Refaquin

REFAQUIN^®

(HYDROQUINONE 4%, TRETINOIN 0.05%, FLUOCINOLONE ACETONIDE 0.01 %)
Skin Bleaching Cream

Mode of Action	:	Hydroquinone is classified therapeutically as a depigmenting agent. Tretinoin is classified therapeutically as a keratolytic. Fluocinolone acetonide is classified therapeutically as an anti-Inflammatory. One of the components in REFAQUIN® cream, hydroquinone, is a depigmenting agent, and may interrupt one or more steps In the tyrosine-tyrosinase pathway of melanin synthesis. However, the mechanism of action of the active ingredients in REFAQUIN® cream in the treatment of melasma is unknown.
Indication and Usage	:	REFAQUIN® cream is indicated for the short-term treatment of moderate to severe melasma of the face, in the presence of measures for sun avoidance, including the use of sunscreens. REFAQUIN® cream, a combination drug product containing corticosteroid, retinoid, and bleaching agent, is not indicated for the maintenance treatment of melasma. The safety and efficacy of REFAQUIN® cream in the treatment of hyperpigmentation conditions other than melasma of the face have not been studied.
Contraindications	:	REFAQUIN® cream is contraindicated in individuals with a history of hypersensitivity, allergy, or Intolerance to this product or any of its components.
Precautions	:	REFAQUIN® cream, a combination drug product containing corticosteroid, retinoid, and bleaching agent, is not indicated for the maintenance treatment of melasma. After achieving control wtth REFAQUIN® cream, some patients may be managed with other treatments instead of triple therapy with REFAQUIN® cream. Because melasma usually recurs upon discontinuation of REFAQUIN® cream, patients need to avoid sunlight exposure, use sunscreen of SPF 30 or greater, wear protective clothing, and change to non-hormonal forms of birth control, if hormonal methods are used. REFAQUIN® cream contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible people. REFAQUIN® cream 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 this condition are Black, but It may also occur in Caucasians and Hispanics. The safety and efficacy of REFAQUIN® cream in patients of skin types V and VI have not been studied. The safety and efficacy of REFAQUIN®  cream in pregnant women and nursing mothers have not been established. Exposure to sunlight, sun lamp, or ultra-violet light should be avoided. Patients who are consistently exposed to sunlight or skin irritants either through their work environment or habits should exercise particular caution. Sunscreen and protective covering (such as the use of a hat) over the treated areas should be used. Sunscreen use is an essential aspect of melasma therapy, as even minimal sunlight sustains melanocytic activity. Weather extremes, such as heat or cold, may be irritating to patients treated with REFAQUIN® cream. Because of the drying effect of this medication, a moisturizer may be applied to the face in the morning after washing. Application of REFAQUIN® cream should be kept away from the eyes, nose, or angles of the mouth, because the mucosa is much more sensitive than the skin to the irritant effect. If local irritation persists or becomes severe, application of the medication should be discontinued, and the health care provider consulted. Allergic contact dermatitis, blistering, crusting, and severe burning or swelling of the skin and irritation of the mucous membranes of the eyes, nose, and mouth require medical attention. Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies of hydroquinone in animals have demonstrated some evidence of carcinogenicity. The carcinogenic potential of hydroquinone in humans is unknown. Studies in hairless albino mice suggest that concurrent exposure to tretinoin may enhance the tumorigenic potential of carcinogenic doses of UVB and UVA light from a solar simulator. Mutagenicity studies were not conducted with this combination of active ingredients. Published studies have demonstrated that hydroquinone is a mutagen and a clastogen. Pregnancy: Teratogenic effects: REFAQUIN® cream contains the teratogen, tretinoin, which may cause embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits. There are no adequate and well-controlled studies in pregnant women. REFAQUIN® cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Adverse Reactions	:	Local Irritation, such as skin reddening, peeling, mild burning sensation, dryness. If a reaction suggests hypersensitivity or chemical irritation, the use of the medication should be discontinued.
Drug Interactions	:	Patients should avoid medicated or abrasive soaps and cleansers, soaps and cosmetics with drying effects, products with high concentration of alcohol and astringent. Patients are cautioned on concomitant use of medications that are known to be photosensitizing.
Dosage and Administration	:	REFAQUIN® 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. Rinse and pat the skin dry. Apply a thin film of the cream to the hyperpigmented areas of melasma. Application of REFAQUIN® cream should be kept away from the eyes, nose, or angles of the mouth. Not using more often than prescribed. Do not use occlusive dressing. If local irritation persists or becomes severe, application of the medication should be discontinued, and the health care provider consulted. During the day, use a sunscreen of SPF 30 or greater and wear protective clothing such as the use of a hat. Patients may use moisturizers and/or cosmetics during the day. Therapeutic effects may be observed as early as 4 weeks.
Storage	:	Keep tightly closed. Store at controlled room temperature 15°-25°C
Packaging	:	Aluminium tube of 15 g net. ON PRESCRIPTION ONLY Reg. No. OKL 0828604829A1

