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| نشرة الممارس الصحي | نشرة معلومات المريض بالعربية | نشرة معلومات المريض بالانجليزية | صور الدواء | بيانات الدواء |
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DESCRIPTION:
GYNO-CANDIZOL® (Miconazole nitrate) is a bactericidal agent and a broad spectrum fungicidal. It acts by altering the permeability of the fungal cell membrane, which allows leakage of intracellular components thus leading of cell necrosis.
Following insertion of the ovule into the vagina, the outer cover disintegrates and the active drug is released.
INDICATIONS:
GYNO-CANDIZOL® is mainly indicated for local treatment of vulvovaginal candidosis. It is also effective in super-infections due to gram-positive bacteria.
CONTRAINDICATION:
Hypersensitivity to miconazole nitrate or other components of the product.
PRECAUTIONS:
· If vaginal itch or discomfort occurs consult your physician.
· If abdominal pain, fever or foul-smelling vaginal discharge is present, do not use this product.
· Treatment of the sexual partner is advisable to prevent re-infection.
DRUG INTERACTIONS:
No known drug interactions have been so far reported. The base used in some of these formulations may interact with the rubber of certain latex products such as contraceptive condoms or diaphragms.
USE DURING PREGNANCY and LACTATION:
· Although absorption of miconazole from vagina is minimum, it should not be used during the first trimester of pregnancy unless otherwise prescribed by the physician.
· It is not known if miconazole is excreted in breast milk. Therefore care should be taken when using it during lactation.
DOSAGE and ADMINISTRATION:
· GYNO-CANDIZOL® 200: Insert 1 ovule deep into the vagina at bed time for seven consecutive nights.
· GYNO-CANDIZOL® 400: Insert 1 ovule deep into the vagina at bed time for three consecutive nights.
Miconazole generally is well tolerated though few cases of local irritation, pruritis, or vulvovaginal burning have been reported especially at the start of treatment.
Store below 30C
GYNO-CANDIZOL® 200: Each soft gelatin vaginal ovule contains miconazole nitrate BP 200 mg, packed in blisters of 7 ovules.
GYNO-CANDIZOL® 400: Each soft gelatin vaginal ovule contains miconazole nitrate BP 400 mg, packed in blisters of 3 ovules.
UNITED PHARMACEUICALMANUFACTURINGCO. LTD.
P.O. Box 69Amman 11591 - Jordan
جاينو-كانديزول® (مايكونازول نترات) هو مضاد للبكتيريا وله طيف واسع ضد الفطريات. إذ يعمل على تغيير نفاذية الغشاء الخلوي للفطريات، مما يسمح بتسرب محتويات الخلايا الفطرية إلى الخارج وهلاكها.
بعد إدخال البويضة بعمق داخل المهبل؛ يذوب غلافها الخارجي بسرعة وتنطلق محتوياتها الفعالة داخله.
دواعي الإستعمال:
يستعمل جاينو-كانديزول® بشكل رئيسي في العلاج الموضعي لداء المبيَضات الفرجي المهبلي. كما ويستعمل لعلاج الاخماج الإضافية الناتجة عن البكتيريا الموجبة الغرام.
موانع الإستعمال:
فرط الحساسية للمايكونازول نترات أو للمواد الأخرى الداخلة في تركيب المستحضرات.
محاذير الإستعمال:
· من الأفضل مراجعة الطبيب عند حدوث حكه بالمهبل أو الشعور بعدم الراحه.
· لا يستخدم هذا الدواء لمن تشتكي من إفرازات مهبلية مصحوبة برائحة كريهة، ألم في البطن أو إرتفاع في درجة الحرارة.
· يُنصح بمعالجة الزوج أيضاً لتفادي تجدد الإصابة.
التداخلات الدوائية:
لم يسجل حدوث تداخلات دوائية حتى الآن. ومع ذلك قد تتفاعل السواغات الداخلية في تركيب هذا المستحضر والتركيبات المشابهة الأخرى مع موانع الحمل الفيزيائية المصنوعة من المطاط مثل الواقي أو الحجاب.
