Fluocinolone Acetonide Oil
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Manufacturer Warnings
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Uses
Fluocinolone Acetonide 0.01% Topical Oil is a low to medium potency corticosteroid indicated:
In adult patients for the treatment of psoriasis of the scalp (Scalp Oil).
History
There is currently no drug history available for this drug.
Other Information
Fluocinolone Acetonide 0.01 % Topical Oil contains 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 for topical use dermatologic use. This formulation is also marketed as Fluocinolone Acetonide 0.01% Topical Oil for use as body oil for atopic dermatitis in adults and for moderate to severe atopic dermatitis in pediatric patients 2 years and older, and as fluocinolone acetonide oil, 0.01% for chronic eczematous external otitis. Chemically, fluocinolone acetonide is C24H30F2O6. It has the following structural formula:
Fluocinolone acetonide in Fluocinolone Acetonide 0.01% Topical Oil has a molecular weight of 452.50. It is a white crystalline powder that is odorless, stable in light, and melts at 270ºC with decomposition; soluble in alcohol, acetone and methanol; slightly soluble in chloroform; insoluble in water.
Each gram of Fluocinolone Acetonide 0.01% Topical Oil contains approximately 0.11 mg of fluocinolone acetonide in a blend of oils, which contains isopropyl alcohol, isopropyl myristate, light mineral oil, oleth-2, and refined peanut oil NF.
Each packaged product contains 2 shower caps. The shower cap is made of low density polyethylene material with rubber elastic.
Sources
Fluocinolone Acetonide Oil Manufacturers
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Physicians Total Care, Inc.
![Fluocinolone Acetonide Oil [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Fluocinolone Acetonide Oil | Physicians Total Care, Inc.
Fluocinolone Acetonide 0.01% Topical Oil for scalp psoriasis in adults (Scalp Oil):
For the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. Apply a thin film of Fluocinolone Acetonide 0.01% Topical Oil on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight, or for a minimum of 4 hours before washing off. Wash hair with regular shampoo and rinse thoroughly.
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Amneal Pharmaceuticals, Llc
Fluocinolone Acetonide Oil | Amneal Pharmaceuticals, Llc
Fluocinolone acetonide 0.01% topical oil is not for oral, ophthalmic, or intravaginal use.
The dosing of fluocinolone acetonide 0.01% topical oil is different for adult and pediatric patients.
2.1 Adult Patients with Atopic DermatitisApply fluocinolone acetonide 0.01% topical oil as a thin film to the affected areas three times daily.
2.2 Pediatric Patients with Atopic DermatitisMoisten skin and apply fluocinolone acetonide 0.01% topical oil as a thin film to the affected areas twice daily for up to four weeks.
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Amneal Pharmaceuticals, Llc
Fluocinolone Acetonide Oil | Zydus Pharmaceuticals (usa) Inc.
Ribavirin should be taken with food. Ribavirin should be given in combination with peginterferon alfa-2a; it is important to note that ribavirin should never be given as monotherapy. See peginterferon alfa-2a Package Insert for all instructions regarding peginterferon alfa-2a dosing and administration.
2.1 Chronic Hepatitis C MonoinfectionAdult Patients
The recommended dose of ribavirin tablets is provided in Table 1. The recommended duration of treatment for patients previously untreated with ribavirin and interferon is 24 to 48 weeks.
The daily dose of ribavirin is 800 mg to 1200 mg administered orally in two divided doses. The dose should be individualized to the patient depending on baseline disease characteristics (e.g., genotype), response to therapy, and tolerability of the regimen (see Table 1).
Table 1Peginterferon alfa-2a and Ribavirin Dosing Recommendations Hepatitis C Virus (HCV) Genotype
Peginterferon Alfa-2a Dose*
(once weekly)
Ribavirin Dose
(daily)
Duration
Genotypes 2 and 3 showed no increased response to treatment beyond 24 weeks (see Table 10).
Data on genotypes 5 and 6 are insufficient for dosing recommendations.
*See Peginterferon alfa-2a Package Insert for further details on peginterferon alfa-2a dosing and administration, including dose modification in patients with renal impairment.
Genotypes 1, 4
180 mcg
< 75 kg = 1000 mg
≥ 75 kg = 1200 mg
48 weeks
48 weeks
Genotypes 2, 3
180 mcg
800 mg
24 weeks
Pediatric Patients
Peginterferon alfa-2a is administered as 180 mcg/1.73m2 x BSA once weekly subcutaneously, to a maximum dose of 180 mcg, and should be given in combination with ribavirin. The recommended treatment duration for patients with genotype 2 or 3 is 24 weeks and for other genotypes is 48 weeks.
Ribavirin should be given in combination with peginterferon alfa-2a. Ribavirin is available only as a 200 mg tablet and therefore the healthcare provider should determine if this sized tablet can be swallowed by the pediatric patient. The recommended doses for Ribavirin are provided in Table 2. Patients who initiate treatment prior to their 18th birthday should maintain pediatric dosing through the completion of therapy
Table 2 Ribavirin Dosing Recommendations for Pediatric Patients*approximately 15 mg/kg/day
Body Weight in kilograms (kg)
Ribavirin Daily Dose*
Ribavirin Number of Tablets
23 to 33
400 mg/day
1 x 200 mg tablet A.M.
1 x 200 mg tablet P.M.
34 to 46
600 mg/day
1 x 200 mg tablet A.M.
2 x 200 mg tablets P.M.
47 to 59
800 mg/day
2 x 200 mg tablets A.M.
2 x 200 mg tablets P.M.
60 to 74
1000 mg/day
2 x 200 mg tablets A.M.
3 x 200 mg tablets P.M.
≥ 75
1200 mg/day
3 x 200 mg tablets A.M.
3 x 200 mg tablets P.M.
2.2 Chronic Hepatitis C with HIV CoinfectionAdult Patients
The recommended dose for treatment of chronic hepatitis C in patients coinfected with HIV is peginterferon alfa-2a 180 mcg subcutaneous once weekly and ribavirin 800 mg by mouth daily for a total duration of 48 weeks, regardless of HCV genotype.
2.3 Dose ModificationsAdult and Pediatric Patients
If severe adverse reactions or laboratory abnormalities develop during combination ribavirin/peginterferon alfa-2a therapy, the dose should be modified or discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after dose adjustment, ribavirin/peginterferon alfa-2a therapy should be discontinued. Table 3 provides guidelines for dose modifications and discontinuation based on the patient's hemoglobin concentration and cardiac status.
Ribavirin should be administered with caution to patients with pre-existing cardiac disease. Patients should be assessed before commencement of therapy and should be appropriately monitored during therapy. If there is any deterioration of cardiovascular status, therapy should be stopped [see WARNINGS AND PRECAUTIONS (5.2)].
Table 3Ribavirin Dose Modification Guidelines in Adults and Pediatrics Body weight in kilograms (kg)
Laboratory Values
Hemoglobin <10 g/dL in patients with no cardiac disease, or Decrease in hemoglobin of ≥2 g/dL during any 4 week period in patients with history of stable cardiac disease
Hemoglobin <8.5 g/dL in patients with no cardiac disease, or Hemoglobin <12 g/dL despite 4 weeks at reduced dose in patients with history of stable cardiac disease
Adult Patients older than 18 years of age
Any weight
1 x 200 mg tablet A.M.
2 x 200 mg tablets P.M.
Discontinue Ribavirin
Pediatric Patients 5 to 18 years of age
23 to 33 kg
1 x 200 mg tablet A.M.
34 to 46 kg
1 x 200 mg tablet A.M.
1 x 200 mg tablet P.M.
47 to 59 kg
1 x 200 mg tablet A.M.
1 x 200 mg tablet P.M.
Discontinue Ribavirin
60 to 74 kg
1 x 200 mg tablet A.M.
2 x 200 mg tablets P.M.
≥ 75kg
1 x 200 mg tablet A.M.
2 x 200 mg tablets P.M.
The guidelines for ribavirin dose modifications outlined in this table also apply to laboratory abnormalities or adverse reactions other than decreases in hemoglobin values.
Adult Patients
Once ribavirin has been withheld due to either a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart ribavirin at 600 mg daily and further increase the dose to 800 mg daily. However, it is not recommended that ribavirin be increased to the original assigned dose (1000 mg to 1200 mg).
Pediatric Patients
Upon resolution of a laboratory abnormality or clinical adverse reaction, an increase in ribavirin dose to the original dose may be attempted depending upon the physician's judgment. If ribavirin has been withheld due to a laboratory abnormality or clinical adverse reaction, an attempt may be made to restart ribavirin at one-half the full dose.
2.4 Renal ImpairmentThe total daily dose of ribavirin should be reduced for patients with creatinine clearance less than or equal to 50 mL/min; and the weekly dose of peginterferon alfa-2a should be reduced for creatinine clearance less than 30 mL/min as follows in Table 4 [see USE IN SPECIFIC POPULATIONS (8.7), PHARMACOKINETICS (12.3), and Peginterferon Alfa-2a PACKAGE INSERT].
Table 4Dosage Modification for Renal Impairment Creatinine Clearance
Peginterferon Alfa-2a Dose (once weekly)
Ribavirin Dose
(daily)
30 to 50 mL/min
180 mcg
Alternating doses, 200 mg and 400 mg every other day
Less than 30 mL/min
135 mcg
200 mg daily
Hemodialysis
135 mcg
200 mg daily
The dose of ribavirin should not be further modified in patients with renal impairment. If severe adverse reactions or laboratory abnormalities develop, ribavirin should be discontinued, if appropriate, until the adverse reactions abate or decrease in severity. If intolerance persists after restarting ribavirin, ribavirin /peginterferon alfa-2a therapy should be discontinued.
No data are available for pediatric subjects with renal impairment.
2.5 Discontinuation of DosingDiscontinuation of peginterferon alfa-2a /ribavirin therapy should be considered if the patient has failed to demonstrate at least a 2 log10 reduction from baseline in HCV RNA by 12 weeks of therapy, or undetectable HCV RNA levels after 24 weeks of therapy.
Peginterferon alfa-2a/ribavirin therapy should be discontinued in patients who develop hepatic decompensation during treatment [see WARNINGS AND PRECAUTIONS (5.3)].
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Amneal Pharmaceuticals, Llc
Fluocinolone Acetonide Oil | Amneal Pharmaceuticals, Llc
Fluocinolone Acetonide 0.01% Topical Oil for scalp psoriasis in adults (Scalp Oil):
For the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. Apply a thin film of Fluocinolone Acetonide 0.01% Topical Oil on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight, or for a minimum of 4 hours before washing off. Wash hair with regular shampoo and rinse thoroughly.
-
Physicians Total Care, Inc.
Fluocinolone Acetonide Oil | Physicians Total Care, Inc.
Fluocinolone acetonide 0.01% topical oil is not for oral, ophthalmic, or intravaginal use.
The dosing of fluocinolone acetonide 0.01% topical oil is different for adult and pediatric patients.
2.1. Adult Patients with Atopic DermatitisApply fluocinolone acetonide 0.01% topical oil as a thin film to the affected areas three times daily.
2.2. Pediatric Patients with Atopic DermatitisMoisten skin and apply fluocinolone acetonide 0.01% topical oil as a thin film to the affected areas twice daily for up to four weeks.
-
Seton Pharmaceuticals
Fluocinolone Acetonide Oil | Seton Pharmaceuticals
Fluocinolone Acetonide 0.01% Topical Oil (Body Oil) is not for oral, ophthalmic, or intravaginal use.
