Fluticasone 0.05% Lotion 60ml
It is used to treat skin rashes and other skin irritation.
Drug Class
Corticosteroid, Topical
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
May 1993
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluticasone lotion is a topical corticosteroid medication used to reduce inflammation, redness, and itching caused by various skin conditions like eczema or psoriasis. It works by calming down the 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. Use this medication only as directed, and continue to use it 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 applying the medication, 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 make sure it is completely dry.
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.
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
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 continue with your regular schedule.
* Do not apply two doses at the same time or use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication only as directed, and continue to use it 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 applying the medication, 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 make sure it is completely dry.
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.
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
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 continue with your regular schedule.
* Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Apply a thin layer to the affected skin area(s) exactly as directed by your doctor, usually once daily.
- Wash your hands before and after applying the lotion.
- Do not apply to the face, groin, or armpits unless specifically directed by your doctor.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Do not cover the treated area with bandages or occlusive dressings unless instructed by your doctor, as this can increase absorption and side effects.
- Do not use for longer than prescribed, especially in children, as prolonged use can lead to skin thinning or systemic side effects.
- Inform your doctor if your condition does not improve after 2-4 weeks of treatment or if it worsens.
Available Forms & Alternatives
Available Strengths:
- Fluticasone 50mcg Nasal Sp (120) Rx
- Fluticasone 0.05% Cream 15gm
- Fluticasone 0.05% Cream 30gm
- Fluticasone 0.005% Ointment 30gm
- Fluticasone 0.05% Cream 60gm
- Fluticasone 0.005% Ointment 60gm
- Fluticasone 0.005% Ointment 15gm
- Fluticasone 0.05% Lotion 60ml
- Fluticasone 0.05% Lotion 60ml
- Fluticasone Allergy Nasal 50mcg Sp
- Fluticasone HFA 220mcg Oral Inh
- Fluticasone HFA 110mcg Oral Inh
- Fluticasone HFA 44mcg Inh 120inh
- Fluticasone 250mcg Diskus (60 Inh)
- Fluticasone 50mcg Diskus (60 Inh)
- Fluticasone 100mcg Diskus (60 Inh)
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the affected skin areas once daily.
Condition-Specific Dosing:
atopicDermatitis:
Apply a thin film to the affected skin areas once daily.
psoriasis:
Apply a thin film to the affected skin areas once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for infants under 3 months. For 3 months to 1 year: Apply a thin film to the affected skin areas once daily for up to 4 weeks.
Child:
For children 1 to 18 years: Apply a thin film to the affected skin areas once daily for up to 4 weeks.
Adolescent:
Apply a thin film to the affected skin areas once daily.
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
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. It binds to glucocorticoid receptors in the cytoplasm, translocates to the nucleus, and modulates gene expression.
Pharmacokinetics
Absorption:
Bioavailability:
Less than 5% (systemic absorption after topical application, varies with skin integrity, area, and occlusion)
Tmax:
Not well-defined for topical systemic absorption, but local effects are seen within days.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not applicable for topical formulation (minimal systemic distribution)
ProteinBinding:
Approximately 91% (systemically absorbed portion)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 3.1 hours (systemically absorbed portion)
Clearance:
High systemic clearance (approximately 1.1 L/min)
ExcretionRoute:
Primarily via feces (as metabolites), with a small amount excreted in urine.
Unchanged:
Less than 5% (systemically absorbed portion)
Pharmacodynamics
OnsetOfAction:
Within days for anti-inflammatory effects.
PeakEffect:
Typically within 1-2 weeks of consistent application.
DurationOfAction:
Effects persist as long as applied; local effects can last for hours after application.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help 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 attention 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 fainting
+ 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 serious side effects, including:
+ Skin changes (pimples, stretch marks, slow healing, hair growth)
+ Skin irritation
+ Thinning of the skin
+ Changes in eyesight
Other Side Effects
Most people do not experience serious side effects, and many have no side effects or only minor ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
* 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.
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 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 fainting
+ 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 serious side effects, including:
+ Skin changes (pimples, stretch marks, slow healing, hair growth)
+ Skin irritation
+ Thinning of the skin
+ Changes in eyesight
Other Side Effects
Most people do not experience serious side effects, and many have no side effects or only minor ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention:
* 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.
Seek Immediate Medical Attention If You Experience:
- Severe burning, itching, or irritation at the application site
- Signs of skin infection (increased redness, swelling, pus, warmth)
- Skin thinning, easy bruising, or stretch marks (striae)
- Acne or increased hair growth at the application site
- Unusual weight gain, swelling in ankles/feet, increased thirst/urination (signs of systemic absorption)
- Blurred vision or other vision problems
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 is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, 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 with all your current 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 is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, 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 with all your current 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. Before using any other medications or skin products, such as soaps, consult with your doctor to ensure safe use.
