Kenalog 0.1% Ointment 15gm

Manufacturer APOTHECON 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
Anti-inflammatory, Antipruritic
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Pharmacologic Class
Corticosteroid, Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Triamcinolone ointment is a type of medicine called a corticosteroid. It works by reducing swelling, redness, and itching caused by various skin conditions like eczema or psoriasis. It helps to calm 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. 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.
Clean the affected area before application 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 the face, underarms, or groin area unless your doctor instructs you to do so.
Do not use bandages, dressings, or coverings unless your doctor advises you to do so.
If the treated area is in the diaper region, avoid using tight-fitting diapers or plastic pants, as this may 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 this 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.
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 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 to the affected skin area, gently rubbing it in completely.
  • Do not cover the treated area with bandages or dressings unless specifically instructed by your doctor, as this can increase absorption and side effects.
  • Avoid applying the ointment to your eyes, mouth, or inside your nose.
  • Do not use for longer than prescribed or on large areas of the body without consulting your doctor.
  • If you miss a dose, apply it as soon as you remember, then continue with your regular schedule. Do not apply extra to make up for a missed dose.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected area two to four times daily.

Condition-Specific Dosing:

occlusiveDressing: Not recommended unless directed by physician due to increased systemic absorption risk.
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Pediatric Dosing

Neonatal: Not established (increased risk of systemic absorption and HPA axis suppression)
Infant: Apply sparingly, avoid prolonged use or occlusive dressings due to increased risk of systemic absorption and HPA axis suppression.
Child: Apply sparingly, avoid prolonged use or occlusive dressings due to increased risk of systemic absorption and HPA axis suppression.
Adolescent: Apply a thin film to the affected area two to four times daily, similar to adults, but monitor for systemic effects if used extensively.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use.
Dialysis: No specific considerations for topical use.

Hepatic Impairment:

Mild: No adjustment needed for topical use.
Moderate: No adjustment needed for topical use.
Severe: No adjustment needed for topical use.

Pharmacology

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Mechanism of Action

Triamcinolone acetonide is a synthetic fluorinated corticosteroid. It exerts its anti-inflammatory, antipruritic, and vasoconstrictive actions by inducing phospholipase A2 inhibitory proteins (lipocortins). These proteins 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 (<5%) with intact skin; can increase significantly (up to 90%) with compromised skin barrier, inflammation, occlusion, or large surface area application.
Tmax: Not well-defined for topical systemic absorption; systemic absorption is slow and continuous.
FoodEffect: Not applicable for topical administration.

Distribution:

Vd: Not well-defined for topical systemic absorption; if absorbed systemically, distributes widely throughout the body.
ProteinBinding: Not well-defined for topical systemic absorption; systemic corticosteroids are typically highly protein bound (e.g., to albumin and transcortin).
CnssPenetration: Limited (for topical application, systemic absorption is minimal; if significant systemic absorption occurs, corticosteroids can penetrate the CNS).

Elimination:

HalfLife: Not well-defined for topical systemic absorption; systemic half-life of absorbed drug is approximately 2-5 hours.
Clearance: Not well-defined for topical systemic absorption.
ExcretionRoute: Renal (primarily as metabolites), some biliary.
Unchanged: Minimal (if absorbed systemically).
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Pharmacodynamics

OnsetOfAction: Within hours for local anti-inflammatory and antipruritic effects.
PeakEffect: Within days of consistent application.
DurationOfAction: Varies with application frequency and severity of condition; effects persist as long as applied.

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
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. Many people may not experience any side effects or only minor 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 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 the prescribed treatment period.
  • Signs of a skin infection (e.g., increased redness, swelling, pain, pus).
  • Severe burning, itching, or irritation at the application site.
  • Skin thinning, easy bruising, or stretch marks appearing where the ointment is applied.
  • Unusual hair growth or acne-like breakouts.
  • Any signs of systemic side effects like unusual weight gain, swelling in the face or ankles, or extreme tiredness (especially with prolonged or extensive 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 to this medication, its components, or other substances, including foods and drugs. Be sure to describe the allergic reaction you experienced, including the 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 they may interact with this medication. Your doctor and pharmacist need to be aware of your complete medical profile to ensure safe treatment.
Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication with all your other drugs and health conditions.
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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 treatment and do not use this drug for longer than recommended by your doctor.

Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use. 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 you are treating a child with this drug, use it with caution, as children may be at a higher risk for certain side effects. In some cases, this medication 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 weigh the benefits and risks of using this medication during pregnancy or breastfeeding, and your doctor will help you make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic absorption and symptoms of hypercorticism (Cushing's syndrome), including: moon face, buffalo hump, central obesity, skin thinning, easy bruising, striae, muscle weakness, hyperglycemia, hypertension, and HPA axis suppression.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control Center) for advice.

Drug Interactions

Monitoring

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Baseline Monitoring

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

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

Local skin reactions (e.g., burning, itching, irritation, dryness, folliculitis, skin atrophy, striae, hypopigmentation)

Frequency: At each follow-up visit or as symptoms arise.

Target: Absence or reduction of symptoms.

Action Threshold: Worsening symptoms, new adverse reactions, or signs of infection warrant re-evaluation and potential discontinuation.

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

Frequency: Periodically, especially with prolonged use, large surface area application, or in pediatric patients.

Target: Normal physiological function.

Action Threshold: Any signs or symptoms of systemic corticosteroid effects warrant immediate medical evaluation and potential discontinuation or dose reduction.

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Symptom Monitoring

  • Worsening of skin condition
  • New or increased burning, itching, or irritation at application site
  • Skin thinning, easy bruising, or striae
  • Changes in skin color (hypopigmentation)
  • Development of acne-like lesions or folliculitis
  • Signs of secondary infection (redness, warmth, pus)
  • Unusual fatigue, weight gain, or swelling (signs of systemic absorption)

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 or prolonged use.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though data for topical corticosteroids is limited and generally low risk with appropriate use.
Second Trimester: Risk of systemic absorption and potential fetal effects (e.g., growth restriction, HPA axis suppression) if used extensively.
Third Trimester: Risk of systemic absorption and potential fetal effects (e.g., growth restriction, HPA axis suppression) if used extensively.
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Lactation

Use with caution. It is not known whether topical corticosteroids are excreted in human milk. Systemic corticosteroids are excreted in human milk. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited, short-term use. Potential for adverse effects on infant growth or endogenous corticosteroid production with extensive maternal use.
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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 (e.g., HPA axis suppression, Cushing's syndrome, intracranial hypertension, growth retardation). 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 typically needed. However, geriatric patients may have thinner skin, which could increase the risk of local side effects (e.g., skin atrophy, purpura) and potentially systemic absorption. Monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Topical corticosteroids should be applied as a thin film; 'less is more' to minimize systemic absorption and local side effects.
  • Avoid using potent topical corticosteroids on the face, groin, or axillae unless specifically directed by a physician, due to increased risk of skin atrophy and other local side effects.
  • Patients should be educated on the signs of skin atrophy (thinning, shiny skin, visible blood vessels) and HPA axis suppression.
  • If no improvement is seen after 2-4 weeks, re-evaluate the diagnosis and treatment plan.
  • For chronic conditions, consider intermittent therapy or step-down to lower potency corticosteroids to reduce side effect risk.
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Alternative Therapies

  • Other topical corticosteroids (e.g., hydrocortisone, fluocinonide, clobetasol)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema
  • Topical phosphodiesterase-4 (PDE4) inhibitors (e.g., crisaborole) for eczema
  • Emollients and moisturizers for dry skin conditions
  • Systemic therapies (e.g., biologics, oral immunosuppressants) for severe, widespread conditions
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Cost & Coverage

Average Cost: $15 - $50 per 15gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.