Monistat (Miconazole Nitrate)

MONISTAT® 7 Cream MONISTAT 7 Vaginal Suppositories MONISTAT® 7 DUAL-PAK® Package (Also known as Combination Packs) MONISTAT® DERM Cream MONISTAT® 3 DUAL-PAK® Package (Also known as Combination Packs) MONISTAT® 3 Vaginal Ovules

McNeil Consumer Products

Miconazole Nitrate

Antifungal

Action And Clinical Pharmacology: Depending upon concentration, miconazole exhibits broad spectrum in vitro fungistatic or fungicidal activity against species of the genus Candida. Miconazole also inhibits several other genera of fungi, including dermatophytes and yeasts, as well as Gram-positive bacteria.

Miconazole inhibits the biosynthesis of ergosterol or other sterols, damaging the fungal cell wall membrane and altering its permeability. In fungi, it also inhibits biosynthesis of triglycerides and phospholipids as well as oxidative and peroxidative enzymes. The latter action results in intracellular buildup of toxic concentrations of hydrogen peroxide, which may contribute to deterioration of subcellular organelles and cellular necrosis.

C. albicans cells have been observed to exhibit progressive cytoplasmic deterioration and prominent shape changes resulting in complete cell necrosis depending on the dose and duration of exposure to miconazole. The sequence of morphologic alterations induced by miconazole at fungistatic doses (106M) are lysis of cytoplasmic organelles, focal to complete loss of cell plasmalemma and irregular thickening of the cell wall containing multiple inclusions. Administration of fungicidal doses (104M) induces a completely necrotic cell interior with an unaltered cell wall.

In C. albicans, miconazole inhibits the transformation of blastospores into invasive mycelial form. Not all species or strains of a particular organism may be susceptible to miconazole.

Miconazole has been clinically effective in treating tinea pedis (athlete’s foot), tinea cruris, tinea corporis, and tinea versicolor caused by dermatophytes. Monistat Derm Cream is also effective in cutaneous candidiasis. Among the organisms against which Monistat Derm Cream has been found effective are T. rubrum, T. mentagrophytes, T. interdigitale, E. floccosum, M. canis, M. gypseum, species of Candida including C. albicans, and M. furfur.

To date, no wild strains or fungal mutants with substantial acquired resistance to miconazole have been reported; however, miconazole resistant C. albicans has been isolated from an infant following bladder irrigation with miconazole for the treatment of urinary candidiasis.

Indications And Clinical Uses: Monistat 7 Vaginal Cream, Monistat 7 Vaginal Suppositories and Monistat 3 Vaginal Ovules: For the local treatment of vulvovaginal candidiasis (moniliasis).

Monistat 7 Dual-pak and Monistat 3 Dual-pak: For the local treatment of vulvovaginal candidiasis (moniliasis) and for the relief of particularly severe external itching and irritation associated with vulvovaginal candidiasis.

Although vulvovaginal candidiasis may be more difficult to cure during pregnancy, pregnant patients can be treated with the same regimen as nonpregnant patients. The 3-day regimen is preferred, with the 7-day regimen providing an effective alternative.

No significant difference in therapeutic cure rate (therapeutic cure includes both symptomatic and microbiological cure) was reported between the pregnant and nonpregnant patient groups who participated in clinical evaluations of the 3-day (ovules) or 7-day (suppositories+cream) treatment regimens.

Similarly, users and non-users of oral contraceptives who participated in these clinical evaluations experienced therapeutic cure rates which did not differ significantly.

In addition, no statistically significant differences in therapeutic cure rates were noted between patients undergoing dosage regimens of varying duration (3, 7, 10 and 14 day).

Monistat Derm Cream: Used clinically in conjunction with vaginal ovules or suppositories in Monistat 3 and Monistat 7 Dual-paks, respectively, when symptoms of vulvovaginal candidiasis are particularly extensive. Also effective for other Candida infections, dermatophytes and lesions caused by mixed infections involving susceptible fungi.

Contra-Indications: Hypersensitivity to any of the components.

Precautions: Discontinue medication if sensitization or other signs of irritation (rash, burning, blistering, redness), not present before therapy, occur from intravaginal or topical use. Avoid contact with the eyes.

Patients should not use vaginal preparations for self-medication if vaginal pruritus or discomfort is occurring for the first time. In this instance, a physician must be consulted to establish the diagnosis of vulvovaginal candidiasis.

Patients should not use vaginal preparations for self-medication if they experience unusual pain in the back or lower abdomen, fever or a malodorous vaginal discharge is present, as a condition more serious than vulvovaginal candidiasis may exist.

Intractable candidiasis may be the presenting symptom of unrecognized diabetes; thus appropriate urine/blood studies may be indicated in patients not responding to treatment. In any case unresponsive to therapy, repeat appropriate microbiological studies to confirm the diagnosis of vulvovaginal candidiasis and to rule out other pathogens.

During vaginal therapy it may be advisable to instruct the patient to abstain from intercourse.

Pregnancy and Lactation: Advise pregnant patients either to exercise caution in the insertion of the applicator during vaginal therapy or to insert the suppository or ovule digitally.

Follow up reports on infants born to 167 of 263 pregnant patients (some follow-up reports are not yet available) who participated in North American clinical evaluations of miconazole nitrate 2% cream administered in a 14-day regimen, and infants born to 26 pregnant patients who participated in European and North American clinical evaluations of miconazole nitrate 100 mg suppositories, described no complications or adverse effects attributed to this therapeutic agent. Nevertheless, since miconazole nitrate is absorbed in small amounts from the human vagina, Monistat vaginal preparations should not be used by pregnant or nursing women unless the physician considers it essential to the welfare of the patient.

