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Drug overview for FML (fluorometholone):
Generic name: FLUOROMETHOLONE (FLOOR-oh-METH-oh-lone)
Drug class: Ophthalmic Steroids
Therapeutic class: Ophthalmic Agents
Fluorometholone is a synthetic fluorinated corticosteroid that also is structurally related to progesterone.
No enhanced Uses information available for this drug.
Generic name: FLUOROMETHOLONE (FLOOR-oh-METH-oh-lone)
Drug class: Ophthalmic Steroids
Therapeutic class: Ophthalmic Agents
Fluorometholone is a synthetic fluorinated corticosteroid that also is structurally related to progesterone.
No enhanced Uses information available for this drug.
DRUG IMAGES
FML LIQUIFILM 0.1% EYE DROP
The following indications for FML (fluorometholone) have been approved by the FDA:
Indications:
Acne rosacea keratitis
Allergic conjunctivitis
Corneal abrasion
Corneal ulcer
Cyclitis
Herpes zoster keratitis
Iridocyclitis
Iritis
Ocular inflammation
Post-op ocular inflammation
Punctate epithelial keratopathy
Uveitis
Professional Synonyms:
Acute iritis
Allergy eye itch
Atopic conjunctivitis
Corneal abrasion injury
Corneal injury
Itchy eyes due to allergies
Ocular itching due to allergies
Ophthalmic inflammation
Postoperative ocular inflammation
Postoperative ophthalmic inflammation
Punctate keratopathy
Rosacea keratitis
Ulcerative keratitis
Indications:
Acne rosacea keratitis
Allergic conjunctivitis
Corneal abrasion
Corneal ulcer
Cyclitis
Herpes zoster keratitis
Iridocyclitis
Iritis
Ocular inflammation
Post-op ocular inflammation
Punctate epithelial keratopathy
Uveitis
Professional Synonyms:
Acute iritis
Allergy eye itch
Atopic conjunctivitis
Corneal abrasion injury
Corneal injury
Itchy eyes due to allergies
Ocular itching due to allergies
Ophthalmic inflammation
Postoperative ocular inflammation
Postoperative ophthalmic inflammation
Punctate keratopathy
Rosacea keratitis
Ulcerative keratitis
The following dosing information is available for FML (fluorometholone):
Fluorometholone and fluorometholone acetate are applied topically to the eye. Care should be taken to avoid contamination of the tip of the dropper or ointment tube.
One drop of the 0.1% or 0.25% ophthalmic suspension (containing fluorometholone) may be instilled into the conjunctival sac of the affected eye(s) 2-4 times daily or 1.3
cm (1/2 inch) of the 0.1% ointment may be applied in the conjunctival sac of the affected eye(s) 1-3 times daily. During the initial 24-48 hours of therapy with fluorometholone 0.1%
suspension or ointment, dosage may be increased to 1 drop of suspension or 1.3 cm of ointment every 4 hours. If improvement does not occur within several days, the drug should be discontinued and other therapy begun.
The duration of treatment depends on the type and severity of the disease and may range from a few days to several weeks; long-term therapy should be avoided. When the drug is discontinued, dosage should be gradually tapered to avoid exacerbation of the disease.
When fluorometholone acetate is used, 1 to 2 drops of the 0.1% ophthalmic suspension may be instilled into the conjunctival sac 4 times daily. During the initial 24-48 hours of therapy, dosage may be increased to 2 drops every 2 hours.
If improvement does not occur after 2 weeks, patients should contact a clinician; fluorometholone acetate therapy should not be discontinued prematurely.
One drop of the suspension containing a fixed combination of fluorometholone and sulfacetamide sodium may be instilled into the lower conjunctival sac 4 times daily. When the suspension containing a fixed combination of fluorometholone acetate and tobramycin is used, 1 or 2 drops may be instilled into the conjunctival sac every 4-6 hours; during the initial 24-48 hours of therapy, dosage may be increased to 1 or 2 drops every 2 hours. Therapy should not be discontinued prematurely.
