Triamcin/orabas 0.1% Dent-Past 5gm

Manufacturer TARO Active Ingredient Triamcinolone Dental Paste(trye am SIN oh lone) Pronunciation trye-am-SIN-oh-lone
It is used to treat mouth irritation.
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Drug Class
Anti-inflammatory agent
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Pharmacologic Class
Corticosteroid, topical
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Pregnancy Category
Category C
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FDA Approved
Aug 1964
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

This medication is a type of steroid that helps reduce swelling, redness, and itching. It's used as a paste applied directly to sores or inflamed areas inside your mouth to help them heal and relieve discomfort.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly. Using a cotton swab, apply a thin layer of the medication to the affected area, but do not rub it in. It is essential to note that this medication is for topical use only and should not be swallowed.

Storing and Disposing of Your Medication

Store the medication at room temperature, avoiding freezing. Keep all medications in a safe and secure location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the proper disposal method or inquire about potential drug take-back programs in your area.

Missing a Dose

If you miss a dose, apply it as soon as you remember. However, if it is 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 the missed one.
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Lifestyle & Tips

  • Maintain good oral hygiene.
  • Avoid irritating foods (spicy, acidic, very hot) that may worsen oral lesions.
  • Do not eat or drink immediately after applying the paste to allow it to adhere to the lesion.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a small amount (about 1/4 inch) to the lesion at bedtime and, if necessary, 2 or 3 times a day, preferably after meals.

Condition-Specific Dosing:

oralLesions: Apply a small amount to cover the lesion with a thin film. Do not rub in. Apply at bedtime and, if necessary, 2 or 3 times a day, preferably after meals, depending on the severity of the condition.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Use with caution; similar adult dosing may be used, but systemic absorption risk is higher in children due to larger skin surface area to body weight ratio. Limit duration of use.
Adolescent: Similar to adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed due to minimal systemic absorption.
Moderate: No adjustment needed due to minimal systemic absorption.
Severe: No adjustment needed due to minimal systemic absorption.
Dialysis: No specific considerations due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed due to minimal systemic absorption.
Moderate: No adjustment needed due to minimal systemic absorption.
Severe: No adjustment needed due to 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. Corticosteroids bind to glucocorticoid receptors, translocate to the nucleus, and modulate gene expression, leading to reduced inflammation and immune response.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption from intact skin/mucosa; varies with integrity of mucosal barrier, duration of exposure, and presence of occlusive dressing. Systemic absorption is possible, especially with prolonged use, large surface areas, or damaged mucosa.
Tmax: Not readily quantifiable due to minimal systemic absorption.
FoodEffect: Not applicable for topical dental paste.

Distribution:

Vd: Not readily quantifiable due to minimal systemic absorption.
ProteinBinding: Not readily quantifiable due to minimal systemic absorption; if absorbed, similar to other corticosteroids (high).
CnssPenetration: Limited/No (with minimal systemic absorption).

Elimination:

HalfLife: Not readily quantifiable due to minimal systemic absorption; if absorbed, similar to other corticosteroids (variable, typically hours).
Clearance: Not readily quantifiable due to minimal systemic absorption.
ExcretionRoute: Renal (primarily), if systemically absorbed.
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Within hours for local anti-inflammatory effect.
PeakEffect: Within 1-2 days of consistent application.
DurationOfAction: Several hours per application.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 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

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Burning
Itching
Dry skin

This is not an exhaustive list of all 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:

  • Worsening of the oral lesion or no improvement after 7 days.
  • Development of new sores or white patches in the mouth (may indicate a fungal infection).
  • Increased pain, burning, or irritation after applying the paste.
  • Signs of infection (fever, pus, spreading redness).
  • Unusual fatigue, weakness, or swelling (rare, but could indicate systemic absorption).
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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, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you currently have a mouth or throat infection.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other medications and health issues.

Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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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.

When administering this medication to a child, exercise caution, as the risk of certain side effects may be increased in pediatric patients. In some cases, this drug may impact growth in children and teenagers, necessitating regular growth checks. Consult with your doctor to discuss the potential effects and necessary monitoring.

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

Overdose Symptoms:

  • Unlikely with topical dental paste due to minimal systemic absorption.
  • Prolonged or excessive use may rarely lead to systemic corticosteroid effects such as adrenal suppression, Cushing's syndrome symptoms (e.g., moon face, buffalo hump, weight gain), hyperglycemia, or growth retardation in children.

What to Do:

Discontinue use. Consult a healthcare professional. For accidental ingestion, call Poison Control at 1-800-222-1222.

Drug Interactions

Monitoring

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Routine Monitoring

Resolution of oral lesion symptoms (pain, inflammation)

Frequency: Daily

Target: Improvement or resolution

Action Threshold: Lack of improvement or worsening after 7 days, or development of new symptoms (e.g., infection).

Signs of local irritation or infection (e.g., burning, itching, secondary infection)

Frequency: Daily

Target: Absence of irritation/infection

Action Threshold: Presence of irritation, pain, or signs of fungal/bacterial infection (e.g., candidiasis).

Signs of systemic corticosteroid effects (rare with proper use)

Frequency: Periodically, especially with prolonged use or large areas

Target: Absence of systemic effects

Action Threshold: Unusual fatigue, weight gain, hyperglycemia, adrenal suppression (rare).

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Symptom Monitoring

  • Pain relief
  • Reduction in inflammation/swelling
  • Healing of oral lesions
  • Signs of local irritation (burning, stinging, itching)
  • Signs of secondary infection (e.g., white patches indicative of candidiasis, pus)
  • Unusual fatigue or weakness (rare, systemic absorption)

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected with proper topical use.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity with high systemic doses; minimal risk with topical dental paste due to low absorption.
Second Trimester: Low risk with topical dental paste due to low absorption.
Third Trimester: Low risk with topical dental paste due to low absorption.
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Lactation

Considered low risk. Minimal systemic absorption means negligible amounts are likely to be excreted in breast milk. Use with caution, avoid application to areas where infant may ingest.

Infant Risk: Low risk of adverse effects in breastfed infants.
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Pediatric Use

Use with caution. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, growth retardation). Limit duration of use and amount applied. Not recommended for infants.

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Geriatric Use

No specific dosage adjustments are necessary. Elderly patients may be more susceptible to local adverse reactions or, rarely, systemic effects if absorption is significant due to compromised mucosal barrier.

Clinical Information

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Clinical Pearls

  • Apply a thin film to the lesion without rubbing it in, as rubbing may cause the paste to crumble.
  • Apply at bedtime to allow the paste to remain on the lesion for an extended period.
  • Avoid eating or drinking for at least 30 minutes after application to maximize adherence.
  • This product is for oral use only; do not swallow large amounts.
  • If symptoms do not improve within 7 days, or if they worsen, consult a dentist or physician to rule out other conditions or infections.
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Alternative Therapies

  • Fluocinonide topical gel (for oral lesions, off-label)
  • Clobetasol propionate topical gel/ointment (for severe oral lesions, off-label)
  • Dexamethasone elixir (rinse and spit, for diffuse oral inflammation)
  • Amlexanox oral paste (Aphthasol) for aphthous ulcers
  • Over-the-counter oral pain relievers (e.g., benzocaine, lidocaine gels)
  • Silver nitrate (for cauterization of aphthous ulcers)
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Cost & Coverage

Average Cost: $20 - $50 per 5gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet; consult your pharmacist for more information. If you have any questions or concerns about this medication, discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.