STEROMOM

Home ⁄ STEROMOM

STEROMOM CREAM

For Doctors
For patients

Composition

Mometasone furoate 0.1% cream

Description

STEROMOM 0.1% Cream contain mometasone furoate for dermatologic use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties.

HIGHLIGHTS (USPs)

Superior efficacy to high potency steroids like Betamethasone in Psoriasis and Dermatitis
Lower potential to cause skin atrophy, telangectasia and HPA axis suppression
Lower risk of primary sensitization
Convenience of once a day dosing

CLINICAL PHARMACOLOGY

Mometasone furoate has anti-inflammatory, antipruritic, and vasoconstrictive properties. It acts by the induction of phospholipase A2 inhibitory proteins,
collectively called lipocortins. These proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

Studies in humans indicate that approximately 0.1% of the applied dose of mometasone furoate cream and ointment 0.1% [0.7% of ointment] enters the circulation after 8 hours of contact on normal skin without occlusion. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.

Mometasone furoate lotion was applied at 15 ml twice daily (30 ml per day) to diseased skin (patients with scalp and body psoriasis) of four patients for seven days. Plasma cortisol levels for each of the four patients remained well within the normal range and changed little from baseline

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

INDICATIONS AND USAGE

Mometasone furoate is a high potency corticosteroid indicated for the relief of
the inflammatory and pruritic manifestations of corticosteroid responsive
dermatoses. or as indicated by the physician

CONTRAINDICATIONS

Mometasone furoate cream and ointment are contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

PRECAUTIONS

Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary- adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.

Patients applying a topical steroid to a large surface area or areas under occlusion should be evaluated periodically for evidence of HPA axis suppression.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt upon discontinuation of topical corticosteroids.

If irritation develops, mometasone furoate cream and ointment should be discontinued and appropriate therapy instituted. Allergic contact dermatitis
with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of mometasone furoate cream and ointment should be discontinued until the infection has been adequately controlled.

Laboratory Tests

The following Tests May be Helpful in Evaluating HPA Axis Suppression:
1. Urinary free cortisol test
2. ACTH stimulation test
3. A.M. plasma cortisol test (for cream and ointment only)

Pregnancy

Pregnancy category C : There are no adequate and well-controlled studies of the teratogenic potential of mometasone furoate in pregnant women. Mometasone furoate cream and ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Caution should be exercised when mometasone furoate cream and ointment are administered to a nursing woman.

Pediatric Use

Mometasone furoate cream and ointment may be used with caution in pediatric patients 2 years of age or older, although the safety and efficacy of drug use for longer than 3 weeks have not been established.

ADVERSE REACTIONS

Reported reactions included stinging, pruritus, and furunculosis.The following additional local adverse reactions have been reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.

DOSAGE AND ADMINISTRATION

Apply a thin film of mometasone cream / lotion to the affected skin areas once daily.

OVERDOSAGE

Topically applied mometasone furoate can be absorbed in sufficient amounts to produce systemic effects.

STEROMOM
1. What is Steromom?
A: It contains mometazone furoate 0.1% which is a topical corticosteroid for the
treatment of psoriasis and dermatoses.

2. What is the active ingredient?
A: Steromom Cream contains: Mometasone furoate 0.1% w/w

3. How is it available?
A: Steromom is available in two forms: Steromom Cream – Tube of 5gm

4. What are its indications or uses?
A: Steromom is used to reduce inflammation and itchiness in conditions like
Eczema or dermatitis and psoriasis.

5. What is the right dosage?
A: Steromom Cream: Apply a thin film of Steromom cream to the affected skin
areas once daily for three weeks followed by maintenance treatment of twice
weekly for 6 months.
Or
Steromon Lotion: Apply a few drops of Steromom lotion to the affected
areas once daily for three weeks followed by maintenance treatment of twice
weekly for 6 months.

6. What are the precautions while taking the product?
A: This medication is to be used as directed by the physician. It is for
external use only. Avoid contact with the eyes.
This medication should not be used for any disorder other than that for
which it was prescribed.
The treated skin area should not be bandaged or otherwise covered or
wrapped so as to be occlusive, unless directed by the physician.
Patients should report to their physician any signs of local adverse
reactions.
Parents of pediatric patients should be advised not to use STEROMOM
Ointment 0.1% in the treatment of diaper dermatitis. STEROMOM
Ointment 0.1% should not be applied in the diaper area as diapers or
plastic pants may constitute occlusive dressing.
This medication should not be used on the face, underarms, or groin
areas unless directed by the physician.
As with other corticosteroids, therapy should be discontinued when control
is achieved. If no improvement is seen within 2 weeks, contact the
physician.
Other corticosteroid-containing products should not be used with
STEROMOM Ointment 0.1% without first consulting with the physician.

7. Which drugs should be avoided along with it?
A: Before starting any new medication, talk to your doctor about possible drug
interactions.

8. What is the time of taking the medicine, dosage and the usual duration?
A: Steromom Cream : Apply a thin film of the cream and ointment to the affected skin areas once daily.
Steromom Lotion: Apply a few drops of the lotion to the affected areas once daily and massage lightly until it disappears. For the most effective and
economical use, hold the nozzle of the bottle very close to the affected areas and gently squeeze.

9. Who cannot take the medicine?
A: Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Caution should be exercised when topical corticosteroids are administered to a nursing woman.

10.What are the possible common and rare adverse effects of the medicine?
A: Side effects are more likely with the stronger steroids, with large amounts applied, with use for a long time and if the area being treated allows more drug penetration (e.g. the face, covered areas or skin folds) and if the area is covered (occlusion).
Skin thinning after a few weeks of use can occur but the skin goes back to normal if the product is stopped for a while.
Burning, stinging and irritation can sometimes occur .
Striae (stretch marks) can occur on long term usage.
Reduced skin colour
Acne and infections in hair follicles
Dermatitis around the mouth or rosacea on stopping the steroid
Contact dermatitis to ingredients in the steroid cream
With large quantities in children adrenal suppression can occur

11.How to store the medicine?
A: Keep this medication in the container it came in, tightly closed, and out of reach
of children. Store it away from excess heat and moisture.
Store Steromom Cream between 2° and 25°C.

12. What is the Price per unit?
A: Steromom cream is available in a tube of 5gm for Rs. 45/- and 15gm for Rs.
78.75/-