洛霉欣阴道栓剂(Lomexin vag supp)

成 分:
阴 道 栓 剂:每 粒含Fenticonazole Nitrate......... 200 mg
特 性:
LOMEXIN 为广效的抗霉菌药物,用於皮肤科及妇科,主成分为fenticonazole ,〔1(2,4-
dichlorophenyl)-2-(N-imidazolyl)ethyl-4-phenylthiohenzyl ether nitrate〕,本品为imidazole衍生物,由Recordati所合成.
LOMEXIN具有杀菌及抑制霉菌之效用,作用於表皮癣菌属,致病酵母菌,dimorphous fungi及丝菌上.
LOMEXIN对於下列菌种有效:Tricophyton mentagrophytes, T. verrucosum, T. rubrum., T.
tonsurans, T. terrestre, Microsporum canis, M. gypseum, M. audouinii, M. fulvum, M. cookei;
Epidermophyton floccosum; candida albicans; Criptococcus neoformans; Geotrichum
candidum; Torulopsis glabrata; Sporotricum schenckii; Aspergillus niger, A. fumigatus, A.
flavus; Penicillium crysogenum.
适应症:
皮霉菌病(Dermatomycosis):导因於皮霉菌感染;包括发癣菌属(Trichophyton),小芽胞癣
菌属(Microsporum),以及表皮癣菌属(Epidermophyton)因感染部位不同可分为:秃发癣,
钱癣,股癣,足癣,tinea manuum,tinea faciei,发癣,<B style=\'color:black;background-color:>甲癣等.
皮肤念珠菌病:常见的有肛擦烂,念珠性口角疮,脸部念珠菌病,\"napkin\",会阴及阴囊
念珠菌病,生殖器念珠菌病:(女阴与阴道炎,阴道炎,月经感染,阴茎头炎,阴茎头包皮
炎),甲床炎及甲沟炎.
用法用量:
˙阴道栓剂:每日一次睡前使用200毫克栓剂一颗.
Lomexin不油,不脏,且易用水洗净.
副作用:
Lomexin在皮肤及黏膜上有很好的耐受力,仅有轻微瞬间红斑性反应,局部使用於伤口
或阴道给药有轻微的灼热感,然很快会消失,如有持续性刺激反应,并扩散到其他器官
,应立刻停药,并向医师求诊.
禁 忌:
已知对本品有过敏者不可使用.
警 语:
局部使用於开於性伤口,或在阴道内用药后,会产生轻微短暂的灼热感,但若长期局
部使用会有过敏现象,怀孕期间请勿使用本药.
包 装:
阴 道 栓 剂:2-1000粒盒装.
有效期限:3年
本品应置於孩童伸手不及处,且不可使用於眼睛.
本药须由医师处方使用
生产厂商:Cardinal Health Italy 407 S.P.A.
研发厂商:Recordati Industria Chimica E Farmaceutica S.P.A.

LOMEXIN VAGINAL CREAM
LOMEXIN 200 MG VAGINAL OVULES
LOMEXIN 600 MG VAGINAL OVULES
SCHEDULING STATUS:
S3
PROPRIETARY NAME
(and dosage form)
LOMEXIN VAGINAL CREAM
LOMEXIN 200 MG VAGINAL OVULES
LOMEXIN 600 MG VAGINAL OVULES
COMPOSITION
LOMEXIN VAGINAL CREAM: Each 5 g contains 100 mg fenticonazole nitrate.
LOMEXIN 200 MG VAGINAL OVULES: Each ovule contains 200 mg fenticonazole nitrate.
Preservatives: Sodium ethyl hydroxybenzoate 0,09% m/m. Sodium propyl hydroxybenzoate 0,045% m/m.
LOMEXIN 600 MG VAGINAL OVULES: Each ovule contains 600 mg fenticonazole nitrate.
Preservatives: Sodium ethyl hydroxybenzoate 0,07% m/m. Sodium propyl hydroxybenzoate 0,035% m/m.
PHARMACOLOGICAL CLASSIFICATION
A 18.6 Vaginal preparations.
PHARMACOLOGICAL ACTION
Pharmacodynamics Fenticonazole is a potent broad-spectrum antimycotic agent. The mechanism of action of fenticonazole is thought to be the blocking of oxidant enzymes with accumulation of peroxides and necrosis of the fungal cell; direct action on the membrane.
