Fluticasone 0.05% Cream 15gm

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.
đŸˇī¸
Drug Class
Topical Corticosteroid
đŸ§Ŧ
Pharmacologic Class
Glucocorticoid Receptor Agonist
🤰
Pregnancy Category
Category C
✅
FDA Approved
Oct 1991
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Fluticasone cream is a medicine applied to the skin to reduce redness, swelling, and itching caused by skin conditions like eczema or psoriasis. It works by calming down the body's immune response in the skin.
📋

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 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.
Avoid applying the medication to your 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, away from freezing temperatures.
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 application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
💡

Lifestyle & Tips

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

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

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

Condition-Specific Dosing:

atopicDermatitis: Apply a thin film to affected skin areas once or twice daily for up to 4 weeks or until condition improves, whichever is sooner. Do not use for more than 4 weeks without re-evaluation.
psoriasis: Apply a thin film to affected skin areas once or twice daily for up to 4 weeks or until condition improves, whichever is sooner. Do not use for more than 4 weeks without re-evaluation.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established (use with extreme caution, increased risk of systemic effects)
Child: Apply a thin film to affected skin areas once daily. Limit treatment to 2 weeks. Do not use on face, groin, or axillae. Increased risk of systemic effects (HPA axis suppression) due to higher surface area to body weight ratio.
Adolescent: Apply a thin film to affected skin areas once or twice daily for up to 4 weeks or until condition improves, whichever is sooner. Do not use for more than 4 weeks without re-evaluation.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: Not typically required due to minimal systemic absorption
Moderate: Not typically required due to minimal systemic absorption
Severe: Not typically required due to minimal systemic absorption
Dialysis: Not typically required due to minimal systemic absorption

Hepatic Impairment:

Mild: Not typically required due to minimal systemic absorption
Moderate: Not typically required due to minimal systemic absorption
Severe: Not typically required due to minimal systemic absorption

Pharmacology

đŸ”Ŧ

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.
📊

Pharmacokinetics

Absorption:

Bioavailability: Less than 5% (intact skin, varies with skin integrity, site, occlusion)
Tmax: Not applicable (topical, minimal systemic absorption)
FoodEffect: Not applicable

Distribution:

Vd: Not available (minimal systemic distribution)
ProteinBinding: Approximately 91% (systemically absorbed portion)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 3.1 hours (systemically absorbed portion)
Clearance: Not available (primarily local action)
ExcretionRoute: Fecal (primarily as metabolites), minimal renal excretion
Unchanged: Less than 5% (systemically absorbed portion)
âąī¸

Pharmacodynamics

OnsetOfAction: Hours to days (for anti-inflammatory effect)
PeakEffect: Days to weeks
DurationOfAction: Varies, typically 12-24 hours per application

Safety & Warnings

âš ī¸

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 immediate medical attention:

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
Other potential side effects, including:
+ Skin changes (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 may cause side effects in some people. Many individuals experience no side effects or only minor ones. If you notice any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor or seek medical help:

* Burning or stinging

This is not an exhaustive list of potential 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:

  • Worsening of your skin condition or new skin problems (e.g., severe irritation, burning, itching)
  • Signs of skin infection (increased redness, swelling, pus, warmth)
  • Skin thinning, easy bruising, stretch marks (striae), or spider veins (telangiectasias) in the treated area
  • Acne-like breakouts or increased hair growth where the cream is applied
  • Unusual fatigue, weakness, nausea, vomiting, or dizziness (rare, but could indicate systemic absorption)
📋

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 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. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
âš ī¸

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.

To use this medication safely, avoid applying it 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 beforehand.

Adhere to your doctor's prescribed treatment duration, as using this medication for an extended period can exacerbate your skin condition. Additionally, be aware that excessive use may worsen your skin problem.

This medication may increase the risk of developing cataracts or glaucoma, so it is crucial to discuss this potential risk with your doctor.

When using this medication in children, exercise caution, as they may be more susceptible to certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. 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 both you and your baby. When breastfeeding, avoid applying this medication directly to the nipple or the surrounding area to prevent potential harm.
🆘

Overdose Information

Overdose Symptoms:

  • Prolonged or extensive use, especially under occlusion or in children, can lead to systemic effects of corticosteroids, including:
  • Cushing's syndrome (e.g., moon face, buffalo hump, central obesity)
  • Hyperglycemia (high blood sugar)
  • Glucosuria (sugar in urine)
  • Adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure)

What to Do:

If you suspect an overdose or experience systemic symptoms, contact your doctor or poison control center immediately. Call 1-800-222-1222 (Poison Control Center).

