Fluocinolone Acetonide

Pronunciation: floo-oh-SIN-oh-lone ah-SEE-toe-nide
Class: Corticosteroid

Trade Names

Capex
- Shampoo 0.01%

Derma-Smoothe/FS
- Oil 0.01%

Fluocinolone Acetonide
- Solution 0.01%
- Cream 0.01%
- Cream 0.025%
- Ointment 0.025%

Retisert
- Implant 0.59 mg

Fluoderm (Canada)

Pharmacology

Low- to medium-potency topical corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. Thought to act by induction of phospholipase A2 inhibitory proteins (lipocortins). Lipocortins appear to control biosynthesis of potent mediators of inflammation (prostaglandins, leukotrienes) by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Indications and Usage

Capex

Treatment of seborrheic dermatitis of the scalp.

Cream, Ointment, Solution

Relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatosis.

Derma-Smoothe/FS

Treatment of scalp psoriasis.

Retisert intravitreal implant

Treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.

Contraindications

Hypersensitivity to any component of the product. Retisert : Most viral diseases of cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also mycobacterial infections of the eye and fungal diseases of ocular structures.

Dosage and Administration

Adults and Children

Topical Apply sparingly to affected areas 2 to 4 times daily (once daily for medicated shampoo and topical oil).

Chronic Non-Infectious Uveitis ( Retisert only)
Adults

Intravitreal implant Surgically inserted into posterior segment of affected every 30 mo.

General Advice

  • Topical
  • For topical use only. Not for ophthalmic, oral, or intravaginal use.
  • Do not apply to face, groin, or axillae unless directed by health care provider.
  • Avoid contact with eyes. If medication does come into contact with eyes, wash them with large amounts of cool water. Notify health care provider if eye irritation occurs.
  • Apply medication sparingly, but in sufficient quantity to cover affected area(s), and rub in gently.
  • Do not cover with occlusive dressing unless ordered by health care provider.
  • If using solution on scalp, part the hair, apply a small amount of the medicine on the affected area, rub it in gently, then protect the area from washing and rubbing until the solution dries. Advise patient that they may wash hair as usual but not right after applying the medicine.
  • Shampoo: Shake well before using. Apply approximately 1 oz to scalp area, work into a lather. Allow lather to remain on the scalp for about 5 min, then rinse hair and scalp thoroughly with water.
  • Topical oil: Thoroughly wet or dampen hair and scalp; apply thin film of oil on scalp, massage well and cover scalp with supplied shower cap. Leave on overnight or for minimum of 4 h before washing off. Wash hair with regular shampoo and rinse thoroughly.
  • Implant
  • The ocular implant contains 1 tablet of fluocinolone 0.59 mg, designed to release fluocinolone at a nominal initial rate of 0.6 mcg/day, decreasing over the first month to a steady state between 0.3 to 0.4 mcg/day over approximately 30 months.

Storage/Stability

Store solution, cream, ointment, shampoo, and oil below 86°F. Protect from freezing. Store intravitreal implants at controlled room temperature (59° to 77°F). Protect from freezing.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Retisert

Headache (31%); dizziness (5% to 15%).

Dermatologic

Burning; itching; irritation; dryness; folliculitis; hypertrichosis; acneiform eruptions; hypopigmentation; perioral dermatitis; allergic contact dermatitis; maceration of the skin; secondary infection; skin atrophy; striae; miliaria.

Retisert

Rash (5% to 15%).

EENT

Cataracts; glaucoma.

Retisert

Elevated IOP with possible development of glaucoma, eye pain, procedural complications (including cataract fragments, implant expulsion, injury, mechanical complications of implant, migration of implant, post-op complications, post-op wound complication, wound dehiscence [50% to 90%]); within 2 yr post-implant, nearly all phakic eyes are expected to develop cataracts and require surgery; within 34 wk post-implantation, about 60% of patients will require IOP-lowering medication to control IOP; within an average post-implantation period of about 2 yr, approximately 32% of patients are expected to require filtering procedures to control IOP; reduced visual acuity, conjunctival hemorrhage, conjunctival hyperemia, glaucoma, blurred vision, abnormal sensation in the eye, eye irritation, hypotony, pruritus, vitreous floaters, maculopathy, vitreous hemorrhage, ptosis, eye inflammation, eyelid edema, increased tearing, dry eye (10% to 35%); macular edema, visual disturbances, eye discharge, conjunctival edema/chemosis, photophobia, blepharitis, corneal edema, photopsia, retinal hemorrhage, choroidal detachment, vitreous opacities, eye swelling (5% to 9%); nasopharyngitis (5% to 15%); optic nerve damage, visual acuity and field defects; posterior subcapsular cataract formation; delayed wound healing; perforation of the globe where there is thinning of the sclera; development of secondary ocular infections (including bacterial, fungal, and viral).

GI

Retisert

Nausea, vomiting (5% to 15%).

Musculoskeletal

Retisert

Arthralgia, back pain, limb pain (5% to 15%).

Respiratory

Retisert

Cough, sinusitis, upper respiratory tract infection (5% to 15%).

Miscellaneous

Systemic absorption may produce reversible hypothalamic pituitary adrenal (HPA) axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glycosuria.

Retisert

Influenza, pain, pyrexia (5% to 15%).

