Fluticasone 0.005% Ointment 15gm
It is used to treat skin rashes and other skin irritation.
Drug Class
Topical Corticosteroid
Pharmacologic Class
Glucocorticoid Receptor Agonist
Pregnancy Category
Category C
FDA Approved
Oct 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluticasone ointment is a steroid medicine that you put on your skin. It helps reduce redness, itching, and swelling caused by skin conditions like eczema or psoriasis. It works by calming down your 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 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 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.
Do not use this medication to treat diaper rash.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep the lid tightly closed when not in use.
Store 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 resume 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. 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 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.
Do not use this medication to treat diaper rash.
Storage and Disposal
Store this medication at room temperature, avoiding freezing.
Keep the lid tightly closed when not in use.
Store 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 resume your regular schedule.
* Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Wash your hands before and after applying the ointment.
- Apply a thin layer of the ointment only to the affected skin areas, as directed by your doctor.
- Do not use more than the prescribed amount or apply more often than directed.
- Avoid getting the ointment in your eyes, nose, or mouth. If it gets into these areas, rinse thoroughly with water.
- Do not cover the treated area with bandages, plastic wrap, or other occlusive dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
- Do not use on the face, groin, or armpits unless specifically directed by your doctor, as these areas are more sensitive to side effects.
- Do not use for longer than prescribed, especially in children.
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 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.
Pediatric Dosing
Neonatal:
Not established (generally not recommended for infants under 3 months).
Infant:
Apply a thin film to the affected skin areas once daily for short durations, with caution due to increased risk of systemic absorption. Not recommended for infants under 3 months.
Child:
Apply a thin film to the affected skin areas once daily for short durations, with caution due to increased risk of systemic absorption.
Adolescent:
Apply a thin film to the affected skin areas once or twice daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical use due to minimal systemic absorption.
Moderate:
No specific adjustment needed for topical use due to minimal systemic absorption.
Severe:
No specific adjustment needed for topical use due to minimal systemic absorption.
Dialysis:
No specific considerations for topical use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical use due to minimal systemic absorption.
Moderate:
No specific adjustment needed for topical use due to minimal systemic absorption.
Severe:
No specific adjustment needed for topical use 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.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<5% typically, but varies with skin integrity, vehicle, site, and occlusion).
Tmax:
Not precisely quantifiable for topical systemic absorption; local effects are rapid.
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not precisely quantifiable for topical systemic absorption; if absorbed, distributed throughout the body.
ProteinBinding:
Approximately 91% (for systemically absorbed drug).
CnssPenetration:
Limited (for systemically absorbed drug).
Elimination:
HalfLife:
Approximately 7.8 hours (for systemically absorbed drug).
Clearance:
High systemic clearance (for systemically absorbed drug).
ExcretionRoute:
Primarily via feces (as metabolites), with minor renal excretion.
Unchanged:
<5% (for systemically absorbed drug).
Pharmacodynamics
OnsetOfAction:
Hours to days for anti-inflammatory and antipruritic effects.
PeakEffect:
Days to weeks of consistent application.
DurationOfAction:
Maintained with continued application; effects diminish upon discontinuation.
Confidence:
Medium
Safety & Warnings
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 serious 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 can cause side effects. Although many people experience no side effects or only 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:
* Burning or stinging
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
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 serious 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 can cause side effects. Although many people experience no side effects or only 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:
* Burning or stinging
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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:
- Worsening of your skin condition or development of new skin problems (e.g., infection, severe irritation, thinning skin, stretch marks, acne-like rash).
- Signs of infection (increased redness, swelling, pain, pus).
- Signs of systemic absorption, especially with prolonged or extensive use: unusual weight gain, swelling in the face (moon face), increased thirst or urination, fatigue, muscle weakness, or changes in mood.
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.
If the patient is a child, as this medication is not intended for pediatric use.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all your medications, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any existing health problems, as they may affect the safety of taking this medication.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions or complications.
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.
If the patient is a child, as this medication is not intended for pediatric use.
Potential interactions with other medications or health conditions. To ensure safe use, disclose all your medications, including:
+ Prescription and over-the-counter (OTC) drugs
+ Natural products
+ Vitamins
Any existing health problems, as they may affect the safety of taking this medication.
