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.

PATIENT CARE CONSIDERATIONS

 

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.

OVERDOSAGE: SIGNS & SYMPTOMS   Cushingoid changes, moonface, striae, central obesity, hirsutism, acne, ecchymoses, hypertension, osteoporosis, myopathy, sexual dysfunction, diabetes mellitus, hyperlipidemia, peptic ulcer, GI bleeding, increased susceptibility to infection, electrolyte and fluid imbalance, psychosis

 

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.

Indications for Drugs ::

(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.

PATIENT CARE CONSIDERATIONS

 

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.

OVERDOSAGE: SIGNS & SYMPTOMS   Cushingoid changes, moonface, striae, central obesity, hirsutism, acne, ecchymoses, hypertension, osteoporosis, myopathy, sexual dysfunction, diabetes mellitus, hyperlipidemia, peptic ulcer, GI bleeding, increased susceptibility to infection, electrolyte and fluid imbalance, psychosis

 

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.

Drug Dose ::

(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.

PATIENT CARE CONSIDERATIONS

 

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.

OVERDOSAGE: SIGNS & SYMPTOMS   Cushingoid changes, moonface, striae, central obesity, hirsutism, acne, ecchymoses, hypertension, osteoporosis, myopathy, sexual dysfunction, diabetes mellitus, hyperlipidemia, peptic ulcer, GI bleeding, increased susceptibility to infection, electrolyte and fluid imbalance, psychosis

 

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.

Contraindication ::

(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.

PATIENT CARE CONSIDERATIONS

 

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.

OVERDOSAGE: SIGNS & SYMPTOMS   Cushingoid changes, moonface, striae, central obesity, hirsutism, acne, ecchymoses, hypertension, osteoporosis, myopathy, sexual dysfunction, diabetes mellitus, hyperlipidemia, peptic ulcer, GI bleeding, increased susceptibility to infection, electrolyte and fluid imbalance, psychosis

 

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.

Drug Precautions ::

(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.

PATIENT CARE CONSIDERATIONS

 

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.

OVERDOSAGE: SIGNS & SYMPTOMS   Cushingoid changes, moonface, striae, central obesity, hirsutism, acne, ecchymoses, hypertension, osteoporosis, myopathy, sexual dysfunction, diabetes mellitus, hyperlipidemia, peptic ulcer, GI bleeding, increased susceptibility to infection, electrolyte and fluid imbalance, psychosis

 

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.

Drug Side Effects ::

(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.

PATIENT CARE CONSIDERATIONS

 

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.

OVERDOSAGE: SIGNS & SYMPTOMS   Cushingoid changes, moonface, striae, central obesity, hirsutism, acne, ecchymoses, hypertension, osteoporosis, myopathy, sexual dysfunction, diabetes mellitus, hyperlipidemia, peptic ulcer, GI bleeding, increased susceptibility to infection, electrolyte and fluid imbalance, psychosis

 

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.

Drug Mode of Action ::  

(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.