Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/727
Predicate | Object |
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rdf:type | |
rdfs:label |
FML (Ointment)
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dailymed-instance:dosage |
A small amount (approximately 1/2 inch ribbon) of ointment should
be applied to the conjunctival sac one to three times daily. During the
initial 24 to 48 hours, the frequency of dosing may be increased to one
application every 4 hours. Care should be taken not to discontinue
therapy prematurely. If signs and symptoms fail to improve after 2 days, the patient
should be re-evaluated . The dosing of FML ophthalmic ointment may be
reduced, but care should be taken not to discontinue therapy
prematurely. In chronic conditions, withdrawal of treatment should be
carried out by gradually decreasing the frequency of
applications.
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dailymed-instance:descripti... |
FML (fluorometholone ophthalmic ointment)
0.1 % is a topical anti-inflammatory agent for ophthalmic
use.<br/>Chemical Name:: Fluorometholone: 9-Fluoro-11��,
17-dihydroxy-6��-methylpregna-1,4-diene-3,20-dione Structural Formula: Contains: Active:
fluorometholone 0.1%. Preservative: phenylmercuric acetate (0.0008%).Inactives: mineral oil;
petrolatum (and) lanolin alcohol; and white
petrolatum.
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dailymed-instance:clinicalP... |
Corticosteroids inhibit the inflammatory response to a variety of
inciting agents and probably delay or slow healing. They inhibit the
edema, fibrin deposition, capillary dilation, leukocyte migration,
capillary proliferation, fibroblast proliferation, deposition of
collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of
action of ocular corticosteroids. However, corticosteroids are thought
to act by the induction of phospholipase Ainhibitory
proteins, collectively called lipocortins. It is postulated that these
proteins control the biosynthesis of potent mediators of inflammation
such as prostaglandins and Ieukotrienes by inhibiting the release of
their common precursor arachidonic acid. Arachidonic acid is released
from membrane phospholipids by phospholipase A. Corticosteroids are capable of producing a rise in intraocular
pressure. In clinical studies of documented steroid-responders,
fluorometholone demonstrated a significantly longer average time to
produce a rise in intraocular pressure than dexamethasone phosphate;
however, in a small percentage of individuals, a significant rise in
intraocular pressure occurred within one week. The ultimate magnitude of
the rise was equivalent for both drugs.
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dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
FML ophthalmic ointment is contraindicated
in most viral diseases of the cornea and conjunctiva including
epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and
varicella, and also in mycobacterial infection of the eye and fungal
diseases of ocular structures. FML ointment is also
contraindicated in individuals with known or suspected hypersensitivity
to any of the ingredients of this preparation and to other
corticosteroids.
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dailymed-instance:supply |
FML (fluorometholone ophthalmic ointment)
0.1 % is supplied in a collapsible aluminum tube with a black low
density polyethylene screw cap in the following size: 3.5g in 3.5g tube���NDC 0023-0316-04 Note: Store at or below
25��C (77��F). Avoid exposure to temperatures above
40��C (104��F). Rx Only Rev November 2001 ��2001 Allergan, Inc.Irvine, California 92612
U.S.A.' Marks owned by Allergan, Inc.Printed in
U.S.A2366X71091US11J
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dailymed-instance:genericDr... | |
dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
General:: The initial prescription and renewal of the medication
order beyond 8 grams of FML ophthalmic
ointment should be made by a physician only after examination of
the patient with the aid of magnification, such as slit lamp
biomicroscopy, and, where appropriate, fluorescein staining. If
signs and symptoms fail to improve after 2 days, the patient
should be re-evaluated. As fungal infections of the cornea are particularly prone
to develop coincidentally with long-term local corticosteroid
applications, fungal invasion should be suspected in any
persistent corneal ulceration where a corticosteroid has been
used or is in use. Fungal cultures should be taken when
appropriate. It this product is used for 10 days or longer,
intraocular pressure should be monitored . Ophthalmic ointments may retard corneal
healing.<br/>Information for Patients:: If inflammation or pain persists longer than 48 hours or
becomes aggravated, the patient should be advised to discontinue
use of the medication and consult a physician. This product is sterile when packaged. To prevent
contamination, care should be taken to avoid touching the tube
tip to eyelids or to any other surface. The use of this tube by
more than one person may spread infection. Keep tube tightly
closed when not in use. Keep out of the reach of
children.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: No studies have been conducted in animals or in humans to
evaluate the possibility of these effects with
fluorometholone.<br/>Pregnancy:: Teratogenic effects. Pregnancy
Category C: Fluorometholone has been shown
to be embryocidal and teratogenic in rabbits when
administered at low multiples of the human ocular dose.
