Fluticasone 0.05% Cream 30gm

Manufacturer PERRIGO 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
Corticosteroid, Topical
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Pharmacologic Class
Glucocorticoid Receptor Agonist
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Pregnancy Category
Category C
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FDA Approved
Oct 1990
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Fluticasone cream is a strong steroid medicine applied to the skin to reduce redness, itching, and swelling caused by skin conditions like eczema or psoriasis. It works by calming down the immune response in the skin.
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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, avoiding the mouth, nose, and eyes, as it may cause burning.
Wash your hands before and after application, unless your hand is the treated area, in which case you should not wash it after use.
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.
Avoid applying the medication to the face, underarms, or groin area unless your doctor instructs you to do so.
Do not use bandages or dressings to cover the treated area unless your doctor advises you to do so.
This medication is not intended to treat diaper rash.

Storage and Disposal

Store the medication at room temperature, avoiding freezing.
Keep the lid tightly closed when not in use.
Store all medications in a safe location, 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.
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Lifestyle & Tips

  • Wash hands before and after applying the cream.
  • Apply a thin layer only to the affected skin areas as directed by your doctor.
  • Do not use more cream than prescribed or apply it more often.
  • Do not cover the treated area with bandages or tight dressings unless specifically told to by your doctor, as this can increase absorption.
  • Avoid applying to the face, groin, or armpits unless specifically instructed by your doctor.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not use for longer than prescribed, especially in children, to avoid side effects.
  • Keep out of reach of children.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected skin areas once or twice daily.
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

Atopic Dermatitis: Apply a thin film to affected areas once daily.
Psoriasis: Apply a thin film to affected areas once or twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (use with caution, risk of systemic effects)
Child: Apply a thin film to affected skin areas once daily. Limit treatment to the least amount necessary for therapeutic effect. Avoid use on large surface areas or under 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 specific adjustment needed due to minimal systemic absorption.
Moderate: No specific adjustment needed due to minimal systemic absorption.
Severe: No specific adjustment needed due to minimal systemic absorption.
Dialysis: No specific adjustment needed due to minimal systemic absorption.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent 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.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (typically <5%) through intact skin; increased with inflammation, skin barrier disruption, occlusive dressings, or large surface areas.
Tmax: Not readily quantifiable for topical application due to minimal systemic absorption.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not readily quantifiable for topical application.
ProteinBinding: Approximately 91% (systemically absorbed portion).
CnssPenetration: Limited (minimal systemic absorption).

Elimination:

HalfLife: Approximately 7.8 hours (systemically absorbed portion).
Clearance: High systemic clearance.
ExcretionRoute: Primarily via feces (as metabolites), with a small amount excreted in urine.
Unchanged: <5% (systemically absorbed portion)
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief.
PeakEffect: Days to weeks of consistent application.
DurationOfAction: Up to 24 hours with once-daily application.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 help right away:

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
Signs of skin infection, such as:
+ Oozing
+ Heat
+ Swelling
+ Redness
+ Pain
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Skin irritation
Thinning of the skin
Change in eyesight

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only have 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

This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, contact 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:

  • Worsening of your skin condition or no improvement after 2 weeks.
  • Signs of a skin infection (e.g., increased redness, swelling, pus, fever).
  • Skin thinning, easy bruising, stretch marks (striae), or changes in skin color where the cream is applied.
  • Acne-like rash or increased hair growth on treated areas.
  • Blurred vision or other eye problems (if applied near eyes).
  • Unusual tiredness, weakness, nausea, dizziness, or weight gain (signs of too much steroid absorption).
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Before Using This Medicine

Before taking this medication, it is essential to inform your doctor about the following:

Any allergies you have, including allergies to this drug, any of its components, or other substances, such as foods or other medications. 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) medications, natural products, and vitamins. This is crucial because this drug may interact with other medications or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.

To ensure your safety, it is vital to verify that it is safe to take this medication in conjunction with all your other 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 this medication 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. If the patient is a child, use this medication with caution, as the risk of certain side effects may be higher in children. 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 further.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss 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:

  • Prolonged or excessive use can lead to systemic corticosteroid effects such as Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia, glucosuria, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis (adrenal insufficiency upon withdrawal).
  • Local symptoms include severe skin atrophy, striae, telangiectasias.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

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Major 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). Use with caution and monitor for adverse effects.

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify areas for application.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Skin condition assessment (e.g., erythema, scaling, pruritus)

Frequency: Weekly or as clinically indicated.

Target: Improvement in symptoms and signs of dermatosis.

Action Threshold: Lack of improvement, worsening condition, or signs of local adverse reactions (e.g., atrophy, infection).

Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, hypotension)

Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings.

Target: Absence of symptoms.

Action Threshold: Presence of symptoms, consider ACTH stimulation test if suspected.

Intraocular pressure (IOP) and cataracts (especially in children or with prolonged facial use)

Frequency: Periodically, if clinically indicated.

Target: Normal IOP, absence of cataracts.

Action Threshold: Elevated IOP or visual changes.

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Symptom Monitoring

  • Worsening of skin condition
  • Signs of skin infection (redness, pus, warmth)
  • Skin thinning, bruising, striae (stretch marks)
  • Acne-like eruptions
  • Increased hair growth at application site
  • Perioral dermatitis (rash around the mouth)
  • Fatigue, weakness, nausea, dizziness (signs of systemic absorption/HPA axis suppression)
  • Blurred vision or eye pain (if applied near eyes)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected, but large amounts or prolonged use should be avoided.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk due to minimal systemic absorption. Animal studies show teratogenicity at high systemic doses.
Second Trimester: Similar to first trimester, minimal systemic absorption is key.
Third Trimester: Similar to first trimester, minimal systemic absorption is key. Risk of HPA axis suppression in the neonate is theoretical but low with appropriate topical use.
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Lactation

Considered compatible with breastfeeding when used appropriately. Minimal systemic absorption in the mother suggests negligible amounts in breast milk. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk due to minimal systemic absorption and excretion into breast milk.
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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. HPA axis suppression, Cushing's syndrome, and intracranial hypertension have been reported. Use the least potent effective dose for the shortest duration. Avoid occlusive dressings and large surface areas. Monitor growth and development.

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Geriatric Use

No specific dosage adjustments are required. Use with caution in patients with thin or fragile skin, as they may be more prone to local adverse effects like skin atrophy and purpura.

Clinical Information

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Clinical Pearls

  • Fluticasone propionate 0.05% cream is a medium-potency topical corticosteroid.
  • It is effective for inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
  • Educate patients on proper application technique: thin layer, rub in gently, wash hands.
  • Emphasize that 'more is not better' with topical steroids to minimize local and systemic side effects.
  • Avoid abrupt discontinuation after prolonged use on sensitive areas (e.g., face) to prevent rebound dermatitis.
  • 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 atopic dermatitis, especially on sensitive areas.
  • Emollients and moisturizers for barrier repair.
  • Systemic therapies (e.g., oral corticosteroids, biologics) for severe, widespread conditions.
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Cost & Coverage

Average Cost: $20 - $60 per 30gm tube of 0.05% cream
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (Generic)
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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 your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.