Universal reference book for medicines
Product name: OFLOMIL LAK (OFLOMIL LAK)

Active substance: amorolfine

Type: Antifungal medication for external use

Manufacturer: GLENMARK PHARMACEUTICALS (India)
Composition, form of production and packaging
?
Nail polish in the form of a clear liquid from colorless to light yellow color.
1 ml

amorolfine hydrochloride 55.7 mg,

which corresponds to the content of amorolfin 50 mg

Excipients: triacetin (glycerol triacetate) - 10.5 mg, methyl methacrylate copolymer, trimethylammonioethyl methacrylate chloride and ethyl acrylate copolymer [2: 0.2: 1] (ammonium methacrylate copolymer (type A) (Eudragit RL 100)) 125 mg, ethyl acetate 150 mg, butyl acetate - 50 mg, ethanol anhydrous - up to 1 ml.

2.5 ml - bottles of dark glass (1) complete with applicators (6 pcs.), Equipped with polypropylene blades;
nail files (12 pcs.); sachet with cleaning tampons (12 pcs.) - plastic pallets (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Antifungal drug for external use.
It has a fungistatic and fungicidal effect caused by damage to the cytoplasmic membrane of the fungus by disrupting the sterol biosynthesis. Reduces the content of ergosterol, accumulates the content of atypical steric non-planar sterols.
Has a wide range of action.
Highly active against both the most common and rare pathogens of fungal nail lesions: dermatophytes - Trichophyton spp., Microsporum spp., Epidermophyton spp .; yeast fungi - Candida spp., Cryptococcus spp., Malassezia spp. (Pityrosporum spp.); mold fungi - Alternaria spp., Scopulariopsis spp., Hendersonula spp .; fungi from the family Dematiaceae - Cladosporium spp., Fonsecaea spp., Wangiella spp .; dimorphic fungi - Coccidioides spp., Histoplasma spp., Sporothrix spp.
PHARMACOKINETICS

When applied to the nails penetrates the nail plate and then into the nail bed (almost completely within the first 24 hours).
Effective concentration is maintained in the affected nail plate for 7-10 days after the first application. Systemic absorption is negligible: the concentration in the plasma is below the sensitivity limit of the detection methods (less than 0.5 ng / ml).
INDICATIONS

- treatment of fungal nail lesions caused by dermatophytes, yeast and mold fungi;

- prevention of fungal nail lesions.

DOSING MODE

Outwardly.

Apply to the nails of the fingers or toes 1-2 times a week as follows:

1. Before using the drug, remove the affected areas of the nail (especially on its surface) with the attached nail file.

2. Then clean the surface of the nail and degrease with the attached tampon moistened with alcohol.

The processing of nails with a nail file and a swab with alcohol must be carried out before each use of the preparation.

3. Dip the spatula into the varnish.
The spatula should be removed from the vial, without touching its neck, do not erase excess lacquer on the neck of the vial.
4. Apply the varnish to the entire surface of the affected nail with a spatula.

Repeat the above procedure for each affected nail

5. Close the vial tightly after use.

6. Allow the varnish to dry for about 3 minutes.

7. Sponge wipe with used swab.
Avoid contact of processed nails and a tampon. The used tampon is thrown away.
Treatment should be continued continuously until the nail is regenerated and the wound is completely healed.

The average duration of treatment is 6 months for the nails on the hands and 9-12 months for the nails on the legs.

SIDE EFFECT

Rarely (in 0.01% -0.1% of cases): damage to the nail (discoloration, increased fragility of the nail plate), which may be a consequence of fungal nail injury.

Very rarely (less than 0.01% of cases): slight short-term burning sensation in the nail area after application of the drug, contact dermatitis.

CONTRAINDICATIONS

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

It is not recommended to use the drug during pregnancy and during breastfeeding.

SPECIAL INSTRUCTIONS

The nails used to treat the affected nails should not be used for the treatment of healthy nails.

Persons working with organic solvents should wear impermeable gloves to protect nails covered with varnish.

During treatment, the use of false artificial nails should be avoided and cosmetic nail varnish should not be used.

The tampon contains a highly flammable substance.

Avoid contact with the eyes, ears and mucous membranes.

Patients with conditions predisposing to the development of fungal nail lesions (violation of peripheral blood circulation, diabetes mellitus, immunodeficiencies), as well as patients with nail dystrophy or a destroyed nail plate should consult a doctor.

Use in Pediatrics

Clinical data on the use of the drug in children are absent, so it should not be prescribed to children.

Impact on the ability to drive vehicles and manage mechanisms

Does not affect the ability to drive vehicles and mechanisms.

OVERDOSE

Offlomil Lak - a drug for external use with little systemic absorption and an overdose is unlikely.

In case of accidental ingestion, the stomach must be cleaned and immediately consult a doctor.

DRUG INTERACTION

Not installed.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

Store in a dark place at a temperature of no higher than 25 ° C.
Do not freeze. Keep out of the reach of children. Shelf life - 2 years. Do not use the drug after the expiration date.
Alphabetical index of medicines:
A  B  V  G  D  E  J
Z  I  Y  K  L  M  N
O  P  R  S  T  U  F
H  C  CH  SH  E  U  Y
Privacy policy:
Copyright 2009 - 2017. Universal reference book of medicines. All rights reserved.
When using site materials, an active hyperlink is required!