Fluocinolone 0.01% Cream 60gm
It is used to treat skin rashes and other skin irritation.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Jun 1961
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluocinolone cream is a type of medicine called a corticosteroid. It helps reduce redness, swelling, itching, and discomfort caused by various skin conditions like eczema and psoriasis.
How to Use This Medicine
Using Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions precisely. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply the medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your eyes, nose, or mouth, as it may cause burning. If you accidentally get the medication in your eyes, rinse them immediately with water. If you experience persistent eye irritation or changes in vision, contact your doctor.
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Wash your hands before and after applying the medication, unless the treated area is on your hand. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
When applying the medication to a hairy area, part the hair to ensure the medication reaches the affected skin.
Special Precautions
Avoid using tight-fitting diapers or plastic pants if the treated area is in the diaper region, as this may increase the amount of medication absorbed into the body.
Unless instructed to do so by your doctor, do not apply the medication to the face, groin, armpits, or other skin folds.
Storage and Disposal
Store the medication at room temperature, away from heat sources. Do not freeze.
Keep the medication out of reach of children and pets.
Missing a 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 extra doses.
To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions precisely. Continue using the medication as directed, even if your symptoms improve.
Application Instructions
Apply the medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your eyes, nose, or mouth, as it may cause burning. If you accidentally get the medication in your eyes, rinse them immediately with water. If you experience persistent eye irritation or changes in vision, contact your doctor.
Unless instructed to do so by your doctor, do not cover the treated area with bandages or dressings.
Wash your hands before and after applying the medication, unless the treated area is on your hand. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.
When applying the medication to a hairy area, part the hair to ensure the medication reaches the affected skin.
Special Precautions
Avoid using tight-fitting diapers or plastic pants if the treated area is in the diaper region, as this may increase the amount of medication absorbed into the body.
Unless instructed to do so by your doctor, do not apply the medication to the face, groin, armpits, or other skin folds.
Storage and Disposal
Store the medication at room temperature, away from heat sources. Do not freeze.
Keep the medication out of reach of children and pets.
Missing a 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 extra doses.
Lifestyle & Tips
- Apply a thin layer to the affected skin area as directed by your doctor. Do not use more than prescribed.
- Wash your hands before and after applying the cream.
- Do not cover the treated area with bandages or other dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Avoid applying the cream to your eyes, mouth, or inside your nose.
- Do not use this cream for longer than prescribed, especially on the face, groin, or armpits, as it can cause skin thinning or other side effects.
- Inform your doctor if your condition does not improve after 1-2 weeks of treatment or if it worsens.
Available Forms & Alternatives
Available Strengths:
- Fluocinolone 0.01% Cream 60gm
- Fluocinolone Acet 0.025% Oint 60gm
- Fluocinolone Acet 0.025% Oint 15gm
- Fluocinolone Acet 0.01% Crm 15gm
- Fluocinolone Acet 0.01% Crm 60gm
- Fluocinolone Acet 0.01% Soln 60ml
- Fluocinolone Acetonide Body Oil
- Fluocinolone Acet 0.01% Scalp Oil
- Fluocinolone 0.01% Oil Drops (ear)
- Fluocinolone Acet 0.025% Crm 15gm
- Fluocinolone Acet 0.025% Crm 60gm
- Fluocinolone Acet 0.025% Oint 15gm
- Fluocinolone Acet 0.025% Oint 60gm
- Fluocinolone Acet 0.01% Scalp Oil
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected area 2 to 4 times daily.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
eczema:
Apply a thin film to the affected area 2 to 4 times daily.
psoriasis:
Apply a thin film to the affected area 2 to 4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Apply a thin film to the affected area 2 to 4 times daily, for short durations and small areas. Avoid occlusive dressings.
Child:
Apply a thin film to the affected area 2 to 4 times daily, for short durations and small areas. Avoid occlusive dressings.
Adolescent:
Apply a thin film to the affected area 2 to 4 times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required due to minimal systemic absorption.
Dialysis:
No specific considerations; systemic absorption is minimal.
Hepatic Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Fluocinolone acetonide is a synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. It acts by inducing phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Varies; systemic absorption is generally low but can increase with prolonged use, large surface areas, inflamed skin, or occlusive dressings. Percutaneous absorption ranges from 1% to 8% depending on the site and condition of the skin.
Tmax:
Not precisely quantifiable for topical application due to local action and variable systemic absorption.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantifiable for topical application; minimal systemic distribution if absorbed.
ProteinBinding:
Not precisely quantifiable for topical application; if absorbed systemically, corticosteroids are bound to plasma proteins to varying degrees.
CnssPenetration:
Limited (if any) due to minimal systemic absorption.
Elimination:
HalfLife:
Not precisely quantifiable for topical application; if absorbed systemically, corticosteroids are excreted renally.
