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Drug overview for DERMOTIC OIL (fluocinolone acetonide oil):
Generic name: fluocinolone acetonide oil (FLOO-oh-SIN-oh-lone)
Drug class: Otic Steroids
Therapeutic class: Otic (Ear)
Fluocinolone acetonide is a synthetic fluorinated corticosteroid.
No enhanced Uses information available for this drug.
Generic name: fluocinolone acetonide oil (FLOO-oh-SIN-oh-lone)
Drug class: Otic Steroids
Therapeutic class: Otic (Ear)
Fluocinolone acetonide is a synthetic fluorinated corticosteroid.
No enhanced Uses information available for this drug.
DRUG IMAGES
DERMOTIC OIL 0.01% EAR DROPS
The following indications for DERMOTIC OIL (fluocinolone acetonide oil) have been approved by the FDA:
Indications:
Otitis externa eczema
Professional Synonyms:
Otitis externa eczematoid
Indications:
Otitis externa eczema
Professional Synonyms:
Otitis externa eczematoid
The following dosing information is available for DERMOTIC OIL (fluocinolone acetonide oil):
Dosage of fluocinolone acetonide is expressed in terms of the salt.
The usual dosage of fluocinolone acetonide in adults and pediatric patients 12 years of age and older is 0.59 mg (1 implant) in each affected eye approximately every 30 months. The implant is designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6
mcg daily, which decreases over the first month to a steady state of 0.3-0.4 mcg daily for approximately 30 months. Following depletion of fluocinolone acetonide from the implant (as evidenced by recurrence of uveitis), the implant may be removed and replaced with a new implant to continue therapy.
The usual dosage of fluocinolone acetonide in adults and pediatric patients 12 years of age and older is 0.59 mg (1 implant) in each affected eye approximately every 30 months. The implant is designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6
mcg daily, which decreases over the first month to a steady state of 0.3-0.4 mcg daily for approximately 30 months. Following depletion of fluocinolone acetonide from the implant (as evidenced by recurrence of uveitis), the implant may be removed and replaced with a new implant to continue therapy.
Fluocinolone acetonide is administered as an implant that is inserted intravitreally (through a pars plana incision) into the posterior segment of the affected eye. Simultaneous implantation into both eyes should be avoided to minimize the risk of bilateral postoperative infection. (See Increased Susceptibility to Infection under Warnings/Precautions: Warnings, in Cautions.) Fluocinolone acetonide implants should be handled with extreme caution and only by the suture tab to avoid damaging the implant; damage to the implant may result in an increased rate of drug release.
Care should be taken during implantation and explantation to avoid sheer forces on the implant that could disengage the silicone cup reservoir (which contains a fluocinolone acetonide tablet) from the suture tab. Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure to ensure the sterility of the surgical field and of fluocinolone acetonide implants. Fluocinolone acetonide implants should not be resterilized by any method.
Care should be taken during implantation and explantation to avoid sheer forces on the implant that could disengage the silicone cup reservoir (which contains a fluocinolone acetonide tablet) from the suture tab. Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure to ensure the sterility of the surgical field and of fluocinolone acetonide implants. Fluocinolone acetonide implants should not be resterilized by any method.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| DERMOTIC OIL 0.01% EAR DROPS | Maintenance | Adults instill 5 drops into affected ear(s) by otic route 2 times per day |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| FLUOCINOLONE OIL 0.01% EAR DRP | Maintenance | Adults instill 5 drops into affected ear(s) by otic route 2 times per day |
The following drug interaction information is available for DERMOTIC OIL (fluocinolone acetonide oil):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for DERMOTIC OIL (fluocinolone acetonide oil):
Drug contraindication overview.
Most viral diseases of the cornea and conjunctiva (including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella (chickenpox)); mycobacterial infections of the eye; and fungal diseases of ocular structures. Known or suspected hypersensitivity to fluocinolone acetonide, other corticosteroids, or any ingredient in the formulation.
Most viral diseases of the cornea and conjunctiva (including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella (chickenpox)); mycobacterial infections of the eye; and fungal diseases of ocular structures. Known or suspected hypersensitivity to fluocinolone acetonide, other corticosteroids, or any ingredient in the formulation.
There are 0 contraindications.
There are 5 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Fungal infection in the ear |
| Herpes simplex infection |
| Herpes zoster oticus |
| Tuberculosis of the ear |
| Viral infection in the ear |
There are 0 moderate contraindications.
The following adverse reaction information is available for DERMOTIC OIL (fluocinolone acetonide oil):
Adverse reaction overview.
Adverse ocular effects reported in 50-90% of patients receiving fluocinolone acetonide implants include cataract, increased IOP, ocular pain, and surgical complications (e.g., cataract fragments in the eye; injury; mechanical complication, migration, or expulsion of implant; wound complications or dehiscence). Adverse ocular effects reported in 10-35% of patients include reduced visual acuity, conjunctival hemorrhage, conjunctival hyperemia, glaucoma, blurred vision, abnormal sensation in the eye, ocular irritation, hypotony, pruritus, vitreous floaters, maculopathy, vitreous hemorrhage, ptosis, ocular inflammation, eyelid edema, increased tearing, and dry eye. The most common adverse systemic effect reported in patients receiving fluocinolone acetonide implants was headache (31%).
Adverse ocular effects reported in 50-90% of patients receiving fluocinolone acetonide implants include cataract, increased IOP, ocular pain, and surgical complications (e.g., cataract fragments in the eye; injury; mechanical complication, migration, or expulsion of implant; wound complications or dehiscence). Adverse ocular effects reported in 10-35% of patients include reduced visual acuity, conjunctival hemorrhage, conjunctival hyperemia, glaucoma, blurred vision, abnormal sensation in the eye, ocular irritation, hypotony, pruritus, vitreous floaters, maculopathy, vitreous hemorrhage, ptosis, ocular inflammation, eyelid edema, increased tearing, and dry eye. The most common adverse systemic effect reported in patients receiving fluocinolone acetonide implants was headache (31%).
There are 6 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Acneiform eruption Contact dermatitis Hypercortisolism Infection Skin atrophy Skin striae |
There are 4 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Ear stinging |
| Rare/Very Rare |
|---|
|
Ear irritation Ear itching Folliculitis |
The following precautions are available for DERMOTIC OIL (fluocinolone acetonide oil):
Safety and efficacy not established in children younger than 12 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.)
Systemically administered corticosteroids are distributed into milk and may suppress growth, interfere with endogenous corticosteroid production, or cause other adverse effects. Not known whether ocular administration of fluocinolone acetonide could result in sufficient systemic absorption to produce detectable quantities in milk; caution if used in nursing women.
No substantial differences in safety and efficacy relative to younger adults.
The following prioritized warning is available for DERMOTIC OIL (fluocinolone acetonide oil):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for DERMOTIC OIL (fluocinolone acetonide oil)'s list of indications:
| Otitis externa eczema | |
| H60.54 | Acute eczematoid otitis externa |
| H60.541 | Acute eczematoid otitis externa, right ear |
| H60.542 | Acute eczematoid otitis externa, left ear |
| H60.543 | Acute eczematoid otitis externa, bilateral |
| H60.549 | Acute eczematoid otitis externa, unspecified ear |
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