Mometasone Furoate Ointment
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Mometasone Furoate, USP Ointment 0.1% is a medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Mometasone Furoate, USP Ointment 0.1% may be used 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 (see PRECAUTIONS – Pediatric Use section). Since safety and efficacy of Mometasone Furoate Ointment 0.1% have not been established in pediatric patients below 2 years of age, its use in this age group is not recommended.
History
There is currently no drug history available for this drug.
Other Information
Mometasone Furoate, USP Ointment 0.1% contains mometasone furoate, USP for dermatologic use. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory activity.
Chemically, mometasone furoate is 9α,21-Dichloro-11β,17-dihydroxy-16α-methylpregna-1,4-diene-3,20-dione 17-(2-furoate), with the empirical formula C27H30CI2O6, a molecular weight of 521.4 and the following structural formula:
Mometasone furoate is a white to off-white powder practically insoluble in water, slightly soluble in octanol, and moderately soluble in ethyl alcohol.
Each gram contains: 1 mg mometasone furoate USP in an ointment base of hexylene glycol, phosphoric acid, propylene glycol stearate, white wax, white petrolatum, and purified water.
Sources
Mometasone Furoate Ointment Manufacturers
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Physicians Total Care, Inc.
![Mometasone Furoate Ointment [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Mometasone Furoate Ointment | Physicians Total Care, Inc.
Apply a thin film of Mometasone Furoate, USP Ointment 0.1% to the affected skin areas once daily. Mometasone Furoate, USP Ointment 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of Mometasone Furoate, USP Ointment 0.1% have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended (see PRECAUTIONS – Pediatric Use).
As with other corticosteroids, 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 Mometasone Furoate, USP Ointment 0.1% in pediatric patients for more than 3 weeks of use have not been established.
Mometasone Furoate, USP Ointment 0.1% should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate, USP Ointment 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.
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Dispensing Solutions, Inc.
Mometasone Furoate Ointment | Dispensing Solutions, Inc.
Apply a thin film of Mometasone Furoate, USP Ointment 0.1% to the affected skin areas once daily. Mometasone Furoate, USP Ointment 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of Mometasone Furoate, USP Ointment 0.1% have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended (see PRECAUTIONS – Pediatric Use).
As with other corticosteroids, 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 Mometasone Furoate, USP Ointment 0.1% in pediatric patients for more than 3 weeks of use have not been established.
Mometasone Furoate, USP Ointment 0.1% should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate, USP Ointment 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.
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Rebel Distributors Corp
Mometasone Furoate Ointment | Rebel Distributors Corp
Apply a thin film of Mometasone Furoate, USP Ointment 0.1% to the affected skin areas once daily. Mometasone Furoate, USP Ointment 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of Mometasone Furoate, USP Ointment 0.1% have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended (see PRECAUTIONS – Pediatric Use).
As with other corticosteroids, 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 Mometasone Furoate, USP Ointment 0.1% in pediatric patients for more than 3 weeks of use have not been established.
Mometasone Furoate, USP Ointment 0.1% should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate, USP Ointment 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.
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E. Fougera & Co. , A Division Of Fougera Pharmaceuticals Inc.
Mometasone Furoate Ointment | Massbiologics
PRIMARY IMMUNIZATION
MassBiologics' Td may be used in persons 7 years of age and older who have not been previously immunized against tetanus and diphtheria, as a primary immunization series consisting of three 0.5 ml doses. The first two doses are administered 4-8 weeks apart and the third dose is administered 6-12 months after the second dose.
MassBiologics' Td may be used to complete the primary immunization series for tetanus and diphtheria, following one or two doses of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (whole-cell DTP), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) and/or Diphtheria and Tetanus Toxoids Adsorbed (DT) vaccine. However, the safety and efficacy of MassBiologics' Td in such regimens have not been evaluated.
ROUTINE BOOSTER IMMUNIZATION
MassBiologics' Td may be used for routine booster immunization against tetanus and diphtheria in persons 7 years of age and older who have completed primary immunization against tetanus and diphtheria. Routine booster immunization against tetanus and diphtheria is recommended in children 11-12 years of age and every 10 years thereafter.10
The Advisory Committee on Immunization Practices (ACIP) has specific recommendations on booster immunization against tetanus and diphtheria for adolescents and adults.10, 13, 14
TETANUS PROPHYLAXIS IN WOUND MANAGEMENT
For active tetanus immunization in wound management of patients 7 years of age and older, a preparation containing tetanus and diphtheria toxoids is preferred instead of single-antigen tetanus toxoid to enhance diphtheria protection.15 MassBiologics' Td is approved for wound management of patients 7 years of age and older.
