Fluocinonide Topical application

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blistering, burning, crusting, dryness, or flaking of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)
• thinning, weakness, or wasting away of the skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Fever
• headache
• muscle aches
• sore throat
• stuffy or runny nose
• unusual tiredness or weakness

• Acne or pimples
• burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• 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
• softening of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Applies to fluocinonide topical: compounding powder, topical cream, topical gel, topical ointment, topical solution

General

The most commonly reported side effects were burning, itching, irritation, and dryness.

Hypersensitivity

Postmarketing reports: Hypersensitivity[Ref]

Endocrine

Frequency not reported: Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome[Ref]

Local

Common (1% to 10%): Application site burning
Frequency not reported: Itching, dryness
Postmarketing reports: Discoloration, erythema, pruritus, swelling, pain, condition aggravated[Ref]

Nervous system

Common (1% to 10%): Headache
Frequency not reported: Intracranial hypertension (including bulging fontanelles, bilateral papilledema)
Postmarketing reports: Dizziness[Ref]

Dermatologic

Frequency not reported: Irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria
Postmarketing reports: Acne, dry skin, rash, skin exfoliation, skin tightness[Ref]

Metabolic

Frequency not reported: Hyperglycemia, glucosuria[Ref]

Respiratory

Common (1% to 10%) Nasopharyngitis, nasal congestion[Ref]

Some side effects of fluocinonide topical may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

0.05% cream, gel, ointment: Apply a thin layer to affected area two to four times a day

0.1% cream: Apply a thin layer to affected area once or twice a day

Comments:
-Occlusive dressings may be used; however, if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-Treatment should be limited to 2 consecutive weeks and no more than 60 g per week should be used.

Uses: Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses

0.1% cream: Apply a thin layer to affected area once a day

Comments:
-Occlusive dressings may be used; however, if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-Treatment should be limited to 2 consecutive weeks and no more than 60 g per week should be used.

Use: Relief of the inflammatory and pruritic manifestations of atopic dermatitis

12 years or older:
0.05% cream, gel, ointment: Apply a thin layer to affected area two to four times a day

0.1% cream: Apply a thin layer to affected area once or twice a day

Comments:
-Occlusive dressings may be used; however, if an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy initiated.
-Treatment should be limited to 2 consecutive weeks and no more than 60 g per week should be used.

Uses: Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses

Data not available

Administration advice:
-This drug should not be used on the face, groin, or axillae.
-The treated area should not be bandaged, covered, or wrapped, as to be occlusive, unless directed by a healthcare provider.
-Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area.

Storage requirements:
-Excessive heat should be avoided.

General:
-This drug should not be used in the treatment of rosacea or perioral dermatitis.

Monitoring:
-Endocrine: HPA-axis suppression (Urinary free-cortisol test, ACTH-stimulation test)

Patient advice:
-Patients should report any signs of local adverse reactions, especially those that develop under occlusive dressings.