Metronidazole 1% gel

Quốc gia: Armenia

Ngôn ngữ: Tiếng Anh

Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Thành phần hoạt chất:

metronidazole

Sẵn có từ:

Arpimed LLC

INN (Tên quốc tế):

metronidazole

Liều dùng:

10mg/g

Dạng dược phẩm:

gel

Loại thuốc theo toa:

Prescription

Đặc tính sản phẩm

SUMMARY PRODUCT CHARACTERISTIC (SPC)
METRONIDAZOLE 1% GEL
BRAND NAME – Metronidazole
1% gel
INTERNATIONAL NON-PROPERTY NAME - Metronidazole
COMPOSITION
Each gram contents:
_ACTIVE INGREDIENTS_: metronidazole - 10 mg;
_NON ACTIVE INGREDIENTS_: propylene glycol, carbomer-940,
methylparaben, triethanolamine,
disodium EDTA, purified water.
CHEMICAL NAME AND CAS NUMBER
2-(2-Methyl-5-nitro-1_H_-imidazol-1-yl)ethanol; 443-48-1.
PHARMACOLOGICAL GROUP AND ATC CODE
Metronidazole is a 5-nitroimidazole derivative with antibacterial
activity.
ATC Code:
J01X
D01.
PHARMACOLOGICAL ACTION
Metronidazole is an antiprotozoal and antibacterial agent which is
active against a wide
range of pathogenic micro-organisms. The mechanisms of action of
metronidazole in
rosacea are unknown but available evidence suggests that the effects
may be antibacterial
and/or anti-inflammatory.
PHARMACOKINETICS
The systemic concentration of Metronidazole following the topical
administration of 1 g
Metronidazole gel to 10 patients with rosacea ranged from 25 ng/ml
(limit of detection), to
66 mg/ml with a mean Cmax of 40.6 ng/ml.
The corresponding mean Cmax following the oral administration of a
solution containing 30
mg of metronidazole was 850 ng/ml (equivalent to 212 ng/ml if dose
corrected. The mean
Tmax for the topical formulation was 6.0 hours compared to 0.97 hours
for the oral solution.
USES
Indicated in the treatment of inflammatory papules, pustules and
erythema of rosacea.
DOSAGE AND ADMINISTRATION
_FOR TOPICAL ADMINISTRATION ONLY. _
The average period of treatment is three to four months. The
recommended duration of
treatment should not be exceeded. However, if a clear benefit has been
demonstrated,
continued therapy for a further three to four months period may be
considered by the
prescribing physician depending on the severity of the condition. In
clinical studies, topical
metronidazole therapy for rosacea has been continued for up to 2
years. In the absence of a
clear clinical improvement, therapy should be stopped.
_ADULTS:_ Metronidazol