Patients should initially receive a prescription for 20 mL or less of suspension or 8 g or less of ointment and should be reevaluated by their clinician prior to obtaining a refill.
One drop of the 0.1% or 0.25% ophthalmic suspension (containing fluorometholone) may be instilled into the conjunctival sac of the affected eye(s) 2-4 times daily or 1.3
cm (1/2 inch) of the 0.1% ointment may be applied in the conjunctival sac of the affected eye(s) 1-3 times daily. During the initial 24-48 hours of therapy with fluorometholone 0.1%
suspension or ointment, dosage may be increased to 1 drop of suspension or 1.3 cm of ointment every 4 hours. If improvement does not occur within several days, the drug should be discontinued and other therapy begun.
The duration of treatment depends on the type and severity of the disease and may range from a few days to several weeks; long-term therapy should be avoided. When the drug is discontinued, dosage should be gradually tapered to avoid exacerbation of the disease.
When fluorometholone acetate is used, 1 to 2 drops of the 0.1% ophthalmic suspension may be instilled into the conjunctival sac 4 times daily. During the initial 24-48 hours of therapy, dosage may be increased to 2 drops every 2 hours.
If improvement does not occur after 2 weeks, patients should contact a clinician; fluorometholone acetate therapy should not be discontinued prematurely.
One drop of the suspension containing a fixed combination of fluorometholone and sulfacetamide sodium may be instilled into the lower conjunctival sac 4 times daily. When the suspension containing a fixed combination of fluorometholone acetate and tobramycin is used, 1 or 2 drops may be instilled into the conjunctival sac every 4-6 hours; during the initial 24-48 hours of therapy, dosage may be increased to 1 or 2 drops every 2 hours. Therapy should not be discontinued prematurely.
Patients should initially receive a prescription for 20 mL or less of suspension or 8 g or less of ointment and should be reevaluated by their clinician prior to obtaining a refill.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| FML LIQUIFILM 0.1% EYE DROP | Maintenance | Adults instill 1 drop into affected eye(s) by ophthalmic route 4 times per day |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| FLUOROMETHOLONE 0.1% EYE DROP | Maintenance | Adults instill 1 drop into affected eye(s) by ophthalmic route 4 times per day |
The following drug interaction information is available for FML (fluorometholone):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for FML (fluorometholone):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 4 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Fungal infection of eye |
| Herpes simplex dendritic keratitis |
| Tuberculosis of the eye |
| Vaccinia virus keratitis |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Amebic infection of the eye |
| Ocular hypertension |
There are 4 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Diabetes mellitus |
| Krukenberg spindle |
| Open angle glaucoma |
| Severe myopia |
The following adverse reaction information is available for FML (fluorometholone):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 20 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Ocular hypertension |
| Rare/Very Rare |
|---|
|
Adrenocortical insufficiency Cataracts Central serous chorioretinopathy Corneal degeneration Corneal edema Corneal erosion Corneal ulcer Fungal infection of eye Glaucoma Globe perforation Hypercortisolism Hypersensitivity drug reaction Keratitis Optic nerve damage Punctate keratitis Reduced visual acuity Uveitis Visual changes Visual field defect |
There are 23 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Blurred vision |
Headache disorder Iritis Ocular pain |
| Rare/Very Rare |
|---|
|
Accommodation disorder Allergic dermatitis Blepharoptosis Calcification of cornea Chemosis Conjunctival hyperemia Conjunctivitis Dizziness Dysgeusia Eye tearing Foreign body sensation of eye Impaired wound healing Mydriasis Ocular infection Ocular irritation Ocular itching Ocular redness Photophobia Urticaria |
The following precautions are available for FML (fluorometholone):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
No enhanced Pregnancy information available for this drug.
