MOMETASONE FUROATE ointment

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

MOMETASONE FUROATE (UNII: 04201GDN4R) (MOMETASONE - UNII:8HR4QJ6DW8)

Verfügbar ab:

Torrent Pharmaceuticals Limited

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Mometasone Furoate Ointment is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 2 years of age or older.           Mometasone Furoate Ointment is contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation. Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Therefore, Mometasone Furoate Ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. When administered to pregnant rats, rabbits, and mice, mometasone furoate increased fetal malformations. The doses that produced malformations also decreased fetal growth, a

Produktbesonderheiten:

Mometasone Furoate Ointment USP is a white to off-white uniform ointment and supplied in 15-gram (NDC 13668-527-01) and 45-gram (NDC 13668-527-04) tubes; boxes of one. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

Torrent Pharmaceuticals Limited
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Patient Information
Mometasone Furoate (moe—MET—a—sone) Ointment 0.1 %
Important information: Mometasone Furoate Ointment is for use on skin
only. Do not use
Mometasone Furoate Ointment in your eyes, mouth, or vagina.
W hat is Mometasone Furoate Ointment ?
• Mometasone Furoate Ointment is a prescription medicine used on the
skin (topical) for the relief of
redness, swelling, heat, pain (inflammation) and itching, caused by
certain skin problems in people 2
years of age and older.
• It is not known if Mometasone Furoate Ointment is safe and
effective for use in children under 2
years of age.
• Mometasone Furoate Ointment should not be used in children under 2
years of age.
• It is not known if Mometasone Furoate Ointment is safe and
effective for use in children longer
than 3 weeks.
Do not use Mometasone Furoate Ointment if you are allergic to
mometasone furoate or any of the
ingredients in Mometasone Furoate Ointment. See the end of this
leaflet for a complete list of
ingredients in Mometasone Furoate Ointment.
Before using Mometasone Furoate Ointment , tell your healthcare
provider about all your medical
conditions, including if you:
• have a skin infection at the site to be treated. You may also need
medicine to treat the skin
infection.
• are pregnant or plan to become pregnant. It is not known if
Mometasone Furoate Ointment will
harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if
Mometasone Furoate Ointment passes
into your breast milk.
T el l your healthcare provider about all the medicines you take,
including prescription and over-the-
counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you take other
corticosteroid medicines by mouth or use
other products on your skin or scalp that contain corticosteroids.
How should I use Mometasone Furoate Ointment ?
• Use Mometasone Furoate Ointment exactly as your healthcare
provider tells you to use it.
• Apply a thin film of

Fachinformation

MOMETASONE FUROATE- MOMETASONE FUROATE OINTMENT
TORRENT PHARMACEUTICALS LIMITED
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MOMETASONE FUROATE OINTMENT
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
MOMETASONE FUROATE OINTMENT .
MOMETASONE FUROATE OINTMENT, 0.1% FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1987
RECENT MAJOR CHANGES
Warnings and Precautions
Ophthalmic Adverse Reactions (5.2) 05/2018
INDICATIONS AND USAGE
Mometasone Furoate Ointment is a corticosteroid indicated for the
relief of the inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses in patients ≥ 2 years of age
(1) (1)
DOSAGE AND ADMINISTRATION
Apply a thin film to the affected skin areas once daily. (2)
Discontinue therapy when control is achieved. (2)
If no improvement is seen within 2 weeks, reassess diagnosis. (2)
The safety and efficacy of Mometasone Furoate Ointment in pediatric
patients for more than 3 weeks of use have
been established. (2)
Do not use with occlusive dressings unless directed by a physician.
(2)
DOSAGE FORMS AND STRENGTHS
Ointment, 0.1%. (3)
CONTRAINDICATIONS
Mometasone Furoate Ointment is contraindicated in those patients with
a history of hypersensitivity to any of the
components in the preparation. (4) (4)
WARNINGS AND PRECAUTIONS
Reversible HPA axis suppression with the potential for
glucocorticosteroid insufficiency after withdrawal of
treatment, Cushing's syndrome, and hyperglycemia may occur due to
systemic absorption. Patients applying a topical
steroid to a large surface area or to areas under occlusion should be
evaluated periodically for evidence of HPA axis
suppression. Modify use should HPA axis suppression develop. (5.1,
8.4)
Pediatric patients may be more susceptible to systemic toxicity. (5.1,
8.4)
May increase the risk of cataracts and glaucoma. If visual symptoms
occur, consider referral to an ophthalmologist. (5.2)
ADVERSE REACTIONS
Most common adverse reactions are burning, pruritus, skin atroph