MONICORT CREAM

Description

Description
MONICORT cream contains the bactericidal and fungicidal broad-spectrum antifungal agent, miconazole nitrate, in combination with hydrocortisone, a natural corticosteroid with antiinflammatory and antipruriginous properties.

Properties
Pharmacodynamics
Miconazole combines an antifungal activity against the common dermatophytes, yeasts and various other fungi with an antibacterial activity against certain grampositive 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.
Miconazole has also been proven to be effective in secondary infected mycoses. Miconazole in combination with hydrocortisone acts very rapidly on pruritus, which frequently accompanies dermatophyte and yeast infections. This symptomatic improvement is seen before the first signs of healing are observed. However, treatment with hydrocortisone is symptomatic and lesions may flare up again after a discontinuation of the treatment.

Pharmacokinetics
Miconazole does not produce detectable blood levels after topical application.
Depending on the location and type of infect~on, hy?rocortisone penetrates well into the skin and IS partially absorbed. More than 90% of the absorbed fraction is bound to plasma proteins.
The metabolism takes place in the liver and tissues and
. the metabolites are excreted with the urine, mostly as glucuronides, together with a very small fraction of unchanged hydrocortisone.
The biological half-life is about 100 minutes.

Indications For the topical treatment of inflamed dermatoses where infection by susceptible organisms and inflammation co-exist, eg intertrigo and infected eczema. Moist or dry eczema or dermatitis including atopic eczema, primary irritant or contact allergic eczema or seborrhoeic eczema including that associated with acne. Intertriginous eczema including inframammary intertrigo, perianal and genital dermatitis. Organisms which are susceptible to miconazole are dermatophytes and pathogenic yeasts (eg Candida spp.). Also many Gram-positive bacteria including most strains of Streptococcus and Staphylococcus. The properties of MONICORT indicate it particularly for the initial stages of treatment. Once the inflammatory symptoms have disappeared (after about 7 days), treatment can be continued where necessary with MONICURE cream.

Contra-indications
Shown hypersensitivity to miconazole, hydrocortisone or another ingredient of MONICORT cream. Tuberculous skin affections, herpes simplex, vaccinia, all forms of varicella.

Warnings & Precautions When MONICORT is used by patients taking oral anticoagulants, the anticoagulant effect should be carefully monitored. As with any topical corticosteroid, care is advised with infants and children when MONICORT is to be applied to extensive surface areas or under occlusive dressings including baby napkins; similarly, application to the face should be avoided. In infants, long term continuous topical corticosteroid therapy should be avoided. Adrenal suppression can occur even without occlusion.

Pregnancy and Lactation .
Caution is recommended during pregnancy and lactation period. Treatment of large surfaces and the application under occlusive dressing should be avoided during that time.

Dosage and Administration
MONICORT cream should be applied topically to the lesion (or more, according to its size) once to twice daily. It should be rubbed in gently with your finger until it has been completely penetrated into the skin. The treatment with MONICORT (or subsequently with MONICURE) should be continued without interruption until the lesion has completely disappeared (usually after 2 to 5 weeks). To open the tube unscrew the cap. Then pierce the seal of the tube by means of the pin on the top of the cap.

Adverse Reactions
Rarely, local sensitivity may occur requiring discontinuation of treatment.
Very rare, anaphylactic reaction, dermatitis, erythema and rash

Overdosage
Symptoms
Prolonged and excessive use can result in skin irritation, which usually disappears after discontinuation of therapy. Topically applied, corticosteroids can be absorbed in sufficient amounts to produce systemic effects.
Treatment
If accidental,ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered to be necessary.

Packaging
A carton box containing an Aluminium tube of 10 or 20 gm and an inner pamphlet.

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