groups:
- Group 1: patients with ARS (n = 12) and ACRS (n = 18), who took GeloMyrtol® forte 1 capsule 3 times a day for 7 days. Average age – 34.76 ± 12.19 years; 15 men, 15 women.
- Group 2: patients with ARS (n = 12) and ACRS (n = 18), who took the herbal medicine Sinupret® 2 tablets 3 times a day for 7 days. Mean age 32.03 ± 7.43 years; 13 men, 17 women.
Research results
Before the start of therapy, the sum of the average values of general clinical symptoms of rhinosinusitis was the same in both groups. During the treatment, positive dynamics were noted in both groups, however, there were certain differences (see table).
When analyzing the results obtained, an effective reduction in a number of symptoms (headache, difficulty in nasal breathing, snoring, sneezing, discomfort in the nasal cavity) was noted during treatment in both groups: by more than 50% by the 2nd visit and by more than 70% from baseline to the 4th visit.
For other indicators, the results obtained in the study groups were statistically significantly different. Thus, discharge from the nasal cavity by the 2nd visit in the 1st group decreased by 52%, in the 2nd group - by 35% (p ≥ 0.05), and by the 3rd visit in the 1st group – by 75%, in the 2nd – by 50% (p ≤ 0.05). A significant difference between the groups remained at the 4th visit.
A similar picture was noted in the indicator of the presence of discharge on the posterior wall of the pharynx, which in the 1st group by the 2nd visit decreased by 57%, and in the 2nd group - by 46% (p ≥ 0.05). By the 3rd visit in the 1st group the decrease was already 83%, and in the 2nd group the indicator did not change, which made it possible to achieve statistical significance of the differences (p ≤ 0.05). This difference was persistently maintained by the 4th visit (see figure).
The dynamics of the decrease in radiological signs of rhinosinusitis was more pronounced in group 1, which by the end of the study was reflected in the achievement of statistical significance of the difference between the groups in this indicator (p ≤ 0.05).
During the study, a decrease in mucociliary clearance time was noted in both groups, and the data between them did not differ significantly (see figure).
In the 1st group of patients, on the 3rd day of observation, the need for correction of the treatment regimen appeared in 7 patients, which required additional prescription of a decongestant and antibiotic.
In group 2 there were 8 such patients, which required a similar adjustment of the prescribed treatment.
No adverse events were identified during the study in both groups.
conclusions
The drug GeloMirtol® forte can and should be used as monotherapy for ARS and acute acute respiratory syndrome of mild severity.
The results of the study confirm the high effectiveness of the drug GeloMyrtol® forte in the treatment of patients with mild rhinosinusitis, which exceeds that with monotherapy with the drug Sinupret® and is expressed in more rapid relief of cough, a decrease in the amount of discharge from the nasal cavity, a decrease in the sensation of mucus flowing down the back wall of the pharynx, and objectively – in reducing swelling of the nasal mucosa and the amount of pathological discharge.
The drug GeloMirtol® forte is well tolerated by patients and does not cause unwanted side effects.
The use of Gelo-Myrtol® forte made it possible to avoid additional treatment, including antibacterial therapy, in 77% of patients with ARS and ACRS.
Dosage
Gelomirtol and Gelomirtol forte capsules are recommended to be taken 30 minutes before meals with plenty of cold water or other drinks.
Gelomyrtol. In the clinical picture of an acute inflammatory disease, it is recommended to take 2 capsules of the drug Gelomirtol 4-5 times a day. In order to create conditions for improved sleep, the last dose should be taken before bedtime. For chronic inflammatory processes, 2 capsules of Gelomirtol are prescribed 3 times a day. The same dosage regimen is recommended for long-term therapy.
To facilitate morning mucus discharge in chronic bronchitis, it is recommended to take an additional 2 capsules of Gelomirtol before bedtime.
