Momecort

Momecort

mometasone

Manufacturer:

Asian Antibiotics

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Mometasone furoate.
Description
Each gram cream or ointment contains: Mometasone furoate 1 mg (0.1% w/w).
Action
Mometasone furoate belongs to a group of medicines called topical corticosteroids, which are used on the skin to relieve inflammation (e.g., swelling, redness) and itch caused by certain skin problems. Mometasone furoate cream and ointment are classified as a medium potency topical corticosteroids.
Indications/Uses
For the relief of inflammation and itch caused by skin conditions such as psoriasis (itchy, scaly, pink patches that develop on the elbows, knees, scalp, and other parts of the body), atopic dermatitis (or eczema, a skin disorder that involves scaly and itchy rashes), and contact dermatitis (red, sore or inflamed skin after direct contact with a substance that causes a reaction).
Dosage/Direction for Use
Mometasone furoate cream is suitable for thin skin or moist lesions.
Mometasone furoate ointment is suitable for thick skin or dry, scaling lesions.
Directions for Use: Rub a thin layer of mometasone cream or ointment to affected areas of the skin once a day, or as directed by a doctor.
Do not use on the face for longer than 5 days.
Do not use for longer than 5 days in children, unless directed by a doctor.
Do not use for longer than 7 days in adults, unless directed by a doctor.
Use the minimum quantity for the shortest period of time to achieve the desired results.
Missed Dose: If the patient missed a dose, just apply the next dose if still needed for the condition being treated and the following doses at the recommended time or schedule. If the next dose is due within an hour, do not apply the missed dose.
Do not use a double dose to make up for a missed dose.
Overdosage
Signs and Symptoms: Topically applied corticosteroids, including mometasone furoate, can be absorbed in amounts sufficient to produce systemic effects. Thus, its prolonged use or misuse (e.g., using the product more often that recommended, in skin with altered barrier, or on large areas of the body; use of occlusive dressings) for a longer period of time can suppress the HPA function resulting in secondary adrenal insufficiency, which is usually reversible. The growth and development of children may also be affected.
Treatment/Management: No specific antidote is available for mometasone overdose.
If you have used more than the recommended dosage, consult the doctor immediately. The use of appropriate symptomatic treatment is recommended. Electrolyte imbalance should be treated, if needed. If HPA axis suppression occurred, the doctor may attempt to withdraw the drug, reduce the frequency of application, or substitute a less potent steroid. In case of long-term toxicity, corticosteroid therapy should be withdrawn gradually.
Contraindications
If the patient is allergic to mometasone furoate or other corticosteroids, or to any ingredient in the product.
If the patient is using other corticosteroid-containing products, unless directed by the doctor.
Since the medicine may worsen these conditions, do not use this medicine if the patient has: Rosacea (skin redness on the face); Acne vulgaris; Skin atrophy (thinning of the skin); Skin manifestations relating to tuberculosis, syphilis, or post-vaccine reactions; Ulcerated skin or wounds; Diaper rash or napkin eruptions; Lesions of any viral infections (cold sores, chickenpox, shingles, herpes, warts); A parasitic or fungal skin infection (thrush, tinea or ringworm); A bacterial infection (impetigo, pyodermas); Other skin infections.
Do not use on children younger than 2 years old.
Special Precautions
For external use on the skin only.
Avoid contact with the eyes, eyelids or skin near the eyes because of the risk of corticosteroid-induced glaucoma (damaged optic nerves) and increased fluid pressure in the eye, especially with prolonged use.
Do not use on the face, underarms or groin area unless directed by a doctor.
Do not cover the treated area with occlusive dressing or bandage, especially in children or if the treated area is on the face, unless directed by a doctor.
Do not use on the diaper area since diapers or plastic pants may act as occlusive dressing.
Do not use this product to treat any skin conditions other than that for which it was prescribed.
If an infection occurs, an antifungal or antibacterial medicine should be used as recommended by a doctor. If a favorable response does not occur promptly, corticosteroid use should be discontinued until the infection is under control.
Corticosteroids can change the appearance of some lesions and make it difficult to establish an adequate diagnosis and can also delay the healing of the lesions.
Patients should be evaluated periodically for evidence of HPA axis suppression if topical corticosteroids are applied to large areas of the body or when used under occlusive dressing. Moreover, liver failure, increased frequency of application, prolonged use, and increased skin hydration may also increase the possibility that mometasone furoate will be absorbed systematically.
Adrenal suppression and any of the side effects that have been reported with systemic corticosteroids may also occur with topical corticosteroids, particularly in infants and children.
Patients should be carefully monitored when topical corticosteroids are used in the treatment of psoriasis because worsening of the disease or development of pustular psoriasis (a type of psoriasis seen as defined, raised bumps on the skin that are filled with pus) may occur during therapy or when the drug is suddenly discontinued.
