Myrtex Topical Solution

Adjuvant treatment for:

Minor aphtha

Herpes

Recurrent Aphthous Stomatitis (RAS) is among the most prevalent conditions affecting the oral cavity and is manifested as one or several lesions limited to the oral mucus membrane, which are painful and recurrent. The seasonal peak of this condition occurs during winter and spring. Almost 20% of the population suffers from this condition at any given time.

Factors contributing to the occurrence of aphtha are categorized into two groups: etiologic factors (like bacterial, viral, genetic, immunologic factors, iron deficiency and B-group vitamins deficiency) and trigger factors (like allergic and psychological factors, hormonal conditions and trauma).

Successful treatment of aphtha requires correct diagnosis, recognition and control of contributing factors to formation of aphtha in order to limit the extent of the lesion, pain or duration of the condition; however, due to lack of sufficient knowledge regarding the contributing factors, and due to the fact that current treatments are symptomatic, the treatment process is usually far from satisfactory.

In textual sources of Persian Medicine, it has been pointed to the use of common myrtle in irrigation and disinfection of wounds, alleviation of irritations in oral cavity, alleviation of toothache and looseness of gums and oral lesions.(2,3) Also, due to its having anti-genotoxic and radical scavenging properties, common myrtle is among the proposed treatments for RAS.

In a double-blind clinical trial using continuous sampling, 137 patients suffering RAS were respectively assigned to groups A (myrtle topical solution 5%), B (myrtle topical solution 10%) or C (placebo solution). They were administered, from the day of referral to one day after total alleviation of lesions, 10 drops of the solution dabbed on a piece of cotton and placed on the lesion for 20-30 seconds, 5-6 times per day. At least one week after the commencement of the treatment, the patients were clinically examined again and the time of cessation of burning sensation and total alleviation of lesions after the commencement of treatment was registered in their questionnaires.

Based on the results of this study, the mean time of cessation of burning sensation of minor aphtha lesions in group A was 2.6 days, in group B 4.7 days and in group C 4.1 days, in which regard statistically significant difference existed between the three groups (p<0.0005). This difference was totally significant between groups A and B (p<0.001) and A and C (p<0.05), but not significant between Groups B and C (p=0.44). The mean duration of time for total recovery of minor aphtha lesions in Group A was 5.4 days, in Group B 7.5 days and in Group C 7.3 days, in which regard statistically significant difference was observed between Groups A and B (p<0.01) and A and C (p<0.05), but the difference between the Groups B and C was not statistically significant (p=0.92). The researchers came to the conclusion that Myrtex Topical Solution is effective for reducing the duration of burning sensation and the duration of minor aphtha lesions. In this study, no toxic or adverse effect was reported for the solution.

In a randomized, controlled, double-blind clinical trial, 45 patients with RAS used either a paste containing myrtle extract 5% or a paste lacking thereof for 6 successive days, 4 times per day. Before and after each course of treatment, 5 parameters including size of the lesion, pain, degree of erythema and discharge, oral cavity health profile and a general evaluation of the patient was registered. The results of this study indicated to a statistically significant decrease in size of the lesion (p<0.001), intensity of pain (p<0.05) and the degree of erythema and discharge (p<0.001). In the treatment group, the oral cavity health profile improved significantly (p<0.001). The general evaluation of the patient also improved after using myrtle paste (p<0.05). No adverse effect was reported in this study.

The researchers came to the conclusion that myrtle is effective for reduction in size of lesion, reduction in pain and the degree of erythema and discharge and also improvement of the quality of life in patents suffering RAS.

5-6 times per day, dab 10 drops of Myrtex Topical Solution on a cotton ball and place on the aphtha for 20-30 seconds.

Dosage form

Topical Solution

 

Packaging

15 ml drop with dropper in cardboard box

Patient information leaflet inside

Ingredients

  • Essential oil of common myrtle (Myrtus communis)

Active Ingredients

  • 1,8-cineole
  • alpha-pinene
  • limonene
  • linalool
  • myrtenyl acetate

Contraindications

  • pregnancy
  • lactation
  • children
  • cancer patients

 

Adverse Effects

With the recommended amount and appropriate administration, no adverse effect has been reported.

 

Drug Interaction

No reported drug interaction.

 

Administration during Pregnancy and Lactation

Not to be used during pregnancy and lactation.

 

Further Notes

  • Consult your physician or pharmacist before using Myrtex Topical Solution.
  • The product will be more efficient if used as soon as aphtha manifests itself.
  • Once the cotton smeared with Myrtex is dabbed on aphtha, usually a burning sensation occurs first and then the sore becomes temporarily anesthetized. Therefore, burning sensation after administration of this product is natural.
  • Avoid leaving the cotton smeared with Myrtex Topical Solution on the sore longer than the recommended duration.
  • Keep Myrtex Topical Solution, like all other medication, away from sight and reach of children.
  • Tightly close the container right after administration and keep the medicine away from light and in 15-30°C.
  • Keep this leaflet; you may need to read it again.

Based on presence of 9-15 mg 1,8-cineole per ml of the product.