الإستعمال خلال فترتي الحمل والإرضاع:
· أن إمتصاص مايكونازول من المهبل قليل جداً، إلا إنه لاينصح باستعماله خلال الثلث الأول من الحمل إلا بعد استشارة الطبيب. كما أنه لايوجد مايشير بأن مايكونازول يفرز في حليب الأم. لذا يجب توخي الحذر عند إستعماله من قبل الأم المرضع.
الجرعات وطريقة الإستعمال:
· جاينو-كانديزول® 200: تولج بويضة مهبلية واحدة عميقاً داخل المهبل عند النوم لمدة سبع ليالٍ متتالية.
· جاينو-كانديزول® 400: تولج بويضة مهبلية واحدة عميقاً داخل المهبل عند النوم لمدة ثلاث ليالٍ متتالية.
=
يعتبر مايكونازول جيد الإحتمال بشكل عام، إلا أنه قد تحدث أحياناً بعض حالات التهيج الموضعي، الحكة، أوالشعور بالحرقة في المهبل، خاصة عند البدء بإستعماله.
يحفظ تحت 30 درجة مئوية
جاينو-كانديزول® 200: كل بويضة مهبلية تحتوي على 200 ملغم مايكونازول نترات BP في عبوات سعة 7 بويضات.
جاينو-كانديزول® 400: كل بويضة مهبلية تحتوي على 400 ملغم مايكونازول نترات BP في عبوات سعة 3 بويضات.
جاينو-كانديزول® 200: كل بويضة مهبلية تحتوي على 200 ملغم مايكونازول نترات BP في عبوات سعة 7 بويضات.
جاينو-كانديزول® 400: كل بويضة مهبلية تحتوي على 400 ملغم مايكونازول نترات BP في عبوات سعة 3 بويضات.
الشركة المتحدة لصناعة الأدوية
ص.ب 69 عمان 11591 الأردن
For the local treatment of vulvovaginal candidosis and superinfections due to Gram-positive bacteria.
Gyno-Candizol vaginal capsules are for intra-vaginal administration.
Adults and Elderly
One soft vaginal capsule to be inserted high in the vagina at bedtime, as a single dose. This is best done in the reclining position.
Children
Not recommended.
Should local sensitisation or an allergic reaction occur, treatment should be discontinued.
Appropriate therapy is indicated when the sexual partner is also infected.
Gyno-Candizol vaginal capsules do not stain skin or clothes.
The concurrent use of latex condoms or diaphragms with vaginal anti-infective preparations may decrease the effectiveness of latex contraceptive agents. Therefore Gyno-Candizol vaginal capsules should not be used concurrently with a latex condom or latex diaphragm.
Miconazole administered systemically is known to inhibit CYP3A4/2C9. Due to the limited systemic availability after vaginal application, clinically relevant interactions occur very rarely. In patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored. The effects and side effects of other drugs metabolized by CYP2C9 (e.g.,oral hypoglycemics and phenytoin) and also CYP3A4 (e.g., HMG-CoA reductase inhibitors such as simvastatin and lovastatin and calcium channel blockers such as dihydropyridines and verapamil), when co-administered with miconazole, can be increased and caution should be exercised.
Contact should be avoided between certain latex products such as contraceptive diaphragms or condoms and Gyno-Candizol vaginal capsules since the constituents of the vaginal capsules may damage the latex.
Pregnancy
Although intravaginal absorption is limited, Gyno-Candizol vaginal capsules should only be used in the first trimester of pregnancy if, in the judgment of the physician, the potential benefits outweigh the possible risks.
Lactation
It is not known whether miconazole nitrate is excreted in human milk. Caution should be exercised when using Gyno-Candizol vaginal capsules during lactation.
None known.
The safety of Gyno-Candizol was evaluated in a total of 537 women with microbiologically confirmed candidiasis and symptoms (e.g., vulvovaginal itching, burning/irritation), or signs of vulvar erythema, edema, excoriation, or vaginal erythema or edema who participated in 2 single-blind clinical trials. Subjects were treated with miconazole intravaginally, randomly assigned to either a single 1,200 mg capsule, or a 7-day application of 2% vaginal cream. Adverse Drug Reactions (ADRs) reported by ≥1% of Gyno-Candizol -treated subjects in these trials are shown in Table 1.
