U-CLOSONE OINTMENT

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CLOBETASONE BUTYRATE

Available from:

HOE PHARMACEUTICALS SDN. BHD.

INN (International Name):

CLOBETASONE BUTYRATE

Units in package:

100 gm; 15 gm

Manufactured by:

HOE PHARMACEUTICALS SDN. BHD.

Patient Information leaflet

Please refer to section E12

Summary of Product characteristics

U-CLOSONE CREAM & OINTMENT
Est. 1979
NAME AND STRENGTH OF ACTIVE SUBSTANCE: Clobetasone Butyrate 0.05% w/w.
PRODUCT DESCRIPTION:
Cream: A white cream.
Ointment: White ointment.
Other ingredients for cream are Sodium Citrate. Chlorocresol, Glyceryl
Monostearate, Glycerin,
Cetostearyl Alcohol, Glyceryl Monostearate (and) PEG-100 Stearate,
Dimethicone and Purified
Water.
Other ingredients for ointment are Liquid Paraffin and White Soft
Paraffin.
PHARMACODYNAMICS: Clobetasone Butyrate is a topically active
fluorinated corticosteroid
which has anti-inflammatory, anti-pruritic and vasoconstrictive
actions.
PHARMACOKINETICS:
Topical
corticosteroids
have
anti-inflammatory,
anti-pruritic
and
vasoconstrictive actions. When administered topically, particularly
under occlusive dressings or
when the skin is broken, sufficient corticosteroid may be absorbed to
give systemic effects.
Corticosteroids are extensively bound to plasmaproteins. Only unbound
corticosteroids have
pharmacological effects or are metabolised. They are metabolised
mainly in the liver, also in the
kidney, and are excreted in the urine.
INDICATIONS: All types of eczema and dermatitis, including atopic
eczema, photodermatitis,
otitis externa, primary irritant and allergic dermatitis, prurigo
nodularis, seborrhoeic dermatitis
and insect bite reactions. Maintenance between courses of more potent
topical steroids in more
resistant dermatoses.
CONTRAINDICATIONS: Hypersensitivity to Clobetasone Butyrate, to other
corticosteroids or to
any ingredient in this preparation, rosacea, acne vulgaris, peri-oral
dermatitis, primary cutaneous
viral infections (eg. herpessimplex, chicken pox). The use of
U-Closone is not indicated in the
treatment of primarily infected skin lesions
caused by infection with fungi or
yeasts (eg.
candidiasis, tinea), or bacteria (eg. impetigo), peri-anal and genital
pruritus.
DRUG INTERACTIONS: Unknown.
ADVERSE
EFFECTS: Reported
local
adverse
reactions
are
burning,
itching,
irritation,
dryness, folliculitis, hypertrichosis, acneiform eruptions