fluocinolone

floo-oh-SIN-oh-lone

Therapeutic Classification: corticosteroids

Pharmacologic Classification: corticosteroids

REMS

Management of inflammation and pruritis associated with various allergic/immunologic skin problems.

Suppresses normal immune response and inflammation.

Therapeutic effects:

Suppression of dermatologic inflammation and immune processes.

Absorption: Minimal. Prolonged use on large surface areas, application of large amounts, or use of occlusive dressings may increase systemic absorption.

Distribution: Remains primarily at site of action.

Metabolism/Excretion: Usually metabolized in skin.

Half-Life: Unknown.

(response depends on condition being treated)

ROUTE	ONSET	PEAK	DURATION
Topical	min–hrs	hrs–days	hrs–days

Contraindicated in:

Hypersensitivity or known intolerance to corticosteroids or components of vehicles (ointment or cream base, preservative, alcohol);
Untreated bacterial or viral infections.

Use Cautiously in:

Hepatic dysfunction;
Diabetes mellitus, cataracts, glaucoma, or tuberculosis (use of large amounts of high-potency agents may worsen condition);
Patients with pre-existing skin atrophy;
Pregnancy, lactation, or children (chronic high-dose usage may result in adrenal suppression in mother, growth suppression in children; children may be more susceptible to adrenal and growth suppression).

Derm: allergic contact dermatitis, atrophy, burning, dryness, edema, folliculitis, hypersensitivity reactions, hypertrichosis, hypopigmentation, irritation, maceration, miliaria, perioral dermatitis, secondary infection, striae

Misc: adrenal suppression (use of occlusive dressings, long-term therapy)

Drug-drug:

None significant.

(Adults ): Apply to affected area(s) 2–5 times daily (depends on preparation and condition being treated).
(Children ≥2 yr): Apply to affected area(s) 1–2 times daily (depends on product, preparation, and condition being treated).

(Generic available)

Cream: 0.01%; 0.025%
Ointment: 0.025%
Solution: 0.01%
Shampoo: 0.01%
Oil: 0.01%
In combination with: hydroquinone and tretinoin (Tri-Luma). See Appendix [not included in this PDA edition].

Assess affected skin before and daily during therapy. Note degree of inflammation and pruritus. Notify health care professional if symptoms of infection (increased pain, erythema, purulent exudate) develop.

Lab Test Considerations:

Periodic adrenal function tests may be ordered to assess degree of hypothalamic-pituitary-adrenal (HPA) axis suppression in chronic topical therapy if suspected. Children and patients with dose applied to a large area, using an occlusive dressing, or using high-potency products are at highest risk for HPA suppression.
- May cause increased serum and urine glucose concentrations if significant absorption occurs.

Choice of vehicle depends on site and type of lesion. Ointments are more occlusive and preferred for dry, scaly lesions. Creams should be used on oozing or intertriginous areas, where the occlusive action of ointments might cause folliculitis or maceration. Creams may be preferred for aesthetic reasons even though they may be more drying to skin than ointments. Gels, aerosols, lotions, and solutions are useful in hairy areas.
Apply ointments, creams, orsolutions sparingly as a thin film to clean, slightly moist skin. Wash hands immediately after application. Apply occlusive dressing only if specified by health care professional.
- Apply shampoo oroil to hair by parting hair and applying a small amount to affected area. Rub in gently. Protect area from washing, clothing, or rubbing until medication has dried. Hair may be washed as usual but not immediately after applying medication.

Instruct patient on correct technique of medication administration. Emphasize importance of avoiding the eyes. If a dose is missed, it should be applied as soon as remembered unless almost time for the next dose.
Caution patient to use only as directed. Avoid using cosmetics, bandages, dressings, or other skin products over the treated area unless directed by health care professional.
Advise parents of pediatric patients not to apply tight-fitting diapers or plastic pants on a child treated in the diaper area; these garments work like an occlusive dressing and may cause more of the drug to be absorbed.
Advise patient to consult health care professional before using medicine for condition other than indicated.
Caution women that medication should not be used extensively, in large amounts, or for protracted periods if they are pregnant or planning to become pregnant.
Instruct patient to inform health care professional if symptoms of underlying disease return or worsen or if symptoms of infection develop.

