Negara: Singapura
Bahasa: Inggris
Sumber: HSA (Health Sciences Authority)
MOMETASONE FUROATE ANHYDROUS
ORGANON SINGAPORE PTE. LTD.
D07AC13
0.10%
OINTMENT
MOMETASONE FUROATE ANHYDROUS 0.1%
TOPICAL
Prescription Only
Organon Heist bv
ACTIVE
1993-12-06
ELOMETⓇ Ointment 0.1% Brand of mometasone furoate FOR DERMATOLOGIC USE ONLY DESCRIPTION: Each gram of ELOMET Ointment 0.1% contains 1 mg mometasone furoate, hexylene glycol, white wax, propylene glycol stearate, white petrolatum, purified water and phosphoric acid to adjust the pH. ACTION: Mometasone furoate, a synthetic corticosteroid, exhibits anti-inflammatory, antipruritic and vasoconstrictive properties. PHARMACOLOGY: PRE-CLINICAL DATA: Pharmacodynamics The pharmacologic profile of mometasone furoate was determined by standard laboratory methods. Relative to betamethasone valerate, anti-inflammatory activity and anti-psoriatic activity of mometasone furoate was evaluated in mice and guinea pigs, respectively. Hypothalamic-pituitary-adrenal (HPA) axis suppression, thymolysis and skin atrophy were evaluated in mice. In the croton oil assay in mice, mometasone furoate (ED 50 = 0.02µg/ear) was equipotent to betamethasone valerate after single application, and was approximately eight times as potent as betamethasone valerate after five daily applications (ED 50 = 0.002µg/ear/day vs 0.014µg/ear/day). In guinea pigs, mometasone furoate was approximately twice as potent as betamethasone valerate in reducing M. Ovalis-induced epidermal acanthosis after 14 daily applications. With respect to other pharmacologic activities commonly associated with corticosteroids, mometasone furoate (ED 50 = 5.3µg/ear/day) was less potent than betamethasone valerate (ED 50 = 3.1µg/ear/day) in suppressing the HPA axis in mice after fi Baca dokumen lengkapnya
S-CCDS-MK0887-MTL-082017 ELOMET® Ointment 0.1% Brand of mometasone furoate FOR DERMATOLOGIC USE ONLY DESCRIPTION: Each gram of ELOMET Ointment 0.1% contains 1 mg mometasone furoate, hexylene glycol, white wax, propylene glycol stearate, white petrolatum, purified water and phosphoric acid to adjust the pH. ACTION: Mometasone furoate, a synthetic corticosteroid, exhibits anti-inflammatory, antipruritic and vasoconstrictive properties. PHARMACOLOGY: PRE-CLINICAL DATA: Pharmacodynamics The pharmacologic profile of mometasone furoate was determined by standard laboratory methods. Relative to betamethasone valerate, anti-inflammatory activity and anti-psoriatic activity of mometasone furoate was evaluated in mice and guinea pigs, respectively. Hypothalamic-pituitary-adrenal (HPA) axis suppression, thymolysis and skin atrophy were evaluated in mice. In the croton oil assay in mice, mometasone furoate (ED 50 = 0.02 µg/ear) was equipotent to betamethasone valerate after single application, and was approximately eight times as potent as betamethasone valerate after five daily applications (ED 50 = 0.002 µg/ear/day vs 0.014 µg/ear/day). In guinea pigs, mometasone furoate was approximately twice as potent as betamethasone valerate in reducing M. Ovalis-induced epidermal acanthosis after 14 daily applications. With respect to other pharmacologic activities commonly associated with corticosteroids, mometasone furoate (ED 50 = 5.3 µg/ear/day) was less potent than betamethasone valerate (ED 50 = 3.1 µg/ear/day) in suppressing the HPA axis in mice after five daily application. In the thymolysis assay, mometasone furoate (ED 50 = 26.6 µg/ear/day) was approximately two times as potent as betamethasone valerate (ED 50 = 51.6 µg/ear/day) when applied topically, and following subcutaneous administration for five days, mometasone furoate (ED 50 = 11.2 µg/mouse) was approximately six times as potent as betamethasone valerate (ED 50 = 59.8 µg/mouse). At doses five to 5000 times the effective anti-inflammatory doses, mometasone Baca dokumen lengkapnya