Predsol

Action

Exerts potent anti-inflammatory (glucocorticoid) and weak sodium-retaining (mineralocorticoid) activity. Glucocorticoid activity causes profound and varied metabolic effects.

Availability

Oral solution: 5 mg/ml

Suspension for injection (acetate): 25 mg/ml, 40 mg/ml, 50 mg/ml

Suspension (ophthalmic): 0.12%, 0.125%, 1%

Syrup: 5 mg/5 ml, 15 mg/5 ml

Tablets: 5 mg

Tablets (orally disintegrating, sodium phosphate): 10 mg, 15 mg, 30 mg

Indications and dosages

➣ Severe inflammation; immunosuppression

Adults: Dosage individualized based on diagnosis, severity of condition, and response. Usual dosage ranges from 5 to 60 mg P.O. (prednisolone) daily in two to four divided doses, or 4 to 60 mg I.M. (acetate) daily in divided doses, or 5 to 50 mg P.O. (sodium phosphate) daily in divided doses.

➣ Acute exacerbation of multiple sclerosis

Adults: 200 mg P.O. daily for 1 week, followed by 80 mg every other day for 1 month

➣ Refractory bronchial asthma

Children: 1 to 2 mg/kg/day (sodium phosphate) as a single dose or in divided doses; may continue for 3 to 10 days or until symptoms resolve or patient achieves peak expiratory flow rate of 80% of personal best

➣ Nephrotic syndrome in children

Children: 60 mg/m² P.O. (sodium phosphate solution) daily in three divided doses for 4 weeks, then 4 weeks of alternate-day therapy at single doses of 40 mg/m²

➣ Various allergic conditions and dermatologic, endocrine, GI, hematologic, neoplastic, nervous system, ophthalmic, respiratory, and rheumatic disorders

Adults: Variable and individualized depending on condition being treated and patient response. Initially, 10 to 60 mg (ODT) P.O. daily.

Children: Variable and individualized depending on condition being treated. Initial dosage range is 0.14 to 2 mg/kg/day P.O. in three or four divided doses.

➣ Steroid-responsive inflammatory eye conditions

Adults: In severe cases, initially one to two drops (acetate or sodium phosphate) instilled into conjunctival sac q hour during day and q 2 hours at night. In mild or moderate inflammation or in severe cases that respond favorably, one to two drops q 3 to 12 hours.

Contraindications

• Hypersensitivity to drug, other corticosteroids, alcohol, bisulfite, or tartrazine (with some products)

• Systemic fungal infections

• Active untreated infections (except in selected patients with meningitis)

• Acute superficial herpes simplex, keratitis, fungal or viral eye diseases, tuberculosis of eye, or after uncomplicated removal of superficial corneal foreign body (ophthalmic use)

• Idiopathic thrombocytopenic purpura (with I.M. use)

• Live-virus vaccines (with immunosuppressive prednisolone dosages)

Precautions

Use cautiously in:

• diabetes mellitus, glaucoma, renal or hepatic disease, hypothyroidism, cirrhosis, diverticulitis, nonspecific ulcerative colitis, recent intestinal anastomoses, inflammatory bowel disease, thromboembolic disorders, seizures, myasthenia gravis, heart failure, hypertension, osteoporosis, ocular herpes simplex, immunosuppression, emotional instability

• pregnant or breastfeeding patients

• children younger than age 6 (younger than age 2 when treated for nephrotic syndrome; younger than age 1 month when treated for aggressive lymphomas and leukemias with ODT form).

Administration

See Be aware that prednisolone has many different formulations that may be given by various routes: P.O., I.M., or ophthalmic. Before administering, make sure formulation can be given by prescribed route.

• Don't break ODT tablets.

• Place ODT tablet on tongue and either swallow tablet whole or allow it to dissolve in mouth with or without water.

• Inject I.M. form deep into gluteal muscle. Rotate injection sites.

• Avoid subcutaneous injection.

See In systemic therapy, don't discontinue drug abruptly, even if inhaled steroid is added.

• Know that additional corticosteroids are needed during stress or trauma.

Adverse reactions

CNS: headache, nervousness, depression, euphoria, personality changes, psychosis, vertigo, paresthesia, insomnia, restlessness, seizures, meningitis, increased intracranial pressure, hypertrophic cardiomyopathy in premature infants

CV: hypotension, hypertension, vasculitis, thrombophlebitis, thrombo-embolism, fat embolism, arrhythmias, heart failure, shock

EENT: cataracts, glaucoma, visual disturbances, exacerbation of ocular infection, secondary ocular infections, globe perforation at corneal or scleral thinning site, transient stinging or burning of eyes, dry eyes, corneal ulcers, mydriasis (all with ophthalmic use); posterior subcapsular cataracts (especially in children), glaucoma, nasal irritation and congestion, rebound congestion, sneezing, epistaxis, nasopharyngeal and oropharyngeal fungal infections, perforated nasal septum, anosmia, dysphonia, hoarseness, throat irritation (with long-term use)