No enhanced Lactation information available for this drug.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for FML (fluorometholone):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for FML (fluorometholone)'s list of indications:
| Acne rosacea keratitis | |
| H16.9 | Unspecified keratitis |
| L71.8 | Other rosacea |
| Allergic conjunctivitis | |
| H10.1 | Acute atopic conjunctivitis |
| H10.10 | Acute atopic conjunctivitis, unspecified eye |
| H10.11 | Acute atopic conjunctivitis, right eye |
| H10.12 | Acute atopic conjunctivitis, left eye |
| H10.13 | Acute atopic conjunctivitis, bilateral |
| H10.44 | Vernal conjunctivitis |
| H10.45 | Other chronic allergic conjunctivitis |
| H16.26 | Vernal keratoconjunctivitis, with limbar and corneal involvement |
| H16.261 | Vernal keratoconjunctivitis, with limbar and corneal involvement, right eye |
| H16.262 | Vernal keratoconjunctivitis, with limbar and corneal involvement, left eye |
| H16.263 | Vernal keratoconjunctivitis, with limbar and corneal involvement, bilateral |
| H16.269 | Vernal keratoconjunctivitis, with limbar and corneal involvement, unspecified eye |
| Corneal abrasion | |
| S05.00xA | Injury of conjunctiva and corneal abrasion without foreign body, unspecified eye, initial encounter |
| S05.01xA | Injury of conjunctiva and corneal abrasion without foreign body, right eye, initial encounter |
| S05.02xA | Injury of conjunctiva and corneal abrasion without foreign body, left eye, initial encounter |
| Corneal ulcer | |
| H16.0 | Corneal ulcer |
| H16.00 | Unspecified corneal ulcer |
| H16.001 | Unspecified corneal ulcer, right eye |
| H16.002 | Unspecified corneal ulcer, left eye |
| H16.003 | Unspecified corneal ulcer, bilateral |
| H16.009 | Unspecified corneal ulcer, unspecified eye |
| H16.01 | Central corneal ulcer |
| H16.011 | Central corneal ulcer, right eye |
| H16.012 | Central corneal ulcer, left eye |
| H16.013 | Central corneal ulcer, bilateral |
| H16.019 | Central corneal ulcer, unspecified eye |
| H16.02 | Ring corneal ulcer |
| H16.021 | Ring corneal ulcer, right eye |
| H16.022 | Ring corneal ulcer, left eye |
| H16.023 | Ring corneal ulcer, bilateral |
| H16.029 | Ring corneal ulcer, unspecified eye |
| H16.03 | Corneal ulcer with hypopyon |
| H16.031 | Corneal ulcer with hypopyon, right eye |
| H16.032 | Corneal ulcer with hypopyon, left eye |
| H16.033 | Corneal ulcer with hypopyon, bilateral |
| H16.039 | Corneal ulcer with hypopyon, unspecified eye |
| H16.04 | Marginal corneal ulcer |
| H16.041 | Marginal corneal ulcer, right eye |
| H16.042 | Marginal corneal ulcer, left eye |
| H16.043 | Marginal corneal ulcer, bilateral |
| H16.049 | Marginal corneal ulcer, unspecified eye |
| H16.05 | Mooren's corneal ulcer |
| H16.051 | Mooren's corneal ulcer, right eye |
| H16.052 | Mooren's corneal ulcer, left eye |
| H16.053 | Mooren's corneal ulcer, bilateral |
| H16.059 | Mooren's corneal ulcer, unspecified eye |
| H16.06 | Mycotic corneal ulcer |
| H16.061 | Mycotic corneal ulcer, right eye |
| H16.062 | Mycotic corneal ulcer, left eye |
| H16.063 | Mycotic corneal ulcer, bilateral |
| H16.069 | Mycotic corneal ulcer, unspecified eye |
| H16.07 | Perforated corneal ulcer |
| H16.071 | Perforated corneal ulcer, right eye |