Precautions

Monitor

Assess and document skin condition before initial topical application and periodically throughout treatment. Inform health care provider if condition does not improve, worsens, or if application site reactions develop. Periodically evaluate patient applying medication to a large surface area, or to areas under occlusion, for evidence of HPA axis suppression (eg, ACTH stimulation, A.M. plasma cortisol, urinary free cortisol tests). If HPA axis suppression is noted, ensure that attempts are made to discontinue the drug, reduce frequency of application, or substitute a less potent corticosteroid. Be prepared to supplement with systemic corticosteroids if symptoms of glucocorticosteroid insufficiency occur. Monitor IOP following implantation of vitreal implant.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established. Children may be more susceptible to systemic toxicity from equivalent doses because of their larger skin surface to body mass ratios. Safety and efficacy of intravitreal implant has not been established in children younger than 12 years of age.

Topical Products

Concomitant skin infection

Ensure that appropriate antifungal or antibacterial therapy is used in a patient who has a concomitant skin infection.

Systemic effects

Systemic absorption may produce reversible HPA axis suppression, manifestations of Cushing syndrome, hyperglycemia, and glucosuria. Prolonged application or application to large surface areas or areas under occlusion increase risk of systemic effects.

Intravitreal Implant

Surgical risk

Potential complications accompanying intraocular surgery may include: cataract formation, choroidal detachment, temporary decreased visual acuity, endophthalmitis, hypotony, increased IOP, exacerbation of intraocular inflammation, retinal detachment, vitreous hemorrhage, vitreous loss, wound dehiscence.

Glaucoma

Use with caution in presence of glaucoma. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation.

Decreased visual acuity

Following implantation nearly all patients will experience an immediate and temporary decrease in visual acuity in the implanted eye which lasts for approximately 1 to 4 wk.

Viral infection of the eye

Ocular steroids may prolong the course and may exacerbate severity of many viral infections of the eye. Use with great caution in patients with viral disease of the cornea and conjunctiva or in patients with history of herpes simplex infection.

Secondary ocular infections

Ocular corticosteroids may suppress host response and increase the hazard of secondary ocular infections.

Cataract surgery

Use of corticosteroids after cataract surgery may delay healing and increase incidence of bleb formation.

Overdosage

Symptoms

Absorption may be sufficient to produce systemic effects.

Patient Information

  • Topical Products
  • Advise patient to apply cream, ointment, or solution 2 to 4 times daily as directed by health care provider.
  • Caution patient not to apply in greater quantity, or more frequently than prescribed by health care provider.
  • Teach patient or caregiver proper technique for applying cream, ointment, or solution: wash or soak the affected area before applying medication, unless it irritates the affected area(s); wash hands; apply sufficient cream, ointment, or solution to cover affected area(s) sparingly then gently massage into skin; wash hands after applying fluocinonide.
  • Advise patient using solution on scalp to part the hair, apply a small amount of the medicine on the affected area, rub it in gently, then protect the area from washing and rubbing until the solution dries. Advise patient that they may wash hair as usual but not right after applying the medicine.
  • Advise patient using medicated shampoo to shake well before using, then apply approximately 1 oz to scalp area and work into a lather. Allow lather to remain on the scalp for about 5 min, then rinse hair and scalp thoroughly with water.
  • Advise patient using topical oil to thoroughly wet or dampen hair and scalp then apply thin film of oil on scalp, massage well and cover scalp with supplied shower cap. Leave on overnight or for minimum of 4 h before washing off. Wash hair with regular shampoo and rinse thoroughly.
  • Advise patient who has been instructed to use an occlusive dressing to do the following after applying medication to affected area(s): cover the area with plastic wrap. The plastic may be held in place with gauze or an elastic bandage or adhesive tape on the normal skin beside the treated area. Advise patient that instead of using plastic wrap, plastic gloves may be used for the hands, plastic bags for the feet, or a shower cap for the scalp; leave the plastic wrapping or covering in place as long as instructed by health care provider. Instruct patient to cleanse the skin and reapply the medication each time a new plastic wrapping is applied.
  • Advise patient that if an application is missed, to apply it as soon as remembered and then continue on a regular schedule. If it is almost time for the next application, instruct patient to skip the application and continue on a regular schedule. Caution patient not to apply double doses.
  • Caution patient not to apply to face, underarms, or groin area unless directed by health care provider.
  • Caution caregiver of child not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area.
  • Caution patient not to bandage, cover, or wrap treated skin areas or use cosmetics or other skin products over treated areas unless advised by health care provider.
  • Caution patient to avoid contact with eyes. Advise patient that if medication does come into contact with eyes to wash them with large amounts of cool water and to contact their health care provider if eye irritation occurs.
  • Advise patient that symptoms should begin to improve fairly soon after starting treatment and to notify health care provider if condition does not improve, worsens, or if application site reactions (eg, burning, stinging, redness, itching) develop.
  • Advise patient that therapy is usually discontinued when control has been achieved.
  • Intravitreal Implant
  • Review action, potential surgical risks, and potential adverse reactions (eg, decreased visual acuity, elevation of IOP, cataract formation) of intravitreal implant.
  • Advise patient that implant locally treats inflammation in the eye but does not treat the underlying disease and that additional medications may be prescribed to treat the underlying condition.
  • Advise patient that regular ophthalmic follow-up examinations of both eyes will be required and to keep appointments.

Copyright © 2009 Wolters Kluwer Health.

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