Fluopar
Generic: FLUOCINONIDE, DIMETHICONE
Basic Information
Manufacturer
PureTek Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
FDA Set ID
9ff7fa78-0fca-976f-e053-2995a90a4641
Purpose
Purpose Skin Protectant
Indications & Usage
1 INDICATIONS AND USAGE These highlights do not include all the information needed to use Fluocinonide Cream USP, 0.1% safely and effectively.
See full prescribing information for Fluocinonide Cream USP, 0.1%.
Fluocinonide Cream USP, 0.1% For topical use Initial U.S.
Approval: 1971 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Fluocinonide Cream USP, 0.1% safely and effectively.
See full prescribing information for Fluocinonide Cream USP, 0.1%.
Fluocinonide Cream USP, 0.1% For topical use Initial U.S.
Approval: 1971 Fluocinonide Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older.
Limitation of Use: Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
(1) Avoid use on the face, groin, or axillae.
(1.2) Avoid use in perioral dermatitis or rosacea.
1.1 Indication Fluocinonide Cream USP, 0.1%, is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see Use in Specific Populations (8.4)].
1.2 Limitation of Use Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Fluocinonide Cream USP, 0.1% for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Therapy should be discontinued when control of the disease is achieved.
If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Do not use more than half of the 120 g tube per week.
Fluocinonide Cream USP, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
Uses ■ for the treatment and/or prevention of diaper rash ■ temporarily protects and helps relieve chapped or cracked skin
See full prescribing information for Fluocinonide Cream USP, 0.1%.
Fluocinonide Cream USP, 0.1% For topical use Initial U.S.
Approval: 1971 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use Fluocinonide Cream USP, 0.1% safely and effectively.
See full prescribing information for Fluocinonide Cream USP, 0.1%.
Fluocinonide Cream USP, 0.1% For topical use Initial U.S.
Approval: 1971 Fluocinonide Cream USP, 0.1% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older.
Limitation of Use: Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
(1) Avoid use on the face, groin, or axillae.
(1.2) Avoid use in perioral dermatitis or rosacea.
1.1 Indication Fluocinonide Cream USP, 0.1%, is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in patients 12 years of age or older [see Use in Specific Populations (8.4)].
1.2 Limitation of Use Treatment beyond 2 consecutive weeks is not recommended and the total dosage should not exceed 60 g per week because the safety of Fluocinonide Cream USP, 0.1% for longer than 2 weeks has not been established and because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.
Therapy should be discontinued when control of the disease is achieved.
If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.
Do not use more than half of the 120 g tube per week.
Fluocinonide Cream USP, 0.1% should not be used in the treatment of rosacea or perioral dermatitis, and should not be used on the face, groin, or axillae.
Uses ■ for the treatment and/or prevention of diaper rash ■ temporarily protects and helps relieve chapped or cracked skin
Warnings
Warnings For external use only Do not use on ■ deep or puncture wounds ■ animal bites ■ serious burns When using this product ■ do not get into eyes Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
If swallowed, get medical help or contact a Poison Control Center right away.
Adverse Reactions
6 ADVERSE REACTIONS The most commonly reported adverse reactions (≥1%) were headache, application site burning, nasopharyngitis, and nasal congestion.
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In clinical trials, a total of 443 adult subjects with atopic dermatitis or plaque-type psoriasis were treated once daily or twice daily with fluocinonide cream, 0.1% for 2 weeks.
The most commonly observed adverse reactions in these clinical trials were as follows: Table 1: Most Commonly Observed Adverse Reactions (≥1%) in Adult Clinical Trials Safety in patients 12 to 17 years of age was similar to that observed in adults.
Table 1 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of fluocinonide cream, 0.1%: Administration Site Conditions : discoloration, erythema, irritation, pruritus, swelling, pain and condition aggravated.
Immune System Disorders: hypersensitivity.
Nervous System Disorders : headache and dizziness.
Skin and Subcutaneous Tissue Disorders : acne, dry skin, rash, skin exfoliation and skin tightness.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In clinical trials, a total of 443 adult subjects with atopic dermatitis or plaque-type psoriasis were treated once daily or twice daily with fluocinonide cream, 0.1% for 2 weeks.
The most commonly observed adverse reactions in these clinical trials were as follows: Table 1: Most Commonly Observed Adverse Reactions (≥1%) in Adult Clinical Trials Safety in patients 12 to 17 years of age was similar to that observed in adults.
Table 1 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of fluocinonide cream, 0.1%: Administration Site Conditions : discoloration, erythema, irritation, pruritus, swelling, pain and condition aggravated.
Immune System Disorders: hypersensitivity.
Nervous System Disorders : headache and dizziness.
Skin and Subcutaneous Tissue Disorders : acne, dry skin, rash, skin exfoliation and skin tightness.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.