Prednisolone

A to Z Drug Facts

(pred-NISS-oh-lone)

Prednisolone

Delta-Cortef, Prelone,  Minims Prednisolone, Novo-Prednisolone

Prednisolone Acetate

Econopred, Econopred Plus, Key-Pred 25, Key-Pred 50, Predcor-50, Predalone 50, Pred Forte, Pred Mild,  Diopred, Ophtho-Tate

Prednisolone Sodium Phosphate

AK-Pred, Hydeltrasol, Inflamase Forte, Inflamase Mild, Key-Pred-SP, Pediapred,  R.O.-Predphate

Prednisolone Tebutate

Prednisol TBA

Class: Corticosteroid

 Action Intermediate-acting glucocorticoid that depresses formation, release and activity of endogenous mediators of inflammation including prostaglandins, kinins, histamine, liposomal enzymes and complement system. Also modifies body's immune response.

 Indications

Oral/Parenteral administration: Endocrine disorders: rheumatic disorders; collagen diseases; dermatologic diseases; allergic and inflammatory ophthalmic processes; respiratory diseases; hematologic disorders; neoplastic diseases; edematous states caused by nephrotic syndrome; GI diseases; multiple sclerosis; tuberculous meningitis; trichinosis with neurologic or myocardial involvement. Intra-articular or soft tissue administration: Short-term adjunctive therapy of synovitis of osteoarthritis, rheumatoid arthritis, bursitis, acute gouty arthritis, epicondylitis, acute nonspecific tenosynovitis, posttraumatic osteoarthritis. Intralesional administration: Treatment of the following lesions: keloids; localized hypertrophic, infiltrated, inflammatory lesions of lichen planus, psoriatic plaques, granuloma annulare, lichen simplex chronicus; discoid lupus erythematosus; necrobiosis lipoidica diabeticorum; alopecia areata; cystic tumors of aponeurosis or tendon. Ophthalmic administration: Treatment of steroid-responsive inflammatory conditions of palpebral and bulbar conjunctiva, lid, cornea and anterior segment of globe. Unlabeled use(s): Adjunctive therapy for tuberculous pleurisy.

 Contraindications

Oral/Parenteral: Systemic fungal infections; administration of live virus vaccines. IM: Idiopathic thrombocytopenic purpura; sulfite sensitivity. Ophthalmic: Acute superficial herpes simplex keratitis; fungal diseases of ocular structures, vaccinia, varicella and most other viral diseases of cornea and conjunctiva; ocular tuberculosis.

 Route/Dosage

ADULTS: PO 5 to 60 mg/day (prednisolone, prednisolone sodium phosphate). IM 4 to 60 mg/day (prednisolone acetate). IV/IM 4 to 60 mg/day (prednisolone sodium phosphate). Ophthalmic 1 to 2 gtt into conjunctival sac q hr during day and q 2 hr during night (prednisolone acetate, prednisolone sodium phosphate).

Intra-Articular, Intralesional, Or Soft Tissue Administration

ADULTS: 4 to 100 mg (prednisolone acetate); 4 to 30 mg or lesions (prednisolone tebutate), or 2 to 30 mg prednisolone sodium phosphate.

Multiple Sclerosis

ADULTS: PO 200 mg/day for 1 wk then 80 mg qod for 1 mo (prednisolone, prednisolone sodium phosphate). IM 200 mg/day for 1 wk then 80 mg qod for 1 mo (prednisolone acetate).

Tuberculous Pleurisy

ADULTS: PO 0.75 mg/kg/day then taper as tolerated until patient is drug-free (prednisolone).

 Interactions

Anticholinesterases: May antagonize anticholinesterase effects in myasthenia gravis. Barbiturates: May decrease pharmacologic effect of prednisolone. Contraceptives (oral), estrogens, ketoconazole: May decrease clearance of prednisolone. Hydantoins, rifampin: May increase clearance and decrease efficacy of prednisolone. Salicylates: May reduce serum levels and efficacy of salicylates. Troleandomycin: May increase prednisolone effects.

 Lab Test Interferences May cause increased serum cholesterol; decreased serum levels of potassium, T₃ and T₄; decreased uptake of thyroid I¹³¹; false-negative results of nitroblue-tetrazolium test for systemic bacterial infection; suppression of skin test reactions.

 Adverse Reactions

CV: Thromboembolism or fat embolism; thrombophlebitis; necrotizing angiitis; cardiac arrhythmias or ECG changes; syncopal episodes; hypertension; myocardial rupture; CHF. CNS: Convulsions; pseudotumor cerebri (increased intracranial pressure with papilledema); vertigo; headache; neuritis; paresthesias; psychosis. DERM: Impaired wound healing; thin, fragile skin; petechiae and ecchymoses; erythema; lupus erythematosus–like lesions; subcutaneous fat atrophy; striae; hirsutism; acneiform eruptions; allergic dermatitis; urticaria; angioneurotic edema; perineal irritation; hyperpigmentation or hypopigmentation. EENT: Posterior subcapsular cataracts; increased intraocular pressure; glaucoma; exophthalmos. With ophthalmic use: glaucoma with optic nerve damage; visual acuity and field defects; posterior subcapsular cataract formation; secondary ocular infections; transient stinging or burning; perforation of globe. GI: Pancreatitis; abdominal distention; ulcerative esophagitis; nausea; vomiting; increased appetite and weight gain; peptic ulcer with perforation and hemorrhage; small and large bowel perforation. GU: Increased or decreased motility and number of spermatozoa. HEMA: Leukocytosis. META: Sodium and fluid retention; hypokalemia; hypokalemic alkalosis; metabolic alkalosis; hypocalcemia; negative nitrogen balance. OTHER: Musculoskeletal effects (eg, weakness, myopathy, muscle mass loss, tendon rupture, osteoporosis, aseptic necrosis of femoral and humoral heads, spontaneous fractures); endocrine abnormalities (eg, menstrual irregularities, cushingoid state, growth suppression in children, sweating, decreased carbohydrate tolerance, hyperglycemia, glycosuria, increased insulin or sulfonylurea requirements in diabetic patients, hirsutism); anaphylactoid or hypersensitivity reactions; aggravation or masking of infections; fatigue; insomnia. With intra-articular administration: osteonecrosis; tendon rupture; infection, skin atrophy; postinjection flare; hypersensitivity; facial flushing.