Drug Interactions

đŸšĢ

Contraindicated Interactions

  • Not available (no known contraindications for topical drug-drug interactions)
🔴

Major Interactions

  • Not available (systemic interactions are rare due to minimal absorption)
🟡

Moderate Interactions

  • CYP3A4 inhibitors (e.g., ritonavir, ketoconazole): May increase systemic exposure to fluticasone, leading to potential systemic corticosteroid effects, especially with extensive or prolonged use.
đŸŸĸ

Minor Interactions

  • Not available

Monitoring

đŸ”Ŧ

Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any signs of infection or contraindications.

Timing: Prior to initiation of therapy

📊

Routine Monitoring

Clinical response (reduction in inflammation, pruritus)

Frequency: Weekly or as clinically indicated

Target: Improvement in symptoms

Action Threshold: Lack of improvement or worsening of symptoms after 2-4 weeks; consider re-evaluation of diagnosis or treatment.

Local adverse reactions (e.g., atrophy, striae, telangiectasias, folliculitis)

Frequency: At each follow-up visit

Target: Absence of or minimal adverse effects

Action Threshold: Presence of significant local adverse effects; consider reducing frequency, potency, or discontinuing.

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

Frequency: Periodically, if risk factors present

Target: Normal HPA axis function

Action Threshold: Symptoms suggestive of HPA axis suppression; consider ACTH stimulation test or plasma cortisol levels.

đŸ‘ī¸

Symptom Monitoring

  • Worsening of skin condition
  • Signs of skin infection (redness, pus, warmth, pain)
  • Skin thinning, bruising, stretch marks (striae)
  • Acne-like eruptions
  • Increased hair growth (hypertrichosis)
  • Changes in skin pigmentation
  • Fatigue, weakness, nausea, vomiting, dizziness (rare, signs of systemic absorption/HPA axis suppression)

Special Patient Groups

🤰

Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Topical corticosteroids are generally considered Category C. Systemic absorption is minimal, but prolonged or extensive use should be avoided.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk due to minimal systemic absorption.
Second Trimester: Limited data, but generally considered low risk due to minimal systemic absorption.
Third Trimester: Limited data, but generally considered low risk due to minimal systemic absorption. Avoid large areas or prolonged use.
🤱

Lactation

Use with caution. It is not known whether topical fluticasone is excreted in human milk. Due to minimal systemic absorption, risk to the infant is likely low. Avoid applying to the breast area to prevent direct infant exposure.

Infant Risk: Low risk, but monitor for adverse effects if used extensively or for prolonged periods.
đŸ‘ļ

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. Use the lowest effective dose for the shortest duration possible. Avoid use on the face, groin, or axillae. Monitor for signs of HPA axis suppression and growth retardation.

👴

Geriatric Use

No specific dose adjustments are typically required. Elderly patients may have thinner skin, which could increase the risk of local adverse effects like skin atrophy or purpura. Monitor for skin integrity.

Clinical Information

💎

Clinical Pearls

  • Fluticasone propionate 0.05% cream is a medium-potency topical corticosteroid.
  • Always apply a thin layer; more cream does not mean better results and increases the risk of side effects.
  • Avoid using on the face, groin, or axillae unless specifically instructed by a healthcare professional, as these areas are more prone to corticosteroid-induced side effects.
  • Do not use for longer than the prescribed duration (typically 2-4 weeks) to minimize the risk of skin atrophy, striae, and HPA axis suppression.
  • If no improvement is seen after 2-4 weeks, re-evaluate the diagnosis and treatment plan.
  • Patients should be advised to moisturize regularly, even when using corticosteroids, to help maintain skin barrier function.
🔄

Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, betamethasone, clobetasol - varying potencies)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus - for atopic dermatitis)
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole - for atopic dermatitis)
  • Emollients and moisturizers (for dry skin conditions)
  • Systemic therapies (for severe or widespread conditions)
💰

Cost & Coverage

Average Cost: $15 - $40 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred 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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.