Mometasone cream and ointment both contain propylene glycol which may cause skin irritation. Mometasone ointment contains stearyl alcohol which may cause local skin reactions (e.g., contact dermatitis).
As with other potent topical corticosteroids, sudden discontinuation of the treatment should be avoided to prevent the development of rebound phenomenon which takes the form of skin inflammation with intense redness, stinging, and burning. The treatment may be discontinued by slowly reducing the amount applied, or applying the product on an intermittent basis before discontinuing.
Use in caution in patients with inflammatory skin diseases associated with impaired circulation. The use of corticosteroids around chronic leg ulcers may result to higher occurrence of local allergic reactions and infections.
Do not use after the expiry date on the label.
Consult the Doctor: Consult the doctor before use if: The patient is pregnant or breastfeeding.
The patient has used this medicine before.
The patient is using other corticosteroids.
The patient is using other medicines on the skin.
The patient has kidney or liver problems.
Stop using this product and contact a doctor immediately if: Undesirable effects (such as skin irritation, thinning, or softening) are experienced.
Concomitant skin infections develop.
Condition worsens or does not improve within days in children and 7 days in adults.
Use In Pregnancy & Lactation
Consult the doctor before use if the patient is pregnant or breastfeeding.
Adverse Reactions
Although mometasone furoate is generally well tolerated, skin reactions may occur. The most common adverse events of topical mometasone furoate were burning sensation, pruritus (itching), and skin atrophy or skin thinning. Signs of skin thinning (e.g., shininess of the skin, stretch marks, "spider veins" or enlarged blood vessels near skin surface) also occurred.
Infections and infestations: Bacterial skin infections, folliculitis (inflammation of hair follicles), infections, moniliasis (candida infections), secondary infection.
Immune system disorders: Allergic contact dermatitis (skin inflammation caused by allergy from materials or substances in contact with the skin), worsening of allergy.
Endocrine disorders: Adrenal suppression, cushingoid features (e.g., moon face), Cushing's syndrome, hypothalamic-pituitary-adrenal (HPA) axis disorder, reversible HPA axis suppression, unspecified endocrine disorders.
Metabolism and nutrition disorders: Hyperglycemia (increased blood sugar level), obesity.
Nervous system disorders: Bulging fontanel, headache, hyperesthesia (increased sense of touch or sensation), hypoesthesia (reduced sense of touch or sensation), intracranial hypertension (increased pressure around the brain), paresthesia (tingling or numbness).
Eye disorders: Bilateral papilledema (swelling of optic disc in both eyes), cataract, glaucoma.
Vascular disorders: Ecchymoses (capillary brittleness), hypertension, purpura (reddish purple discoloration in the skin).
Gastrointestinal disorders: Dry mouth, nausea.
Skin and subcutaneous tissue disorders: Acne, acneiform eruptions, alopecia (hair loss), blister, bruising, dermatitis (inflammation of the skin), dry skin, erythema (abnormal redness of the skin or mucous membranes), furunculosis, hyperpigmentation (darkening of the skin), hypertrichosis (excessive hair growth), hypopigmentation (lightening of the skin), increased size of lesions, loss of skin elasticity, maceration of the skin (softening of skin as a result of prolonged exposure to moisture), miliaria (prickly heat or sweat rash), papule (solid, raised spots on the skin), perioral dermatitis (inflammation of the skin around the mouth), pustular psoriasis, pustule (small collection of pus in the top layer of skin), rosacea (skin condition where parts or the entire face are unusually red, with or without tine visible blood, bumps, or pus-filled bumps), skin depigmentation (loss of color or markings on the skin), skin irritation, unspecified skin disorder, urticaria (hives).
Musculoskeletal and connective tissue disorder: Growth retardation (in children), osteoporosis.
Renal and urinary disorders: Glycosuria (glucose in the urine).
Reproductive system and breast disorders: Vaginal discharge.
General disorders and administration site conditions: Application site pain, application site reactions, steroid withdrawal syndrome, stinging, worsening of disease.
Investigations: Decreased glucocorticoid levels, delayed weight gain (in children), increased weight.
Drug Interactions
Other corticosteroid-containing products, unless prescribed by the doctor.
Medications that inhibit the enzyme CYP3A4 (e.g., ritonavir, itraconazole), since these drugs may inhibit the metabolism of corticosteroids and may increase the patient’s exposure to mometasone. The clinical relevance of this interaction depends on the dose and route of administration of the corticosteroid and the potency of the CYP3A4 inhibitor.
Concomitant use with other topical products, since the efficacy, safety, and stability of mometasone furoate cream or ointment may be altered.
Tell the doctor if the patient is using, have recently used, or might use any other medicine.
Storage
Store at temperatures not exceeding 30°C.
Keep containers tightly closed.
Do not freeze.
ATC Classification
D07AC13 - mometasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
Presentation/Packing
Cream 0.1% (white, homogeneous, smooth, and non-gritty cream with a characteristic odor) x 5 g. Oint 0.1% (translucent, homogeneous, smooth, and non-gritty ointment with a characteristics odor) x 5 g.
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