Prednisone

Prednisone · oral tablet

Steroid

Approved uses

Severe ocular inflammatory and allergic disease, including uveitis, iritis and iridocyclitis, chorioretinitis, keratitis, and sympathetic ophthalmia

5 to 60 mg PO daily initially, by disease entity and severity, taken in the morning before 9 am, then reduced in small increments to the lowest maintenance dose that holds the response.

Adrenal suppression lasts only 1.25 to 1.5 days after a single dose, making alternate-day dosing feasible.

OFF-LABELNot in the FDA label for this product

Giant cell arteritis, including arteritic anterior ischemic optic neuropathy

High-dose oral prednisone begun the day of suspicion, before temporal artery biopsy: 80 to 120 mg daily in Hayreh's series, or 60 to 80 mg daily by body weight after methylprednisolone 1 g IV daily for 3 days in the Danesh-Meyer vision-loss protocol.

Case series · n=144

Hayreh's noncomparative interventional case series of 144 biopsy-proven patients (271 eyes) found further acuity loss in 9 of the 91 who presented with visual loss and in none of the 53 who presented without it, and every deterioration began within 5 days of starting high-dose steroid; IV megadose was not more effective than oral (6 of 48 versus 3 of 97, P = 0.060). A prospective multicenter series of 34 patients given 1 g IV methylprednisolone daily for 3 days then oral prednisone still lost vision in 27% of eyes during the first week, while 15% of eyes gained acuity within the first month with matching visual field gain in only 5%. The 2021 ACR/VF guideline conditionally prefers pulse IV glucocorticoid over high-dose oral when vision loss is threatened, high-dose oral when there is no cranial ischemia, and daily over alternate-day dosing; only 2 of the guideline's 42 GCA and Takayasu arteritis recommendations are strong, and the rest are conditional on low-quality evidence.

Hayreh SS, Zimmerman B. Visual deterioration in giant cell arteritis patients while on high doses of corticosteroid therapy. Ophthalmology. 2003;110(6):1204-1215. Danesh-Meyer H, Savino PJ, Gamble GG. Poor prognosis of visual outcome after visual loss from giant cell arteritis. Ophthalmology. 2005;112(6):1098-1103 (doi 10.1016/j.ophtha.2005.01.036). Maz M, Chung SA, Abril A, et al. 2021 American College of Rheumatology/Vasculitis Foundation guideline for the management of giant cell arteritis and Takayasu arteritis. Arthritis Rheumatol. 2021;73(8):1349-1365 (doi 10.1002/art.41774).

IV methylprednisolone followed by an 11-day oral prednisone course, the ONTT regimen for acute demyelinating optic neuritis

Prednisone 1 mg/kg PO daily for 11 days following methylprednisolone 250 mg IV every 6 hours for 3 days, then a short taper, as given in the Optic Neuritis Treatment Trial.

RCT · n=457 · no acuity gain

The ONTT randomized 457 patients to IV methylprednisolone then oral prednisone, to oral prednisone 1 mg/kg daily alone for 14 days, or to placebo. The IV-then-oral arm recovered visual function faster, with only marginal differences remaining at 6 months and no acuity benefit; the oral-alone arm did not differ from placebo and had a higher rate of new optic neuritis episodes in either eye (relative risk 1.79 versus placebo, 95% CI 1.08 to 2.95). At 1 year the investigators concluded that oral prednisone alone, in the dose range used, should not be prescribed.

Beck RW, Cleary PA, Anderson MM, et al. A randomized, controlled trial of corticosteroids in the treatment of acute optic neuritis. N Engl J Med. 1992;326(9):581-588. One-year results: Beck RW, Cleary PA. Optic neuritis treatment trial. One-year follow-up results. Arch Ophthalmol. 1993;111(6):773-775 (doi 10.1001/archopht.1993.01090060061023).

Contraindications

Systemic fungal infections.
Known hypersensitivity to any component.
Live or live-attenuated vaccines during immunosuppressive-dose therapy.
Active ocular herpes simplex, because of possible corneal perforation.