The need for active immunization with a tetanus toxoid-containing preparation, with or without Tetanus Immune Globulin (TIG) (Human) depends on both the condition of the wound and the patient's vaccination history (Table 1).
When indicated, TIG (Human) should be administered using a separate needle and syringe at a different anatomic site, according to the manufacturer's package insert. If a contraindication to using a tetanus toxoid-containing vaccine exists in a person who has not completed tetanus primary immunization and other than a clean, minor wound is sustained, only passive immunization with TIG (Human) should be given.15
TABLE 1 GUIDE TO TETANUS PROPHYLAXIS IN ROUTINE WOUND MANAGEMENT IN PERSONS AGED 7 YEARS AND OLDER13, 14, 15
History of Adsorbed Tetanus
Toxoid (Doses) Clean, Minor Wounds All Other Wounds* Td† TIG Td † TIG Unknown or < 3 Yes No Yes Yes > 3‡ No§ No No¶ No* Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns and frostbite.
† The ACIP has specific recommendations on use of Td or Tetanus Toxoid, Reduced Diphtheria Toxoids and Acellular Pertussis Vaccine Adsorbed (Tdap) in adolescents and adults.13,14
‡ If only three doses of fluid tetanus toxoid have been received, then a fourth dose of toxoid, preferably an adsorbed toxoid, should be given.
§ Yes, if > 10 years since the last tetanus toxoid-containing vaccine dose.
¶ Yes, if > 5 years since the last tetanus toxoid-containing vaccine dose. (More frequent boosters are not needed and can accentuate side effects.)
DIPHTHERIA PROPHYLAXIS FOR CASE CONTACTS
MassBiologics' Td may be used for post-exposure diphtheria prophylaxis in persons 7 years of age and older who have not completed primary vaccination, whose vaccination status is unknown, or who have not been vaccinated with diphtheria toxoid within the previous 5 years. Consult ACIP recommendations for additional interventions for post-exposure diphtheria prophylaxis.15
ADMINISTRATION
Shake the vial well to resuspend the vaccine before withdrawing the dose. After shaking, MassBiologics' Td is a homogenous milky white suspension. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions exist, MassBiologics' Td should not be administered.
Inject 0.5 ml of MassBiologics' Td intramuscularly. The preferred site is the deltoid muscle. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Do not administer this vaccine intravenously, subcutaneously, or intradermally.
MassBiologics' Td should not be combined through reconstitution or mixed with any other vaccine. -
Remedyrepack Inc.
Mometasone Furoate Ointment | Remedyrepack Inc.
Apply a thin film of Mometasone Furoate, USP Ointment 0.1% to the affected skin areas once daily. Mometasone Furoate, USP Ointment 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of Mometasone Furoate, USP Ointment 0.1% have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended (see PRECAUTIONS – Pediatric Use).
As with other corticosteroids, 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 Mometasone Furoate, USP Ointment 0.1% in pediatric patients for more than 3 weeks of use have not been established.
Mometasone Furoate, USP Ointment 0.1% should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate, USP Ointment 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.
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Taro Pharmaceuticals U.s.a., Inc.
Mometasone Furoate Ointment | Taro Pharmaceuticals U.s.a., Inc.
Apply a thin film of Mometasone Furoate Ointment USP, 0.1% to the affected skin areas once daily.
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 mometasone furoate ointment in pediatric patients for more than 3 weeks of use have not been established [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
Mometasone furoate ointment should not be used with occlusive dressings unless directed by a physician. Mometasone furoate ointment should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.
Mometasone furoate ointment is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Avoid use on the face, groin, or axillae.
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Perrigo New York Inc
Mometasone Furoate Ointment | Perrigo New York Inc
Apply a thin film of Mometasone Furoate Ointment USP, 0.1% to the affected skin areas once daily.