Fluorometholone was applied ocularly to rabbits daily on
day 6 - 18 of gestation, and dose-related fetal loss and
fetal abnormalities including cleft palate, deformed rib
cage, anomalous limbs and neural abnormalities such as
encephalocele, craniorachischisis, and spina bifida were
observed. There are no adequate and well-controlled
studies of fluorometholone in pregnant women, and it is
not known whether fluorometholone can cause fetal harm
when administered to a pregnant woman. Fluorometholone
should be used during pregnancy only if the potential
benefit justifies the potential risk to the
fetus.<br/>Nursing Mothers:: It is not known whether topical ophthalmic administration
of corticosteroids could result in sufficient systemic
absorption to produce detectable quantities in human milk.Systemically administered corticosteroids appear in human milk
and could suppress growth, interfere with endogenous
corticosteroid production, or cause other untoward effects.
Because of the potential for serious adverse reactions in
nursing infants from fluorometholone, a decision should be made
whether to discontinue nursing or to discontinue the drug,
taking into account the importance of the drug to the
mother.<br/>Pediatric Use:: Safety and effectiveness in infants below the age of 2
years have not been established.<br/>Geriatric Use:: No overall differences in safety or effectiveness have
been observed between elderly and younger patients.
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dailymed-instance:genericMe... |
fluorometholone
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dailymed-instance:fullName |
FML (Ointment)
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dailymed-instance:adverseRe... |
Adverse reactions include, in decreasing order of frequency,
elevation of intraocular pressure (IOP) with possible development of
glaucoma and infrequent optic nerve damage, posterior subcapsular
cataract formation, and delayed wound healing. Although systemic effects are extremely uncommon, there have been
rare occurrences of systemic hypercorticoidism after use of topical
steroids. Corticosteroid-containing preparations have also been reported to
cause acute anterior uveitis and perforation of the globe. Keratitis,
conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss
of accommodation and ptosis have occasionally been reported following
local use of corticosteroids. The development of secondary ocular infection (bacterial, fungal,
and viral) has occurred. Fungal and viral infections of the cornea are
particularly prone to develop coincidentally with long-term applications
of steroids. The possibility of fungal invasion should be considered in
any persistent corneal ulceration where steroid treatment has been used
.
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dailymed-instance:warning |
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. Prolonged use
may also suppress the host immune response and thus increase the hazard
of secondary ocular infections. Various ocular diseases and long-term use of topical
corticosteroids have been known to cause corneal and scleral thinning.
Use of topical corticosteroids in the presence of thin corneal or
scleral tissue may lead to perforation. Acute purulent infections of the eye may be masked or activity
enhanced by the presence of corticosteroid medication. If this product is used for 10 days or longer, intraocular
pressure should be routinely monitored even though it may be difficult
in children and uncooperative patients. Steroids should be used with
caution in the presence of glaucoma. Intraocular pressure should be checked frequently. The use of steroids after cataract surgery may delay healing and
increase the incidence of bleb formation. Use of ocular steroids may prolong the course and may exacerbate
the severity of many viral infections of the eye (including herpes
simplex). Employment of a corticosteroid medication in the treatment of
patients with a history of herpes simplex requires great caution;
frequent slit lamp microscopy is recommended. Corticosteroids are not effective in mustard gas keratitis and
Sj��gren's keratoconjunctivitis.
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dailymed-instance:indicatio... |
FML ophthalmic ointment is indicated for the
treatment of steroid-responsive inflammation of the palpebral and bulbar
conjunctiva, cornea, and anterior segment of the globe.
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dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
FML
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