Fluocinonide 0.05% Cream 15gm
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Keep the medication away from your mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the area being treated.
Clean the affected area before applying the medication and make sure it is dry.
Apply a thin layer of the medication to the affected skin and gently rub it in.
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Storage and Disposal
Store the medication at room temperature with the lid tightly closed.
Protect the medication from heat.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Wash your hands before and after applying the cream.
- Apply a thin layer of cream to the affected skin area, gently rubbing it in until it disappears. Do not use more than prescribed.
- Do not cover the treated area with bandages or other dressings unless directed by your doctor, as this can increase absorption and side effects.
- Avoid applying the cream to the face, groin, or armpits unless specifically instructed by your doctor, as these areas are more prone to side effects.
- Do not use this medication for longer than prescribed, especially on children, as it can lead to serious side effects.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not use for diaper rash unless specifically advised by a doctor.
Available Forms & Alternatives
Available Strengths:
- Fluocinonide -E 0.05% Cream 15gm
- Fluocinonide -E 0.05% Cream 60gm
- Fluocinonide -E 0.05% Cream 30gm
- Fluocinonide 0.05% Gel 15gm
- Fluocinonide 0.05% Soln 20ml
- Fluocinonide 0.05% Ointment 30gm
- Fluocinonide 0.05% Oint 60gm
- Fluocinonide 0.05% Gel 60gm
- Fluocinonide 0.05% Oint 15gm
- Fluocinonide 0.05% Gel 30gm
- Fluocinonide 0.1% Cream 120gm
- Fluocinonide 0.1% Cream 30gm
- Fluocinonide 0.1% Cream 60gm
- Fluocinonide 0.05% Cream 60gm
- Fluocinonide 0.05% Cream 30gm
- Fluocinonide 0.05% Cream 120gm
- Fluocinonide 0.05% Cream 15gm
- Fluocinonide 0.05% Soln 60ml
- Fluocinonide 0.05% Soln 60ml
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Skin irritation
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Burning or stinging
Dry skin
Itching
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased irritation, redness, or burning at the application site
- Signs of skin infection (pus, spreading redness, fever)
- Skin thinning, easy bruising, or stretch marks
- Acne or hair growth in the treated area
- If used extensively or for prolonged periods, watch for signs of systemic absorption like unusual tiredness, weight gain (especially in the face/trunk), or swelling in the ankles/feet.
Before Using This Medicine
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This drug may interact with other prescription or over-the-counter (OTC) medications, natural products, or vitamins, which could affect its safety and efficacy.
A complete list of all your current medications, including prescription and OTC drugs, natural products, and vitamins. This will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as these may impact the safety and effectiveness of this medication.
To minimize risks and ensure safe use, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
Precautions & Cautions
To ensure safe use, avoid applying this medication to cuts, scrapes, or damaged skin. When applying it to a large area of skin or near open wounds, exercise caution and discuss with your doctor.
Adhere to your doctor's instructions regarding the duration of use; do not use this medication for longer than prescribed. If the treated area is in the diaper region, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.
When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this population. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks; consult with your doctor to discuss this potential risk.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic effects due to absorption, including Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
- Local symptoms may include severe skin atrophy, striae, or telangiectasias.
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Rationale: To establish baseline severity of dermatosis and identify any contraindications (e.g., active infection).
Timing: Prior to initiation of therapy.
Routine Monitoring
Frequency: Regularly during treatment, typically weekly or bi-weekly initially.
Target: Improvement in symptoms and skin appearance.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation or alternative therapy.
Frequency: At each follow-up visit.
Target: Absence of or minimal adverse effects.
Action Threshold: Presence of significant adverse effects warrants reduction in potency, frequency, or discontinuation.
Frequency: Periodically, especially in pediatric patients or those at high risk for systemic absorption.
Target: Normal adrenal function.
Action Threshold: Suspicion of HPA axis suppression may warrant laboratory testing (e.g., ACTH stimulation test, morning cortisol) and gradual withdrawal of therapy.
Symptom Monitoring
- Worsening of skin condition
- Signs of skin infection (redness, pus, warmth, pain)
- Excessive skin thinning or bruising
- Development of stretch marks (striae)
- Increased hair growth at application site
- Acne-like eruptions
- Fatigue, weakness, dizziness (signs of systemic absorption/HPA axis suppression)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Avoid large amounts, prolonged use, or application to large surface areas.
Trimester-Specific Risks:
Lactation
L3 (Moderately Safe). Use with caution. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Minimize infant exposure by avoiding application to the breast area and ensuring the infant does not come into direct contact with treated skin.
Pediatric Use
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio. Use the least potent corticosteroid that provides effective therapy. Limit treatment to the smallest amount compatible with an effective therapeutic regimen. Avoid occlusive dressings. Monitor for signs of systemic toxicity.
Geriatric Use
No specific dosage adjustments are typically required. However, geriatric patients may have thinner, more fragile skin, increasing susceptibility to local adverse effects like skin atrophy, purpura, and striae. Monitor closely for skin integrity.
Clinical Information
Clinical Pearls
- Fluocinonide 0.05% is a high-potency topical corticosteroid; use it judiciously and for the shortest duration necessary to control symptoms.
- Avoid prolonged use, especially on the face, intertriginous areas (skin folds), or in children, due to increased risk of local and systemic side effects.
- Educate patients on proper application technique: a thin film, gently rubbed in, and avoiding occlusive dressings unless specifically instructed.
- Consider step-down therapy to a lower potency corticosteroid or intermittent use once the acute flare is controlled to minimize side effects.
- Always rule out fungal or bacterial infections before initiating corticosteroid therapy, as corticosteroids can worsen these conditions.
Alternative Therapies
- Clobetasol propionate (very high potency)
- Betamethasone dipropionate (high potency)
- Mometasone furoate (medium potency)
- Triamcinolone acetonide (medium potency)
- Hydrocortisone (low potency)
- Calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy
- Emollients and moisturizers for barrier repair