Manufactured by

PT. SURYA DERMATO MEDICA LABORATORIES
Surabaya, Indonesia

---

REFAQUIN^®

(HYDROQUINONE 4%, TRETINOIN 0.05%, FLUOCINOLONE ACETONIDE 0.01 %)
Skin Bleaching Cream

Cara Kerja Obat	:	Hydroquinone : depigmenting agent Tretinoin : keratolytic Fluocinolone acetonide : anti-inflamasi REFAQUIN® cream mengandung hydroquinone yang merupakan depigmenting agent dan dapat mengganggu satu atau lebih rangkaian jalur tyrosine-tyrosinase pada sintesis melanin. Mekanisme kerja bahan aktif yang terkandung dalam REFAQUIN® cream untuk pengobatan melasma tidak diketahui.
Indikasi	:	Untuk pengobatan jangka pendek melasma sedang sampai berat pada wajah. Hindari sinar matahari dan gunakan sunscreen pada daerah yang diobati. Refaquin cream mengandung kortikosteroid, retinoid dan bleaching agent tidak diindikasikan untuk pemeliharaan pengobatan melasma. Keamanan dan kemanjuran REFAQUIN® cream untuk pengobatan hiperpigmentasi selain melasma pada wajah belum dipelajari.
Kontra Indikasi	:	Untuk individu yang hipersensitif, alergi atau intoleransi terhadap komponen obat ini.
Peringatan dan Perhatian	:	REFAQUIN® cream merupakan obat yang mengandung kortikosteroid, tretinoin dan bleaching agent, obat ini tidak diindikasikan untuk pemeliharaan pengobatan melasma. Setelah hasil pengobatan tercapai dapat dilanjutkan dengan pengobatan lain sebagai pengganti REFAQUIN® cream sebab melasma dapat timbul kembali setelah REFAQUIN® cream dihentikan. Paparan matahari harus dihindarkan, gunakan sun-screen dengan SPF 30 atau lebih, payung, topi dan ubahlah untuk tidak menggunakan bentuk hormon sebagai pil KB, bila metode hormon digunakan.  REFAQUIN® cream mengandung sodium metabisulfite, dimana sulfite dapat menyebabkan tipe reaksi alergi seperti anaphylactic symptoms dan life-threatening asthmatic pada pasien yang peka.  REFAQUIN® cream mengandung hydroquinone yang dapat menyebabkan exogenous ochronosis, yaitu penggelapan kulit secara berangsur-angsur dan terapi harus cepat dihentikan. Umumnya hal ini terjadi pada kelompok kulit hitam, namun juga dapat terjadi pada kelompok Caucasians dan Hispanics.  Keamanan dan kemanjuran obat terhadap pasien dengan kulit tipe V dan VI belum dipelajari.  Keamanan pada wanita hamil dan menyusui belum ditetapkan,  Hindarkan paparan dengan sinar matahari atau cahaya ultraviolet. Pasien yang secara terus menerus terpapar sinar matahari atau bahan iritan pada lingkungan kerja atau karena kebiasaan harus lebih berhati-hati. Gunakan sunscreen dan pelindung seperti topi pada daerah yang diobati. Penggunaan sunscreen merupakan aspek penting dalam pengobatan melasma karena minimnya sinar matahari akan menghambat aktivitas melanocytic.  