Children aged 3–10 years (this drug is prescribed to children at a time when they can swallow the capsule on their own) should be prescribed no more than half the recommended dose for adults. The drug is taken during the period of symptoms of the disease and for 2–4 days after their disappearance.
Gelomirtol forte. In case of clinical picture of acute inflammation, take 1 capsule 3-4 times a day. In order to create conditions for improved sleep, the last dose should be taken before bedtime.
For a chronic process, take 1 capsule 2 times a day. The same dosage is recommended for long-term therapy.
To facilitate morning mucus discharge in chronic bronchitis, it is recommended to take an additional 1 capsule of Gelomirtol Forte in the evening, before bed.
Children aged 6 to 10 years (this drug is prescribed to children at a time when they can swallow the capsule on their own) are prescribed 1 capsule 2 times a day.
The drug Gelomirtol and Gelomirtol Forte are taken during the period of symptoms of the disease and for 2-4 days after their disappearance.
GeloMyrtol
GeloMyrtol is a natural expectorant. Used in the treatment of inflammatory diseases of the respiratory tract (inflammation of the paranasal sinuses, bronchi). In the structure of ENT pathology, inflammatory diseases account for about 90%, with the most common complication of acute respiratory infections being sinusitis. One of its signs is a pathological change in secretion. The secretion of the epithelium of the respiratory tract is one of the links in the mucociliary system, which, in turn, represents the first “line of defense” in the human body in the path of exogenous antigens. The presence of various protective factors in the secretion determines the biocenosis of the respiratory tract, external nose, nasal cavity, maxillary, frontal, sphenoid, and ethmoid sinuses. When inhaling, 60% of inhaled bacteria remain on the mucous membrane of the respiratory tract. The optimal physiological balance between the structure of the secretion and the functionality of the ciliated epithelium prevents excessive colonization of the respiratory tract by constantly inhaled microflora. The result of exposure to viral and bacterial agents is a change in the nature of the secretion and disruption of the transport of pathogenic agents by the mucociliary system. In this regard, one of the key aspects of the treatment of sinusitis is the use of drugs that change the characteristics of sputum - mucoregulators. One of these mucoregulators is GeloMyrtol, which combines the properties of a mucokinetic, mucus-thinning agent, antibacterial and anti-inflammatory drug.
The basis of the drug is a complex of essential oils. GeloMyrtol has passed all stages of clinical studies, in which its effectiveness and safety were confirmed. It has been used in Western European countries for more than four decades. After oral administration, essential oils are quickly absorbed from the gastrointestinal tract and enter the bloodstream, partially excreted through the respiratory tract. The drug improves the rheological properties of sputum, reducing its viscosity by shifting the pH to the alkaline side, thereby facilitating its evacuation from the bronchial tree. In addition, the drug has bacteriostatic and antifungal effects. GeloMyrtol is contraindicated in case of individual intolerance to the active and auxiliary components of the drug, cholelithiasis and urolithiasis, during pregnancy (1st trimester) and breastfeeding. In pediatric practice, GeloMyrtol is used starting from the age of 10. The optimal time to take it is half an hour before meals. single dose – 2 capsules (for adults), 1 capsule (for children). Frequency of administration – 4-5 times a day (for acute forms of the disease), 3 times a day (for chronic forms of the disease). The duration of the medication course is determined by the clinical picture and determined by the doctor. Possible undesirable side effects: allergic reactions, dyspepsia, exacerbation of urinary and cholelithiasis.
special instructions
If the symptoms of the disease do not disappear or the patient’s condition worsens, shortness of breath appears, body temperature rises, blood or pus appears in the sputum, you should immediately consult a doctor.
Patients with asthma or whooping cough should consult a doctor before using the drug.
During pregnancy and breastfeeding. Although there is no information about the negative effects of the drug Gelomirtol on the fetus, during pregnancy and lactation it is taken only under the supervision of a doctor, especially in the first trimester.
Children. Gelomirtol is used in children aged from 3 years, and Gelomirtol forte - from 6 years.