Resolution of skin inflammation, pruritus, or other dermatologic conditions.

Capex, Derma-Smoothe/FS, Synalar

Fluoderm

Risk for impaired skin integrity(Indications)
Risk for infection(Side Effects)
Deficient knowledge, Relate med(Patient/Family Teaching)

NDC Code

0168- E. Fougera and Co. a division of Fougera Pharmaceuticals Inc.
- 0168-0058- Fluocinolone Acetonide
  - 0168-0058-15- 15 g in 1 TUBE (0168-0058-15)

0168- E. Fougera and Co. a division of Fougera Pharmaceuticals Inc.
- 0168-0058- Fluocinolone Acetonide
  - 0168-0058-60- 60 g in 1 TUBE (0168-0058-60)

0168- E. FOUGERA and CO., A division of Fougera Pharmaceuticals Inc.
- 0168-0059- Fluocinolone Acetonide
  - 0168-0059-60- 60 mL in 1 BOTTLE (0168-0059-60)

0168- E. Fougera and Co. a division of Fougera Pharmaceuticals Inc.
- 0168-0060- Fluocinolone Acetonide
  - 0168-0060-15- 15 g in 1 TUBE (0168-0060-15)

0168- E. Fougera and Co. a division of Fougera Pharmaceuticals Inc.
- 0168-0060- Fluocinolone Acetonide
  - 0168-0060-60- 60 g in 1 TUBE (0168-0060-60)

0168- E. Fougera and Co. a division of Fougera Pharmaceuticals Inc.
- 0168-0064- Fluocinolone Acetonide
  - 0168-0064-15- 15 g in 1 TUBE (0168-0064-15)

0168- E. Fougera and Co. a division of Fougera Pharmaceuticals Inc.
- 0168-0064- Fluocinolone Acetonide
  - 0168-0064-60- 60 g in 1 TUBE (0168-0064-60)

0299- Galderma Laboratories, L.P.
- 0299-5500- Capex
  - 0299-5500-04- 1 KIT in 1 CARTON (0299-5500-04) * 12 mg in 1 PACKAGE * 118 mL in 1 BOTTLE

0713- ACP Nimble Buyer, Inc.
- 0713-0223- Fluocinolone Acetonide
  - 0713-0223-15- 1 TUBE in 1 CARTON (0713-0223-15) > 15 g in 1 TUBE

0713- ACP Nimble Buyer, Inc.
- 0713-0223- Fluocinolone Acetonide
  - 0713-0223-60- 1 TUBE in 1 CARTON (0713-0223-60) > 60 g in 1 TUBE

0713- ACP Nimble Buyer, Inc.
- 0713-0224- Fluocinolone Acetonide
  - 0713-0224-15- 1 TUBE in 1 CARTON (0713-0224-15) > 15 g in 1 TUBE

0713- ACP Nimble Buyer, Inc.
- 0713-0224- Fluocinolone Acetonide
  - 0713-0224-60- 1 TUBE in 1 CARTON (0713-0224-60) > 60 g in 1 TUBE

0713- Cosette Pharmaceuticals, Inc.
- 0713-0324- Fluocinolone Acetonide
  - 0713-0324-15- 1 TUBE in 1 CARTON (0713-0324-15) > 15 g in 1 TUBE

0713- Cosette Pharmaceuticals, Inc.
- 0713-0324- Fluocinolone Acetonide
  - 0713-0324-60- 1 TUBE in 1 CARTON (0713-0324-60) > 60 g in 1 TUBE

0713- Gand W Laboratories, Inc.
- 0713-0325- Fluocinolone Acetonide
  - 0713-0325-53- 1 BOTTLE in 1 CARTON (0713-0325-53) > 60 mL in 1 BOTTLE

0713- Gand W Laboratories, Inc.
- 0713-0709- FLUOCINOLONE ACETONIDE
  - 0713-0709-15- 1 TUBE in 1 CARTON (0713-0709-15) > 15 g in 1 TUBE