GI: nausea, vomiting, abdominal distention, rectal bleeding, dry mouth, esophageal candidiasis, esophageal ulcer, pancreatitis, peptic ulcer

GU: amenorrhea, irregular menses

Hematologic: purpura

Metabolic: sodium and fluid retention, hypokalemia, hypocalcemia, hyper-glycemia, decreased carbohydrate tolerance, growth retardation (in children), diabetes mellitus, cushingoid effects (with long-term use), hypothal-amic-pituitary-adrenal suppression (with systemic use longer than 5 days), adrenal suppression (with high-dose, long-term use)

Musculoskeletal: muscle weakness or atrophy, myalgia, myopathy, osteoporosis, aseptic joint necrosis, spontaneous fractures (with long-term use), osteonecrosis, tendon rupture

Respiratory: cough, wheezing, bron-chospasm

Skin: urticaria, rash, pruritus, contact dermatitis, acne, striae, poor wound healing, thin fragile skin, bruising, hir-sutism, petechiae, subcutaneous fat atrophy, urticaria, angioedema

Other: aggravation or masking of infections, increased or decreased appetite, weight gain (with long-term use), facial edema and erythema, edema, hypersensitivity reaction

Interactions

Drug-drug. Amphotericin B, mezlocillin, piperacillin, thiazide and loop diuretics, ticarcillin: additive hypokalemia Anticholinesterase drugs: decreased anticholinesterase effect (when prednisolone is used for myasthenia gravis)

Aspirin, other nonsteroidal anti-inflammatory drugs: increased risk of GI discomfort and bleeding

Cardiac glycosides: increased risk of digitalis toxicity due to hypokalemia

Cyclosporine: therapeutic benefits in organ transplant recipients, but with increased risk of toxicity

Erythromycin, indinavir, itraconazole, ketoconazole, ritonavir, saquinavir: increased prednisolone blood level and effects

Hormonal contraceptives: impaired metabolism and increased effects of prednisolone

Isoniazid: decreased isoniazid blood level

Live-virus vaccines: decreased antibody response to vaccine, increased risk of adverse effects

Oral anticoagulants: reduced anticoagulant requirement, opposition to anticoagulant action

Phenobarbital, phenytoin, rifampin: decreased prednisolone efficacy Salicylates: reduced salicylate blood level

Somatrem: inhibition of somatrem's growth-promoting effects

Theophylline: altered pharmacologic effects of either drug

Skin tests: suppressed results

Drug-diagnostic tests. Calcium, potassium, thyroid ¹³¹I uptake, thyroxine, tri-iodothyronine: decreased levels

Cholesterol, glucose: increased levels Nitroblue tetrazolium test for bacterial infection: false-negative result

Skin tests: suppressed results

Drug-herbs. Alfalfa: activation of quiescent systemic lupus erythematosus

Echinacea: increased immune-stimulating effects

Ephedra (ma huang): decreased drug blood level

Ginseng: potentiation of immunomodulating effect

Licorice: prolonged drug activity

Drug-behaviors. Alcohol use: increased risk of gastric irritation and GI ulcers

Patient monitoring

• Monitor weight, blood pressure, and electrolyte levels.

• Watch for cushingoid effects (moon face, central obesity, buffalo hump, hair thinning, high blood pressure, frequent infections).

See Assess patient for depression and psychosis.

• Monitor blood glucose level carefully in diabetic patient.

• Evaluate for signs and symptoms of infection, which drug may mask or exacerbate.

See Monitor for signs and symptoms of early adrenal insufficiency (fatigue, weakness, joint pain, fever, anorexia, shortness of breath, dizziness, syncope).

• Assess musculoskeletal status for joint, tendon, and muscle pain.

Patient teaching

• Tell patient to take oral dose with food or milk to reduce GI upset.

• Instruct patient to remove ODT tablet from blister just before taking.

• Instruct patient to place ODT tablet on tongue and either swallow tablet whole or allow it to dissolve in mouth with or without water. Caution patient not to cut, split, or break tablet.

See Teach patient to recognize and immediately report cushingoid effects and signs and symptoms of early adrenal insufficiency.

See Advise patient and significant other to immediately report depression or psychosis.

• Explain that drug increases risk of infection. Instruct patient to contact prescriber at first sign of infection.

See Caution patient not to suddenly stop drug (including ophthalmic forms). Instruct him to discuss any changes in therapy with prescriber.

See Tell patient to immediately report bleeding or joint, muscle, tendon, or abdominal pain.

• Inform patient that he may need higher dosage during periods of stress. Encourage him to wear or carry medical identification stating this.

• Tell patient to avoid vaccinations during therapy. Mention that others in household shouldn't receive oral polio vaccine because they could pass poliovirus to him.

• Caution patient not to take over-the-counter drugs or herbs during therapy.

• Teach patient how to use eye drops. Caution him not to touch dropper tip to eye or any other surface.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.