Triamcinolone 0.5% Cream 15gm

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 0.5% Cream is a strong corticosteroid 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 body's inflammatory 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 irritation.

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 that 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 advises you to do so.
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, away from freezing temperatures. 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. You may also want to check with your pharmacist about drug take-back programs in your area.

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

  • Apply a thin layer of cream to the affected skin area as directed by your doctor, usually 2 to 4 times a day.
  • Gently rub it in until it disappears.
  • Wash your hands before and after applying the cream, unless your hands are the treated area.
  • Do not cover the treated area with bandages or tight dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid applying the cream to your eyes, mouth, or inside your nose. If it gets into these areas, rinse thoroughly with water.
  • Do not use this cream for longer than prescribed, especially on the face, groin, or armpits, or in children, as it can cause thinning of the skin or other side effects.
  • Do not use on broken skin or open wounds unless directed by a healthcare professional.
  • Inform your doctor if your condition does not improve after 1-2 weeks of treatment or if it worsens.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Use with caution; apply sparingly to small areas for short durations. Increased risk of systemic absorption.
Child: Apply a thin film to the affected area two to four times daily. Use the least amount for the shortest duration possible. Avoid use on face, groin, or axillae unless directed by physician.
Adolescent: Apply a thin film to the affected area two to four 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: Minimal systemic absorption; varies with vehicle, integrity of epidermal barrier, and use of occlusive dressings. Can be up to 1-5% or higher with damaged skin/occlusion.
Tmax: Not applicable for topical effect; systemic absorption Tmax not well-defined for topical use.
FoodEffect: Not applicable

Distribution:

Vd: Not applicable for topical use; if absorbed systemically, distributes widely.
ProteinBinding: Not applicable for topical use; if absorbed systemically, binds to plasma proteins.
CnssPenetration: Limited (if systemically absorbed)

Elimination:

HalfLife: Not well-defined for topical use; systemic half-life of triamcinolone is approximately 2-5 hours.
Clearance: Not well-defined for topical use.
ExcretionRoute: Renal (if systemically absorbed)
Unchanged: Not significant for topical use
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Pharmacodynamics

OnsetOfAction: Hours to days for noticeable improvement
PeakEffect: Days to weeks of consistent use
DurationOfAction: Varies; effects persist as long as applied, but chronic use can lead to tachyphylaxis.

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:

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
Irritation at the site where the medication was applied
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Change in skin color
Thinning of the skin

Other Possible Side Effects

Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:

Burning
Itching
* Dry skin

This is not an exhaustive list of all 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:

  • Increased redness, swelling, or pus at the application site (signs of infection)
  • Severe burning, itching, or irritation that was not present before
  • Skin thinning, easy bruising, or stretch marks (striae) developing
  • Changes in skin color (lightening or darkening)
  • Acne-like breakouts or increased hair growth in the treated area
  • Any signs of systemic effects, though rare with proper topical use, such as unusual weight gain, swelling in ankles/feet, increased thirst/urination (signs of high blood sugar), or unusual fatigue.
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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 information will help your doctor assess potential interactions between this medication and other substances you are taking.
Any health problems you have, as they may affect the safety and efficacy of this medication.

To ensure your safety, it is crucial to:

Verify that it is safe to take this medication with all your other medications and health conditions.
* Consult with your doctor before starting, stopping, or changing the dose of any medication, including this one.
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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 treatment duration, and do not use this drug for an extended period beyond what your doctor has recommended.

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 this with your doctor if necessary.

Using this medication too frequently can exacerbate your skin condition. If the patient is a child, use this medication with caution, as the risk of certain side effects may be increased in children. In some cases, this drug may affect growth in children and teenagers, and regular growth checks may be necessary. Consult with your doctor to discuss this potential risk.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use, especially over large surface areas, under occlusion, or in children, can lead to systemic absorption and symptoms of hypercorticism (e.g., Cushing's syndrome, adrenal suppression).
  • Symptoms may include: moon face, buffalo hump, central obesity, thinning skin, easy bruising, striae, muscle weakness, fatigue, high blood pressure, high blood sugar, mood changes.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.

Drug Interactions

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Contraindicated Interactions

  • None known for topical application
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Major Interactions

  • None known for topical application
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Moderate Interactions

  • None known for topical application
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Minor Interactions

  • None known for topical application

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify any contraindications (e.g., active infection).

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in inflammation, pruritus)

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

Target: Significant improvement in symptoms

Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks may indicate need for re-evaluation or alternative therapy.

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

Frequency: At each follow-up visit, especially with prolonged use or use on sensitive areas.

Target: Absence of or minimal adverse effects

Action Threshold: Presence of significant adverse effects warrants discontinuation or reduction in potency/frequency.

Signs of infection (bacterial, fungal, viral)

Frequency: At each follow-up visit

Target: Absence of infection

Action Threshold: Presence of infection requires appropriate antimicrobial therapy and potential discontinuation of corticosteroid.

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Symptom Monitoring

  • Burning
  • Itching
  • Irritation
  • Dryness
  • Folliculitis
  • Hypertrichosis
  • Acneiform eruptions
  • Hypopigmentation
  • Perioral dermatitis
  • Allergic contact dermatitis
  • Skin maceration
  • Secondary infection
  • Skin atrophy
  • Striae
  • Miliaria
  • Signs of systemic absorption (e.g., Cushing's syndrome symptoms, hyperglycemia, adrenal suppression - rare with appropriate topical use)

Special Patient Groups

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Pregnancy

Category C. Should be used 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, though data for topical corticosteroids is limited and generally low risk with appropriate use.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: No specific risks identified beyond general corticosteroid risks; avoid prolonged use or large areas.
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Lactation

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

Infant Risk: Low risk with appropriate use; monitor infant for adverse effects if significant maternal systemic absorption is suspected.
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Pediatric Use

Children 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, intracranial hypertension) than adult patients. Use the least potent formulation for the shortest duration possible. Avoid use on face, groin, or axillae unless directed by physician. Not recommended for children under 2 years of age.

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Geriatric Use

No specific dosage adjustments are required. However, elderly patients may have thinner skin, which could increase the risk of local adverse effects (e.g., skin atrophy, purpura) and potentially systemic absorption. Use with caution and monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Triamcinolone 0.5% cream is a high-potency topical corticosteroid; use it judiciously and for limited durations to minimize local and systemic side effects.
  • Educate patients on proper application technique: thin layer, gentle rub, and avoiding occlusive dressings unless specifically instructed.
  • Warn patients about potential skin thinning, stretch marks, and easy bruising with prolonged use, especially on sensitive areas like the face or skin folds.
  • Always consider the underlying cause of the dermatosis; topical corticosteroids treat symptoms, not the root cause.
  • If no improvement is seen after 1-2 weeks, re-evaluate the diagnosis and treatment plan.
  • Tapering off high-potency corticosteroids after prolonged use may be necessary to prevent rebound flares.
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Alternative Therapies

  • Lower potency topical corticosteroids (e.g., hydrocortisone, desonide)
  • Medium potency topical corticosteroids (e.g., fluocinolone acetonide, betamethasone valerate)
  • Other high-potency topical corticosteroids (e.g., clobetasol propionate, halobetasol propionate)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema, especially on sensitive areas.
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for eczema.
  • Systemic therapies (e.g., oral corticosteroids, biologics, immunosuppressants) for severe, widespread conditions.
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Cost & Coverage

Average Cost: $10 - $50 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance. 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 name of the medication taken, the amount consumed, and the time it occurred.