Fluticasone 0.005% Ointment 60gm

Manufacturer G & W LABS /COSETTE 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
Category C
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FDA Approved
Oct 1993
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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, itching, and swelling caused by skin conditions like eczema or psoriasis. It belongs to a group of medicines called corticosteroids.
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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 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 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, 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 resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses.
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Lifestyle & Tips

  • Wash your hands before and after applying the ointment.
  • Apply a thin layer of ointment only to the affected skin areas, as directed by your doctor.
  • Do not use more than the prescribed amount or for longer than recommended.
  • Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption.
  • Avoid contact with eyes, mouth, and other mucous membranes.
  • Do not use on the face, groin, or armpits unless directed by your doctor.
  • 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.

Condition-Specific Dosing:

atopicDermatitis: Apply a thin film to affected areas once daily.
psoriasis: Apply a thin film to affected areas twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (use with extreme caution, increased risk of systemic absorption)
Child: Apply a thin film to affected areas once daily for up to 4 weeks. Use with caution, especially in infants and children, due to increased risk of systemic absorption and HPA axis suppression.
Adolescent: Apply a thin film to affected areas once or twice daily.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

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: Less than 5% (systemic after topical application)
Tmax: Not precisely quantifiable for topical systemic absorption, but local effect is rapid.
FoodEffect: Not applicable for topical formulation.

Distribution:

Vd: Not available (primarily local action)
ProteinBinding: Approximately 91% (systemic)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 11 hours (systemic)
Clearance: Not precisely quantifiable for topical systemic absorption.
ExcretionRoute: Fecal (major), Renal (minor)
Unchanged: Not available (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Within hours to days for symptomatic relief
PeakEffect: Days to weeks for maximal therapeutic effect
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 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 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 attention if they bother you or do not go away:

* 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 2-4 weeks.
  • Signs of a skin infection (e.g., increased redness, swelling, pain, pus).
  • Skin thinning, easy bruising, or stretch marks at the application site.
  • Unusual hair growth or acne-like rash where the ointment is applied.
  • Blurred vision or other eye problems (rare, but report if experienced).
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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 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. Your doctor and pharmacist need this information to assess potential interactions and ensure your safety while taking this medication.
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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 can exacerbate your skin condition. Additionally, be aware that frequent use of this medication 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. 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 potential harm to your baby.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is unlikely with topical application.
  • Chronic overuse or use on large areas/occluded skin can lead to systemic effects such as Cushing's syndrome (e.g., moon face, weight gain, fatigue, muscle weakness), hyperglycemia, and suppression of the adrenal glands.

What to Do:

If you suspect chronic overuse or systemic effects, contact your doctor immediately. For acute accidental ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive.

Drug Interactions

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Moderate Interactions

  • Strong CYP3A4 inhibitors (e.g., ritonavir, ketoconazole): Potential for increased systemic exposure to fluticasone, especially with extensive or prolonged use, leading to systemic corticosteroid effects. Clinical significance is low for typical topical use.

Monitoring

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Baseline Monitoring

Skin condition (type, severity, location of lesions)

Rationale: To establish baseline for efficacy assessment and identify contraindications (e.g., active infection).

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus, lesion size)

Frequency: Weekly or as clinically indicated

Target: Improvement in symptoms and skin appearance

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

Local adverse effects (skin atrophy, striae, telangiectasias, folliculitis, perioral dermatitis, secondary infection)

Frequency: At each follow-up visit

Target: Absence of new or worsening adverse effects

Action Threshold: Presence of significant adverse effects may require dose reduction, discontinuation, or alternative therapy.

Signs of systemic absorption (e.g., Cushing's syndrome, hyperglycemia, HPA axis suppression)

Frequency: Periodically, especially with extensive use, prolonged use, or in pediatric patients

Target: Normal HPA axis function (e.g., normal morning cortisol levels)

Action Threshold: Symptoms of systemic absorption or abnormal HPA axis tests (e.g., ACTH stimulation test) require immediate re-evaluation and potential discontinuation.

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Symptom Monitoring

  • Worsening of skin condition
  • Signs of skin infection (redness, warmth, pus, pain)
  • Thinning of skin
  • Easy bruising
  • Stretch marks
  • Increased hair growth at application site
  • Acne-like eruptions
  • Changes in vision (e.g., blurred vision, cataracts, glaucoma - rare with topical use)
  • Unusual fatigue or weakness (signs of HPA axis suppression)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids. Systemic absorption is minimal with topical use, but caution is advised.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of oral clefts in animal studies, but human data are limited and inconsistent for topical corticosteroids.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: No specific risks identified, but continued caution with extensive use.
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Lactation

It is not known whether topical fluticasone is excreted in human milk. Systemic absorption is minimal, so infant exposure is expected to be low. Use with caution. Avoid applying to the breast area to prevent direct infant ingestion.

Infant Risk: Low risk, but monitor infant for potential adverse effects if used on large areas or for prolonged periods by the mother.
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Pediatric Use

Pediatric patients may be 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 corticosteroid for the shortest duration possible. Avoid occlusive dressings.

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Geriatric Use

No specific dose adjustments are required. However, elderly patients may have thinner skin, which could potentially increase systemic absorption. Monitor for local and systemic adverse effects.

Clinical Information

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Clinical Pearls

  • Topical fluticasone ointment is generally preferred for dry, scaly, or lichenified lesions due to its emollient base.
  • Apply sparingly and rub in gently until the ointment disappears.
  • Do not use for longer than the prescribed duration (typically 2-4 weeks) to minimize the risk of skin atrophy and other local side effects.
  • If no improvement is seen after 2-4 weeks, re-evaluate the diagnosis and treatment plan.
  • Avoid abrupt discontinuation after prolonged use on large areas, as this can lead to rebound flares of the skin condition.
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Alternative Therapies

  • Other topical corticosteroids (e.g., triamcinolone, clobetasol, hydrocortisone)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for atopic dermatitis
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for atopic dermatitis
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Coal tar preparations
  • Phototherapy
  • Systemic immunomodulators (for severe cases)
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Cost & Coverage

Average Cost: $30 - $100 per 60gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often preferred generic)
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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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.