| H16.072 | Perforated corneal ulcer, left eye |
| H16.073 | Perforated corneal ulcer, bilateral |
| H16.079 | Perforated corneal ulcer, unspecified eye |
| Cyclitis | |
| H20 | Iridocyclitis |
| H20.0 | Acute and subacute iridocyclitis |
| H20.00 | Unspecified acute and subacute iridocyclitis |
| H20.01 | Primary iridocyclitis |
| H20.011 | Primary iridocyclitis, right eye |
| H20.012 | Primary iridocyclitis, left eye |
| H20.013 | Primary iridocyclitis, bilateral |
| H20.019 | Primary iridocyclitis, unspecified eye |
| H20.02 | Recurrent acute iridocyclitis |
| H20.021 | Recurrent acute iridocyclitis, right eye |
| H20.022 | Recurrent acute iridocyclitis, left eye |
| H20.023 | Recurrent acute iridocyclitis, bilateral |
| H20.029 | Recurrent acute iridocyclitis, unspecified eye |
| H20.03 | Secondary infectious iridocyclitis |
| H20.031 | Secondary infectious iridocyclitis, right eye |
| H20.032 | Secondary infectious iridocyclitis, left eye |
| H20.033 | Secondary infectious iridocyclitis, bilateral |
| H20.039 | Secondary infectious iridocyclitis, unspecified eye |
| H20.04 | Secondary noninfectious iridocyclitis |
| H20.041 | Secondary noninfectious iridocyclitis, right eye |
| H20.042 | Secondary noninfectious iridocyclitis, left eye |
| H20.043 | Secondary noninfectious iridocyclitis, bilateral |
| H20.049 | Secondary noninfectious iridocyclitis, unspecified eye |
| H20.1 | Chronic iridocyclitis |
| H20.10 | Chronic iridocyclitis, unspecified eye |
| H20.11 | Chronic iridocyclitis, right eye |
| H20.12 | Chronic iridocyclitis, left eye |
| H20.13 | Chronic iridocyclitis, bilateral |
| H20.2 | Lens-induced iridocyclitis |
| H20.20 | Lens-induced iridocyclitis, unspecified eye |
| H20.21 | Lens-induced iridocyclitis, right eye |
| H20.22 | Lens-induced iridocyclitis, left eye |
| H20.23 | Lens-induced iridocyclitis, bilateral |
| H20.9 | Unspecified iridocyclitis |
| Herpes zoster keratitis | |
| B02.33 | Zoster keratitis |
| Iridocyclitis | |
| H20 | Iridocyclitis |
| H20.0 | Acute and subacute iridocyclitis |
| H20.00 | Unspecified acute and subacute iridocyclitis |
| H20.01 | Primary iridocyclitis |
| H20.011 | Primary iridocyclitis, right eye |
| H20.012 | Primary iridocyclitis, left eye |
| H20.013 | Primary iridocyclitis, bilateral |
| H20.019 | Primary iridocyclitis, unspecified eye |
| H20.02 | Recurrent acute iridocyclitis |
| H20.021 | Recurrent acute iridocyclitis, right eye |
| H20.022 | Recurrent acute iridocyclitis, left eye |
| H20.023 | Recurrent acute iridocyclitis, bilateral |
| H20.029 | Recurrent acute iridocyclitis, unspecified eye |
| H20.03 | Secondary infectious iridocyclitis |
| H20.031 | Secondary infectious iridocyclitis, right eye |
| H20.032 | Secondary infectious iridocyclitis, left eye |
| H20.033 | Secondary infectious iridocyclitis, bilateral |
| H20.039 | Secondary infectious iridocyclitis, unspecified eye |
| H20.04 | Secondary noninfectious iridocyclitis |
| H20.041 | Secondary noninfectious iridocyclitis, right eye |
| H20.042 | Secondary noninfectious iridocyclitis, left eye |
| H20.043 | Secondary noninfectious iridocyclitis, bilateral |
| H20.049 | Secondary noninfectious iridocyclitis, unspecified eye |
| H20.1 | Chronic iridocyclitis |
| H20.10 | Chronic iridocyclitis, unspecified eye |
