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PREDNISOLONE ACETATE ophthalmic suspension, USP 1% sterile |
Prednisolone acetate ophthalmic suspension usp dosage. Prednisolone Ophthalmic
The drug helps in the treatment of a number of conditions like skin problems, arthritis , breathing disorders, psoriasis, lupus and allergic reactions. Before starting the steroid it is important that you are aware of generic information about it. For instance, prednisolone acetate ophthalmic suspension USP should not be taken if you are allergic to it or any component it has.
The doctor should be aware of your medical history, including any allergies or health issues that you suffer from. Let your doctor know if you have cirrhosis , diabetes , thyroid issues, kidney disease , depression , hypertension , heart problems or muscle disorders. The doctor will then determine if prednisolone acetate ophthalmic suspension USP is safe for your body and will prescribe a calculated dose.
Although it has not been established if the steroid harms an unborn child, doctors do not generally recommend prednisolone acetate ophthalmic suspension USP to pregnant women or even mothers who are breast feeding. Do not take a lower or higher dose without consulting your doctor. The drug is available in the form of oral suspension as well as tablets. When taking the liquid form of prednisolone acetate ophthalmic suspension USP shake the bottle well before measuring the required dose.
Tablets should be stored in blister packs, and should be handled with dry hands. 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. Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
Prednisolone acetate ophthalmic 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. Prednisolone acetate ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
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 IOP 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. IOP 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 Sjogren's keratoconjunctivitis.
Close your eye for 2 to 3 minutes and tip your head down as though looking at the floor. Try not to blink or squeeze your eyelids.
Place a finger on the tear duct and apply gentle pressure. Wipe any excess liquid from your face with a tissue. If you are to use more than one drop in the same eye, wait at least 5 minutes before instilling the next drop. Replace and tighten the cap on the dropper bottle. Do not wipe or rinse the dropper tip. Wash your hands to remove any medication. Toapply the eye ointment, follow these steps: Wash your hands thoroughly with soap and water.
Use a mirror or have someone else apply the ointment. Avoid touching the tip of the tube against your eye or anything else. The ointment must be kept clean. Tilt your head forward slightly. Holding the tube between your thumb and index finger, place the tube as near as possible to your eyelid without touching it. Brace the remaining fingers of that hand against your cheek or nose. With the index finger of your other hand, pull the lower lid of your eye down to form a pocket.
Place a small amount of ointment into the pocket made by the lower lid and the eye. Gently close your eyes and keep them closed for 1 to 2 minutes to allow the medication to be absorbed.
Replace and tighten the cap right away. Wipe off any excess ointment from your eyelids and lashes with a clean tissue. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.
Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute. Shake well before using. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary.
Care should be taken not to discontinue therapy prematurely. The pH during its shelf life ranges from 5. WARNINGS Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision.
Information for Patients Advise patients that if eye inflammation or pain persists longer than 48 hours or becomes aggravated, they should consult a physician. Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted in animals or in humans to evaluate the potential of these effects.
Pregnancy Prednisolone has been shown to be teratogenic in mice when given in doses times the human dose. Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.
Pediatric Use The safety and effectiveness in pediatric patients have been established. Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
❿Prednisolone acetate ophthalmic suspension usp dosage.DESCRIPTION:
Prednisolone Acetate Ophthalmic Suspension, USP, 1% - Proper Use
Wait at least 15 minutes after using this medicine before putting your contact lenses back in. The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label.
The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. There is a problem with information submitted for this request. Sign up for free, and stay up to date on research advancements, health tips and current health topics, like COVID, plus expertise on managing health.
Prednisolone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast 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 prednisolone, 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.
The safety and effectiveness in pediatric patients have been established. Use in pediatric patients is supported by evidence from adequate and well-controlled studies of prednisolone acetate ophthalmic suspension in adults with additional data in pediatric patients. No overall differences in safety or effectiveness have been observed between elderly and younger patients. Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions include elevation of intraocular pressure IOP with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. 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.
Other adverse reactions reported with the use of prednisolone acetate ophthalmic suspension include: allergic reactions; dysgeusia; eye pain; foreign body sensation; headache; pruritus; rash; transient burning and stinging upon instillation and other minor symptoms of ocular irritation; urticaria; and visual disturbance blurry vision. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.
Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. Overdosage will not ordinarily cause acute problems.
If accidentally ingested, drink fluids to dilute. Shake well before using. Instill one to two drops into the conjunctival sac two to four times daily.
During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely. The pH during its shelf life ranges from 5. The initial prescription and renewal of the medication order 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 reevaluated. 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 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 the reach of children. No studies have been conducted in animals or in humans to evaluate the potential of these effects. Prednisolone has been shown to be teratogenic in mice when given in doses times the human dose. Dexamethasone, hydrocortisone and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on Days 10 through 13 of gestation.
A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate and well controlled studies in pregnant women.
Prednisolone acetate ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether topical 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 prednisolone acetate, 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.
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Adverse reactions include, in decreasing order of frequency, elevation of 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.
Prednisolone acetate ophthalmic suspension is an adrenocortical steroid product prepared as sterile ophthalmic suspension.
The active ingredient is represented by the chemical structure:. Each mL contains: Active : prednisolone acetate 1. Preservative : benzalkonium chloride 0. Vehicle : hypromellose. Inactives: citric acid to adjust pHdibasic sodium phosphate, edetate disodium, glycerin, polysorbate 80, purified water, sodium hydroxide to adjust pH.
