Molev

Cream: Each gram of Mometasone furoate (Molev) Cream contains 1 mg mometasone furoate.

Ointment: Each gram of Mometasone furoate (Molev) Ointment contains 1 mg mometasone furoate.

Lotion: Each gram of Mometasone furoate (Molev) Lotion contains: 1 mg of mometasone furoate.

The Mometasone furoate (Molev*) Cream, Ointment and Lotion formulations contain mometasone furoate (SCH 32088), a synthetic 17-heterocyclic corticosteroid with anti-inflammatory, antipruritic and vasoconstrictive properties, which is presently being therapeutically used for the treatment of corticosteroid responsive dermatoses, such as psoriasis and atopic dermatitis.

Mometasone furoate, 9,21-dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2)-furoate, is a synthetic, anti-inflammatory corticosteroid whose steroid nucleus is the 16α-methyl analog of beclomethasone, but with a 21-chloro group and a novel (2)-furoate 17-ester function. The empirical formula is C₂₇H₃₀CI₂O₆ and Molecular Weight (MW) is 521.44.

Excipients/Inactive Ingredients: Cream: White petrolatum, white wax, propylene glycol stearate, stearyl alcohol and ceteareth-20, hexylene glycol, titanium dioxide, aluminum starch octenylsuccinate, purified water and phosphoric acid to adjust the pH.

Ointment: Hexylene glycol, white wax, propylene glycol stearate, white petrolatum, purified water and phosphoric acid to adjust the pH.

Lotion: Isopropyl alcohol, hydroxypropylcellulose, sodium phosphate monobasic monohydrate, propylene glycol, purified water and phosphoric acid, if needed, to adjust the pH.

Molev (mometasone furoate lotion), 0.1%, is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid- responsive dermatoses. Since safety and efficacy of Molev (mometasone furoate lotion) have not been established in pediatric patients below 12 years of age, its use in this age group is not recommended..

Molev (mometasone) is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation.

Molev is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Molev may also be used for other purposes not listed in this medication guide.

Apply a thin film of Molev to the affected skin areas once daily. Molev may be used in pediatric patients 2 years of age or older. Since safety and efficacy of Molev have not been established in pediatric patients below 2 years of age; use in this age group is not recommended.

Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Safety and efficacy of Molev in pediatric patients for more than 3 weeks of use have not been established.

Molev should not be used with occlusive dressings unless directed by a physician. Molev should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.

Molev is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Avoid use on the face, groin, or axillae.

How supplied

Dosage Forms And Strengths

Cream, 0.1%. Each gram of Molev contains 1 mg of mometasone furoate in a white to off-white smooth and homogenous cream base.

Storage And Handling

Molev is white to off-white in color and supplied in 15-gram (NDC 0085-3149-01) and 50-gram (NDC 0085-3149-03) tubes.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Avoid excessive heat.

Manufactured for : Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Manufactured by: Schering-Plough Labo NV Heist-op-den-Berg, Belgium. Revised: Apr 2013

See also:
What is the most important information I should know about Molev?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts or for longer than recommended.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with Molev can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Follow your doctor's instructions.

Do not use this medication on a child without a doctor's advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication over a long treatment period.

Contact your doctor if your condition does not improve within 2 weeks of using this medicine, or if you develop signs of a bacterial, fungal, or viral skin infection.

Use Molev as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Shake well before each use.
• Apply a small amount of Molev to the affected area once a day. Gently rub the medicine in until it is evenly distributed. Wash your hands immediately after using Molev, unless your hands are part of the treated area.
• If you miss a dose of Molev, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Molev.

Molev is used to treat symptoms of allergic rhinitis (hay fever), perennial rhinitis (symptoms lasting almost a year) and nasal polyps (fleshy swelling inside the nose). It is used to treat inflammation and various skin conditions like eczema (inflammation and blistering on skin in patches causing redness and bleeding), psoriasis (red, itchy, scaly patches on skin), and dermatitis (redness and swelling of skin due to allergy).

See also:
What other drugs will affect Molev?

No drug-drug interaction studies have been conducted with Molev.

See also:
What are the possible side effects of Molev?

Applies to Molev: topical application cream, topical application lotion, topical application ointment, topical application solution

In addition to its needed effects, some unwanted effects may be caused by Molev (the active ingredient contained in Molev). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Molev:

Less common:

• Burning
• itching
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)

• Dryness
• irritation
• redness and scaling around the mouth

Minor Side Effects

Some of the side effects that can occur with Molev may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:

• Acne or pimples
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• dry mouth
• loss of elasticity
• loss of normal skin markings
• raised, dark red, and wart-like spots on the skin, especially when used on the face
• shininess

• Burning and itching of the skin with pinhead-sized red blisters
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin