The pharmaceutical company has decided to discontinue this product, other preparations of this medicine may still be available. This information has been left on the eMC for reference purposes.
Gyno-Daktarin mg vaginal capsule 2. Qualitative and quantitative composition Each capsule contains mg miconazole nitrate For full list of excipients, see section 6. Pharmaceutical form Vaginal capsule, soft. White to off white egg-shaped soft vaginal capsule containing a white to cream coloured hydrophobic mass.
Adults aged 18 years and older. 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. Paediatrics aged under 18 years.
The safety and efficacy of Gyno-Daktarin vaginal capsule in children and adolescents has not been studied. If a reaction suggesting hypersensitivity or irritation should occur, the treatment should be discontinued. Appropriate therapy is indicated when the sexual partner is also infected. Gyno-Daktarin 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-Daktarin vaginal capsules should not be used concurrently with a latex condom or latex diaphragm. Due to albothyl liquid latex 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. Contact should be avoided between certain latex products such as contraceptive diaphragms or condoms and Gyno-Daktarin vaginal capsules since the constituents of the vaginal capsules may damage the latex see section 4. Although intravaginal absorption is limited, Gyno-Daktarin 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.
It is not known whether miconazole albothyl liquid latex is excreted in human milk. Caution should be exercised when using Gyno-Daktarin vaginal capsules during breastfeeding. In the table, the frequencies are provided according to the following convention: However due to the design of these studies, a definitive causal relationship could not be established.
Healthcare professionals are asked to report albothyl liquid latex suspected albothyl liquid latex reactions via the Yellow Card Scheme at: Gyno-Daktarin vaginal capsules are albothyl liquid latex for local application and not for oral albothyl liquid latex. In case of accidental ingestion, no problems are expected. In the event of accidental ingestion of large quantities, use appropriate supportive care. Antiinfectives and antiseptics, excl. Miconazole is a synthetic imidazole antifungal agent with albothyl liquid latex broad spectrum of activity against pathogenic fungi including albothyl liquid latex 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. Miconazole persists in the vagina for up to 72 hours after a single 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. Absorbed miconazole is bound to plasma proteins 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. Liquid paraffin White petrolatum Lecithin Capsule shell: This site uses cookies.
By continuing to browse the site you are agreeing to our policy on the use of cookies. Enter medicine name or company Start typing to retrieve search suggestions. Continue typing to refine. Gyno-Daktarin mg vaginal capsule. Janssen-Cilag Ltd contact details. Active ingredient miconazole nitrate. Last updated on eMC: Show table of contents Hide table of contents 1. Name of the medicinal product 2. Qualitative and quantitative composition 3.
Marketing authorisation holder 8. Marketing authorisation number s 9. Date of revision of the text. This information is intended for use by albothyl liquid latex professionals. Each capsule contains mg miconazole nitrate For full list of excipients, see section 6. For the local treatment of vulvovaginal candidosis and superinfections due to Gram-positive bacteria. Gyno-Daktarin vaginal capsules are for intravaginal administration.
Adults aged 18 years and older One soft vaginal capsule to be albothyl liquid latex high in the vagina at bedtime, as a single dose. Paediatrics aged under 18 years The albothyl liquid latex and efficacy of Gyno-Daktarin vaginal capsule in children and adolescents has not been studied. Severe hypersensitivity reactions, including anaphylaxis and albothyl liquid latex, have been reported albothyl liquid latex treatment with Gyno-Daktarin albothyl liquid latex capsule and with other miconazole formulations see section 4.
Pregnancy Although intravaginal absorption is limited, Gyno-Daktarin vaginal capsules should only be used in the first albothyl liquid latex of pregnancy if, in the judgment of the physician, the potential benefits outweigh the possible risks. Breastfeeding It is not known whether miconazole nitrate is excreted in human milk.
Symptoms Gyno-Daktarin vaginal capsules are intended albothyl liquid latex local application and not for oral use. Treatment In the event of accidental ingestion of large quantities, use appropriate supportive care. G01A F04 Miconazole is a synthetic imidazole antifungal agent with a broad spectrum albothyl liquid latex activity against pathogenic fungi including yeasts and dermatophytes and gram-positive bacteria staphylococcus and streptococcus spp.
After the capsule has been inserted into the vagina, the outer covering rapidly disintegrates and the active suspension albothyl liquid latex almost instantaneously released. Preclinical data reveal no special hazard for humans based on studies of local irritation, single and repeated dose toxicity, genotoxicity, and toxicity to reproduction. Date of first authorisation: Company contact details Janssen-Cilag Ltd.
To bookmark a medicine you must be a registered user. To email a medicine you must albothyl liquid latex a registered user. Find out more here. Skin and Subcutaneous Tissue Disorders. Reproductive System and Breast Disorders. Genital pruritus female, vaginal burning sensation, vulvovaginal discomfort. Hypersensitivity including Anaphylactic and Anaphylactoid reactions.
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