Fluticasone 0.005% Ointment 30gm

Manufacturer G & W LABS Active Ingredient Fluticasone Ointment(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
Not available (old Category C)
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FDA Approved
Mar 1997
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Fluticasone ointment 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.
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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's 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.
Gently rub a thin layer of the medication onto the affected skin.
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, 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's 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.
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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 applying the ointment to your face, groin, or armpits unless specifically instructed by your doctor.
  • Do not cover the treated area with bandages or tight dressings unless your doctor tells you to, as this can increase absorption.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not use for longer than prescribed, especially in children, to avoid potential side effects.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

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

Neonatal: Not established (use with extreme caution, if at all, due to increased systemic absorption risk)
Infant: Not established (use with extreme caution, if at all, due to increased systemic absorption risk)
Child: Apply a thin film to the affected skin areas once daily for short periods (e.g., up to 4 weeks). Use with caution due to higher risk of systemic effects (e.g., HPA axis suppression) compared to adults.
Adolescent: Apply a thin film to the affected skin areas once daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No specific considerations (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)

Pharmacology

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Mechanism of Action

Fluticasone propionate is a synthetic trifluorinated corticosteroid that possesses 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: <5% (systemic absorption after topical application; varies with skin integrity, area, duration, and occlusion)
Tmax: Not well-defined for topical application due to minimal systemic absorption
FoodEffect: Not applicable (topical administration)

Distribution:

Vd: Not well-defined for topical application due to minimal systemic absorption
ProteinBinding: >90% (for systemically absorbed drug)
CnssPenetration: Limited (for systemically absorbed drug)

Elimination:

HalfLife: Not well-defined for topical application due to minimal systemic absorption (systemic half-life of absorbed drug is approximately 7.8 hours)
Clearance: Not well-defined for topical application due to minimal systemic absorption
ExcretionRoute: Fecal (primarily as metabolites), Renal (minor route for metabolites)
Unchanged: <5% (systemically absorbed drug)
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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 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
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. 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 help:

Burning or stinging

This is not an exhaustive list of 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 a few weeks.
  • Signs of a new skin infection (e.g., increased redness, swelling, pus, warmth, pain).
  • Severe burning, itching, or irritation where the ointment is applied.
  • Changes in your skin, such as thinning, easy bruising, or stretch marks.
  • Unusual tiredness, weakness, or dizziness (rare, but can indicate systemic absorption).
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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.
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 prescription and over-the-counter medications, natural products, and vitamins you are taking to your doctor and pharmacist.
All your health problems, as they may affect the safety of taking this medication.

Remember to consult with your doctor before starting, stopping, or changing the dose of any medication, including this one, to guarantee safe and effective treatment.
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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.

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 may exacerbate your skin condition. Additionally, using this medication too frequently can 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.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use, especially over large areas, under occlusion, or in children, can lead to systemic side effects.
  • Symptoms of systemic absorption may include: Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), hyperglycemia (high blood sugar), glucosuria (sugar in urine), and suppression of the hypothalamic-pituitary-adrenal (HPA) axis (e.g., fatigue, weakness, nausea, vomiting, low blood pressure).

What to Do:

If you suspect an overdose or experience systemic symptoms, stop using the ointment and contact your doctor immediately or call a poison control center (1-800-222-1222). Treatment is supportive and may involve gradual withdrawal of the corticosteroid.

Drug Interactions

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Moderate Interactions

  • Ritonavir (and other strong CYP3A4 inhibitors)

Monitoring

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Baseline Monitoring

Skin condition and extent of affected area

Rationale: To assess severity of dermatosis and guide treatment duration.

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)

Target: Improvement in symptoms

Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation of diagnosis or treatment.

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

Frequency: Regularly during treatment

Target: Absence or minimal reactions

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

Signs of HPA axis suppression (e.g., fatigue, weight loss, hypotension) - especially with prolonged, extensive, or occlusive use, or in pediatric patients

Frequency: Periodically, if risk factors are present

Target: Normal HPA axis function

Action Threshold: Symptoms or signs of HPA axis suppression warrant immediate evaluation (e.g., ACTH stimulation test) and potential discontinuation/tapering.

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Symptom Monitoring

  • Worsening of skin condition
  • Signs of skin infection (redness, pus, warmth, pain)
  • Severe burning, itching, or irritation at application site
  • Skin thinning, easy bruising, stretch marks (striae)
  • Unusual fatigue or weakness
  • Weight loss
  • Swelling in ankles or feet (rare, systemic effect)

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 with topical use, 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.
Second Trimester: Limited data, generally considered low risk due to minimal systemic absorption.
Third Trimester: Limited data, generally considered low risk due to minimal systemic absorption.
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Lactation

Considered low risk. Minimal systemic absorption of fluticasone propionate is expected, making infant exposure via breast milk unlikely to be clinically significant. Apply to skin areas away from the breast to avoid direct infant ingestion.

Infant Risk: Low
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Pediatric Use

Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects, including HPA axis suppression and Cushing's syndrome. Use the least potent effective corticosteroid for the shortest duration possible. Avoid use in infants and young children unless specifically directed by a physician. Monitor for growth retardation if prolonged use.

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Geriatric Use

No specific dose adjustments are required. However, 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

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Clinical Pearls

  • Fluticasone propionate 0.005% ointment is a medium-potency topical corticosteroid.
  • Ointments are generally more potent than creams for the same concentration and are preferred for dry, scaly lesions.
  • Educate patients on the 'thin film' application technique to avoid overuse and minimize systemic absorption.
  • Warn patients about the potential for skin atrophy, striae, and telangiectasias with prolonged use, especially in intertriginous areas or on the face.
  • Consider HPA axis suppression testing (e.g., ACTH stimulation test) if extensive body surface area is treated, especially in children or with occlusive dressings.
  • Avoid abrupt discontinuation after prolonged, extensive use to prevent rebound flares of the dermatosis.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, mometasone, clobetasol, hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing therapy
  • Emollients and moisturizers for barrier repair
  • Systemic therapies (e.g., oral corticosteroids, immunosuppressants, biologics) for severe, widespread disease
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Cost & Coverage

Average Cost: $30 - $100 per 30gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.