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Gyno-Daktarin: Product
Information
GYNO-DAKTARIN™ 7
Miconazole nitrate 100 mg vaginal
cream
Presentation
GYNO-DAKTARIN 7 Cream contains
the synthetic bactericidal and fungicidal broad-spectrum
antifungal agent miconazole nitrate.
Actions
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.
Pharmacokinetics
Systemic absorption after
intravaginal administration is limited. Eight hours after
application 90% of miconazole nitrate is still present in the
vagina. Unchanged miconazole could not be traced in blood
plasma or urine.
Indications
Local treatment of vulvovaginal
candidiasis and superinfections due to gram-positive
bacteria.
GYNO-DAKTARIN 7 Cream may also be
used for the treatment of mycotic balanitis.
Dosage and
Administration
Once daily (before bedtime), the
contents of one applicator (approximately 5g of cream) should
be squeezed deeply into the vagina, for seven days, even after
pruritis and leukorrhoea has disappeared.
Contraindications
GYNO-DAKTARIN 7 Cream is
contraindicated in individuals with a known hypersensitivity
to miconazole or any other components of these
medicines.
Warnings and
Precautions
Should local sensitisation or an
allergic reaction occur, the treatment should be
discontinued.
General hygienic measures should
be observed to control sources of infection and
reinfection.
Appropriate therapy is indicated
when the sexual partner is also infected.
Pregnancy and
Lactation
Although intravaginal absorption
is limited, GYNO-DAKTARIN 7 should only be used in the first
trimester of pregnancy if, in the judgement of the physician,
the potential benefits outweigh the possible risks.
It is not known whether
miconazole nitrate is excreted in human milk. Caution should
be exercised when using GYNO-DAKTARIN 7 Cream during
lactation.
Adverse
Effects
GYNO-DAKTARIN 7 Cream is usually
well tolerated, and adverse reactions are rare and mild in
most cases.
A few cases of local irritation,
pruritus and burning sensation have been observed, especially
at the start of treatment. Complaints of pelvic cramping,
hives, skin rash have also been reported.
Interactions
Contact should be avoided between
certain latex products such as contraceptive diaphragms or
condoms and GYNO-DAKTARIN 7 since the rubber may be damaged.
Unintended pregnancy or transmission of infectious disease may
result.
Overdosage
In the event of accidental
ingestion of large quantities of either of these medicines, an
appropriate method of gastric emptying may be used if
considered appropriate.
Pharmaceutical Precautions
Store below 25°C.
Package
Quantities
Vaginal cream 40 g with 5 g
applicator.
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