Available Forms

5 mg, 10 mg and 20 mg tablets

Mechanism of Action

Synthetic glucocorticoid, a prodrug converted in the liver to prednisolone, which acts on the glucocorticoid receptor to suppress inflammatory mediator production and to modify immune responses across many organ systems. Short acting, producing adrenocortical suppression for only about 1.25 to 1.5 days after a single dose, which is why alternate-day dosing is feasible with it and not with dexamethasone or betamethasone.

Warnings & Precautions

Optic neuritis: Oral corticosteroids are not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes.
Cataract, glaucoma, and ocular infection: Corticosteroid use may produce posterior subcapsular cataracts and glaucoma with possible damage to the optic nerves, and may enhance establishment of secondary bacterial, fungal, or viral ocular infection.
IOP monitoring: Intraocular pressure may rise; monitor IOP when systemic corticosteroid therapy continues beyond 6 weeks.
HPA axis suppression: Reversible hypothalamic-pituitary-adrenal suppression can leave corticosteroid insufficiency after withdrawal; relative insufficiency may persist up to 12 months, so hormone therapy should be reinstituted or increased for any stress within that window.
Abrupt withdrawal: Too rapid withdrawal causes adrenocortical insufficiency; taper gradually after long-term therapy. Withdrawal syndrome includes myalgia, arthralgia, and malaise.
Infection susceptibility: Decreased resistance and inability to localize infection, with signs sometimes masked; risk rises with dose. Latent amebiasis, Strongyloides, and tuberculosis may reactivate.
Chickenpox and measles: More serious or even fatal course in pediatric and adult patients on corticosteroids; varicella zoster immune globulin or pooled immunoglobulin prophylaxis may be indicated after exposure.
Vaccine response: Killed or inactivated vaccines may be given, but the response may be diminished and cannot be predicted.
Cardio-renal effects: Large doses raise blood pressure and cause salt and water retention with increased potassium excretion; great caution after recent myocardial infarction because of reported left ventricular free wall rupture.

Common Side Effects

Ocular: Posterior subcapsular cataract, glaucoma with possible optic nerve damage, raised intraocular pressure, central serous chorioretinopathy, blurred vision, exophthalmos, papilledema, secondary bacterial, fungal, and viral infection.
Endocrine and metabolic: Adrenal insufficiency, cushingoid state with moon face, new-onset or unmasked diabetes and hyperglycemia, increased insulin or oral hypoglycemic requirement, hypokalemia, sodium retention with edema, growth suppression in children.
Musculoskeletal: Osteopenia and osteoporosis, vertebral compression and pathologic fracture, aseptic necrosis of femoral and humeral heads, steroid myopathy with muscle loss and weakness, tendon rupture, particularly of the Achilles.
Neuropsychiatric: Insomnia, euphoria, mood swings, emotional instability, depression, steroid psychosis, impaired cognition, benign intracranial hypertension; increased intracranial pressure with papilledema usually follows discontinuation of treatment.
Gastrointestinal: Increased appetite and weight gain, gastric irritation, peptic ulcer with possible perforation and hemorrhage, pancreatitis, elevated liver enzymes usually reversible on discontinuation.
Cardiovascular: Hypertension or its aggravation, fluid retention and edema, congestive heart failure in susceptible patients, thromboembolism, myocardial rupture after recent myocardial infarction.
Immune: Decreased resistance to infection, masking or aggravation of infection, rare anaphylactoid reactions.

Pregnancy & Lactation

Pregnancy: Category C on this label. Teratogenic in many species at doses equivalent to the human dose, with increased cleft palate in mice, rats, and rabbits; no adequate and well-controlled studies in pregnant women. Observe infants exposed in utero to substantial doses for signs of hypoadrenalism.

Psychiatric reactions: Euphoria, mood swings, insomnia, depression, and frank steroid psychosis; pre-existing psychiatric conditions may be aggravated.

Peptic ulceration: Peptic ulcer with possible perforation and hemorrhage; gastric irritation is reduced by dosing with food, and antacids between meals are recommended when large doses are given.

Lactation: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects; weigh discontinuing nursing against the importance of the drug to the mother.

Pediatric Use

Growth velocity may fall even at low systemic doses.