INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo VAGMYCIN VAGINAL CREAM

SCHEDULING STATUS:
S4

PP ZIMBABWE

PROPRIETARY NAME
(and dosage form)

VAGMYCIN VAGINAL CREAM

COMPOSITION
VAGMYCIN VAGINAL CREAM:
Amphotericin B: 50 mg activity/4 g. Tetracycline base: 100 mg tetracycline hydrochloride activity/4 g.
Preservatives: Methylparaben 0,228%; propylparaben 0,0228%.

PHARMACOLOGICAL CLASSIFICATION:
Category A 18.6 Vaginal Preparations.

PHARMACOLOGICAL ACTION
VAGMYCIN combines a broad spectrum antibiotic with an anti-fungal agent having activity against a wide variety of fungi and yeasts. These products have been designed to provide simultaneous antibacterial, antimonilial and antitrichomonal therapy.
Tetracycline has proved effective therapeutically against infections caused by a broad spectrum of micro-organisms including both gram- positive and gram-negative bacteria, spirochaetes, certain rickettsiae and viruses. While the direct action of tetracycline against trichomonas in vitro is slight, it acts against the bacteria with which trichomonas often exists in symbiosis in vivo.
Amphotericin B is an antifungal antibiotic with specific activity against Candida albicans. It has a broad spectrum of activity against filamentous fungi, yeast-like fungi and dermatophytes.

INDICATIONS
Indicated in the treatment of candidal, trichomonal, and/or mixed bacterial vaginitis. These preparations are also useful in the treatment of infective complications of atrophic or senile vaginitis, in non-specific vaginitis, and in vaginal infections in which an offending organism cannot be identified.
Among the most common vaginal infections are Candida albicans and Trichomonas vaginalis. Candidal infections of the vagina are being reported with increasing frequency in women on oral antibacterial agents and during oral contraceptive therapy. Additional factors that increase susceptibility to vaginal candidal infections include diabetes, endocrine disorders, corticosteroid therapy, malnutrition and debility.
The amphotericin B included in these preparations provides specific activity against Candida albicans and it has been used extensively in topical form for the treatment of monilial infections of the vagina. Amphotericin B also acts prophylactically to prevent overgrowth of candida due to alteration of the patient’s normal vaginal microbial flora by the tetracycline. Trichomonal infections are seldom pure. They are usually found in conjunction with mixed bacterial infections. Bacteria have been shown to provide some of the metabolic requirements of the Trichomonas. Symptomatology seldom develops in the absence of bacteria. The utilisation of the glycogen of the vaginal wall by Trichomonas and the subsequent elevation of the vaginal pH encourages bacterial invasion. The main line of attack of tetracycline is to eradicate the bacteria which support the growth of Trichomonas organisms.

CONTRA-INDICATIONS
Where sensitivity to active ingredients is present.
Safety in pregnancy and lactation has not been established

DOSAGE AND DIRECTION FOR USE
VAGMYCIN should be deposited high in the vagina. The usual dosage is 1 or 2 applicatorfuls intravaginally daily for two weeks or as required. It is important that therapy be continued during menstruation. If cultures remain positive after the course of therapy, a second or even a third course may be given.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
VAGMYCIN is virtually non-toxic and non-sensitizing. The preparations have been well tolerated and well accepted. Like any intravaginal preparation the preparations may produce burning and itching in highly sensitive individuals. Should this occur, treatment should be discontinued.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Treatment of overdosage should be symptomatic and supportive.

IDENTIFICATION
VAGMYCIN VAGINAL CREAM: A lemon yellow, practically odourless cream in a vanishing cream type base.

PRESENTATION
VAGMYCIN VAGINAL CREAM –60 g tubes with 4 g applicator.

STORAGE INSTRUCTIONS
VAGMYCIN VAGINAL CREAM: Store in a cool, dry place at room temperature not exceeding 25°C.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBERS:
VACMYCIN VAGINAL CREAM: C/18.6/78

NAME AND BUSINESS ADDRESS OF APPLICANT
Bristol-Myers Squibb (Pty) Ltd*
47 Van Buuren Road
BEDFORDVIEW.        2008

DATE OF PUBLICATION OF THIS PACKAGE INSERT
SEPTEMBER 2000

*Authorised user of the TM VAGMYCIN

Updated on this site: June 2005
Source: Pharmaceutical Industry

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