Lamigex Otic Drop

Adjuvant treatment for Acute Otitis Externa (AOE)

Acute infection of the external ear (AOE, Tropical ear or Swimmer’s ear) is the diffuse inflammation of the outer ear canal which can engage the auricle and the eardrum as well. AOE is one of the most prevalent infections that physicians see. The annual incidence of AOE in the general public is between 1:100 and 1:250 and the incidence during a life span is up to 10%.

The diagnosis of AOE is confirmed by a swift onset (usually within 24 hours) in the past 3 weeks, along with symptoms of inflammation of ear canal like severe pain, itching and sensation of fullness of the ear, erythema or both with and without expulsion of pus from the ears, local lymphadenitis, erythema of the eardrum or auricle cellulite and its adjacent skin. The hallmark for diffuse AOE is the tenderness of the tragus, the auricle or both, which is usually severe and is not relevant to the overall clinical profile. The diagnosis of the condition is made entirely based on clinical manifestations; however, in resistant cases, microbial evidence is examined as well. The prevalent pathogens in AOE include: Pseudomonas aeruginosa (50%), Staphylococcus aureus (23%), anaerobic and gram negative organisms (12.5%) and fungi (12.5%).

The inhibitory effects of the essential oils of clove, lavender and rose geranium have been studied on the isolated strains of Pseudomonas aeruginosa. The main active ingredients in these essential oils were eugenol (80-90%), 1,8-cineol (13%) and citronellol (45%), respectively. Clove’s was the most effective essential oil against Pseudomonas aeruginosa and a combination of these essential oils with a ratio of 3:1:1 had the strongest inhibitory effect (32-64 μg/ml) and strong synergistic effect with gentamycin.

To compare the effect of Lamigex Otic Drop (containing essential oils of rose geranium, clove and lavender) and ciprofloxacin drop in treatment of AOE, in a double-blind clinical trial, 56 patients aging 18-66 with AOE were randomly placed in the Lamigex Otic Drop group (25 patients) or ciprofloxacin group (31 patients), to use for one week, 3 drops of the product every 12 hours. The patients were examined before and after the treatment for presence of pain, tenderness, itching, discharge, redness and edema in ear canal and ear discharge was cultured for bacteria and smear was prepared to detect fungi. Furthermore, in the third day of the study, the patients were followed up via telephone for pain, itching and discharge. Based on the results of this study, with regard to the results of microbial culture, the degree of efficacy was 80% in Lamigex Otic Drop group and 87.1% in the ciprofloxacin group. No statistically significant difference was observed between the two groups (p>0.05). Pain reduced significantly in both groups (in both groups p=0.00) and clinical manifestations including itching, erythema of the canal, edema and tenderness of the canal improved in both groups and no statistically significant difference was observed between the two groups (p>0.05). Considering the similar antibiotic effects of the two drugs Lamigex Otic Drop and ciprofloxacin and the identical effects of both drugs on the improvement of clinical manifestations, use of Lamigex Otic Drop as a herbal product is recommended for treatment of AOE.

Before administration, thoroughly wash and dry the external ear. Every 12 hours drip 3 drops into the ear. After administration, stay in supine position for 5 minutes, the affected ear facing upwards.

Dosage form

Otic Drop

Packaging

5 ml drop with dropper in cardboard box

Patient information leaflet inside

Ingredients

  • Essential oils of clove (Eugenia caryophyllata)
  • Lavender (Lavandula stoechas)
  • Rose geranium (Pelargonium roseum)

Active Ingredients

  • Eugenol
  • Citronellol
  • 1,8-cineol

Contraindications and Cautions

  • Known allergy to any of the product’s ingredients.
  • Perforated eardrum

Adverse Effects

With the recommended amounts, no adverse reaction is expected. However, in some individuals headache has been reported. Theoretically, in individuals with allergy to the product’s ingredients, irritation and sensitivity of the skin and mucus membrane may occur.

 

Drug Interaction

Interaction with other drugs is not known.

 

Administration during Pregnancy and Lactation

Sufficient evidence does not exist regarding the safety of this product during pregnancy and lactation; therefore, its use is not allowed during this period.

 

Further Notes

  • Keep Lamigex Otic Drop, like all other medication, away from sight and reach of children.
  • This product is for topical use in the ear only.
  • Complete the course of treatment.
  • 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 at least 1.81 mg citronellol and 11 mg eugenol per ml of the product.