Clearance:
Not precisely quantifiable for topical application.
ExcretionRoute:
Renal (if absorbed systemically).
Unchanged:
Minimal (if absorbed systemically).
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Within days of consistent application.
DurationOfAction:
Varies; effects persist as long as applied, with residual effects for a short period after discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Irritation at the site of application
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:
Burning or stinging sensations
Dry skin
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Irritation at the site of application
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:
Burning or stinging sensations
Dry skin
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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 redness, swelling, or pus (signs of infection)
- Severe burning, itching, or irritation at the application site
- Thinning of the skin, easy bruising, or stretch marks (striae)
- Acne-like breakouts or increased hair growth in the treated area
- Any signs of systemic side effects like unusual weight gain, moon face, or muscle weakness (rare, but possible with extensive or prolonged use)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Do not use this medication to treat diaper rash. Before using any other medications or products on your skin, including soaps, consult with your doctor 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.
Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.
If you are a parent or caregiver of a child taking this medication, use it with caution, as children may be at a higher risk of experiencing certain side effects. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss this potential risk.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication during these situations to ensure the best possible outcome for you and your baby.
Do not use this medication to treat diaper rash. Before using any other medications or products on your skin, including soaps, consult with your doctor 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.
Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.
If you are a parent or caregiver of a child taking this medication, use it with caution, as children may be at a higher risk of experiencing certain side effects. In some cases, this medication may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss this potential risk.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of using this medication during these situations to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, central obesity, thinning skin, easy bruising, muscle weakness, hyperglycemia, and hypertension.
- Adrenal suppression may also occur.
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
Skin condition assessment (type, severity, location of dermatosis)
Rationale: To establish baseline for efficacy and safety monitoring.
Timing: Prior to initiation of therapy.
Area of body surface affected
Rationale: To assess potential for systemic absorption, especially in pediatric patients.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in inflammation, pruritus, erythema)
Frequency: Weekly or as clinically indicated.
Target: Improvement in symptoms.
Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks may indicate need for re-evaluation or alternative therapy.
Local adverse effects (skin atrophy, striae, telangiectasias, folliculitis, secondary infection)
Frequency: At each follow-up visit.
Target: Absence of adverse effects.
Action Threshold: Presence of significant adverse effects warrants discontinuation or reduction in frequency/potency.
Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, adrenal suppression)
Frequency: Periodically, especially with prolonged use, large surface areas, or occlusive dressings.
Target: Normal endocrine function.
Action Threshold: Any signs or symptoms require immediate medical evaluation and discontinuation of therapy.
Symptom Monitoring
- Burning
- Itching
- Irritation
- Dryness
- Folliculitis
- Hypertrichosis
- Acneiform eruptions
- Hypopigmentation
- Perioral dermatitis
- Allergic contact dermatitis
- Skin maceration
- Secondary infection
- Skin atrophy
- Striae
- Miliaria
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large areas, prolonged use, or occlusive dressings.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm, though systemic absorption is low.
Second Trimester:
Potential for fetal harm, though systemic absorption is low.
Third Trimester:
Potential for fetal harm, though systemic absorption is low. Risk of low birth weight has been associated with potent topical corticosteroid use.
Lactation
Considered compatible with breastfeeding when used appropriately. Apply to the smallest area of skin for the shortest duration. Avoid application to the breast or nipple area to prevent infant ingestion.
Infant Risk:
Low risk of adverse effects to the infant due to minimal systemic absorption by the mother.
Pediatric Use
Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension) than adult patients. Use the lowest effective dose for the shortest duration. Avoid occlusive dressings. Not recommended for infants under 2 years of age unless directed by a physician.
Geriatric Use
No specific dosage adjustments are typically required. However, geriatric patients may have thinner skin, which could potentially increase systemic absorption. Monitor for skin atrophy and other local adverse effects.
Clinical Information
Clinical Pearls
- Fluocinolone 0.01% cream is a low-to-medium potency topical corticosteroid.
- It is generally used for inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
- Avoid prolonged use, especially on the face, groin, or axillae, due to increased risk of skin atrophy, striae, and telangiectasias.
- Do not use on infected skin without concomitant antimicrobial therapy.
- Patients should be advised to use the smallest amount necessary to cover the affected area.
- Occlusive dressings should generally be avoided unless specifically prescribed by a physician, as they significantly increase systemic absorption and local side effects.
Alternative Therapies
- Other topical corticosteroids (e.g., hydrocortisone, triamcinolone, betamethasone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
- Topical vitamin D analogs (e.g., calcipotriene) for psoriasis
- Emollients and moisturizers for dry skin conditions
Cost & Coverage
Average Cost:
$20 - $50 per 60gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.