MONICURE NH Vaginal suppositories

Description

Pharmacological action:
MONICURE NH vaginal suppositories contain four active constituents designed to act synchronously for treatment of inflammatory conditions associated with mixed vulvovaginal infections. Miconazole exerts broad spectrum of activity against the most common pathogenic fungi including Candida species and yeasts. Nystatin is an antifungal antibiotic known by its reliable fungistatic effect against wide variety of yeasts and yeast-like fungi including Candida species. Neomycin is an aminoglycoside antibiotic known by its highly effective and confirmed bactericidal action against wide variety of gram-negative and gram-positive bacteria. Hydrocortisone is a corticosteroid with prompt antiallergic, antipruritic and anti-inflammatory actions with excellent safety profile. MONICURE NH has the advantage of rapid symptomatic relief of pruritis and burning sensation accompanying vaginal infections. Therefore, MONICURE NH provides a full range of therapeutic action as well as patient’s compliance.

pHarmacokinetics:
Small amount if miconazole nitrate are absorbed systemically following intravaginal administration, Nystatin is almost not absorbed systemically. Neomycin sulfate is absorbed systemically and absorption may be increased in conditions which damage or inflame the mucosa, and hydrocortisone acteate is not considerably absorbed yet absorption is increased in inflamed or abraded membranes.
INDICATIONS:
ϖ Vulvovaginal candidiasis.
ϖ Vaginal mycoses secondarily infected by gram-positive bacteria.
ϖ Leukorrhea with itching and burning sensation of the vulva when candidal or bacterial infection is suspected.

DOSAGE & ADMINISTRATION:
One suppository is to be inserted intravaginally at bedtime for 6 consecutive days according to the case.

Contraindications:
Hypersensitivity to any of the components.

SIDE EFFECTS:
MONICURE NH is well tolerated but rare cases of vaginal irritation may occur.

DRUG INTERACTIONS:
ϖ Concomitant use of warfarin and intravaginal miconazole may cause an increase in PI, INR and bleeding, monitoring should be appropriate.
ϖ The base used may interact with or weaken certain latex contraceptives (condoms, diaphragms or vaginal spermicides), this occurs only during treatment.

PREGNANCY & LACTATION:
Pregnancy:
Micronazole nitrate: (FDA pregnancy category B), Nystatin: (FDA pregnancy category A), Hydrocortisone acetate and neomycin sulfate: (FDA pregnancy category C). Thus MONICURE NH vaginal suppositories should be used in pregnant women only if the physician considers it to be necessary.
Lactation:
It is not known whether vaginal azoles (miconazole nitrate) and polene antifungals (Nystatin) are distributed into breast milk, however problems in humans have not been documented.
Aminoglycosides (Neomycin sulfate) are excreted in breast milk in small variable amounts. Also hydrocortisone may be distributed to breast milk, thus Monicre NH should be used in nursing mothers only if the physician considers it to be necessary.
PRECAUTIONS & warnings:
ϖ Discontinue the treatment if irritation or sensitization occurs
ϖ Should be used with caution in patients with diabetes, impaired circulation and renal dysfunction.

PACKING:
A box containing 6 vaginal suppositories.

STORAGE:
Keep at a temperature not exceeding 30C.
Keep out of reach of children.

INSTRUCTIONS TO PATIENTS:
ϖ For vaginal use only.
ϖ Complete full course of treatment even if menstruation begins.