Web Page: http://www.rotapharm.co.uk/
LIMENDA-L (vaginal suppositories)
(Metronitazole, Miconazole, Lidocaine)
Composition: vaginal suppositories containing metronitazole 750 mg, miconazole nitrate 200 mg, lidocaine 100 mg.
PHARMACOLOGICAL PROPERTIES.
PHARMACODYNAMICS.
Limenda-L contains miconazole nitrate and metronidazole for antibacterial effects and also lidocaine for local unaesthetic effect.
Metronidazole is an antiprotozoal and an antibacterial agent, effective against Gardnerella vaginalis and anaerobic bacteria including anaerobic streptococci and Trichomonas vaginalis. Miconazole nitrate which is a synthetic imidazole antifungal agent has a wide spectrum of activity and is particularly effective against pathogen fungi including Candida albicans. In addition, miconazole nitrate is effective against Gram positive bacteria. Lidocaine stabilizes the neuronal membrane by inhibiting the conduction of impulses, thereby producing local anesthetic action.
PHARMACOKINETICS.
Bioavailability of metronidazole by the intravaginal route is app. 20 % compared to oral administration. Steady state levels of metronidazole in plasma ranged 1.6 - 7.2 μg/ml after
application of Lımenda-L. Absorption level of miconazole nitrate from Limenda-L is very low (1.4 % of dose). Miconazole nitrate plasma levels have not been determined. Metronidazole is metabolized in the liver. Its hydroxy metabolite is active.
Metronidazole half life is 6-11 hours. The ratio of the drug excreted unchanged in the urine is 20%.
Lidocaine is absorbed from injured skin and mucous membranes in very low amounts. Following application of Limenda- L, lidocaine was absorbed minimally and steady state levels in plasma ranged 0.04 - 1 μg/ml. Lidocaine is excreted in urine as metabolites and unchanged form (10% of the applied dose).
- bacterial vaginitis; - trichomonal vaginitis;
- in patients known to be hypersensitive to the ingredients;
- severe liver function disorders;
- epilepsy;
- porphyria;
- during the first trimester of pregnancy,
In rare cases hypersensitivity reactions (rash) and such side effects like undue fatiguability, dizziness, headache, loss of appetite, nauses, vomiting, abdominal spasms and pains, diarrhea, changes of taste, constipation, dry mouth, metallic aftertaste.
Miconazole nitrate can cause vaginal irritation (burning, itching)
These symptoms may be prevented with the local anesthetic action of lidocaine. If there is severe irritation, treatment should be discontinued.
One suppository should be inserted high into the vagina for a night during 7 days. In recurrent cases, or when the vaginitis has been resistant to other treatments, application of one suppository for a night for 14 days is recommended. Vaginal suppository shoulf be inserted high into the vagina using disposable finger stalls provided in the package.
Vaginal suppositories. 7 suppositories in a blister. 1 blister with a pack of disposable finger stalls (7 pieces) and an enclosed leaflet in a carton box.