0713- Gand W Laboratories, Inc.
- 0713-0709- FLUOCINOLONE ACETONIDE
  - 0713-0709-60- 1 TUBE in 1 CARTON (0713-0709-60) > 60 g in 1 TUBE

10135- Marlex Pharmaceuticals Inc
- 10135-670- fluocinolone acetonide
  - 10135-670-61- 60 mL in 1 BOTTLE, WITH APPLICATOR (10135-670-61)

13925- Seton Pharmaceuticals
- 13925-506- Fluocinolone Acetonide
  - 13925-506-04- 1 BOTTLE in 1 CARTON (13925-506-04) > 118.28 mL in 1 BOTTLE

13925- Seton Pharmaceuticals
- 13925-507- Fluocinolone Acetonide
  - 13925-507-04- 1 BOTTLE in 1 CARTON (13925-507-04) > 118.28 mL in 1 BOTTLE

13925- Seton Pharmaceuticals
- 13925-508- Fluocinolone acetonide 0.01%
  - 13925-508-20- 1 BOTTLE, DROPPER in 1 CARTON (13925-508-20) > 20 mL in 1 BOTTLE, DROPPER

24208- Bausch and Lomb Incorporated
- 24208-416- Retisert
  - 24208-416-01- 1 POUCH in 1 CARTON (24208-416-01) > 1 IMPLANT in 1 POUCH

39328- Patrin Pharma, Inc.
- 39328-079- Flac Otic Oil
  - 39328-079-20- 1 BOTTLE, DROPPER in 1 CARTON (39328-079-20) > 20 mL in 1 BOTTLE, DROPPER

42291- AvKARE, Inc.
- 42291-284- Fluocinolone Acetonide
  - 42291-284-04- 1 BOTTLE in 1 CARTON (42291-284-04) > 118.28 mL in 1 BOTTLE

42291- AvKARE, Inc.
- 42291-285- Fluocinolone Acetonide
  - 42291-285-04- 1 BOTTLE in 1 CARTON (42291-285-04) > 118.28 mL in 1 BOTTLE

43386- Lupin Pharmaceuticals,Inc.
- 43386-069- Fluocinolone Acetonide
  - 43386-069-60- 1 BOTTLE in 1 CARTON (43386-069-60) > 60 mL in 1 BOTTLE

43538- Medimetriks Pharmaceuticals, Inc.
- 43538-900- Synalar
  - 43538-900-12- 1 TUBE in 1 CARTON (43538-900-12) > 120 g in 1 TUBE

43538- Medimetriks Pharmaceuticals, Inc.
- 43538-900- Synalar
  - 43538-900-99- 6 TUBE in 1 CARTON (43538-900-99) > 3 g in 1 TUBE

43538- Medimetriks Pharmaceuticals, Inc.
- 43538-901- Synalar
  - 43538-901-12- 1 KIT in 1 CARTON (43538-901-12) * 255 g in 1 TUBE * 1 TUBE in 1 CARTON > 120 g in 1 TUBE

43538- Medimetriks Pharmaceuticals, Inc.
- 43538-910- Synalar
  - 43538-910-12- 1 TUBE in 1 CARTON (43538-910-12) > 120 g in 1 TUBE

43538- Medimetriks Pharmaceuticals, Inc.
- 43538-910- Synalar
  - 43538-910-99- 6 TUBE in 1 CARTON (43538-910-99) > 3 g in 1 TUBE

43538- Medimetriks Pharmaceuticals, Inc.
- 43538-911- Synalar
  - 43538-911-12- 1 KIT in 1 CARTON (43538-911-12) * 1 TUBE in 1 CARTON > 120 g in 1 TUBE * 255 g in 1 TUBE

43538- Medimetriks Pharmaceuticals, Inc.
- 43538-920- Synalar
  - 43538-920-60- 1 BOTTLE, WITH APPLICATOR in 1 CARTON (43538-920-60) > 60 mL in 1 BOTTLE, WITH APPLICATOR