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions or complications.
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 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 beyond the recommended timeframe 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; therefore, it is crucial to discuss this potential risk with your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor to weigh the benefits and risks of using this medication for both you and your baby.
When breastfeeding, take precautions to avoid applying this medication directly to the nipple or the surrounding area to prevent any 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 beyond the recommended timeframe 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; therefore, it is crucial to discuss this potential risk with your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor to weigh the benefits and risks of using this medication for both you and your baby.
When breastfeeding, take precautions to avoid applying this medication directly to the nipple or the surrounding area to prevent any potential harm to 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, striae, muscle weakness, fatigue, hyperglycemia, and suppression of the hypothalamic-pituitary-adrenal (HPA) axis.
What to Do:
If you suspect an overdose or significant systemic absorption, contact your doctor or poison control center immediately (e.g., call 1-800-222-1222). Management typically involves gradual withdrawal of the corticosteroid and supportive care.
Drug Interactions
Monitoring
Baseline Monitoring
Skin condition assessment
Rationale: To establish baseline severity of dermatosis and identify any pre-existing skin infections or integrity issues.
Timing: Prior to initiation of therapy.
Routine Monitoring
Therapeutic efficacy (reduction in inflammation, pruritus)
Frequency: Regularly during treatment, typically weekly to bi-weekly initially.
Target: Improvement in symptoms and skin appearance.
Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation of diagnosis or treatment.
Local adverse effects (e.g., skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis)
Frequency: Regularly during treatment, especially with prolonged use.
Target: Absence of new or worsening local side effects.
Action Threshold: Development of significant local side effects may require discontinuation or change in therapy.
Signs of systemic absorption (e.g., HPA axis suppression, Cushing's syndrome, hyperglycemia)
Frequency: Periodically, especially with prolonged use, large surface area application, occlusion, or in pediatric patients.
Target: Normal adrenal function, blood glucose levels.
Action Threshold: Symptoms or signs of systemic absorption (e.g., unexplained weight gain, moon face, fatigue, increased thirst/urination) warrant immediate medical evaluation and potential discontinuation.
Symptom Monitoring
- Worsening of skin condition
- Signs of skin infection (redness, pus, warmth, pain)
- Skin thinning, easy bruising, stretch marks
- Unusual hair growth
- Increased thirst or urination
- Fatigue, weakness
- Weight gain, especially in the face or trunk
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 with topical use, but high doses or prolonged use over large areas 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. Neonates born to mothers who received substantial doses of corticosteroids during pregnancy should be observed for signs of hypoadrenalism.
Lactation
Considered compatible with breastfeeding. Minimal systemic absorption of topical fluticasone makes it unlikely to cause adverse effects in a breastfed infant. Apply to the smallest area of skin possible and avoid application to the breast or nipple area to prevent direct infant exposure.
Infant Risk:
Low risk.
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, growth retardation) than adult patients. Use the lowest effective dose for the shortest duration possible. Not recommended for infants under 3 months.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Fluticasone propionate 0.005% ointment is a medium-potency topical corticosteroid.
- Ointments are generally more potent than creams or lotions of the same concentration due to increased penetration and occlusion.
- Instruct patients to apply a very thin layer; a 'pea-sized' amount is often sufficient for an area the size of an adult hand.
- Avoid abrupt discontinuation after prolonged use on sensitive areas (e.g., face) to prevent rebound flares.
- Educate patients on the signs of skin atrophy (thinning, bruising, shiny appearance) and systemic absorption.
- This ointment is for external use only. Do not ingest.
Alternative Therapies
- Topical calcineurin inhibitors (e.g., Tacrolimus ointment, Pimecrolimus cream) for atopic dermatitis.
- Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., Crisaborole ointment) for atopic dermatitis.
- Systemic therapies (e.g., biologics like dupilumab, oral corticosteroids) for severe or widespread dermatoses.
- Emollients and moisturizers for barrier repair.
- Phototherapy.
Cost & Coverage
Average Cost:
$20 - $60 per 15gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic usually preferred)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. 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.