To minimize potential risks, 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 the application 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, be aware that excessive use may worsen your skin problem.
This medication may increase the risk of developing cataracts or glaucoma; therefore, it is crucial to discuss this potential risk with your doctor.
When administering this medication to children, use it with 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 of using this medication. When breastfeeding, avoid applying this medication directly to the nipple or the surrounding area to prevent potential harm to your baby.
To minimize potential risks, 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 the application 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, be aware that excessive use may worsen your skin problem.
This medication may increase the risk of developing cataracts or glaucoma; therefore, it is crucial to discuss this potential risk with your doctor.
When administering this medication to children, use it with 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 of using this medication. When breastfeeding, avoid applying this medication directly to the nipple or the surrounding area to prevent potential harm to your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use 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 (adrenal insufficiency).
What to Do:
Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call a poison control center immediately (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Moderate Interactions
- CYP3A4 inhibitors (e.g., ritonavir, ketoconazole): Potential for increased systemic exposure to fluticasone, leading to increased risk of systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression). Use with caution, especially with extensive or prolonged use.
Monitoring
Baseline Monitoring
Skin condition and extent of affected area
Rationale: To establish baseline severity and guide treatment.
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 symptoms after 2-4 weeks may require re-evaluation of diagnosis or treatment.
Local adverse reactions (e.g., skin atrophy, striae, telangiectasias, folliculitis)
Frequency: At each follow-up visit
Target: Absence of or minimal adverse effects
Action Threshold: Presence of significant skin changes may require discontinuation or change in therapy.
Signs of systemic absorption (e.g., Cushing's syndrome, HPA axis suppression)
Frequency: Periodically, especially with extensive or prolonged use, or in pediatric patients.
Target: Absence of systemic effects
Action Threshold: Symptoms like weight gain, moon face, fatigue, or laboratory evidence of HPA axis suppression (e.g., low morning cortisol) require immediate evaluation and potential discontinuation.
Symptom Monitoring
- Worsening of skin condition
- Signs of skin infection (redness, pus, warmth, pain)
- Skin thinning or atrophy
- Stretch marks (striae)
- Easy bruising
- Increased hair growth at application site
- Acne-like eruptions
- Burning, itching, irritation at application site
- Signs of systemic absorption: unusual weight gain, swelling in ankles/feet, increased thirst/urination, muscle weakness, fatigue, mood changes.
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but high doses or prolonged use over large surface areas should be avoided.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with high systemic exposure, though unlikely with topical use.
Second Trimester:
Generally considered safer than first trimester, but still use with caution.
Third Trimester:
No specific risks identified beyond general corticosteroid effects; monitor for HPA axis suppression in neonate if extensive maternal use.
Lactation
Use with caution. It is not known whether topical fluticasone is excreted in human milk. Systemic absorption is minimal, so infant exposure is likely low. 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.
Pediatric Use
Pediatric patients may be more susceptible to systemic toxicity from topical corticosteroids, including HPA axis suppression and Cushing's syndrome, due to a larger skin surface area to body weight ratio. Prolonged use should be avoided. Monitor growth and development. Not recommended for infants under 3 months.
Geriatric Use
No specific dosage adjustments are necessary. However, elderly patients may have thinner skin and be more prone to local adverse effects such as skin atrophy and purpura. Use with caution and monitor skin integrity.
Clinical Information
Clinical Pearls
- Fluticasone propionate lotion is a medium-potency topical corticosteroid.
- It is crucial to apply a thin layer and rub it in gently; excessive application does not improve efficacy and increases the risk of side effects.
- Avoid prolonged use, especially on the face, intertriginous areas, or in children, due to increased risk of skin atrophy, telangiectasias, and HPA axis suppression.
- If an infection develops at the site of application, appropriate antifungal or antibacterial therapy should be instituted. If a favorable response does not occur promptly, fluticasone should be discontinued until the infection has been adequately controlled.
- Patients should be advised to use the medication for the shortest duration necessary to achieve control of symptoms.
Alternative Therapies
- Other topical corticosteroids (e.g., triamcinolone, betamethasone, clobetasol, hydrocortisone)
- Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for atopic dermatitis
- Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for atopic dermatitis
- Topical vitamin D analogs (e.g., calcipotriene) for psoriasis
- Topical retinoids (e.g., tazarotene) for psoriasis
- Emollients and moisturizers for dry skin conditions
Cost & Coverage
Average Cost:
$50 - $150 per 60ml lotion
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for 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 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, including the amount taken and the time it happened, to ensure you receive the best possible care.