In the table, the frequencies are provided according to the following convention:
Very common | ≥1/10 |
Common | ≥1/100 and < 1/10 |
Uncommon | ≥1/1,000 and <1/100 |
Rare | ≥1/10,000, <1/1,000 |
Very rare | < 1/10,000 |
Table 1. Adverse Drug Reactions Reported by Gyno-Candizol -treated Subjects in 2 Single Blind Clinical Trials | |
Body System/Organ Class Frequency Category | Undesirable effects |
Skin and subcutaneous tissue disorders |
|
Common | Rash |
Uncommon | Rash pruritic, urticaria |
Reproductive System and Breast Disorders |
|
Very common | Genital pruritus female, vaginal burning sensation, vulvovaginal discomfort |
Common | Dysmenorrhoea |
A range of additional reactions were reported during the clinical trials, such as: vaginal discharge, vaginal haemorrhage, vaginal pain, headache, dysuria, urinary tract infection, abdominal pain, rosacea, swelling of the face and nausea. However due to the design of these studies, a definitive causal relationship could not be established.
Table 2. Adverse Drug Reactions Identified During Post marketing Experience with Gyno-Candizol by Frequency Category Estimated from Spontaneous Reporting Rates | |
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Immune System Disorders | |
Not known | Hypersensitivity including Anaphylactic and Anaphylactoid reactions, Angioedema |
Skin and Subcutaneous Tissue Disorders | |
Not known | Pruritis |
Reproductive System and Breast Disorders | |
Not known | Vaginal irritation, pelvic cramps |
Symptoms
In case of accidental ingestion, no problems are expected.
Treatment
In the event of accidental ingestion of large quantities, an appropriate method of gastric emptying may be used if considered appropriate.
ATC code: G01A F04
Pharmacotherapeutic classification:
(Antiinfectives and antiseptics, excl. combinations with corticosteroids, imidazole derivative)
Miconazole is a synthetic imidazole antifungal agent with a broad spectrum of activity against pathogenic fungi (including yeasts and dermatophytes) and gram-positive bacteria (staphylococcus and streptococcus spp). Miconazole combines a potent antifungal activity against common dermatophytes and yeasts with an antibacterial activity against certain gram-positive bacilli and cocci.
Miconazole inhibits the biosynthesis of ergosterol in fungi and changes the composition of other lipid components in the membrane, resulting in fungal cell necrosis.
In general, miconazole exerts a very rapid effect on pruritus, a symptom that frequently accompanies dermatophyte and yeast infections.
After the capsule has been inserted into the vagina, the outer covering rapidly disintegrates and the active suspension is almost instantaneously released.
Absorption: Miconazole persists in the vagina for up to 72 hours after a single dose. Systemic absorption of miconazole after intravaginal administration is limited, with a bioavailability of 1 to 2% following intravaginal administration of a 1200 mg dose. Plasma concentrations of miconazole are measurable within 2 hours of administration in some subjects, with maximal levels seen 12 to 24 hours after administration. Plasma concentrations decline slowly thereafter and were still measurable in most subjects 96 hours post-dose. A second dose administered 48 hours later resulted in a plasma profile similar to that of the first dose.
Distribution: Absorbed miconazole is bound to plasma proteins (88.2%) and red blood cells (10.6%).
Metabolism and Excretion: The small amount of miconazole that is absorbed is eliminated predominantly in faeces as both unchanged drug and metabolites over a four-day post-administration period. Smaller amounts of unchanged drug and metabolites also appear in urine. The apparent elimination half-life ranges from 15 to 49 hours in most subjects and likely reflects both absorption from the site of application and metabolism/excretion of the drug.
Not Applicable
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Not Applicable
Store between 15 - 30ºC.
PVDC/PVC/Aluminum Foil Blister.
Outer box
Multi folded leaflet
None
