BETAVAL-N CREAM

Country: Malaysia

Language: English

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

Active ingredient:

BETAMETHASONE-17 VALERATE; NEOMYCIN SULPHATE

Available from:

PAHANG PHARMACY SDN. BHD.

INN (International Name):

BETAMETHASONE-17 VALERATE; NEOMYCIN SULPHATE

Units in package:

10 gm mcg/mL; 15 gm mcg/mL; 5 gm mcg/mL; 10 gm mcg/mL; 5 gm mcg/mL

Manufactured by:

Noripharma Sdn. Bhd.

Summary of Product characteristics

BETAVAL-N CREAM
DESCRIPTION:
White smooth homogenous mass
COMPOSITION:
Each gm of the cream contains
Betamethasone 17-Valerate (Micronised) 1 mg Neomycin (as sulphate)
5mg
PHARMACODYNAMICS:
Betamethasone valerate is an active topical corticosteroids which
produces a rapid response in those
inflammatory dermatoses that are normally responsive to topical
corticosteroids therapy and is often
effective in the less responsive conditions, e.g.: psoriasis. Neomycin
Sulphate, an aminoglycoside, is a
broad spectrum bactericidal antibiotic. It is actively transported
across the bacterial cell membrane, binds
to a specific receptor protein on the 30S subunit of bacterial
ribosomes, and interferes with an initiation
complex between mRNA and the 30S subunit, inhibiting protein
synthesis. DNA may be misread, thus
producing nonfunctional proteins. Polyribosomes are split apart and
are unable to synthesize protein.
PHARMACOKINETICS:
Absorbed systemically across the stratum corneum. Stratum corneum
penetration is primarily enhanced
by increasing skin hydration and or temperature particularly when
occlusive dressing are used. Increased
percutaneous absorption also occurs when the skin or mucosa is abraded
or inflamed, with prolonged use
or with excessive/extensive use. Readily absorbed from large denuded,
burned or granulating areas.
INDICATIONS:
Treatment of the following conditions where secondary bacterial
infection is present, suspected or likely
to occur: Eczema, including atopic, infantile and discoid eczemas:
prurigo; psoriasis; neurodermatoses,
including lichen simplex; lichen planus; seborrhoeic dermatitis,
intertrigo, contact sensitivity reactions
and may be used as an adjunct to systemic therapy in generalized
erytroderma.
Betaval-N can also be used in the management of secondarily infected
insect bites, sunburn, prickly heat,
anal and vulval pruritus (see Contraindications).
CONTRAINDICATIONS:
Contraindicated
in
those
who
are
allergic
to
corticosteroids
and
neomycin
sulphate
and
other
aminoglycosides. Contraindicated i