43538- Medimetriks Pharmaceuticals, Inc.
- 43538-920- Synalar
  - 43538-920-90- 1 BOTTLE, WITH APPLICATOR in 1 CARTON (43538-920-90) > 90 mL in 1 BOTTLE, WITH APPLICATOR

43538- Medimetriks Pharmaceuticals, Inc.
- 43538-920- Synalar
  - 43538-920-99- 1 BOTTLE, WITH APPLICATOR in 1 CARTON (43538-920-99) > 13 mL in 1 BOTTLE, WITH APPLICATOR

43538- Medimetriks Pharmaceuticals, Inc.
- 43538-921- Synalar TS
  - 43538-921-60- 1 KIT in 1 CARTON (43538-921-60) * 60 mL in 1 BOTTLE, WITH APPLICATOR * 454 g in 1 BOTTLE, PUMP

43538- Medimetriks Pharmaceuticals, Inc.
- 43538-921- Synalar TS
  - 43538-921-90- 1 KIT in 1 CARTON (43538-921-90) * 1 BOTTLE, WITH APPLICATOR in 1 CARTON > 90 mL in 1 BOTTLE, WITH APPLICATOR * 454 g in 1 BOTTLE, PUMP

45802- Perrigo New York Inc
- 45802-009- Fluocinolone Acetonide
  - 45802-009-10- 1 BOTTLE in 1 CARTON (45802-009-10) > 20 mL in 1 BOTTLE

45802- Perrigo New York Inc
- 45802-485- Fluocinolone acetonide
  - 45802-485-26- 1 BOTTLE in 1 CARTON (45802-485-26) > 118.28 mL in 1 BOTTLE

45802- Perrigo New York Inc
- 45802-887- fluocinolone acetonide
  - 45802-887-26- 1 BOTTLE in 1 CARTON (45802-887-26) > 118.28 mL in 1 BOTTLE

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-1356- Fluocinolone Acetonide
  - 51672-1356-8- 1 BOTTLE in 1 CARTON (51672-1356-8) > 118.28 mL in 1 BOTTLE

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-1357- Fluocinolone Acetonide
  - 51672-1357-8- 1 BOTTLE in 1 CARTON (51672-1357-8) > 118.28 mL in 1 BOTTLE

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-1365- Fluocinolone Acetonide
  - 51672-1365-2- 1 BOTTLE in 1 CARTON (51672-1365-2) > 20 mL in 1 BOTTLE

51672- Taro Pharmaceuticals U.S.A., Inc.
- 51672-1365- Fluocinolone Acetonide
  - 51672-1365-4- 1 BOTTLE in 1 CARTON (51672-1365-4) > 60 mL in 1 BOTTLE

52565- Teligent Pharma, Inc.
- 52565-012- Fluocinolone Acetonide
  - 52565-012-59- 1 BOTTLE, WITH APPLICATOR in 1 CARTON (52565-012-59) > 60 mL in 1 BOTTLE, WITH APPLICATOR

52565- Teligent Pharma, Inc.
- 52565-013- Fluocinolone Acetonide
  - 52565-013-15- 1 TUBE in 1 CARTON (52565-013-15) > 15 g in 1 TUBE

52565- Teligent Pharma, Inc.
- 52565-013- Fluocinolone Acetonide
  - 52565-013-60- 1 TUBE in 1 CARTON (52565-013-60) > 60 g in 1 TUBE

52565- Teligent Pharma, Inc.
- 52565-020- Fluocinolone Acetonide
  - 52565-020-15- 1 TUBE in 1 CARTON (52565-020-15) > 15 g in 1 TUBE

52565- Teligent Pharma, Inc.
- 52565-020- Fluocinolone Acetonide
  - 52565-020-60- 1 TUBE in 1 CARTON (52565-020-60) > 60 g in 1 TUBE

52565- Teligent Pharma, Inc.
- 52565-031- Fluocinolone Acetonide
  - 52565-031-15- 1 TUBE in 1 CARTON (52565-031-15) > 15 g in 1 TUBE

