LOCETAR 50 Mg/Ml Medicated Nail Varnish 5 Ml

ACTION AND MECHANISM

- Antifungal. Amorolfine is a topical antifungal derived from morpholine with fungicidal action. It acts at the permeability of the fungal membrane, inhibiting the synthesis of ergosterol through the inhibition of two enzymes: delta 14 reductase and delta 7-8 isomerase. It has a broad antifungal spectrum, being effective against:

* Yeasts: Candida (albicans and other species), Malassezia or Pityrosporum, Cryptococcus;

* Dermatophytes: Trichophyton (rubrum, mentagrophytes, interdigitale and other species), Microsporum, Epidermophyton (floccosum);

* molds: Alternaria, Hendersonula, Scopulariopsis, Scytalidium, Aspergillus

* Dermatiaceous: Cladosporium, Fonsecaea, Wangiella;

* Dimorphic fungi: Coccidioides, Histoplasma, Sporothrix.

Amorolfine has shown an additive or even synergistic effect in vitro and in vivo with some antifungals, including ketoconazole, itraconazole, terbinafine and griseofulvin, against dermatophytes.

With the exception of Actinomyces, bacteria are not sensitive to amorolfine. Propionibacterium acnes is only slightly sensitive.

DOWNLOAD PROSPECTUS

SPECIAL WARNINGS

- The diagnosis of the disease must be confirmed either by direct microscopic examination, in potassium hydroxide solution, or by culture in appropriate medium.

SENIORS

No specific problems have been described in the elderly that require dosage readjustment.

ADVICE TO THE PATIENT

- Continue treatment without interruption until the nail has regenerated and the affected areas are healed or until the skin infection is cured and for several days afterwards.

- This medication is intended for topical use only. Avoid contact with eyes and mucous membranes.

- In patients with nail infections being treated and who regularly work with organic solvents, hand protection with waterproof gloves is recommended.

- Healthy nails should not be filed with the same file used for diseased nails.

- Along with the nail solution, the use of nail polishes (cosmetics) and artificial nails should be avoided during the treatment.

CONTRAINDICATIONS

- Patients allergic to the medication.

PREGNANCY

Studies in experimental animals, using high oral doses of amorolfine, have recorded embryotoxicity. Although systemic absorption after topical administration is very low, given the prolonged treatment, its use is not recommended during pregnancy.

PHARMACOKINETICS

- Nail solution: the amorolfine contained in the nail solution penetrates and diffuses into the nail solution, thus destroying even the inaccessible fungi in the nail bed. With this mode of application, the systemic absorption of the active ingredient is very low. After prolonged use there is no evidence of accumulation of the medication in the body.

INDICATIONS

- Treatment of [Ringworm of the Nails] caused by dermatophytes, [ONYCHIA BY CANDIDAS] or onychomycosis due to other fungi sensitive to amorolfine, without affecting the nail matrix.

LACTATION

This medication is not expected to be excreted in significant quantities with breast milk, since systemic absorption after topical administration is very low. However, since the treatment is prolonged, its use in nursing mothers is not recommended.

CHILDREN

Safety and efficacy have not been evaluated in children and adolescents < 18 years of age, so it is recommended to avoid its use.

RULES FOR CORRECT ADMINISTRATION

Instructions for administration of medicated varnish:

1. File the affected nails deeply with one of the files. These files should not be used on healthy nails.

2. Clean and degrease the surface of the nail with the cleaning wipe (or with a cotton pad soaked in alcohol or nail polish remover).

3. Dip the applicator in the medicated varnish and, without dripping into the mouth of the bottle, apply to the entire surface of the nail.

4. Let the varnish dry for approximately 3-5 min.

5. Clean the applicator with the cleaning wipe. Avoid contact of the wipe with the nail on which the varnish has been applied.

Repeat steps 1-4 for each of the affected nails.

Avoid contact with mucous membranes (eyes, nose or mouth), as well as inhale vapors.

Wash your hands after each application.

POSOLOGY

Medicated varnish:

- Adults: apply a thin layer 1-2 times a week (fingernails) or once a week (toenails).

- Children and adolescents < 18 years: not recommended.

- Elderly: no dosage adjustment required.

Duration of treatment: prolong the treatment until the nail has regenerated. Typically 6 months (hands) or 9-12 months (feet) are required.

Monitor the treatment every 3 months.

Forgotten dose: administer the forgotten dose as soon as possible. Administer the next dose on the scheduled day. Do not double the next dose.

DOSAGE IN LIVER FAILURE

No specific dosage recommendations have been made.

DOSAGE IN KIDNEY FAILURE

No specific dosage recommendations have been made.

ADVERSE REACTIONS

Nail Solution:

- [CONTACT DERMATITIS]: some cases of contact dermatitis have been reported after the application of amorolfine.

- On rare occasions, mild and temporary periungual stinging has been reported after application of the nail solution.

- Cases of nail disorders have been rarely described, e.g., [NAIL DEPIGMENTATION], [ONYCHODYSTROPHY] and brittle nails. However, these reactions may be related to onychomycosis itself.

COMPOSITION

AMOROLFINE: 50 MILLIGRAMS - HYDROCHLORIDE