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 Mometasone Furoate Ointment USP, 0.1% in pediatric patients for more than 3 weeks of use have not been established [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
Mometasone Furoate Ointment USP, 0.1% should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate Ointment USP, 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.
Mometasone Furoate Ointment USP, 0.1% is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Avoid use on the face, groin, or axillae.
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Global Pharmaceuricals, Division Of Impax Laboratories, Inc.
Mometasone Furoate Ointment | Global Pharmaceuricals, Division Of Impax Laboratories, Inc.
Apply a thin film of Mometasone Furoate Ointment to the affected skin areas once daily.
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 Mometasone Furoate Ointment in pediatric patients for more than 3 weeks of use have not been established [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
Mometasone Furoate Ointment should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate Ointment should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.
Mometasone Furoate Ointment is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Avoid use on the face, groin, or axillae.
-
Remedyrepack Inc.
Mometasone Furoate Ointment | Remedyrepack Inc.
Apply a thin film of Mometasone Furoate, USP Ointment 0.1% to the affected skin areas once daily. Mometasone Furoate, USP Ointment 0.1% may be used in pediatric patients 2 years of age or older. Since safety and efficacy of Mometasone Furoate, USP Ointment 0.1% have not been adequately established in pediatric patients below 2 years of age, its use in this age group is not recommended (see PRECAUTIONS – Pediatric Use).
As with other corticosteroids, 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 Mometasone Furoate, USP Ointment 0.1% in pediatric patients for more than 3 weeks of use have not been established.
Mometasone Furoate, USP Ointment 0.1% should not be used with occlusive dressings unless directed by a physician. Mometasone Furoate, USP Ointment 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants as these garments may constitute occlusive dressing.
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Glenmark Generics Inc., Usa
Mometasone Furoate Ointment | Glenmark Generics Inc., Usa
Apply a thin film of mometasone furoate ointment USP, 0.1% to the affected skin areas once daily.
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 mometasone furoate ointment USP, 0.1% in pediatric patients for more than 3 weeks of use have not been established [see Warnings and Precautions (5.1) and Use in Specific Populations (8.4)].
Mometasone furoate ointment USP, 0.1% should not be used with occlusive dressings unless directed by a physician. Mometasone furoate ointment USP, 0.1% should not be applied in the diaper area if the child still requires diapers or plastic pants, as these garments may constitute occlusive dressing.
Mometasone furoate ointment USP, 0.1% is for topical use only. It is not for oral, ophthalmic, or intravaginal use.
Avoid use on the face, groin, or axillae.
![Mometasone Furoate Ointment [Dispensing Solutions, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=db303d11-eba4-49f7-bf9c-7d944ddb43e7&name=NDC68258-3997-04------GW.jpg)
![Mometasone Furoate Ointment [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=79957ee5-5d59-45a9-8ff8-10cc75848d2a&name=79957ee5-5d59-45a9-8ff8-10cc75848d2a-02.jpg)
![Mometasone Furoate Ointment [E. Fougera & Co. , A Division Of Fougera Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b732ba37-e6dd-45fd-9bb7-75a8df9300f4&name=Carton_Label_C0144.jpg)
![Mometasone Furoate Ointment [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2b9d91e1-6bbc-49f2-8913-998aa0f1989c&name=MM2.jpg)
![Mometasone Furoate Ointment [Taro Pharmaceuticals U.s.a., Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d8cf50d4-0448-4527-a498-cddd511213f0&name=mometasone-02.jpg)
![Mometasone Furoate Ointment [Perrigo New York Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d986282f-da3c-43b6-a3f6-40886d4a1915&name=63f7acdb-be01-46c6-b799-66ae97cab15f-03.jpg)
![Mometasone Furoate Ointment [Global Pharmaceuricals, Division Of Impax Laboratories, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c5769a09-3416-4b5e-a5a4-1c0fa36c402b&name=250ca78a-figure-01.jpg)
![Mometasone Furoate Ointment [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cdc3f40b-b089-4b02-8a9b-5a21efe61e71&name=MM2.jpg)
![Mometasone Furoate Ointment [Glenmark Generics Inc., Usa]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=209c15dd-72b2-4f00-a2f0-011219f7eaea&name=b5c899d6-70fa-4609-84ca-0ec2b604aef5-03.jpg)
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