Fluticasone 0.05% Cream 60gm

Manufacturer PERRIGO PHARMACEUTICALS Active Ingredient Fluticasone Cream and Lotion(floo TIK a sone) Pronunciation floo TIK a sone
It is used to treat skin rashes and other skin irritation.
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Drug Class
Topical Corticosteroid
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Pharmacologic Class
Glucocorticoid Receptor Agonist
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Pregnancy Category
Category C
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FDA Approved
Oct 1991
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Fluticasone cream is a type of medicine called a corticosteroid. It works by reducing inflammation, redness, and itching caused by various skin conditions like eczema and psoriasis. It should be applied thinly to the affected skin areas.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to use this 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.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication, unless your hand is the treated area.
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.

Important Usage Precautions

Do not apply this medication to your face, underarms, or groin area unless your doctor instructs you to do so.
Avoid using bandages or dressings to cover the treated area unless your doctor advises you to do so.
Do not use this medication to treat diaper rash.

Storage and Disposal

Store this medication at room temperature, away from freezing temperatures.
Keep the lid tightly closed when not in use.
Keep all medications in a safe place, out of the reach of children and pets.

Missed Dose Instructions

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 application schedule.
Do not apply two doses at the same time or use extra doses.
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Lifestyle & Tips

  • Wash hands before and after applying the cream.
  • Apply a thin layer of cream to the affected area(s) as directed by your doctor. Do not use more than prescribed.
  • Gently rub the cream into the skin until it disappears.
  • Do not cover the treated area with bandages or other occlusive dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid contact with eyes, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use on the face, groin, or armpits unless directed by your doctor.
  • Do not use for longer than prescribed, especially in children, as prolonged use can lead to skin thinning or systemic side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected skin areas once or twice daily.

Condition-Specific Dosing:

eczema: Apply a thin film to the affected skin areas once or twice daily.
psoriasis: Apply a thin film to the affected skin areas once or twice daily.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, increased risk of systemic effects)
Infant: Apply a thin film to the affected skin areas once daily. Limit treatment to the least amount necessary for therapeutic effect. Avoid prolonged use or use on large surface areas. Avoid occlusive dressings.
Child: Apply a thin film to the affected skin areas once daily. Limit treatment to the least amount necessary for therapeutic effect. Avoid prolonged use or use on large surface areas. Avoid occlusive dressings.
Adolescent: Apply a thin film to the affected skin areas once or twice daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed due to minimal systemic absorption.
Moderate: No adjustment needed due to minimal systemic absorption.
Severe: No adjustment needed due to minimal systemic absorption.
Dialysis: No specific considerations due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed due to minimal systemic absorption.
Moderate: No adjustment needed due to minimal systemic absorption.
Severe: No adjustment needed due to minimal systemic absorption.

Pharmacology

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Mechanism of Action

Fluticasone propionate is a synthetic trifluorinated corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. 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. Corticosteroids bind to glucocorticoid receptors in the cytoplasm, translocate to the nucleus, and modulate gene expression, leading to reduced inflammation and immune suppression.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (<5% in healthy skin; increased with damaged skin, occlusion, or large surface areas)
Tmax: Not well-defined for topical application due to minimal systemic absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not well-defined for topical application due to minimal systemic absorption.
ProteinBinding: Approximately 91% (systemic)
CnssPenetration: Limited (systemic absorption is minimal)

Elimination:

HalfLife: Approximately 7.8 hours (systemic, after IV administration)
Clearance: High systemic clearance (systemic, after IV administration)
ExcretionRoute: Primarily via bile (as metabolites), with some renal excretion.
Unchanged: <5% (systemic)
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief.
PeakEffect: Days to weeks for maximal therapeutic effect.
DurationOfAction: Varies, typically once or twice daily application is sufficient.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, unusual 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
Signs of skin infection: oozing, heat, swelling, redness, or pain
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Skin irritation
Thinning of the skin
Changes in vision

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Burning or stinging sensations

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.
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Seek Immediate Medical Attention If You Experience:

  • Increased redness, burning, itching, or irritation at the application site
  • Development of new skin problems like acne, folliculitis (hair follicle inflammation), or stretch marks (striae)
  • Signs of skin thinning (e.g., easy bruising, shiny skin)
  • Any signs of infection (pus, fever, increased pain, spreading redness)
  • Unusual fatigue, weakness, nausea, vomiting, or dizziness (rare, but can indicate systemic absorption and adrenal suppression)
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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.
* 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 current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. 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.

