Prednisolone 15 mg/5mL
Prednisolone · SOLUTION · RedPharm Drug, Inc.
Prednisolone is a solution containing prednisolone at 15 mg/5mL, taken oral. Manufactured by RedPharm Drug, Inc..
Key Facts
- Brand Name
- Prednisolone
- Generic Name
- Prednisolone
- NDC Code (Product)
67296-1656- Manufacturer
- RedPharm Drug, Inc.
- Strength
- 15 mg/5mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- ANDA040401
- Drug Class
- Corticosteroid [EPC]
- Marketing Start
- 02/27/2003
Recall History
Allergan Sales, LLC
Failed Impurities/Degradation Specifications: stability testing results did not meet the specification for impurities.
Akorn, Inc.
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Morton Grove Pharmaceuticals, Inc.
Defective Container: Tamper Evident foil seal not completely intact.
Promise Pharmacy, LLC
Lack of sterility assurance.
Imprimis NJOF, LLC
Lack of Assurance of Sterility
Imprimis NJOF, LLC
Subpotent Drug
Promise Pharmacy, LLC
Lack of sterility assurance.
Promise Pharmacy, LLC
Lack of sterility assurance.
Leiter's Compounding
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Prednisolone acetate ophthalmic suspension 1% is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
Dosage & Administration
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 taken not to discontinue therapy prematurely. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated (see PRECAUTIONS ).
Warnings
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. 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 severit…
Contraindications
CONTRAINDICATIONS Prednisolone acetate ophthalmic suspension 1% is contraindicated in acute untreated purulent ocular infections, 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 1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
Adverse Reactions
ADVERSE REACTIONS The following adverse reactions have been identified during use of prednisolone acetate ophthalmic suspension 1%. 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. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used (see PRECAUTIONS ). 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; ur…
Frequently Asked Questions
What is Prednisolone used for?
Prednisolone contains Prednisolone. It is a solution taken oral. Consult your doctor for specific uses.
Is Prednisolone a controlled substance?
Prednisolone is not classified as a controlled substance by the DEA.
What is the generic name for Prednisolone?
The generic name for Prednisolone is Prednisolone. There are 9 other brand versions of Prednisolone.
What is the NDC code for Prednisolone 15 mg/5mL?
The NDC (National Drug Code) for Prednisolone 15 mg/5mL is 67296-1656, listed by RedPharm Drug, Inc..
Other Prednisolone Dosages
Other Prednisolone Brands
See all →- PREDNISOLONE ACETATE10 mg/mL85766-124
- PREDNISOLONE ACETATE10 mg/mL50090-7539
- Prednisolone Sodium Phosphate15 mg/5mL67296-2134
- PREDNISOLONE ACETATE10 mg/mL67296-2176
- Prednisolone Sodium Phosphate15 mg/5mL68788-4046
- PRED MILD1.2 mg/mL11980-174
- PREDNISOLONE ACETATE10 mg/mL50090-1912
- Orapred ODT30 mg/159212-702
- Prednisolone Acetate10 mg/mL61314-637
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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