COMPOSITION :
| Hydroquinone USP | 2% w/w |
| Tretinoin USP | 0.025% w/w |
| Hydrocortisone Acetate I.P. | 1% w/w |
| In a cream base |
PHARMACOLOGY:
Hydroquinone 2% in HQ LITE Cream is depigmenting agent. It causes a reversible depigmentation of the skin.
Tretinoin 0.025% in HQ LITE is a Keratolytic agent. Although the exact mechanism is unknown, current evidence suggests that topical tretinoin functions in this formula as a mild irritant to facilitate the epidermal penetration of Hydroquinone. Tretinoin has a protective effect, to reduce any chances of skin atrophy with topical Hydrocortisone, and as an anti-oxidant to prevent oxidation of Hydroquinone. Hydrocortisone Acetate 1% in HQ LITE Cream is a low potent corticosteroid, classified therapeutically as an anti-inflammatory. It may have some role in reducing melanin formation. It also eliminates the irritation causes by Hydroquinone and / or Tretinoin.
The combination of these three agents in HQ LITE Cream act by inhibiting one or more steps in the tyrosine-tyrosinase pathway of melanin synthesis. It inhibits the formation and melanization of melanosomcs and eventually causes necrosis of the whole melanocytes. The hyperpigmented areas fade rapidly than the surrounding skin.
INDICATIONS:
HQ LITE Cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.
DOSAGE AND ADMINISTRATION:
HQ LITE Cream should be applied once daily at the night. The night time application should be made at least 30 minutes prior to going to bed. Duration of application would be decided by the treating physician depending upon the response.
Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply a thin film of the cream to the hyperpigmented areas. Rub lightly and uniformly into the skin. Do not use occlusive dressing. HQ LITE Cream should be washed off from the application area in the morning.
During the day, use a sunscreen of SPF 15 SPF 30, and wear protective clothing. Avoid sunlight exposure or to any artificial source of UV Light.
CONTRAINDICATIONS:
Contraindicated in those patients with a history of hypersensitivity to any component of this formulation. Safety and efficacy in pregnant women and nursing mothers have not been established. The safety of topical hydroquinone on children (< 12 years) has not been established.
WARNINGS AND PRECAUTIONS:
Keep out of reach of children. Use only as directed. Do not apply in excess. Cutaneous hypersensitivity reactions have been reported with the individual ingredients. This preparation may cause mild to moderate irritation. Local irritation, including skin reddening, peeling, and mild burning sensation, dryness, and pruritus may be expected at the site of application. Exogenous ochronosis, a gradual blue-black darkening of the skin, has been reported with hydroquinone, whose occurrence should prompt discontinuation of therapy. In case of any reaction which suggests hypersensitivity or chemical irritation, the use of the medication should be discontinued.
Exposure to sunlight, sunlamp or ultraviolet light should be avoided. Those with sunburn should be advised not to use the product until fully recovered because of heightened susceptibility to sunlight as a result of the use of tretinoin. Those who may be required to have considerable sunlight exposure due to occupation and those with inherent sensitivity to sun light should exercise particular caution.
Use of sunscreen products and protective clothing over treated areas are recommended when exposure can not be avoided. Sunscreen use is an essential aspect of melasma therapy, as minimal sunlight sustains melanocytic activity. Weather extremes, such as wind or cold, also may be irritating to patients under treatment. Because of the drying effect of this medication, a moisturizer may be applied to the face in the morning after washing.
Application should be kept away from the eyes, nose or angles of the mouth.
ADVERSE REACTIONS:
The most frequently reported adverse events include : erythema, desquamation, bunting, dryness and pruritus at the site of application. Other reported adverse reactions include acne, paracsthesia, telangiectasia, hyperesthesia, pigmentary changes, irritation, papules, acne like rash, rosacea, dry mouth, vesicles, itching, infection, skin atrophy, striae, miliaria, etc.
STORAGE:
Protect from light. Keep in a cool dark place. For external use only. Keep out of reach of children.