Adhere to your doctor's prescribed treatment duration, as using this medication for an extended period can exacerbate your skin condition. Additionally, using it too frequently may worsen your skin problem.

This medication may increase the risk of developing cataracts or glaucoma, so it is crucial to discuss this with your doctor. When used in children, this medication requires careful consideration, as the risk of certain side effects may be higher. In some cases, it may affect growth in children and teenagers, necessitating regular growth checks. Consult with your doctor to discuss the potential risks and benefits.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to weigh the benefits and risks to you and your baby. When breastfeeding, avoid applying this medication directly to the nipple or the surrounding area.
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Overdose Information

Overdose Symptoms:

  • Acute overdose with topical fluticasone is unlikely due to minimal systemic absorption.
  • Chronic excessive use or use on large surface areas, especially in children, can lead to systemic effects such as Cushing's syndrome (e.g., moon face, central obesity, thin skin, easy bruising), hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. In case of suspected HPA axis suppression, an endocrinologist consultation may be necessary. Call 1-800-222-1222 for Poison Control.

Drug Interactions

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Moderate Interactions

  • Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole): May increase systemic exposure to fluticasone, leading to potential systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression), especially with extensive or prolonged use.

Monitoring

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Baseline Monitoring

Skin condition (type, severity, extent of dermatosis)

Rationale: To establish baseline for efficacy assessment and identify contraindications (e.g., active infection).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

Frequency: Regularly during treatment (e.g., weekly to bi-weekly initially, then as needed).

Target: Significant improvement in symptoms.

Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation or alternative therapy.

Local skin reactions (e.g., atrophy, striae, telangiectasias, folliculitis, burning, itching, irritation)

Frequency: At each follow-up visit.

Target: Absence or minimal local side effects.

Action Threshold: Presence of significant or worsening local reactions may require dose reduction, discontinuation, or change in therapy.

Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension) - especially with prolonged/extensive use or in children

Frequency: Periodically, if risk factors are present.

Target: Normal adrenal function.

Action Threshold: Symptoms suggestive of HPA axis suppression warrant immediate evaluation (e.g., ACTH stimulation test).

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Symptom Monitoring

  • Worsening skin redness or irritation
  • Skin thinning or bruising easily
  • Development of stretch marks (striae)
  • Increased hair growth at application site
  • Acne-like eruptions
  • Signs of skin infection (pus, fever, increased pain)
  • Unusual fatigue or weakness
  • Weight gain, moon face, or other signs of Cushing's syndrome (rare with topical use)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but animal studies have shown teratogenic effects with high doses of corticosteroids.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though risk is low with topical use due to minimal absorption.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: No specific risks identified beyond general corticosteroid effects; however, monitor for signs of HPA axis suppression in the neonate if used extensively near term.
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Lactation

L3 (Moderately safe). It is not known whether topical fluticasone is excreted in human milk. However, systemic absorption is minimal, making significant exposure to the infant unlikely. Use with caution, avoid applying to the breast area to prevent direct infant ingestion.

Infant Risk: Low risk of adverse effects to the infant due to minimal systemic absorption by the mother.
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Pediatric Use

Children are more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio and immature skin barrier function. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported. Limit treatment to the least amount necessary for therapeutic effect and avoid prolonged use or occlusive dressings.

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Geriatric Use

No specific dosage adjustments are required. However, elderly patients may have thinner skin and be more prone to local side effects such as skin atrophy and purpura. Monitor skin integrity closely.

Clinical Information

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Clinical Pearls

  • Fluticasone cream is a medium-potency topical corticosteroid.
  • Always apply a thin layer; 'less is more' with topical steroids.
  • Avoid abrupt discontinuation after prolonged use on sensitive areas (e.g., face) to prevent rebound flares.
  • Educate patients on proper application technique and the importance of not exceeding prescribed duration or amount.
  • Consider the vehicle (cream vs. ointment) based on skin type and condition (cream for weeping lesions, ointment for dry/scaly lesions).
  • Be vigilant for signs of skin infection, as corticosteroids can mask or worsen them.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, mometasone, clobetasol - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus - for eczema, non-steroidal)
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole - for eczema, non-steroidal)
  • Topical vitamin D analogs (e.g., calcipotriene - for psoriasis)
  • Emollients and moisturizers (for barrier repair and hydration)
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Cost & Coverage

Average Cost: $20 - $80 per 60gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.