Flumetol

When are you taking this medicine? Empty stomach Before food After food With a meal

Flumetol uses

• Flumetol reviews

Flumetol^®

(FLUOROMETHOLONE OPHTHALMIC SUSPENSION, USP) 0.1%

Flumetol (fluorometholone ophthalmic suspension, USP) 0.1%, is a topical anti-inflammatory agent for ophthalmic use.

Chemical Name: 9-fluoro-11ß,17-dihydroxy-6α-methylpregna-1,4-diene-3,20-dione.Contains:Flumetol 0.1%with: polyvinyl alcohol 1.4%; benzalkonium chloride 0.004%, edetate disodium; sodium chloride; sodium phosphate monobasic, monohydrate; sodium phosphate dibasic, anhydrous; polysorbate 80; sodium hydroxide to adjust the pH, and purified water.CLINICAL PHARMACOLOGY

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 A₂ inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A₂.Corticosteroids are capable of producing a rise in intraocular pressure. In clinical studies on patients' eyes treated with both dexamethasone and Flumetol 0.1% suspensions, Flumetol demonstrated a lower propensity to increase intraocular pressure than did dexamethasone.INDICATIONS AND USAGE

Flumetol is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

CONTRAINDICATIONS

Flumetol suspension 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. Flumetol suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

WARNINGS

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 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 untreated 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 Sjögren’s keratoconjunctivitis.PRECAUTIONSGeneral

The initial prescription and renewal of the medication order beyond 20 milliliters of Flumetol suspension 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 two 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. If this product is used for 10 days or longer, intraocular pressure should be monitored.Information to the Patient

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 bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of reach of children.Carcinogenesis, mutagenesis, impairment of fertility

No studies have been conducted in animals or in humans to evaluate the possibility of these effects with Flumetol.

PregnancyTeratogenic effects. Pregnancy Category C

Flumetol has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Flumetol was applied ocularly to rabbits daily on days 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 Flumetol in pregnant women, and it is not known whether Flumetol can cause fetal harm when administered to a pregnant women. Flumetol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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 Flumetol, 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.

Pediatric Use

Safety and effectiveness in children below the age of two years have not been established.

ADVERSE REACTIONS

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 uveitis and perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following 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.DOSAGE AND ADMINISTRATION

Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosage may be increased to one application every four hours. Care should be taken not to discontinue therapy prematurely.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated. The dosing of Flumetol suspension 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.HOW SUPPLIED

Flumetol (fluorometholone ophthalmic suspension, USP) 0.1% is supplied in plastic dropper bottles in the following sizes:

5 mL…………………………………………………………………………..NDC 58768-358-0510 mL…………………………………………………………………………NDC 58768-358-1015 mL…………………………………………………………………………NDC 58768-358-15Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing. Shake well before using. Keep bottle tightly closed when not in use.Rx onlyMfd. by OMJ Pharmaceuticals, Inc., San Germán, P.R., 00683 for:Novartis OphthalmicsDuluth, GA 300976069-B

Flumetol pharmaceutical active ingredients containing related brand and generic drugs:

• Fluorometholone

Flumetol available forms, composition, doses:

• N/A

Flumetol destination | category:

• Human:
• Corticosteroids
• Eye corticosteroids
• Topical corticosteroids used in the treatment of acne

Flumetol Anatomical Therapeutic Chemical codes:

• S01BA07 - Fluorometholone

Flumetol pharmaceutical companies:

• Elmor Laboratorios

References

1. Dailymed."FLUOR-OP (FLUOROMETHOLONE) SUSPENSION [NOVARTIS OPHTHALMICS]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
2. Dailymed."FLUOROMETHOLONE; SULFACETAMIDE SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
3. "fluorometholone". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Flumetol?

Depending on the reaction of the Flumetol after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Flumetol not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Flumetol addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

Review

sdrugs.com conducted a study on Flumetol, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Flumetol consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology