Melanofree topical cream
Company name :
Protech Pharmaceutical Company
Trade name :
Melanolree Topical Cream
Generic name :
fluocinolone acetonide , Tretinoin & Hydroquinone
Composition :
Each 1 gm of Melanofree Topical Cream contain
Fluocinolone acetonide 0,01 %
Tretinoin 0,05 %
Hydroquinone 4 %
Pharmaceutical form :
Cream
Clinical Pharmacology :
One of the components in Melanolree Topical Cream, hydroquinone, is a depigmenting agent, and may Interrupt one or more steps in the tyrosine-tyrosinase pathway of melanin synthesis, RuoClnolone acetonide, like other corticosteroids, has anti-inflammatory, antipruritics and vasoconstrictive properties corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins, It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibrting the release of their common precursor arachidonic acid, Arachidonic add is released Irom membrane phosPholipids by phospholipase AZ,
Tretinoin is classified therapeutically as keratolvtic, it is a retinoid metabolite of vitamin A, it was suggested that Tretinoin promotes detachment of cornified cells and the enhanced shedding of corneocytes Irom the follicle, By increasing the mrtotiG-activity of follieular epithelia, Tretinoin also increases the turnover-rate of thin,
loosely-adherent corneocytes Additionally tretinoin acts by modulating the proliferation and differentiation of epidermal cells, However, the mechanism of action of the active ingredients in Melanolree Topical Cream in the treatment of melasma is unknown,
Pharmacokinetics :
Percutaneous absorption of unchanged tretinoin, hydroquinone and Ruocinolone acetonide in the systemic circulation was found to be minimal fonowing 8 weeks of daily application of 1 gm of Melanolree Topical Cream, ,
– For tretinoin quantifiable plasma concentrations, the exposure to tretinoin as reflected by the Cmax values ranged Irom 2.01 to 5.34 ng/ml .
– For hydroquinone quantiflable plasma concentrations, the exposure to hydroquinone as reflected by the Cmax values ranged from 25.55 to 86.52 ng/ml.
– For Fluodnolone acetonide, post-dose plasma concentration below quantrtation limit.
Indication :
Melanolree Topical Cream is indicated for the short-term intermittent treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens
Contraindications :
Melanofree Topical Cream is contraindicated in individuals with a history of hypersensitivity, allergy or intolerance to this product or any of its components.
Dosage and Adminstration :
– Melanolree Topical Cream should be applied once daily at night. It should be applied at least 30 minutes before bedtime.
– Gently wash the face and neck with a mild cleanser don’t use a wash cloth to apply the cleanser, just your fingers. Rinse and pat your skin dry
– Put a small amount (pea sized or 1/2 inches or less) of Melanolree Topical Cream on your fingertip. Apply a thin coat onto the discolored spot(sl.lnclude about 1/2 inch of normal skin surrounding the affected area.
– Therapeutic effects may be observed as early as 4 weeks, <Use Melanofree Topical Cream daily for as long as the melasma lesions persist.
– Treatment should be discontinued when melasma is resolved ,
Side effects :
– Very lew patients may get severe allergic reactions from Melanofree. This includes people allergic to sulfites.
– While you use. Melanolree Topical Cream, your skin may develop mild to moderate redness, peeTIng, burning, dryness, or rtchlng.
– Melanofree Topical Cream contains corticosteroid medicine as one of its active components. The followin side effects have been reported with application of corticosteroid medicines to the skin itching , irritation, dryness,infection of the hair follicles, acne, and change in skin color, inflammation around the mou ,allergic skin reaction, skin infection, skin thinning, stretch marks, and sweat problems,
– Some Patients using Melanofree Topical Cream develop dark spots on their skin(hyperpigmention), tingling, increased skin sensitivity, rash, acne, skin redness caused by a condition called rosacea, SKin bumps, blisters, or tiny red lines or blood vessels showing through the skin (telangiectasia).
Pregnancy & Nursing mothers :
– there are no adequate and well controlled studies in pregnant women. Melanolree Topical Cream should be used during Pregnancy only if the fotential benefit justifies the potential risk to the fetus.
– It is recommended that pregnan women use Melanofree Topical Cream after asking the doctor.
Drug-drug interactions :
– patients shour avoid meicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentration of alcohol and astringent, and other irritants or keratolyic drugs while on Melanolree Topical Cream treatment. Patients are cautioned on concomitant use of medications that are known to be photosensrtizing.
Precautions & warning :
– Melanolree Topical (ream contains hydroquinone, which may produce exogenous ochronosis, a gradual blue-black darkening of the skin, whose occurrence should prompt discontinuation of therapy The majority of patients developing 1his condrtion are black, but rt may also occur in Caucasians and Hspanks,
– Cutaneous hypersensrtivity to the active ingredients of Melanofree Topical Cream has been reported. That may cause mild to moderate local irritation, such as skin reddening, peeling, mild burning sensation, dryness, and pruritus may be expected at the site of application. Transient skin reddening or mild burning sensation ooes not preclude treatment. If a reaction suggests hypersensitivITy or chemical irritation, the use of the medication should be discontinued.
– Melanolree Topical Cream also contains the corticosteroid fluocinolone acetonide. Systemic absorption of topical corticosteroids can produce reversible Hypothalamic-rrturtary-adrenal (HPA) axis
suppression with the potential for glucocorticosteroid insufficiency after withdrawal 0 treatment.
– Manifestations of Cushing’s syndrome, hyperglvcemia, and glucosuria can also be produced by systemic absorption of topical corticosteroid while on trealment. If HPA axis suppression is noted, the use 01 Melanofree Topical Cream should be discontinued and recovery generally occurs upon discontinuation of topical corticosteroids
How supplied :
Melanolree Topical Cream is supplied in 30 gm aluminum tube.
Storage :
Store at a temperature below 3O”C
Protect Irom freezing.
( Keep all medicine out of reach of children)
Manulactured by :
T3A Industrial for Protech Pharmaceutical Company
