Fluticasone 0.005% Ointment 60gm
Overview
What is this medicine?
How to Use This Medicine
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.
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.
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
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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).
Before Using This Medicine
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.
Precautions & Cautions
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.
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
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
Baseline Monitoring
Rationale: To establish baseline for efficacy assessment and identify contraindications (e.g., active infection).
Timing: Prior to initiation of therapy
Routine Monitoring
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.
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.
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.
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
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:
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.
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.
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
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.
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)