The dosing of Fluocinolone Acetonide 0.01% Topical Oil (Body Oil) is different for adult and pediatric patients.
2.1 Adult Patients with Atopic DermatitisApply Fluocinolone Acetonide 0.01% Topical Oil as a thin film to the affected areas three times daily.
2.2 Pediatric Patients with Atopic DermatitisMoisten skin and apply Fluocinolone Acetonide 0.01% Topical Oil as a thin film to the affected areas twice daily for up to four weeks.
-
Seton Pharmaceuticals
Fluocinolone Acetonide Oil | Seton Pharmaceuticals
Fluocinolone Acetonide 0.01% Topical Oil for scalp psoriasis in adults (Scalp Oil):
For the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. Apply a thin film of Fluocinolone Acetonide 0.01% Topical Oil on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight or for a minimum of 4 hours before washing off. Wash hair with regular shampoo and rinse thoroughly.
-
Avkare, Inc.
Fluocinolone Acetonide Oil | Avkare, Inc.
For the treatment of chronic eczematous external otitis, using the supplied ear-dropper, apply 5 drops of fluocinolone acetonide oil 0.01% 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 oil 0.01% into the ear. Keep head tilted for about a minute to allow fluocinolone acetonide oil 0.01% 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.
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Avkare, Inc.
Fluocinolone Acetonide Oil | Avkare, Inc.
Fluocinolone acetonide 0.01% topical oil is not for oral, ophthalmic, or intravaginal use.
The dosing of fluocinolone acetonide 0.01% topical oil is different for adult and pediatric patients.
2.1. Adult Patients with Atopic DermatitisApply fluocinolone acetonide 0.01% topical oil as a thin film to the affected areas three times daily.
2.2. Pediatric Patients with Atopic DermatitisMoisten skin and apply fluocinolone acetonide 0.01% topical oil as a thin film to the affected areas twice daily for up to four weeks.
-
Avkare, Inc.
Fluocinolone Acetonide Oil | Avkare, Inc.
Fluocinolone Acetonide 0.01% Topical Oil for scalp psoriasis in adults (Scalp Oil):
For the treatment of scalp psoriasis, wet or dampen hair and scalp thoroughly. Apply a thin film of Fluocinolone Acetonide 0.01% Topical Oil on the scalp, massage well and cover scalp with the supplied shower cap. Leave on overnight, or for a minimum of 4 hours before washing off. Wash hair with regular shampoo and rinse thoroughly.
![Fluocinolone Acetonide Oil [Amneal Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=64586ff9-941a-418a-a870-ffb5dafbe24b&name=df21fdb6-figure-01.jpg)
![Fluocinolone Acetonide Oil [Amneal Pharmaceuticals, Llc]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
![Fluocinolone Acetonide Oil [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d4160d8e-1b2c-4577-bdf5-9d340587774d&name=6383.jpg)
![Fluocinolone Acetonide Oil [Seton Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=bd2fe552-f27c-4a54-89f4-6825fdf5a4d2&name=a25d66f9-01c4-4520-b134-b1ea7657838a-02.jpg)
![Fluocinolone Acetonide Oil [Seton Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8d55d846-c833-4040-b02d-ac7783311dd6&name=16e3bb49-35e7-40b9-9004-58f17a71dea6-02.jpg)
![Fluocinolone Acetonide Oil [Avkare, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=99893524-1399-8cd6-3492-23fe29499697&name=7e067c03-figure-01.jpg)
![Fluocinolone Acetonide Oil [Avkare, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3043d75a-c935-c0a9-c51d-d6537a29bf49&name=67e604ed-figure-01.jpg)
![Fluocinolone Acetonide Oil [Avkare, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=272d9245-20bc-996e-c562-8116c2d911ba&name=86f09bb4-figure-01.jpg)
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