| H20.11 | Chronic iridocyclitis, right eye |
| H20.12 | Chronic iridocyclitis, left eye |
| H20.13 | Chronic iridocyclitis, bilateral |
| H20.2 | Lens-induced iridocyclitis |
| H20.20 | Lens-induced iridocyclitis, unspecified eye |
| H20.21 | Lens-induced iridocyclitis, right eye |
| H20.22 | Lens-induced iridocyclitis, left eye |
| H20.23 | Lens-induced iridocyclitis, bilateral |
| H20.9 | Unspecified iridocyclitis |
| Iritis | |
| A18.54 | Tuberculous iridocyclitis |
| B00.51 | Herpesviral iridocyclitis |
| B02.32 | Zoster iridocyclitis |
| D86.83 | Sarcoid iridocyclitis |
| H20 | Iridocyclitis |
| H20.0 | Acute and subacute iridocyclitis |
| H20.00 | Unspecified acute and subacute iridocyclitis |
| H20.01 | Primary iridocyclitis |
| H20.011 | Primary iridocyclitis, right eye |
| H20.012 | Primary iridocyclitis, left eye |
| H20.013 | Primary iridocyclitis, bilateral |
| H20.019 | Primary iridocyclitis, unspecified eye |
| H20.02 | Recurrent acute iridocyclitis |
| H20.021 | Recurrent acute iridocyclitis, right eye |
| H20.022 | Recurrent acute iridocyclitis, left eye |
| H20.023 | Recurrent acute iridocyclitis, bilateral |
| H20.029 | Recurrent acute iridocyclitis, unspecified eye |
| H20.03 | Secondary infectious iridocyclitis |
| H20.031 | Secondary infectious iridocyclitis, right eye |
| H20.032 | Secondary infectious iridocyclitis, left eye |
| H20.033 | Secondary infectious iridocyclitis, bilateral |
| H20.039 | Secondary infectious iridocyclitis, unspecified eye |
| H20.04 | Secondary noninfectious iridocyclitis |
| H20.041 | Secondary noninfectious iridocyclitis, right eye |
| H20.042 | Secondary noninfectious iridocyclitis, left eye |
| H20.043 | Secondary noninfectious iridocyclitis, bilateral |
| H20.049 | Secondary noninfectious iridocyclitis, unspecified eye |
| H20.1 | Chronic iridocyclitis |
| H20.10 | Chronic iridocyclitis, unspecified eye |
| H20.11 | Chronic iridocyclitis, right eye |
| H20.12 | Chronic iridocyclitis, left eye |
| H20.13 | Chronic iridocyclitis, bilateral |
| H20.2 | Lens-induced iridocyclitis |
| H20.20 | Lens-induced iridocyclitis, unspecified eye |
| H20.21 | Lens-induced iridocyclitis, right eye |
| H20.22 | Lens-induced iridocyclitis, left eye |
| H20.23 | Lens-induced iridocyclitis, bilateral |
| H20.8 | Other iridocyclitis |
| H20.81 | Fuchs' heterochromic cyclitis |
| H20.811 | Fuchs' heterochromic cyclitis, right eye |
| H20.812 | Fuchs' heterochromic cyclitis, left eye |
| H20.813 | Fuchs' heterochromic cyclitis, bilateral |
| H20.819 | Fuchs' heterochromic cyclitis, unspecified eye |
| H20.82 | Vogt-koyanagi syndrome |
| H20.821 | Vogt-koyanagi syndrome, right eye |
| H20.822 | Vogt-koyanagi syndrome, left eye |
| H20.823 | Vogt-koyanagi syndrome, bilateral |
| H20.829 | Vogt-koyanagi syndrome, unspecified eye |
| H20.9 | Unspecified iridocyclitis |
| Ocular inflammation | |
| H57.8 | Other specified disorders of eye and adnexa |
| T86.840 | Corneal transplant rejection |
| T86.8401 | Corneal transplant rejection, right eye |
| T86.8402 | Corneal transplant rejection, left eye |
| T86.8403 | Corneal transplant rejection, bilateral |
| T86.8409 | Corneal transplant rejection, unspecified eye |
| T86.841 | Corneal transplant failure |
| T86.8411 | Corneal transplant failure, right eye |