Concurrent use of the suppository, ovule or cream prefilled applicator with natural rubber products, such as vaginal diaphrams or condoms, is not recommended.

Adverse Reactions: In general, the complaints reported with miconazole therapy concerned vulvovaginal burning, itching, irritation, pelvic cramping, edema as well as hives and rash.

A total of 1 089 patients participated in clinical evaluations of miconazole nitrate 2% vaginal cream administered in dosage regimens of varying duration. Of these, 59 patients reported reactions which were possibly drug related but not severe enough to cause discontinuation of therapy, 4 patients discontinued therapy due to vulvovaginal burning and itching, and 1 patient discontinued therapy due to hives.

A total of 1 724 patients participated in clinical evaluations of miconazole nitrate 100 mg vaginal suppositories administered in dosage regimens of varying duration. Of these, 3 patients reported reactions which were interpreted as minor treatment emergent signs and symptoms (burning, itching, edema) and considered by the investigators to be nontherapy related. No patients were reported to have discontinued therapy due to drug related reasons.

The 3-day treatment with miconazole nitrate 400 mg vaginal ovules was exceptionally well tolerated by a total of 410 patients in 3 clinical studies, without any related side effects. However, the generally reported complaints referred to above could be expected with this dosage form and regimen as well.

The combination pack products combine a small amount (9 g) of miconazole nitrate 2% cream to be applied externally during a course of therapy with miconazole nitrate vaginal suppositories or ovules so a similar safety and efficacy profile, as with each individually, could be expected.

Dosage And Administration: Monistat 7 Cream: Administer one 5 g applicatorful intravaginally once daily at bedtime for 7 consecutive days. The course of therapy may be repeated if the patient remains symptomatic and it has been determined by appropriate smears and cultures that the infecting organism is still miconazole susceptible Candida.

Monistat 7 Vaginal Suppositories: Administer 1 suppository intravaginally once daily at bedtime for 7 consecutive days. The course of therapy may be repeated if the patient remains symptomatic and it has been determined by appropriate smears and cultures that the infecting organism is still miconazole susceptible Candida.

Monistat Derm Cream: Apply a thin layer of cream topically to cover the affected area twice daily. Massage gently until cream disappears.

Early clinical improvement (1 to 2 weeks) has been seen in the treatment of infections caused by dermatophytes and Candida species and in mixed fungal infections, but resistant lesions may take longer to clear. Candida infections should be treated for 2 weeks and dermatophyte infections for 1 month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after 30 days of treatment, the diagnosis should be reconsidered.

Monistat 3 Vaginal Ovules: Administer 1 ovule intravaginally once daily at bedtime for 3 consecutive days. The course of therapy may be repeated if the patient remains symptomatic and it has been determined by appropriate smears and cultures that the infecting organism is still miconazole susceptible Candida.

Monistat 7 and Monistat 3 Dual-paks (to be used when symptoms are particularly extensive): One 100 mg suppository or one 400 mg ovule administered intravaginally once daily at bedtime for 7 (Monistat 7) or 3 (Monistat 3) consecutive days, respectively. Apply a thin layer of cream to external areas twice daily, in the morning and evening. Massage gently until cream disappears.

Availability And Storage: Monistat 7 Cream: Each package contains: 7 prefilled disposable applicators of white, water miscible cream containing miconazole nitrate 2%, sufficient for one 7-day course of therapy, and a consumer information leaflet. Nonmedicinal ingredients: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water and stearyl alcohol.

Monistat 7 Vaginal Suppositories: Each white, egg shaped vaginal suppository contains: miconazole nitrate 100 mg. Boxes of 7 suppositories individually sealed in opaque polyvinylchloride moulds, 1 vaginal suppository applicator, and a consumer information leaflet. Nonmedicinal ingredients: hydrogenated vegetable oil base.

Monistat 7 Dual-Pak Package: Each package contains: 7 Monistat 7 vaginal suppositories sufficient for one 7-day course of therapy, a vaginal applicator and a 9 g tube of Monistat Derm Cream, along with a consumer information leaflet. Also known as Combination Packs.

Monistat Derm Cream: Each tube contains: miconazole nitrate 2%. Tubes of 15 and 30 g. Nonmedicinal ingredients: benzoic acid, butylated hydroxyanisole, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water.

Monistat 3 Vaginal Ovules: Each package contains: 3 soft, gelatin ovules filled with a suspension of miconazole nitrate 400 mg, sufficient for one 3-day course of therapy, 1 vaginal applicator and a consumer information leaflet. Nonmedicinal ingredients: gelatin, glycerin, mineral oil, sodium ethylparaben, sodium propylparaben, titanium dioxide and white petrolatum.

Monistat 3 Dual-Pak Package: Each package contains: 3 Monistat 3 vaginal ovules sufficient for one 3-day course of therapy, a vaginal applicator and a 9 g tube of Monistat Derm Cream, along with a consumer information leaflet. Also known as Combination Packs.

MONISTAT® 7 Cream MONISTAT® 7 Vaginal Suppositories MONISTAT® 7 DUAL-PAK® Package (Also known as Combination Packs) MONISTAT® DERM Cream MONISTAT® 3 DUAL-PAK® Package (Also known as Combination Packs) MONISTAT® 3 Vaginal Ovules McNeil Consumer Products Miconazole Nitrate Antifungal

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