Influence on reaction speed when driving vehicles and working with other mechanisms. No data.
Gelomirtol Forte capsules 300 mg No. 20
Compound
The capsule contains:
Active ingredient:
myrtol standardized 300 mg for the minimum content: limonene 75 mg, cineole 75 mg, -pinene 20 mg,
Excipients:
rapeseed oil.
Capsule:
Gelatin, glycerol 85%, sorbitol, 13% hydrochloric acid solution.
Auxiliary components of the capsule shell:
hypromellose acetate succinate, triethyl citrate, sodium lauryl sulfate, talc, dextrin, ammonium glycyrrhizinate.
Pharmacokinetics
Well absorbed in the small intestine. The maximum concentration in blood plasma is achieved 1-3 hours after taking the drug. Approximately 60% of the drug and its metabolites are excreted in the urine, 5% in the feces, and about 2% in the lungs. Can penetrate the placental barrier into the milk of nursing women.
Indications for use
Used in complex therapy for acute and chronic bronchitis, for inflammation of the paranasal sinuses (sinusitis).
Contraindications
In case of accidental overdose, nausea, vomiting, convulsions are possible, and in severe cases, coma or breathing problems. In rare cases, after severe intoxication, disturbances in the functioning of the cardiovascular system are possible.
Treatment:
Vaseline oil in the amount of 3 ml per kilogram of body weight, gastric lavage with a 5% solution of sodium bicarbonate (baking soda), ventilation of the lungs with oxygen.
Directions for use and doses
The drug is taken orally in adults and children over 10 years of age half an hour before meals with a sufficient amount of cool water.
For adults
Prescribed for acute inflammation: 1 capsule 3-4 times a day, for chronic inflammation - 1 capsule 2 times a day. To facilitate mucus discharge in the morning, take an additional 1 capsule of the drug before bed.
Children from 10 to 18 years old
for acute inflammation, 1 capsule of the drug is prescribed 2 times a day, for chronic inflammation - 1 capsule per day.
The duration of treatment depends on the severity of the symptoms of the disease and is determined by the attending physician.
Storage conditions
In a dry place at a temperature not exceeding 25 C.
Keep out of the reach of children.
Best before date
3 years.
Do not take after expiration date.
Description
Soft gelatin capsules, transparent, oblong. The contents of the capsules are a clear, colorless liquid with a characteristic odor.
Conditions for dispensing from pharmacies
Over the counter
Dosage form
enteric capsules
Manufacturer and organization accepting consumer complaints
OJSC "Krasnogorskleksredstva" Russia,
143444, Moscow region, Krasnogorsk, microdistrict. Opalikha, st. Mira, 25
Tel.,
Fax
https://www.krls.ru
Pharmacodynamics
It has anti-inflammatory, antibacterial, mucolytic effects.
Side effects
Allergic reactions are possible (itching, skin rash, facial swelling, bronchospasm), shortness of breath, tachycardia, dry mouth, stomach pain, flatulence, diarrhea, nausea, vomiting, increased mobility of kidney stones and gall bladder.
If side effects not listed in the instructions occur after taking the drug, you should immediately inform your doctor.
Use during pregnancy and breastfeeding
Due to the lack of special studies during pregnancy (II-III trimester), the drug should be taken with caution as prescribed by a doctor, provided that the expected benefit to the mother outweighs the potential risk to the fetus.
Interaction
Not described.
Overdose
In case of accidental overdose, nausea, vomiting, convulsions are possible, and in severe cases, coma or breathing problems. In rare cases, after severe intoxication, disturbances in the functioning of the cardiovascular system are possible.
Treatment:
Vaseline oil in the amount of 3 ml per kilogram of body weight, gastric lavage with a 5% solution of sodium bicarbonate (baking soda), ventilation of the lungs with oxygen.
Release form
Enteric capsules.
Note!
The description of the drug Gelomirtol 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.