| T86.8412 | Corneal transplant failure, left eye |
| T86.8413 | Corneal transplant failure, bilateral |
| T86.8419 | Corneal transplant failure, unspecified eye |
| T86.842 | Corneal transplant infection |
| T86.8421 | Corneal transplant infection, right eye |
| T86.8422 | Corneal transplant infection, left eye |
| T86.8423 | Corneal transplant infection, bilateral |
| T86.8429 | Corneal transplant infection, unspecified eye |
| Post-op ocular inflammation | |
| H57.8 | Other specified disorders of eye and adnexa |
| Punctate epithelial keratopathy | |
| H16.14 | Punctate keratitis |
| H16.141 | Punctate keratitis, right eye |
| H16.142 | Punctate keratitis, left eye |
| H16.143 | Punctate keratitis, bilateral |
| H16.149 | Punctate keratitis, unspecified eye |
| Uveitis | |
| D86.83 | Sarcoid iridocyclitis |
| H20 | Iridocyclitis |
| H20.0 | Acute and subacute iridocyclitis |
| H20.00 | Unspecified acute and subacute iridocyclitis |
| H20.01 | Primary iridocyclitis |
| H20.011 | Primary iridocyclitis, right eye |
| H20.012 | Primary iridocyclitis, left eye |
| H20.013 | Primary iridocyclitis, bilateral |
| H20.019 | Primary iridocyclitis, unspecified eye |
| H20.02 | Recurrent acute iridocyclitis |
| H20.021 | Recurrent acute iridocyclitis, right eye |
| H20.022 | Recurrent acute iridocyclitis, left eye |
| H20.023 | Recurrent acute iridocyclitis, bilateral |
| H20.029 | Recurrent acute iridocyclitis, unspecified eye |
| H20.03 | Secondary infectious iridocyclitis |
| H20.031 | Secondary infectious iridocyclitis, right eye |
| H20.032 | Secondary infectious iridocyclitis, left eye |
| H20.033 | Secondary infectious iridocyclitis, bilateral |
| H20.039 | Secondary infectious iridocyclitis, unspecified eye |
| H20.04 | Secondary noninfectious iridocyclitis |
| H20.041 | Secondary noninfectious iridocyclitis, right eye |
| H20.042 | Secondary noninfectious iridocyclitis, left eye |
| H20.043 | Secondary noninfectious iridocyclitis, bilateral |
| H20.049 | Secondary noninfectious iridocyclitis, unspecified eye |
| H20.1 | Chronic iridocyclitis |
| H20.10 | Chronic iridocyclitis, unspecified eye |
| H20.11 | Chronic iridocyclitis, right eye |
| H20.12 | Chronic iridocyclitis, left eye |
| H20.13 | Chronic iridocyclitis, bilateral |
| H20.2 | Lens-induced iridocyclitis |
| H20.20 | Lens-induced iridocyclitis, unspecified eye |
| H20.21 | Lens-induced iridocyclitis, right eye |
| H20.22 | Lens-induced iridocyclitis, left eye |
| H20.23 | Lens-induced iridocyclitis, bilateral |
| H20.8 | Other iridocyclitis |
| H20.81 | Fuchs' heterochromic cyclitis |
| H20.811 | Fuchs' heterochromic cyclitis, right eye |
| H20.812 | Fuchs' heterochromic cyclitis, left eye |
| H20.813 | Fuchs' heterochromic cyclitis, bilateral |
| H20.819 | Fuchs' heterochromic cyclitis, unspecified eye |
| H20.9 | Unspecified iridocyclitis |
| H44.11 | Panuveitis |
| H44.111 | Panuveitis, right eye |
| H44.112 | Panuveitis, left eye |
| H44.113 | Panuveitis, bilateral |
| H44.119 | Panuveitis, unspecified eye |
| H44.13 | Sympathetic uveitis |
| H44.131 | Sympathetic uveitis, right eye |
| H44.132 | Sympathetic uveitis, left eye |
| H44.133 | Sympathetic uveitis, bilateral |
| H44.139 | Sympathetic uveitis, unspecified eye |
Formulary Reference Tool