Cuaca yang ekstrim seperti panas atau dingin dapat mengiritasi pasien yang sedang diobati menggunakan REFAQUIN® cream. Gunakan pelembab pada pagi hari setelah wajah dibersihkan karena efek obat dapat mengeringkan kulit.  Hindarkan pemakaian REFAQUIN® cream pada daerah mata, hidung atau sudut mulut karena lapisan mukosa pada daerah tersebut lebih sensitif. Hentikan penggunaan obat jika terjadi iritasi lokal atau bertambah parah dan segera konsultasikan dengan dokter. Penanganan khusus diperlukan untuk kondisi seperti allergic contact dermatitis, blistering, crusting, severe burning dan iritasi pada membran mukosa seperti mata, hidung dan mulut.  Karsinogenik, mutagenik dan gangguan kesuburan:  Beberapa penelitian penggunaan hydroquinone pada hewan menunjukkan adanya efek karsinogenik, namun potensi karsinogenik pada manusia tidak diketahui.  Penelitian pada hairless albino mice mengindikasikan bahwa penggunaan tretinoin berpotensi menyebabkan tumor.  Penelitian mutagenik tidak dilakukan dengan kombinasi bahan aktif ini. Hasil penelitian yang dipublikasikan menunjukkan bahwa hydroquinone bersifat mutagen dan clastogen.  Kehamilan : Efek teratogenik: REFAQUIN® cream mengandung tretinoin yang bersifat teratogen dan dapat menyebabkan kematian janin, gangguan pertumbuhan, cacat janin dan mempunyai potensi neurologic deficits. Tidak ada penelitian yang memadai pada wanita hamil. REFAQUIN® cream hanya digunakan selama kehamilan. Jika keuntungan yang didapat lebih besar dibandingkan dengan resiko bagi janin.
Efek Samping	:	Iritasi lokal seperti kekeringan, kemerahan kulit, rasa terbakar, kulit terkelupas. Jika terjadi reaksi hipersensitif/ iritasi kimia. pengobatan harus dihentikan.
Interaksi Obat	:	Dengan sabun/ cleanser yang bersifat abrasive, kosmetik yang mempunyai sifat mengeringkan, mengandung alkohol dan astringent tinggi. Kosmetik yang menimbulkan photosensitizing
Cara Pemakaian	:	Obat dioleskan tipis dan merata 1 kali sehari pada daerah melasma 30 menit sebelum tidur malam setelah wajah dibersihkan.  Jagalah agar obat tidak mengenai selaput mata, hidung dan mulut. Jangan gunakan obat lebih dari yang dianjurkan dokter dan Jangan menutup daerah yang diobati. Bila terjadi iritasi, hentikan pemakaian dan segera hubungi dokter.  Untuk membantu masalah kekeringan kulit gunakanlah krim pelembab setiap pagi setelah muka dibersihkan dan gunakanlah sunscreen dengan SPF 30 atau lebih dan topi yang berpinggir untuk melindungi area yang diobati dari paparan matahari.  Hasil pengobatan akan terlihat dalam waktu 4 minggu
Cara Penyimpanan	:	Simpan dalam wadah tertutup rapat pada suhu 15°- 25°C.
Kemasan	:	Dus, tube aluminium 15 g. HARUS DENGAN RESEP DOKTER Reg. No. DKL 0828604829A1

Manufactured by

PT. SURYA DERMATO MEDICA LABORATORIES
Surabaya, Indonesia

Share this :