Nilac® Gel

COMPOSITION
Nilac® gel : Each 100 gm Nilac® gel contains 0.025 gm Tretinoin USP.

PHARMACOLOGY
Tretinoin is structurally and pharmacologically related to vitamin A. Current
evidence suggests that topical Tretinoin decreases cohesiveness of follicular
epithelial cells with decreased microcomedone formation. Additionally,
Tretinoin stimulates mitotic activity and increases turnover of follicular
epithelial cells, causing extrusion of the comedones.

INDICATION
1. For the treatment of acne vulgaris in which comedones, papules and
pustules predominate.
2. For the treatment of hyperpigmentation, roughness and fine wrinkling of
photodamaged skin due to chronic sun exposure.

DOSAGE AND ADMINISTRATION
Nilac® gel should be applied once or twice a day, before retiring, to the skin
where lesions appear, using enough to cover the entire affected area lightly.
The frequency of application can be adjusted to obtain maximum clinical
efficacy with minimal erythema and scaling.
If Nilac® gel is applied excessively, no more rapid or better results will be
obtained and marked redness, peeling or discomfort may occur. Should this
occur accidentally or through over-enthusiastic use, application should be
discontinued for few days.
Patience is needed in this treatment, since the therapeutic effects will not
usually be observed until after 6-8 weeks of treatment. During the early
weeks of treatment, an apparent exacerbation of inflammatory lesions may
occur. This is due to the action of the medication on deep, previously unseen
comedones and papules. Once the acne lesions have responded
satisfactorily, it should be possible to maintain the improvement with less
frequent applications.
Moisturizers and cosmetics may be used during treatment with Nilac® gel
but should not be applied to the skin at the same time. The skin should be
thoroughly washed before application of Nilac® gel. Astringent toiletries
should be avoided.

CONTRAINDICATION AND PRECAUTION
Tretinoin is contraindicated in patients who are allergic to this drug. It is
contraindicated in pregnancy or suspected pregnancy. It is also
contraindicated in personal or familial history of cutaneous epithelioma.
Local irritation: The presence of cutaneous irritative signs (e.g. erythema,
peeling, pruritus, sunburn, etc.) should prohibit initiation or
recommencement of treatment with Tretinoin until the symptoms resolve.
Tretinoin has been reported to cause severe irritation on eczematous skin
and should be used with caution in patients with this condition.
Exposure to sunlight: Exposure to sunlight, including ultraviolet sun-lamps,
should be avoided or minimised during the use of Tretinoin.
General precaution: Before application of Tretinoin, areas to be treated
should be cleansed thoroughly. Abstain from washing the treated area
frequently; twice daily is sufficient. Use of mild soap is recommended. Dry
the skin without rubbing.
Avoid contact with eyes, eyelids, nostrils, mouth and mucous membranes. If
contact in these areas occurs, careful washing with water is recommended.

SIDE EFFECT
True allergic contact dermatitis is rare but a primary irritant dermatitis,
manifesting itself as irritation, erythema, peeling and sensation of warmth,
is common. Slight stinging is common as a mild reaction in many people but
usually settles with continuous use and/or reduction in frequency of
application of the drug.

DRUG INTERACTION
Particular caution should be exercised in using preparations containing
peeling agents (i.e. sulfur, resorcinol, benzoyl peroxide or salicylic acid). Use
of topical preparations with high concentrations of alcohol, menthol, spices
or lime- such as shaving lotions, astringents and perfume- should be
avoided, especially during initial therapy.

USE IN PREGNANCY AND LACTATION
Tretinoin is contraindicated in pregnancy or suspected pregnancy. The drug
should be avoided by breast feeding mothers.

STORAGE CONDITION
Store in a cool and dry place, away from light. Keep out of reach of children.

HOW SUPPLIED
Nilac® (Tretinoin) 0.025% gel : Tube containing 10 gm gel.