Fluocinolone acetonide 0.01%

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Overview

What is Fluocinolone acetonide 0.01%?

Fluocinolone acetonide 0.01% Oil Ear Drops contain fluocinolone acetonide {(6α, 11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17[(1-methylethylidene)bis(oxy)]-pregna-1,4-diene-3,20-dione, cyclic 16,17 acetal with acetone}, a synthetic corticosteroid.

Chemically, fluocinolone acetonide is C H F O. It has the following structural formula:

Fluocinolone acetonide has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270°C with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.

Each gram of Fluocinolone acetonide 0.01% Oil Ear Drops contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, refined peanut oil NF, and fragrances.

What does Fluocinolone acetonide 0.01% look like?

What are the available doses of Fluocinolone acetonide 0.01%?

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What should I talk to my health care provider before I take Fluocinolone acetonide 0.01%?

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How should I use Fluocinolone acetonide 0.01%?

Fluocinolone acetonide 0.01% Oil Ear Drops is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.

For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of Fluocinolone acetonide 0.01% Oil into the affected ear. To apply, tilt head to one side so that the ear is facing up. Then, gently pull the ear lobe backward and upward and apply 5 drops of Fluocinolone acetonide 0.01% Oil into the ear. Keep head tilted for about a minute to allow Fluocinolone acetonide 0.01% Oil to penetrate lower into the ear canal. Gently pat excess material dripping out of the ear using a clean cotton ball. Follow these instructions twice each day for 7 to 14 days.

What interacts with Fluocinolone acetonide 0.01%?

Fluocinolone acetonide 0.01% Oil Ear Drops is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

This product contains refined peanut oil NF (see ).

What are the warnings of Fluocinolone acetonide 0.01%?

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What are the precautions of Fluocinolone acetonide 0.01%?

This medication is to be used as directed by the physician. It is for external use only. Do not use occlusive dressings.
Avoid contact with the eyes. In case of contact, wash eyes liberally with water.
This medication should not be used for any disorder other than that for which it was prescribed.
Patients should promptly report to their physician any worsening of their skin condition.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.

Information for Patients:

Carcinogenesis, mutagenesis, and impairment of fertility:

in vitro

in vivo

in vitro

Pregnancy: Teratogenic effects: Pregnancy category C:

There are no adequate and well-controlled studies in pregnant women on teratogenic effects from Fluocinolone acetonide 0.01% Oil Ear Drops. Therefore, Fluocinolone acetonide 0.01% Oil Ear Drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

What are the side effects of Fluocinolone acetonide 0.01%?

The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with Fluocinolone acetonide 0.01% Oil.

What should I look out for while using Fluocinolone acetonide 0.01%?

Fluocinolone acetonide 0.01% Oil Ear Drops is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

This product contains refined peanut oil NF (see ).

What might happen if I take too much Fluocinolone acetonide 0.01%?

Topically applied Fluocinolone acetonide 0.01% Oil Ear Drops can be absorbed in sufficient amounts to produce systemic effects (see ).

How should I store and handle Fluocinolone acetonide 0.01%?

Keep tightly closed. Store at 25°C (68° to 77°F); excursions permitted to 15°–30°C (59°–86° F) [see USP Controlled Room Temperature].CAUTION: Rx onlyKeep tightly closed. Store at 25°C (68° to 77°F); excursions permitted to 15°–30°C (59°–86° F) [see USP Controlled Room Temperature].CAUTION: Rx onlyFluocinolone acetonide 0.01% Oil Ear Drops is supplied in a 1 fluid ounce bottle containing 20 mL net weight (Dropper Included). (NDC # 13925-508-20).

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Like other topical corticosteroids, fluocinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A inhibitory proteins, collectively called lipocortins. It is postulated that 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 A.

Non-Clinical Toxicology

Fluocinolone acetonide 0.01% Oil Ear Drops is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

This product contains refined peanut oil NF (see ).

Since cilostazol is extensively metabolized by cytochrome P-450 isoenzymes, caution should be exercised when cilostazol is coadministered with inhibitors of CYP3A4 such as ketoconazole and erythromycin or inhibitors of CYP2C19 such as omeprazole. Pharmacokinetic studies have demonstrated that omeprazole and erythromycin significantly increased the systemic exposure of cilostazol and/or its major metabolites. Population pharmacokinetic studies showed higher concentrations of cilostazol among patients concurrently treated with diltiazem, an inhibitor of CYP3A4 (see , ). Cilostazol does not, however, appear to cause increased blood levels of drugs metabolized by CYP3A4, as it had no effect on lovastatin, a drug with metabolism very sensitive to CYP3A4 inhibition.

General:

Patients applying a topical steroid to a 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, A.M. plasma cortisol, and urinary free cortisol tests.

If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the 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. (See )

Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a 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 Fluocinolone acetonide 0.01% Oil (See section).

If wheal and flare type reactions (which may be limited to pruritus) or other manifestations of hypersensitivity develop, Fluocinolone acetonide 0.01% Oil Ear Drops should be discontinued immediately and appropriate therapy instituted.

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, use of Fluocinolone acetonide 0.01% Oil Ear Drops should be discontinued until the infection has been adequately controlled.

Fluocinolone acetonide 0.01% Oil Ear Drops is formulated with 48% refined peanut oil NF. Peanut oil used in this product is routinely tested for peanut proteins through amino acid analysis; the quantity of amino acids is below 0.5 parts per million.

Physicians should use caution in prescribing Fluocinolone acetonide 0.01% Oil Ear Drops for peanut-sensitive individuals.

The following local adverse reactions have been reported infrequently with topical corticosteroids. They may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria. One peanut sensitive child experienced a flare of his atopic dermatitis after 5 days of twice daily treatment with Fluocinolone acetonide 0.01% Oil.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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