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. Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe, such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.
Prednisolone acetate ophthalmic suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis dendritic keratitisvaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Prednisolone acetate ophthalmic suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
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 IOP 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. IOP 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 Sjogren's keratoconjunctivitis. The initial prescription and renewal of the medication order 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 reevaluated. 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 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 the reach of children. No studies have been conducted in animals or in humans to evaluate the potential of these effects. Prednisolone has been shown to be teratogenic in mice when given in doses times the human dose.
Dexamethasone, hydrocortisone and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on Days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate and well controlled studies in pregnant women.
Prednisolone acetate ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether topical 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 prednisolone acetate, 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.
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Adverse reactions include, in decreasing order of frequency, elevation of 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 steroid. Two drops topically in the affected eye s four times daily. In cases of bacterial infections, concomitant use of anti-infective agents is mandatory. Care should be taken not to discontinue therapy prematurely. The dosing of prednisolone acetate ophthalmic 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. Prednisolone acetate ophthalmic suspension is supplied in a white, round low density polyethylene dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package. After opening, prednisolone acetate ophthalmic suspension can be used until the expiration date on the bottle.
Corticosteroids are capable of producing a rise in intraocular pressure. 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. Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been conducted in animals or in humans to evaluate the potential of these effects.
Teratogenic effects. Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Pediatric Use: Safety and effectiveness in pediatric patients have not been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
HOW SUPPLIED: Prednisolone acetate ophthalmic suspension is supplied in a white, round low density polyethylene dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap. Rx Only Distributed by Sandoz Inc. Product Information. Inactive Ingredients. Marketing Information. Labeler - Sandoz Inc
DOSAGE AND ADMINISTRATION: SHAKE WELL BEFORE USING. Two drops topically in the affected eye(s) four times daily. In cases of bacterial infections, concomitant. DOSAGE AND ADMINISTRATION Shake well before using. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to The typical dosing for prednisolone (Pred Forte) is to place 1 to 2 drops in the affected eye(s) 2 to 4 times daily. It's important to shake the bottle well. Prednisolone Ophthalmic: learn about side effects, dosage, special precautions, and more on MedlinePlus. Adults—Instill one or two drops in the affected eye 2 to 4 times a day. Your doctor may tell you to use the drops more often during the. What are the side effects of prednisolone acetate ophthalmic suspension USP? Follow your doctor's orders or the directions on the label. Try not to blink or squeeze your eyelids. Prednisolone acetate ophthalmic suspension is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis dendritic keratitisvaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Inactive Ingredients. Shake the bottle well if the label says that you should Check the dropper tip to make sure that it is not chipped or cracked. Prednisolone acetate ophthalmic suspension is supplied in a white, round low density polyethylene dispenser with a natural low density polyethylene dispensing plug and pink polypropylene cap.Inactives : benzalkonium chloride as preservative; boric acid; edetate disodium; hypromellose; polysorbate 80; purified water; sodium bisulfite; sodium chloride; and sodium citrate. Prednisolone acetate is a glucocorticoid that, on the basis of weight, has 3 to 5 times the anti-inflammatory potency of hydrocortisone.
Glucocorticoids inhibit the edema, fibrin deposition, capillary dilation, and phagocytic migration of the acute inflammatory response, as well as capillary proliferation, deposition of collagen, and scar formation.
Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. 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. 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.
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.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. 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. Advise patients that if eye inflammation or pain persists longer than 48 hours or becomes aggravated, they should consult a physician.
Advise patients that to prevent eye injury or 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 the reach of children. No studies have been conducted in animals or in humans to evaluate the potential of these effects. Prednisolone has been shown to be teratogenic in mice when given in doses times the human dose.
Dexamethasone, hydrocortisone, and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate well-controlled studies in pregnant women. Prednisolone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast 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 prednisolone, 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. The safety and effectiveness in pediatric patients have been established. Use in pediatric patients is supported by evidence from adequate and well-controlled studies of prednisolone acetate ophthalmic suspension in adults with additional data in pediatric patients.
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions include elevation of intraocular pressure IOP with possible development of glaucoma and infrequent optic nerve damage, posterior subcapsular cataract formation, and delayed wound healing. 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.
Other adverse reactions reported with the use of prednisolone acetate ophthalmic suspension include: allergic reactions; dysgeusia; eye pain; foreign body sensation; headache; pruritus; rash; transient burning and stinging upon instillation and other minor symptoms of ocular irritation; urticaria; and visual disturbance blurry vision. Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids.
Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe. Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute. Shake well before using. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary.
Care should be taken not to discontinue therapy prematurely. The pH during its shelf life ranges from 5. WARNINGS Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision.
Information for Patients Advise patients that if eye inflammation or pain persists longer than 48 hours or becomes aggravated, they should consult a physician. Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted in animals or in humans to evaluate the potential of these effects. Pregnancy Prednisolone has been shown to be teratogenic in mice when given in doses times the human dose.
Nursing Mothers It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Pediatric Use The safety and effectiveness in pediatric patients have been established. Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients. Protect from freezing. Store in an upright position.
All rights reserved. All trademarks are the property of their respective owners. Product Information. Inactive Ingredients. Marketing Information. Labeler - Pacific Pharma, Inc.
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