52565- Teligent Pharma, Inc.
- 52565-031- Fluocinolone Acetonide
  - 52565-031-60- 1 TUBE in 1 CARTON (52565-031-60) > 60 g in 1 TUBE

61748- VersaPharm Inc - an Akorn Company
- 61748-204- Fluocinolone Acetonide
  - 61748-204-04- 1 BOTTLE in 1 CARTON (61748-204-04) > 118.28 mL in 1 BOTTLE

61748- VersaPharm Inc. - an Akorn Company
- 61748-250- Fluocinolone Acetonide
  - 61748-250-20- 1 BOTTLE in 1 CARTON (61748-250-20) > 20 mL in 1 BOTTLE

64980- Rising Pharmaceuticals, Inc.
- 64980-330- Fluocinolone Acetonide Oil
  - 64980-330-04- 118.28 mL in 1 BOTTLE (64980-330-04)

64980- Rising Pharmaceuticals, Inc.
- 64980-331- Fluocinolone Acetonide Oil
  - 64980-331-04- 118.28 mL in 1 BOTTLE (64980-331-04)

65162- Amneal Pharmaceuticals, LLC
- 65162-702- Fluocinolone Acetonide
  - 65162-702-94- 1 BOTTLE in 1 CARTON (65162-702-94) > 20 mL in 1 BOTTLE

65162- Amneal Pharmaceuticals, LLC
- 65162-703- Fluocinolone Acetonide
  - 65162-703-86- 1 BOTTLE in 1 CARTON (65162-703-86) > 118.28 mL in 1 BOTTLE

65162- Amneal Pharmaceuticals, LLC
- 65162-704- Fluocinolone Acetonide
  - 65162-704-86- 1 BOTTLE in 1 CARTON (65162-704-86) > 118.28 mL in 1 BOTTLE

68462- Glenmark Pharmaceuticals Inc., USA
- 68462-185- fluocinolone acetonide
  - 68462-185-56- 1 BOTTLE, DROPPER in 1 CARTON (68462-185-56) > 20 mL in 1 BOTTLE, DROPPER

68462- Glenmark Pharmaceuticals Inc., USA
- 68462-590- FLUOCINOLONE ACETONIDE
  - 68462-590-89- 1 BOTTLE in 1 CARTON (68462-590-89) > 118.28 mL in 1 BOTTLE

68462- Glenmark Pharmaceuticals Inc., USA
- 68462-591- FLUOCINOLONE ACETONIDE
  - 68462-591-89- 1 BOTTLE in 1 CARTON (68462-591-89) > 118.28 mL in 1 BOTTLE

68611- Alimera Sciences, Inc.
- 68611-190- Iluvien
  - 68611-190-02- 1 TRAY in 1 CARTON (68611-190-02) > 1 APPLICATOR in 1 TRAY > 1 IMPLANT in 1 APPLICATOR

68791- Royal Pharmaceuticals
- 68791-101- Derma-Smoothe/FS
  - 68791-101-04- 1 BOTTLE in 1 CARTON (68791-101-04) > 118.28 mL in 1 BOTTLE

68791- Royal Pharmaceuticals
- 68791-102- Derma-Smoothe/FS
  - 68791-102-04- 1 BOTTLE in 1 CARTON (68791-102-04) > 118.28 mL in 1 BOTTLE

68791- Royal Pharmaceuticals
- 68791-103- DermOtic
  - 68791-103-20- 1 BOTTLE, DROPPER in 1 CARTON (68791-103-20) > 20 mL in 1 BOTTLE, DROPPER

71428- Glasshouse Pharmaceuticals Limited Canada
- 71428-002- Fluocinolone Acetonide
  - 71428-002-60- 1 BOTTLE in 1 CARTON (71428-002-60) > 60 mL in 1 BOTTLE

71879- EyePoint Pharmaceuticals US, Inc
- 71879-136- YUTIQ
  - 71879-136-01- 1 POUCH in 1 BOX, UNIT-DOSE (71879-136-01) > 1 POUCH in 1 POUCH > 1 IMPLANT in 1 POUCH

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Pot. Nursing Diagnoses ⬆ ⬇

Code ⬆