Triamcinolone Ace 0.05% Oint 430gm

Manufacturer ENCUBE 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
Corticosteroid, Topical
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Pharmacologic Class
Glucocorticoid receptor agonist
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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 acetonide ointment is a strong corticosteroid medicine applied to the skin to reduce redness, swelling, itching, and discomfort caused by various skin conditions like eczema, psoriasis, or allergic reactions. It works by calming down the body's inflammatory response in the skin.
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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 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 this 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

  • Wash hands before and after applying the ointment.
  • Apply a thin layer only to the affected skin area.
  • Do not cover the treated area with bandages or dressings unless directed by your doctor, as this can increase absorption.
  • 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.
  • 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, or as directed by physician.
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Pediatric Dosing

Neonatal: Not recommended for routine use; use with extreme caution if necessary, due to increased systemic absorption.
Infant: Apply a thin film to the affected area 2 to 4 times daily, or as directed by physician. Use with caution; increased systemic absorption possible.
Child: Apply a thin film to the affected area 2 to 4 times daily, or as directed by physician. Use with caution; increased systemic absorption possible.
Adolescent: Apply a thin film to the affected area 2 to 4 times daily, or as directed by physician.
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment necessary for topical application.
Moderate: No dosage adjustment necessary for topical application.
Severe: No dosage adjustment necessary for topical application.
Dialysis: No specific considerations for topical application.

Hepatic Impairment:

Mild: No dosage adjustment necessary for topical application.
Moderate: No dosage adjustment necessary for topical application.
Severe: No dosage adjustment necessary for topical application.

Pharmacology

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Mechanism of Action

Triamcinolone acetonide is a synthetic 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; depends on skin integrity, vehicle, duration of exposure, and use of occlusive dressings. Systemic absorption can occur.
Tmax: Not well-defined for topical application; systemic levels are generally low.
FoodEffect: Not applicable for topical application.

Distribution:

Vd: Not well-defined for topical application; distributes into skin and systemic circulation if absorbed.
ProteinBinding: Variable, generally high for corticosteroids (e.g., >90% for systemic).
CnssPenetration: Limited, but possible with significant systemic absorption.

Elimination:

HalfLife: Variable; systemic half-life of absorbed drug is approximately 2-5 hours.
Clearance: Not well-defined for topical application.
ExcretionRoute: Renal (metabolites) and biliary.
Unchanged: Minimal unchanged drug excreted.
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Pharmacodynamics

OnsetOfAction: Within hours to days for anti-inflammatory effect.
PeakEffect: Days to weeks of consistent application.
DurationOfAction: Variable, depends on 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 medical attention immediately:

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 application site
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. However, many people experience no side effects or only mild ones. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:

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 wasn't present before
  • Thinning of the skin, easy bruising, or stretch marks developing
  • Acne-like breakouts or hair growth in the treated area
  • Any signs of systemic effects like unusual weight gain, swelling in ankles/feet, or increased thirst/urination (rare, but report immediately)
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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 discuss all your medications and health conditions with your doctor.
* Any health problems you have, as they may interact with this medication.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is your responsibility to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to help you make informed decisions about your medication regimen.
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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 the patient is a child, use this drug with caution, as the risk of certain side effects may be higher in children. 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, as they will need to weigh the benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic effects such as Cushing's syndrome (moon face, buffalo hump, central obesity), hyperglycemia, glucosuria, and adrenal suppression. Local symptoms include skin atrophy, striae, telangiectasias.

What to Do:

Discontinue use gradually under medical supervision. Call 1-800-222-1222 (Poison Control Center) for advice. Seek immediate medical attention if systemic symptoms are severe.

Drug Interactions

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Minor Interactions

  • No significant systemic drug interactions are expected with proper topical use due to minimal systemic absorption. However, with extensive or prolonged use, or use under occlusion, systemic absorption may increase, potentially leading to interactions similar to systemic corticosteroids (e.g., with CYP3A4 inhibitors, drugs affecting glucose metabolism).

Monitoring

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Baseline Monitoring

Skin condition (e.g., erythema, scaling, pruritus)

Rationale: To assess initial severity and guide treatment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Response to therapy (e.g., reduction in inflammation, pruritus)

Frequency: Regularly, as clinically indicated (e.g., weekly to bi-weekly).

Target: Improvement or resolution of symptoms.

Action Threshold: Lack of improvement, worsening of condition, or development of adverse effects.

Adverse skin reactions (e.g., atrophy, striae, telangiectasias, folliculitis)

Frequency: At each follow-up visit.

Target: Absence of adverse reactions.

Action Threshold: Presence of adverse reactions, requiring dose reduction or discontinuation.

Signs of systemic absorption (e.g., Cushing's syndrome, adrenal suppression) - *rare*

Frequency: Only if extensive, prolonged use, or use in children/under occlusion.

Target: Normal endocrine function.

Action Threshold: Clinical signs of systemic effects; consider laboratory testing (e.g., morning cortisol) if suspected.

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Symptom Monitoring

  • Skin irritation
  • burning
  • itching
  • dryness
  • folliculitis
  • acneiform eruptions
  • hypopigmentation
  • perioral dermatitis
  • allergic contact dermatitis
  • skin atrophy
  • striae
  • telangiectasias
  • secondary infection
  • signs of systemic absorption (e.g., weight gain, moon face, fatigue, weakness, hyperglycemia, growth retardation in children)

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 use under occlusion.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high doses of systemic corticosteroids; topical absorption is generally low but caution advised.
Second Trimester: Similar considerations as first trimester; risk generally low with appropriate topical use.
Third Trimester: Similar considerations; potential for fetal growth restriction with very high systemic doses, but unlikely with topical use.
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Lactation

L3 (Moderately safe). Caution advised. It is not known whether topical corticosteroids are excreted in human milk. Systemic corticosteroids are excreted in human milk. If used, apply to the smallest area of skin for the shortest duration. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with appropriate use; potential for adverse effects if significant systemic absorption occurs in mother and drug is excreted in milk, or if infant ingests directly from treated skin.
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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, growth retardation). Use the least potent corticosteroid for the shortest duration possible. Avoid occlusive dressings.

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Geriatric Use

No specific dosage adjustments needed. Elderly patients may have thinner skin, potentially increasing susceptibility to local adverse effects like skin atrophy. Use with caution.

Clinical Information

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Clinical Pearls

  • Triamcinolone acetonide 0.05% ointment is a medium-to-high potency topical corticosteroid. Ointments are generally more potent than creams or lotions for the same concentration due to increased penetration and occlusive properties.
  • Ointments are preferred for dry, scaly lesions, while creams are better for weeping or intertriginous areas.
  • Educate patients on the 'less is more' principle: apply a very thin layer, just enough to cover the affected area.
  • Warn patients about potential for skin atrophy, striae, and telangiectasias with prolonged use, especially on thin skin areas (face, intertriginous areas).
  • Adrenal suppression is rare with appropriate topical use but can occur, especially in children or with extensive/occlusive use. Monitor for signs if risk factors are present.
  • Rebound flares can occur if discontinued abruptly after prolonged use; taper off if necessary.
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Alternative Therapies

  • Other topical corticosteroids of varying potencies (e.g., hydrocortisone, fluocinolone, clobetasol)
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for steroid-sparing effect
  • Emollients/moisturizers
  • Systemic therapies for severe conditions (e.g., oral corticosteroids, biologics)
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Cost & Coverage

Average Cost: Varies widely by pharmacy and quantity (e.g., $20 - $100+) per 430gm ointment
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 this 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 overdose, including the medication taken, the amount, and the time it occurred.