Dosing & Uses
Dosage Forms & Strengths
otic oil
- 0.01%
Eczematous External Otitis
Instill 5 gtt into affected ear(s) twice daily for 7-14 days
Dosage Forms & Strengths
otic oil
- 0.01%
Eczematous External Otitis
<2 years: Safety and efficacy not established
>2 years: Instill 5 gtt into affected ear(s) twice daily for 7-14 days
Adverse Effects
Frequency Not Defined
Burning
Itching
Irritation dryness
Folliculitis
Acneiform eruption
Hypopigmentation, perioral dermatitis
Allergic contact dermatitis
Secondary infection
Skin atrophy
Striae
Miliaria
Ear infection
Warnings
Contraindications
Hypersensitivity
Contains peanut oil; contraindicated in peanut-allergic individuals
Cautions
Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with potential for glucocorticosteroid insufficiency after withdrawal of treatment
Manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria can be produced in some patients by systemic absorption of topical corticosteroids while on treatment
Patients applying a topical steroid to large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression; this may be done by using the ACTH stimulation, AM plasma cortisol, and urinary free cortisol tests
If HPA axis suppression is noted, an attempt should be made to withdraw drug, to reduce frequency of application, or to substitute a less potent corticosteroid
Infrequently, signs and symptoms of glucocorticoid insufficiency may occur requiring supplemental systemic corticosteroids; for information on systemic supplementation, see prescribing information for those products
Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface-to-body mass ratios
Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by failure to heal rather than noting a clinical exacerbation, which may occur with most topical products not containing corticosteroids; such an observation should be corroborated with appropriate diagnostic testing
One peanut-sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with this medication; if wheal and flare-type reactions (which may be limited to pruritus) or other manifestations of hypersensitivity develop, discontinue therapy immediately and institute appropriate therapy
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used; if a favorable response does not occur promptly, discontinue therapy until infection has been adequately controlled
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women on teratogenic effects from therapy; therefore, this drug should be used during pregnancy only if potential benefit justifies potential risk to fetus
Animal data
- Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels; some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals
Lactation
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects
Not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk
Because many drugs are excreted in human milk, caution should be exercised when therapy administered to a nursing woman
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Low-to-medium potency corticosteroid; elicits anti-inflammatory, antipruritic, and vasoconstrictive effects; induces phospholipase A2 inhibitory proteins that are thought to suppress inflammatory mediators (eg, prostaglandins, leukotrienes) by inhibiting arachidonic acid
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| fluocinolone acetonide oil otic (ear) - | 0.01 % drops |  | |
| fluocinolone acetonide oil otic (ear) - | 0.01 % drops |  | |
| fluocinolone acetonide oil otic (ear) - | 0.01 % drops |  | |
| fluocinolone acetonide oil otic (ear) - | 0.01 % drops |  | |
| DermOtic Oil otic (ear) - | 0.01 % drops |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
fluocinolone acetonide oil otic (ear)
FLUOCINOLONE OIL - OTIC
(FLOO-oh-SIN-oh-lone)
COMMON BRAND NAME(S): Dermotic
USES: This medication is used to treat eczema of the outer ear (also known as chronic itchy ear). The main symptom is itchiness, but redness, flaking, or oozing may also occur. Fluocinolone reduces these symptoms. This medication is a low- to medium-strength corticosteroid.
HOW TO USE: To apply ear drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your ear or any other surface. Lie on your side or tilt the affected ear upward. Hold the dropper directly over the ear, and place the prescribed number of drops into the ear canal as directed by your doctor, usually twice a day. To help the drops roll into the ear of an adult, hold the earlobe up and back. In children, hold the earlobe down and back. Keep the head tilted for about 1 minute, or insert a soft cotton plug if so directed. Remove the plug after 1 minute. Repeat for the other ear if so directed. Do not rinse the dropper. Replace the cap after use. Do not bandage, cover, or wrap the area unless directed to do so by your doctor.Avoid getting this medication in the eyes, nose, or mouth. If you get the medication in these areas, rinse with plenty of water.Dosage is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.Use this medication only for the condition for which it was prescribed. Do not use it for longer than prescribed.Tell your doctor if your condition lasts or gets worse after 2 weeks.
SIDE EFFECTS: Stinging, burning, irritation, dryness, or redness at the application site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using fluocinolone, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (such as hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients (such as peanut oil), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.Do not use if there is an infection or sore in the area to be treated. Skin infections can become worse when this medication is used. Tell your doctor promptly if redness, swelling, or irritation does not improve.During pregnancy, this product should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.
MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised May 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
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