Gynomix Soft Cap

Uses

Each soft gelatin capsule (vaginal suppository) contains-

• Neomycin sulphate 35,000 IU
• Polymyxin B sulphate 35,000 IU
• Nystatin 100, 000 IU
• Acetarsol 150 mg
• Postassium sorbate 7.5 mg
• Dimethylpolysiloxane 2 gm as excipients.

Vaginal trichomoniasis, mixed vaginal infections, vaginal leucorrhoeas (mycotic or bacterial).

Gynomix Soft Cap is also used to associated treatment for these conditions: Amoebiasis, Vaginitis caused by Trichomonas Vaginalis, candida albicansAnal candidiasis, Candidiasis, Invasive, Intestinal Candidiasis, Mixed Vaginal Infections caused by Trichomonas Vaginalis, candida albicans, Oral Candidiasis, Pruritus Ani, Pruritus Vulvae, Skin candida, Trichomonas Vaginitis, Vaginal Candidiasis, Vulvovaginal Candidiasis, Corticosteroid-responsive dermatoses, Cutaneous candidiasis

How Gynomix Soft Cap works

The mechanism of action of acetarsol is not well known but it is thought to bind to protein-containing sulfhydryl groups located in the infective microorganism and to form a lethal As-S bond. The formation of this bond impairs the protein to function and it eventually kills the microorganism.

Nystatin is a channel-forming ionophore, meaning it exerts its therapeutic effect via formation of a membrane-spanning pore in the fungal plasma membrane. The formation of this pore results in a change in membrane permeability that allows for leakage of intracellular contents and the subsequent disruption of electrochemical gradients necessary for proper cell function. Selectivity for fungal cells over mammalian cells is due to nystatin’s greater binding affinity for ergosterol, a key sterol found in fungal cell walls, as opposed to its mammalian counterpart, cholesterol.

Dosage

Gynomix Soft Cap dosage

Use in vagina 1 capsule at night (bed time) for 12 days or as directed by the physician.

Side Effects

Skin rash, ulticaria may occur rarely.

Toxicity

The administration of inorganic arsenic is highly carcinogenic and thus acetarsol if thought to be dangerous when absorbed. Some reports indicate that acetarsol can produce effects in the eyes such as optic neuritis and optic atrophy.

The oral LD₅₀ in rats is 10 g/kg. There have been no reports of serious toxic effects following overdosage of nystatin - doses in excess of five million units daily have resulted in nausea and gastrointestinal upset with no other associated effects.

Precaution

Impaired renal function.

Volume of Distribution

This pharmacokinetic property was not addressed.

Nystatin is not absorbed into the systemic circulation and thus does not undergo distribution.

Elimination Route

The absorption seems to be very minimal but there are reports of allergic reactions after vaginal administration of acetarsol.

Systemic absorption of nystatin is minimal following oral administration, and no detectable plasma concentrations are attained following topical or vaginal administration.

Half Life

This pharmacokinetic property was not addressed.

Clearance

This pharmacokinetic property was not addressed.

Elimination Route

The arsenic found in acetarsol is excreted mainly in the urine. The level of arsenic after acetarsol administration almost reaches the toxic range in urine.

The majority of orally administered nystatin is eliminated unchanged in the feces.

Pregnancy & Breastfeeding use

Use in pregnancy: Caution should be taken in case of pregnant women.

Use in lactation: Caution should be taken in case of lactating mothers.

Contraindication

Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components.

There is no known contraindication to the use of Nystatin oral.

Storage Condition

Store at 20° to 25°C. Avoid freezing.

Innovators Monograph

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