pharmacopeia
GET
/api/v1/drug/prednisolone
2D structure
(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-3-one
SMILES C[C@]12C[C@@H]([C@H]3[C@H]([C@@H]1CC[C@@]2(C(=O)CO)O)CCC4=CC(=O)C=C[C@]34C)O
InChIKey OIGNJSKKLXVSLS-VWUMJDOOSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.

Corticosteroid Hormone ReceptorGlucocorticoid ReceptorLipoxygenase

Indications

Sourced from openFDA
  • PRED FORTE ® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

Contraindications

Sourced from openFDA
  • 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), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. PRED FORTE ® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.contraindicated

Dosage & administration

Sourced from openFDA

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 & precautions

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

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 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; 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.

Use in specific populations

Sourced from openFDA

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 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. 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 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. Pediatric Use The safety and effectiveness in pediatric patients have been established.

Overdosage

Sourced from openFDA

Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.

Approval history

Sourced from openFDA
  • Nov 10, 1972NDANDA017100Abbvie
  • May 30, 1973NDANDA017011Abbvie
  • Jul 10, 1973NDANDA017469Sandoz
  • May 31, 1974ANDAANDA080531Chartwell Molecular
  • May 28, 1986NDANDA019157Pai Holdings
  • Jul 29, 1994ANDAANDA040070Bausch And Lomb Inc
  • Dec 29, 1995ANDAANDA074449Bausch And Lomb
  • Jun 1, 2006NDANDA021959Advanz Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
188,018 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use15,7338.4%
  2. 2Drug Ineffective13,5637.2%
  3. 3Pyrexia8,6654.6%
  4. 4Dyspnoea7,2683.9%
  5. 5Pneumonia7,1773.8%
  6. 6Diarrhoea6,9503.7%
  7. 7Condition Aggravated6,1963.3%
  8. 8Nausea5,7543.1%
  9. 9Fatigue5,4642.9%
  10. 10Vomiting5,3062.8%
  11. 11Product Use In Unapproved Indication5,1042.7%
  12. 12Headache5,0132.7%
  13. 13Sepsis4,6472.5%
  14. 14Rash4,5932.4%
  15. 15Arthralgia4,4312.4%

Literature

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Recent PubMed references pinned to Prednisolone as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 2,298 ClinicalTrials.gov registrations naming Prednisolone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Prednisolone work?
Mechanism-of-action classes: Corticosteroid Hormone Receptor Agonists; Glucocorticoid Receptor Agonists; Lipoxygenase Inhibitors.
What is Prednisolone used for?
According to FDA labeling, Prednisolone carries indications including: PRED FORTE ® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Prednisolone?
Prednisolone is classified as Corticosteroids, Corticosteroids acting locally, Corticosteroids/antiinfectives/mydriatics in combination, Corticosteroids for local oral treatment, Corticosteroids, plain, Corticosteroids, weak (group I), Corticosteroids, weak, other combinations, Glucocorticoids, Corticosteroid, Corticosteroid Hormone Receptor Agonists, Glucocorticoid Receptor Agonists, Lipoxygenase Inhibitors, Carbohydrate Metabolism Alteration, Decreased Capillary Permeability, Decreased Fibroblast Migration, Decreased Glucocorticoid Secretion, Decreased Leukotriene Activity, Decreased Lysosomal Function, Decreased Polymorphonuclear Leukocyte Migration, Decreased Prostaglandin Activity, Decreased Protein Synthesis, Decreased Thromboxane Activity, Lipid Metabolism Alteration.
What are the brand names for Prednisolone?
Prednisolone is marketed under brand names including Blephamide, Cortamine, MILLIPRED, Orapred, Pediapred, Pred Forte, Pred Mild, Pred-G.
What are the contraindications for Prednisolone?
Prednisolone labeling lists contraindications including: 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), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. PRED FORTE ® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.. Always consult the full prescribing information and a clinician.
Note. Data for prednisolone is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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