 Precautions

Pregnancy: Category C (prednisolone sodium phosphate). Safety not established. Lactation: Excreted in breast milk. Children: Observe growth and development of infants and children on prolonged therapy. Elderly: May require lower doses. Adrenal suppression: Prolonged therapy may lead to hypothalamic-pituitary-adrenal suppression. Cardiovascular effects: Use drug with great caution in patient who has suffered recent MI. Hepatitis: Drug may be harmful in patients with chronic active hepatitis positive for hepatitis B surface antigen. Hypersensitivity: Reactions may occur, including anaphylaxis. Immunosuppression: Do not administer live virus vaccines during treatment. Infections: Drug may mask signs of infection. May decrease host-defense mechanisms to prevent dissemination of infection. Ocular effects: Use systemic drug with caution in ocular herpes simplex because of possible corneal perforation. Ophthalmic use: Prolonged use may result in cataracts, glaucoma, or other complications. Peptic ulcer: May contribute to peptic ulceration, especially in large doses. Renal impairment: Use drug with caution. Repository injections: Do not inject SC. Avoid injection into deltoid muscle and repeated IM injection into same site. Stress: Increased dosage of rapidly acting corticosteroid may be needed before, during and after stressful situations. Withdrawal: Abrupt discontinuation may result in adrenal insufficiency.

 Administration/Storage

• Check drug name carefully to avoid confusion with prednisone.
• Administer oral medication with food.
• For long-term use, alternate-day regimen may be used.
• Do not inject SC or IM doses into deltoid muscle. IM injection should be given in gluteal muscle. Rotate injection sites.
• Do not administer if patient has had live vaccine within last month.
• Discontinuation of drug must be done gradually.
• If giving ophthalmic solution, do not touch eye with dropper, place drops in lower lid and wait 5 min between drops. Apply pressure on lacrimal sac to prevent systemic effects. Wash hands before and after administering.
• Store dosage forms at room temperature and protect from light.

 Assessment/Interventions

• Obtain patient history, including drug history and any known allergies. Note MI, diabetes, renal impairment, hepatitis, peptic ulcer disease, ocular herpes simplex, or current infections.
• If patient is at increased risk for herpes, chickenpox, or other viruses, notify physician.
• Ensure that baseline lab tests have been obtained before beginning therapy. Monitor for possible hyperglycemia, hypoglycemia and hypocalcemia during treatment.
• Be aware that drug may mask signs of infection and that resistance to infection may be diminished.
• In patients with diabetes, monitor blood glucose carefully.
• Monitor renal function, especially in patients with renal impairment.
• Observe for possible delayed wound healing.
• If menstrual irregularities, muscle wasting or weakness, moon face, fluid retention, GI bleeding or mental status changes occur, notify physician.
• Assess for signs of adrenal insufficiency (eg, fever, myalgia, arthralgia, malaise, anorexia, nausea, orthostatic hypotension, dizziness, fainting) and notify physician immediately if suspected.

 Patient/Family Education

• Advise patient to take single daily or alternate-day doses in morning before 9 AM and to take multiple doses at evenly-spaced intervals throughout day.
• Instruct patient to take medication with meals or snacks to avoid GI irritation.
• Caution patient not to take drug with aspirin or other otc medications containing salicylates unless directed by physician.
• Instruct patient to check weight at home daily at same time of day.
• Advise patient on chronic steroid therapy to wear Medi-Alert identification indicating condition and drug regimen.
• Remind patient to wash hands before and after instillation.
• Teach patient correct method for instilling eye drops.
• Instruct patient not to rub eyes or touch dropper into eye.
• Inform patient of increased appetite and counsel patient on appropriate diet management (ie, diet high in protein, calcium and potassium but low in sodium and carbohydrates).
• Advise family that medication may slow growth in children.
• Inform patient of the possible side effects of moonface, mood swings, and increased emotions.
• Teach patient to monitor for infection, eye burning, or increased bruising.
• Instruct patient not to drive soon after using eye drops because vision may be blurred initially.
• Inform patient that ophthalmic preparation may cause sensitivity to bright light and recommend use of sunglasses to minimize this effect.
• Instruct patient to report the following symptoms to physician: Unusual weight gain, swelling of lower extremities, muscle weakness, black tarry stools, vomiting of blood, puffing of face, menstrual irregularities, prolonged sore throat, fever, cold, or infection.
• Tell patient to notify physician if the following symptoms occur after dosage reduction or withdrawal of therapy: Fatigue, anorexia, nausea, vomiting, diarrhea, weight loss, weakness, dizziness or low blood sugar.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts