Melalite

Uses

Hydroquinone is used -

• For the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines and other unwanted areas of melanin hyperpigmentation.
• To reduce hyperpigmentation caused by photosensitization associated with inflammation or with the use of certain cosmetics.

Octinoxate is a sunscreen agent found in sunscreens that absorbs UV rays.

As an active ingredient in sunscreens and lip balms. Used for protection against damaging effects of sun rays.

Oxybenzone is a sunscreen agent found in sunscreens that absorbs UV rays.

Used as an ingredient in sunscreen and other cosmetics.

Melalite is also used to associated treatment for these conditions: Acne Vulgaris, Melasma, Skin hyperpigmentation, Moderate Melasma, Severe MelasmaSunburnSunburn

How Melalite works

Hydroquinone reduces melanin pigment production through inhibition of the tyrosinase enzyme, which is involved in the initial step of the melanin pigment biosynthesis pathway. Hydroquinone takes several months to take effect.

Absorbs UV-B (predominantly) and UV-A rays while accumulating in the outermost layer of the epidermis. Like any other photoprotective agents, octinoxate prevents the damage to cells and deoxyribonucleic acid (DNA) by reducing the p53 protein expression following UV exposure and also increases the skin's tolerability to UV rays .

Oxybenzone absorbs UV-A ultraviolet rays, preventing them from reaching the skin.

Dosage

Melalite dosage

Apply a thin film of Hydroquinone Cream to the effected area once daily, at least 30 minutes before bedtime. Gently wash the face and neck with a mild cleanser. Rinse and pat the skin dry. Apply Hydroquinone Cream to the hyperpigmented areas of melasma including about ½ inch of normal appearing skin surrounding eachlesion. Rub lightly and uniformly into the skin.

Therapy should be discontinued when control is achieved. During the day, use asunscreenof SPF 30, and wear protective clothing. Avoid sunlight exposure. Patients may use moisturizers and/or cosmetics during the day. Hydroquinone Cream is for topical use only. It is not for oral,ophthalmic, or intravaginal use.

Side Effects

No systemic adverse reactions have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued.

Toxicity

Slightly hazardous in case of skin contact, eye contact, ingestion and inhalation. Octinoxate may form reactive singlet oxygen species and induce anti-estrogenic effects . UV-induced molecular breakdown of octinoxate may interfere with cellular processes or induce oxidative damage in human skin . The NOAEL (no observed adverse effect level) is 450 mg/kg bw/day for fertility and reproductive performance, for systemic parental and developmental toxicity in Wistar rats .

Precaution

Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.

Test for skin sensitivity before using by applying a small amount to an unbroken patch of skin to check in 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. If no bleaching or lightening effect is noted after 2 months of treatment, the medication should be discontinued.

Contact with the eyes and lips should be avoided. Hydroquinone should not be applied to cut or abraded skin.

Elimination Route

Can be systemically absorbed after skin application, being found in the deeper layers of the stratum corneum as well as urine, plasma, and breast milk . The mean maximum plasma concentration detected after application of 2mg/cm2 sunscreen was 7ng/mL in women and 16ng/mL in men .

Elimination Route

Can be detected in urine in unchanged form .

In vivo studies show oxybenzone is abosorbed transdermally (through the skin) and is excreted in the urine.

Pregnancy & Breastfeeding use

Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Lactation: It is not known whether topical hydroquinone is absorbed or excreted in human milk. Caution is advised when topical hydroquinone is used by a nursing mother.

Contraindication

Hydroquinone is contraindicated to patients with prior history of hypersensitivity or allergic reaction to hydroquinone or other ingredients in the preparation.

Acute Overdose

There have been no systemic reactions from the use of topical hydroquinone. Some patients may experience a transient reddening of skin and mild burning sensation which does not preclude treatment.

Storage Condition

Store between 20-25° C. Protect from light.

Innovators Monograph

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