Oralone 0.1% Paste 5gm
It is used to treat mouth irritation.
Drug Class
Anti-inflammatory agent, Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Aug 1964
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oralone paste contains a medicine called triamcinolone, which is a type of steroid. It's used to treat sores or inflammation in your mouth, like canker sores or other painful spots. It works by reducing swelling, redness, and discomfort.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Continue using the medication as directed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly.
To apply, use a cotton swab to put a thin layer of the medication on the affected area. Do not rub the medication into the skin. 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 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. If you have questions about the proper disposal method, consult your pharmacist. You may also want to inquire about drug take-back programs available in your area.
Managing Missed Doses
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 once or use extra doses to make up for a missed application.
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Continue using the medication as directed, even if your symptoms improve. Before and after applying the medication, wash your hands thoroughly.
To apply, use a cotton swab to put a thin layer of the medication on the affected area. Do not rub the medication into the skin. 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 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. If you have questions about the proper disposal method, consult your pharmacist. You may also want to inquire about drug take-back programs available in your area.
Managing Missed Doses
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 once or use extra doses to make up for a missed application.
Lifestyle & Tips
- Maintain good oral hygiene.
- Avoid irritating foods (e.g., spicy, acidic, very hot) that may worsen oral lesions.
- Apply after meals to allow the paste to stay on the lesion longer.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a thin film to the lesion at bedtime. May apply 2 or 3 times a day, preferably after meals.
Dose Range:
2 - 3 mg
Condition-Specific Dosing:
oralmucosalinflammation:
Apply a thin film to the lesion at bedtime. May apply 2 or 3 times a day, preferably after meals. Do not rub in. Continue until symptoms subside.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Use with caution; apply a thin film to the lesion 2-3 times daily. Monitor for signs of systemic absorption, especially in younger children.
Adolescent:
Apply a thin film to the lesion 2-3 times daily, preferably after meals.
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 adjustment needed 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
Mechanism of Action
Triamcinolone acetonide is a synthetic corticosteroid that possesses potent 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 also suppress the immune response by inhibiting the function of lymphocytes and macrophages.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from oral mucosa; however, absorption can occur, especially with inflamed or denuded mucosa.
Tmax:
Not applicable for local action; systemic Tmax not well-defined due to minimal absorption.
FoodEffect:
Application after meals is recommended to prolong contact time with the lesion.
Distribution:
Vd:
Not well-defined for topical application due to minimal systemic absorption.
ProteinBinding:
Approximately 60-70% (for systemically absorbed triamcinolone).
CnssPenetration:
Limited (for systemically absorbed triamcinolone).
Elimination:
HalfLife:
Approximately 2-5 hours (for systemically absorbed triamcinolone).
Clearance:
Not well-defined for topical application due to minimal systemic absorption.
ExcretionRoute:
Renal (for systemically absorbed triamcinolone).
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptomatic relief.
PeakEffect:
Within days of consistent application.
DurationOfAction:
Local effect persists for several hours after application.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 site of application
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you have any of the following side effects or any other concerns, contact your doctor:
Burning
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. For medical advice 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 site of application
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. If you have any of the following side effects or any other concerns, contact your doctor:
Burning
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. For medical advice 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.
Seek Immediate Medical Attention If You Experience:
- Worsening of the oral lesion or pain after 7 days of use.
- Development of new white patches in the mouth (may indicate fungal infection).
- Increased redness, swelling, or pus around the lesion.
- Signs of allergic reaction (e.g., rash, itching, severe swelling).
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 symptoms you experienced as a result of the allergy.
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 issues with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health conditions.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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 symptoms you experienced as a result of the allergy.
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 issues with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other treatments and health conditions.
Remember, do not start, stop, or modify the dosage of any medication without first consulting your doctor to ensure your safety.
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 exceed the recommended usage period as advised by your doctor.
When administering this drug to children, exercise caution, as they may be at a higher risk of experiencing certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Consult with your doctor to discuss the potential risks and benefits.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. It is crucial to have a discussion with your doctor about the potential benefits and risks of this medication to both you and your baby, allowing for an informed decision about treatment.
When administering this drug to children, exercise caution, as they may be at a higher risk of experiencing certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Consult with your doctor to discuss the potential risks and benefits.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. It is crucial to have a discussion with your doctor about the potential benefits and risks of this medication to both you and your baby, allowing for an informed decision about treatment.
Overdose Information
Overdose Symptoms:
- Unlikely with topical application due to minimal systemic absorption. Prolonged or excessive use may rarely lead to systemic corticosteroid effects such as Cushing's syndrome, adrenal suppression, or hyperglycemia, especially in children or if large areas are treated.
What to Do:
Discontinue use. For suspected systemic effects, consult a healthcare professional. For accidental ingestion, call Poison Control at 1-800-222-1222.
Drug Interactions
Monitoring
Routine Monitoring
Clinical improvement of oral lesion
Frequency: Daily
Target: Reduction in inflammation, pain, and lesion size.
Action Threshold: If no improvement within 7 days, or if condition worsens, re-evaluate diagnosis and treatment.
Signs of local infection (e.g., candidiasis)
Frequency: Daily
Target: Absence of white patches, redness, or increased pain.
Action Threshold: If signs of fungal or bacterial infection develop, discontinue use and initiate appropriate antimicrobial therapy.
Symptom Monitoring
- Pain relief
- Reduction in inflammation
- Healing of oral lesions
- Development of secondary infection (e.g., candidiasis)
- Local irritation or burning sensation
Special Patient Groups
Pregnancy
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, corticosteroids have been shown to be teratogenic in animals.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk is low with topical use.
Second Trimester:
Generally considered low risk with topical use.
Third Trimester:
Generally considered low risk with topical use.
Lactation
Lactation Risk L3 (Moderately Safe). It is not known whether topical triamcinolone acetonide is excreted in human milk. Systemic absorption is minimal, so risk to the infant is considered low. Use with caution.
Infant Risk:
Low risk due to minimal maternal systemic absorption.
Pediatric Use
Use with caution in children. Children may be more susceptible to systemic toxicity from topical corticosteroids due to a larger skin surface area to body weight ratio. Adrenal suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Limit duration of treatment and amount applied.
Geriatric Use
No specific dosage adjustments are required. Elderly patients may be more susceptible to the systemic effects of corticosteroids if significant absorption occurs, but this is rare with dental paste.
Clinical Information
Clinical Pearls
- Instruct patients to apply a thin film of the paste without rubbing it in, as rubbing can cause the paste to crumble.
- Advise patients to apply the paste after meals to maximize contact time with the lesion.
- Emphasize that this product is for oral use only and should not be swallowed in large amounts.
- Warn patients about the potential for secondary fungal infections (e.g., oral candidiasis) with prolonged use, and to report any new white patches.
- If no improvement is seen within 7 days, or if the condition worsens, the patient should consult a healthcare professional for re-evaluation.
Alternative Therapies
- Other topical corticosteroids (e.g., clobetasol propionate oral paste, fluocinonide gel)
- Topical anesthetics (e.g., lidocaine viscous, benzocaine)
- Protective barriers (e.g., Orabase Protective Paste)
- Systemic corticosteroids (for severe, widespread oral inflammatory conditions, used with caution)
- Non-pharmacological approaches (e.g., avoiding irritants, good oral hygiene)
Cost & Coverage
Average Cost:
$20 - $50 per 5gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (often covered by most prescription plans)
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.