CANDID LOTION 1%WV

Valsts: Malaizija

Valoda: angļu

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

Aktīvā sastāvdaļa:

CLOTRIMAZOLE

Pieejams no:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

SNN (starptautisko nepatentēto nosaukumu):

CLOTRIMAZOLE

Vienības iepakojumā:

20 ml

Ražojis:

GLENMARK PHARMACEUTICALS LTD

Produkta apraksts

COMPOSITION
Clotrimazole USP 1% w/v
Non-aqueous Base
q.s.
THERAPEUTIC CLASS
T0130
DESCRIPTION
A printed carton with an insert and a labeled, LDPE bottle fitted with
a
plug and cream coloured cap containing a clear, colourless, viscous
liquid.
ACTIONS AND MODE OR MECHANISM OF ACTION
Clotrimazole
has
broad
spectrum
fungicidal
activity
against
Dermatophytes (Trichophyton, Epidermophyton and Microsporum
spp.), Candida and as pergillus spp., Malassezia furfur and other
fungi. It also inhibits some strains of Gram-positive and Gram-
negative bacteria.
PHARMACOLOGY
(SUMMARY
OF
PHARMACODYNAMICS
AND
PHARMACOKINETICS)
PHARMACODYNAMICS
Clotrimazole is an imidazole antifungal agent and is effective against
a wide variety of fungi including Epidermophyton, Microsporum and
Trichophyton spp., Coccidioides immitis, Histoplasma capsulatum,
Aspergillus and Candida spp. Other fungi responding to Clotrimazole
include Cryptococcus neoformans, Malassezia furfur (Pityrosporum
orbiculare),
Paracoccidioides
brasilliensis,
Sporothrix
schenckii,
Pseudallescheria, Medurella and Phialophora spp. Clotrimazole also
has antibacterial action and some strains of Staphylococcus aureus
and Streptococcus pyogenes have been reported to be sensitive.
Clotrimazole is believed to exert its activity on the cell membrane of
the fungus. It appears that the drug inhibits protein synthesis and so
influences the utilisation and the incorporation of the acylated amino
acids essential for fungi.
PHARMACOKINETICS
Clotrimazole appears to be well absorbed in humans following oral
administration and is eliminated mainly as inactive metabolites.
Following topical and vaginal administration, however, Clotrimazole
appears to be minimally absorbed. Six hours after the application of
radioactive Clotrimazole 1% cream and 1% solution onto intact and
acutely inflamed skin, the concentration of Clotrimazole varied from
3
3
100 mcg / cm in the stratum corneum to 0.5 to 1 mcg / cm in the
3
stratum reticulare, and 0.1 mcg / cm in the subcutis. No measurable
amount of radioact