Pharmacokinetics The amount of fenticonazole absorbed by the transcutaneous route is negligible.
INDICATIONS
Vulvovaginal candidiasis.
CONTRA-INDICATIONS
LOMEXIN is contra-indicated in patients hypersensitive to imidazoles.
Safety in pregnancy and lactation has not been established.
LOMEXIN therapy is not recommended for children.
WARNINGS
When applied to the lesion or at the time of the intravaginal insertion, a slight burning sensation may be felt which disappears rapidly.
The use of topical LOMEXIN, especially if extended, may cause sensitivity to the product. In such case, the treatment should be interrupted and a physician should be consulted to commence an appropriate therapy.
INTERACTIONS
LOMEXIN may damage latex contraceptives and additional contraceptive measures are therefore necessary during local administration.
PREGNANCY AND LACTATION
The use of the product during pregnancy is not recommended.
Safety in lactation has not been established.
DOSAGE AND DIRECTIONS FOR USE
LOMEXIN VAGINAL CREAM:
5 g should be administered intravaginally every morning and evening for three days. See “Instructions for use/handling”.
LOMEXIN VAGINAL OVULES:
One 200 mg ovule should be administered intravaginally every evening for three days; alternatively, once only administration of a 600 mg ovule should suffice. See “Instructions for use/handling”.
It is advisable that the sexual partner is also treated locally (glans and foreskin) with LOMEXIN CREAM, to prevent re-infection.
Instructions for use/handling:
LOMEXIN VAGINAL CREAM
Follow the instructions illustrated in the diagram below.
Take care to ensure that the applicator is always perfectly clean.
After each use, wash it carefully with warm water and soap.
If the physician advises sterilisation of the applicator, for particular reasons, follow his instructions.
Do not, however, use water which is hotter than 50°C, nor organic solvents.
Then dry the applicator and store it in its container.
1. Wash hands thoroughly. Place the open end of the applicator over the opening of the tube of cream.
2. Squeeze the bottom of the tube gently so that the cream fills the applicator to the top. If there is certain resistance in the piston, pull it gently.
Unless otherwise instructed by the physician, the applicator must be completely filled.
3. Remove the applicator from the tube, and replace the cap immediately.
4. In a lying position, with knees raised and spread apart, gently insert the applicator into the vagina as deeply as possible. Slowly push the piston completely. Remove the applicator from the vagina without touching the piston.
LOMEXIN VAGINAL OVULES
1. Remove the ovule from the blister pack.
2. Insert one ovule high into the vagina in the evening before going to bed (this is easiest when lying on your back with your knees bent up).
Refer to the diagram. [Please see original package insert for illustration Ed.]
SIDE-EFFECTS AND SPECIAL PRECAUTIONS
LOMEXIN is generally well tolerated.
General disorders and administration site conditions
Less frequent: Mild and transient erythematous reactions or burning sensations have been reported only exceptionally and normally disappear rapidly. Allergic reaction may occur less frequently.
In the event of hypersensitivity reactions or the development of resistant microorganisms, treatment should be discontinued.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Following topical application of LOMEXIN, very little fenticonazole is absorbed systemically. Thus overdosage by this route does not occur. Hypersensitivity reactions should be treated symptomatically and LOMEXIN discontinued.
IDENTIFICATION
LOMEXIN VAGINAL CREAM: A white, homogenous cream intended for intravaginal use.
LOMEXIN VAGINAL OVULES: Oval-shaped, ivory white, opaque, soft gelatine capsules containing a white homogenous oily suspension, intended for intravaginal use. The 200 mg ovule has a mass of approximately 900 mg, and the 600 mg a mass of approximately 1,5 g.
PRESENTATION
LOMEXIN VAGINAL CREAM: Tubes of 30 g supplied with an applicator for vaginal use.
LOMEXIN 200 MG VAGINAL OVULES: Blister packs of 3 ovules.
LOMEXIN 600 MG VAGINAL OVULES: Blister packs of 1 ovule.
STORAGE INSTRUCTIONS
Protect from light.
Store below 30ºC.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBERS
LOMEXIN VAGINAL CREAM: 29/18.6/0055
LOMEXIN 200 MG VAGINAL OVULES: 29/18.6/0053
LOMEXIN 600 MG VAGINAL OVULES: 29/18.6/0054