PRED FORTE Eye drops, suspension (2020)
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Συγγραφείς
Allergan, Inc.
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1. Description
PRED FORTE (prednisolone acetate ophthalmic suspension, USP) 1% is a sterile, topical anti-inflammatory agent for ophthalmic use. Its chemical name is 11ß,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione ...
2. Clinical Pharmacology
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 ...
3. Indications and Usage
PRED FORTE is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
4. Contraindications
PRED FORTE suspension is contraindicated in acute untreated purulent ocular infections, in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), ...
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 ...
6.1. General
The initial prescription and renewal of the medication order beyond 20 milliliters of PRED FORTE suspension should be made by a physician only after examination of the patient with the aid of magnification, ...
6.2. Information for Patients
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 ...
6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been conducted in animals or in humans to evaluate the potential of these effects.
6.7. Pregnancy
Prednisolone has been shown to be teratogenic in mice when given in doses 1-10 times the human dose. Dexamethasone, hydrocortisone, and prednisolone were ocularly applied to both eyes of pregnant mice ...
6.9. 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. Systemically administered corticosteroids ...
6.10. Pediatric Use
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 ...
6.11. Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
7. Adverse Reactions
The following adverse reactions have been identified during use of PRED FORTE. Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate ...
9. Overdosage
Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.
10. 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 48 hours, the dosing frequency may be increased if necessary. Care should be ...
11. How Supplied
PRED FORTE (prednisolone acetate ophthalmic suspension, USP) 1% is supplied sterile in opaque white LDPE plastic bottles with droppers with pink high impact polystyrene (HIPS) caps as follows: 1 mL in ...
12. Storage and Handling
Store at up to 25°C (77°F). Protect from freezing. Store in an upright position.