Triamcinolone 0.025% Ointment 80gm

Manufacturer FOUGERA Active Ingredient Triamcinolone Cream and Ointment(trye am SIN oh lone) Pronunciation trye-am-SIN-oh-lone
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
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Pregnancy Category
Category C
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FDA Approved
Aug 1961
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Triamcinolone ointment is a medicine applied to the skin to reduce redness, swelling, and itching caused by various skin conditions like eczema or psoriasis. It works by calming down the skin's immune response.
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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. Use this medication only on your skin, as directed. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.

Continue using the medication as instructed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly. However, if you're applying the medication to your hand, do not wash your hand after use.

Prepare the affected area by cleaning it before application, and make sure it's completely dry. Then, apply a thin layer of the medication to the affected skin and gently rub it in.

Important Application Guidelines

Do not apply the medication to your face, underarms, or groin area unless your doctor specifically instructs you to do so.
Avoid using bandages, dressings, or other coverings on the treated area unless your doctor recommends it.
If the treated area is in the diaper region, do not use tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.
Do not use this medication to treat diaper rash.
* Avoid applying the medication to cuts, scrapes, or damaged skin.

Storage and Disposal

Store the medication at room temperature, avoiding freezing. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.

Missed Dose Instructions

If you miss a dose, apply it as soon as you remember. However, if it's close to the time for your next scheduled 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 one.
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Lifestyle & Tips

  • Wash your hands before and after applying the ointment.
  • Apply a thin layer to the affected skin area and rub it in gently.
  • Do not cover the treated area with bandages or tight dressings unless directed by your doctor, as this can increase absorption and side effects.
  • Avoid applying to the face, groin, or armpits unless specifically instructed by your doctor.
  • Do not use for longer than prescribed, especially on children.
  • Avoid contact with eyes, nose, and mouth. If contact occurs, rinse thoroughly with water.
  • Keep out of reach of children.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected area 2 to 4 times daily, depending on severity.
Dose Range: 2 - 4 mg

Condition-Specific Dosing:

eczema: Apply 2-3 times daily
psoriasis: Apply 2-4 times daily
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Pediatric Dosing

Neonatal: Not established (use with extreme caution due to increased systemic absorption)
Infant: Apply a thin film to the affected area 1-2 times daily. Use smallest effective amount for shortest duration. Avoid occlusive dressings.
Child: Apply a thin film to the affected area 1-2 times daily. Use smallest effective amount for shortest duration. Avoid occlusive dressings.
Adolescent: Apply a thin film to the affected area 2 to 4 times 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

Triamcinolone acetonide is a synthetic corticosteroid that possesses 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: Variable (generally low, 1-5% but can be higher with damaged skin, inflammation, or occlusive dressings)
Tmax: Not precisely defined for topical application, systemic effects can occur with prolonged or extensive use.
FoodEffect: Not applicable (topical)

Distribution:

Vd: Not precisely defined for topical application; if absorbed systemically, distributes widely.
ProteinBinding: High (to plasma proteins, if absorbed systemically)
CnssPenetration: Limited (unless significant systemic absorption)

Elimination:

HalfLife: Approximately 2-5 hours (systemic, if absorbed)
Clearance: Not precisely defined for topical application
ExcretionRoute: Primarily renal (if absorbed systemically)
Unchanged: Minimal (if absorbed systemically)
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Pharmacodynamics

OnsetOfAction: Hours to days (for noticeable symptomatic relief)
PeakEffect: Days to weeks (for maximal therapeutic effect)
DurationOfAction: Varies with frequency of application and severity of condition

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: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, feeling sleepy, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Irritation at the site of application
Skin changes: acne, stretch marks, slow healing, or excessive hair growth
Changes in skin color
Thinning of the skin

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 experience any of the following side effects, or if they bother you or persist, contact your doctor:

Burning sensation
Itching
* Dry skin

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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:

  • Increased redness, swelling, or pus at the application site (signs of infection)
  • Severe burning, itching, or irritation that was not present before
  • Thinning of the skin, easy bruising, or stretch marks in the treated area
  • Changes in skin color (lightening or darkening)
  • Acne-like breakouts
  • Unusual hair growth
  • If used extensively or for prolonged periods, watch for signs of systemic absorption like weight gain, moon face, or fatigue (rare with proper topical use).
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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, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is not an exhaustive list, and it is crucial to disclose all your medications and health issues to your doctor and pharmacist.
* Any health problems you have, as this information will help your doctor determine if it is safe for you to take this medication.

Remember, it is vital to verify that this medication is safe to take with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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. Adhere to the prescribed duration of use, and do not exceed the recommended treatment period.

Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe and effective treatment. Exercise caution when applying this medication to a large area of skin, and discuss any concerns with your doctor.

Using this medication too frequently can exacerbate your skin condition. If you are a parent or caregiver of a child, use this medication with caution, as children may be at a higher risk of experiencing certain side effects.

In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so be sure to discuss this with your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to weigh the benefits and risks of this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Chronic overdose or misuse can lead to systemic corticosteroid effects, including Cushing's syndrome, hyperglycemia, and HPA axis suppression. Symptoms may include weight gain, 'moon face', thinning skin, easy bruising, muscle weakness, fatigue, and high blood pressure.

What to Do:

Discontinue use gradually under medical supervision. Call a poison control center (1-800-222-1222) or seek emergency medical attention if severe symptoms occur.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment (type, extent, severity of lesion)

Rationale: To establish baseline for treatment efficacy and identify areas of concern.

Timing: Prior to initiation of therapy

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Routine Monitoring

Clinical response (reduction in inflammation, pruritus, lesion size)

Frequency: Regularly, at follow-up visits (e.g., weekly to monthly)

Target: Improvement in symptoms and lesion appearance

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

Local adverse effects (skin atrophy, striae, telangiectasias, folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis)

Frequency: At each follow-up visit and patient self-monitoring

Target: Absence of adverse effects

Action Threshold: Presence of adverse effects, especially skin atrophy, warrants reduction in frequency, potency, or discontinuation.

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

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

Target: Absence of systemic effects

Action Threshold: Any signs of systemic absorption warrant immediate discontinuation and medical evaluation.

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Symptom Monitoring

  • Burning
  • Itching
  • Irritation
  • Dryness
  • Folliculitis
  • Hypertrichosis
  • Acneiform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Maceration of the skin
  • Secondary infection
  • Skin atrophy
  • Striae
  • Miliaria

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid large amounts, prolonged use, or application to large surface areas.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high systemic exposure, but topical absorption is generally low.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Risk of HPA axis suppression in the newborn with extensive maternal use near term.
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Lactation

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with proper use, but monitor infant for potential adverse effects if extensive maternal use.
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Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients due to a larger skin surface area to body weight ratio. Use the smallest effective amount for the shortest duration. Avoid occlusive dressings.

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Geriatric Use

No specific dosage adjustments are typically needed. However, elderly patients may have thinner skin, which could potentially increase systemic absorption or local adverse effects. Use with caution and monitor for skin integrity.

Clinical Information

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Clinical Pearls

  • Topical triamcinolone ointment is generally more potent than cream formulations due to its occlusive nature, which enhances penetration.
  • Always apply a thin layer; more is not better and can increase the risk of side effects.
  • Do not use on infected skin without concomitant antimicrobial therapy.
  • Long-term use, especially on the face, intertriginous areas (skin folds), or under occlusion, significantly increases the risk of local side effects like skin atrophy, telangiectasias, and striae.
  • If no improvement is seen after 2-4 weeks, re-evaluate the diagnosis and treatment plan.
  • Patients should be advised to avoid contact with eyes and mucous membranes.
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Alternative Therapies

  • Other topical corticosteroids (e.g., hydrocortisone, fluocinonide, clobetasol)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Topical vitamin D analogs (e.g., calcipotriene) for psoriasis
  • Emollients and moisturizers for dry skin conditions
  • Systemic therapies for severe conditions (e.g., biologics, oral immunosuppressants)
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 80gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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.