聯亞藥業股份有限公司新竹廠新竹縣湖口鄉光復北路45號

Mineral oil light, emulsifying wax, potassium sorbate, sorbitol solution, squalane, methylparaben, propylparaben, purify water.

賦形劑

L184-01

Ledercort Cream with Neomycin 0.1% contains the acetonide, derivative of Triamcinolone and is chemically 9α fluoro - 16α - 17α isopropylidenedioxy△1 hydrocortisone. Ledercort Cream with Neomycin 0.1% contains, in each gram, Triamcinolone Acetonide 1.0 mg, Neomycin Sulfate 5mg. (equivalent to 3.5mg neomycin base); benzyl alcohol as the preservative and the following inactive ingredients in a water base: glyceryl monostearate, polysorbate 80 squalane, Polawax and isopropyl palmitate USP and 70% sorbitol solution. The topical Ledercort products (creams and ointments) contain the highly active steroid, triamcinolone acetonide, which is a derivative of triamcinolone. The special affinity that oral Triamcinolone has for therapy of diseases of the skin is also obtained with the potent Triamcinolone Acetonide. This potency has been demonstrated to be ten times that of hydrocortisone. No systemic steroid effects have appeared with the use of this topical medicament. Neomycin is an antibiotic which is active against of wide variety of Gram-negative and Gram-positive organisms as well as acid-fast bacilli. It is included in these topical preparations as a prophylactic agent against bacterial invasion of tissues during topical therapy. No systemic effect of neomycin may be expected with the topical use of this product. If infection of the tissues is present, the use of a systemic broad spectrum antibiotic such as Ledermycin Demethylchlortetracycline may be desirable.IndicationsAcute and chronic dermatoses combined with bacterial infections.DosageLedercort Cream with Neomycin 1% should be applied in small quantity to the affected area 3 or 4 times daily.Precautions and side effectsGeneral Topical Steroid Precautions. Side effects are not ordinarily encountered with topical preparations of steroids, but as with all drugs, a few may react unfavourably under certain condition. If reaction or idiosyncrasies are encountered, the drug should be discontinued and appropriate measures taken. The use of steroids on infected areas should be attended with caution and careful observation, bearing in mind the potential spreading of infection by anti-inflammatory steroids and the possible advisability of discontinuing steroid therapy and/or initing antibacterial measures. Ledercort Cream with Neomycin 1% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when topical corticosteroids are administered to a nursing woman. Children may absorb proportionately larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. In infants, long-term continuous topical steroid therapy should be avoided. Adrenal suppression can occur even without occlusion. When occlusive non-permeable dressings are used, miliaria. folliculitis and pyoderma may sometimes develop beneath the occlusive material. Localized atrophy and striate have been reported with corticosteroid use by the occlusive technique. Topical corticosteroids may be hazardous in psoriasis including rebound relapses following development of tolerance, risk of generalized pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin. Specific Ledercort Topical precautions : None General Topical Neomycin Precautions : Neomycin has, on occasion, been responsible for local skin sensitization. Under these circumstances Ledercort Cream with Neomycin 1% should be discontinued and replaced with Ledercort Acetonide Cream or Ointment.ExcipientsMineral oil light, emulsifying wax, potassium sorbate, sorbitol solution, squalane, methylparaben, propylparaben, purify water.Keep out of the reach of children Package: 15g/tubeStorage: store below 25℃Distributer:Pfizer Biotech Corporation177 Chung Cheng East Road, Sec. 2, Tamsui Dist., New Taipei City, 251 TaiwanManufacturer: Hsinchu Plant of UBI Pharma Inc.No. 45, Guangfu N. Rd., Hukou Township, Hsinchu County 30351, Taiwan (R.O.C).Version: Populating (Taiwan 19790302)-2

UBI Pharma Approved by:

Date:

Pfizer Approved by:

Date:LW

120 mm200 mm

L184-01Leaflet Ledercort Cream

Colour

K

Edge CodePharmacode: 106