Oralone

Triamcinolone (topical) is a prescription medication used to treat inflammation, itching, redness, and discomfort associated with a variety of skin conditions.

Triamcinolone (injection) is used to treat inflammation associated with a variety of conditions, including allergies, diseases of the skin, endocrine disorders, inflammation of the intestines, blood disorders, kidney diseases, and diseases and inflammation of the eye.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Oralone is part of the drug classes:

• Corticosteroids for local oral treatment

• Corticosteroids, moderately potent group II

• Corticosteroids, moderately potent, other combinations

• Antiinflammatory Corticosteroids

Serious side effects have been reported with topical triamcinolone including the following:

• Burning, drying and itching of the skin
• Convulsions
• Depression
• Increased blood pressure
• Muscle weakness
• Nervousness
• Psychosis
• Sleepiness
• Changes in menstrual cycle
• Swelling in lower extremities
• Water retention
• Worsening of diabetes or ulcers

Serious side effects have been reported with injectable triamcinolone including the following:

• Stomach upset
• Muscle weakness or atrophy
• Adrenal insufficiency
• Increased blood pressure
• Water and salt retention
• Increased susceptibility to infection

Glaucoma, cataracts, optic nerve damage, and ocular infections have been reported with the ophthalmic injections of triamcinolone.

Triamcinolone can cause dizziness. Do not drive or operate heavy machinery until you know how triamcinolone affects you.

Do not take triamcinolone if you are allergic to triamcinolone or to any of its ingredients.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Triamcinolone topical preparations and most injectable formulations fall into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Triamcinolone injectable formulations for the eye fall into category D. It has been shown that use of triamcinolone in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Triamcinolone has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from triamcinolone, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight, height, or body surface area
• your age

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water. Do not use triamcinolone topical on sunburned, windburned, irritated, or broken skin. Also avoid using this medication in open wounds.

Avoid using skin products that can cause irritation, such as harsh soaps or skin cleansers, or skin products with alcohol, spices, astringents, or lime. Avoid using other medications on the areas you treat with triamcinolone topical unless your doctor tells you to.

Oralone® is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation; it is also contraindicated in the presence of fungal, viral, or bacterial infections of the mouth or throat.

General

Oralone® may cause local adverse reactions. If irritation develops, Oralone® should be discontinued and appropriate therapy instituted. Allergic contact sensitization with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant mucosal infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Oralone® should be discontinued until the infection has been adequately controlled. If significant regeneration or repair of oral tissues has not occurred in seven days, additional investigation into the etiology of the oral lesion is advised.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, glucosuria, and other adverse effects known to occur with parenterally-administered steroid preparations; therefore, it may be advisable to periodically evaluate patients on prolonged therapy with corticosteroid-containing dental pastes for evidence of HPA axis suppression (see PRECAUTIONS, Laboratory Tests). If HPA axis suppression is noted, an attempt should be made to withdraw the drug or to reduce the frequency of application. Recovery of HPA axis function is generally prompt and complete upon discontinuation of therapy.

Information for the Patient

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician or dentist. It is for oral use only; it is not intended for ophthalmic or dermatological use.
2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
3. Patients should report any signs of adverse reactions.
4. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician or dentist.

Laboratory Tests

A urinary free cortisol test and ACTH stimulation test may be helpful in evaluating HPA axis suppression.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been performed to evaluate triamcinolone acetonide for potential to induce carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy Category C

Triamcinolone acetonide has been shown to induce teratogenic effects in several species. In mice and rabbits, triamcinolone acetonide induced an increased incidence of cleft palate at dosages of approximately 120 µg/kg/day and 24 µg/kg/day, respectively (approximately 12 times and 10 times the amount in a typical daily human dose of Oralone® when compared following normalization of the data on the basis of body surface area estimates, respectively). In monkeys, triamcinolone acetonide induced cranial skeletal malformations at the lowest dosage studied (500 µg/kg/day), which was approximately 200 times the amount in a typical daily human dose of Oralone® when compared following normalization of the data on the basis of body surface area estimates. There are no adequate and well-controlled studies in pregnant women. However, a retrospective analysis of birth defects among children born to mothers that used drugs of the same class as Oralone® (corticosteroids) during pregnancy found an approximately 3 times increased incidence of cleft palate. Oralone® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether oral application of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Caution should be exercised when corticosteroid-containing dental pastes are prescribed for a nursing woman.

Pediatric Use

The safety and efficacy of Oralone® in children is unknown. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's Syndrome than mature patients because of a larger skin surface area to body weight ratio. Administration of corticosteroid-containing dental pastes to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Geriatric Use

Clinical studies of Oralone® did not include sufficient numbers of subjects age 65 and older to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Press a small dab (about 1/4 inch) to the lesion until a thin film develops. A larger quantity may be required for coverage of some lesions. For optimal results use only enough to coat the lesion with a thin film. Do not rub in. Attempting to spread this preparation may result in granular, gritty sensation and cause it to crumble. After application, however, a smooth, slippery film develops.

The preparation should be applied at bedtime to permit steroid contact with the lesion throughout the night. Depending on the severity of symptoms, it may be necessary to apply the preparation two or three times a day, preferably after meals. If significant repair or regeneration has not occurred in seven days, further investigation is advisable.