Gelnique and Prednisolone Sodium Phosphate

• Generic Name: oxybutynin
• Dosage Forms: gel
• Other Brand Names: Anturol, Gelnique, Ditropan XL, Oxytrol

Gelnique (oxybutynin) reduces muscle spasms of the bladder and urinary tract.

Gelnique is a quick-drying, colorless topical gel used to treat symptoms of overactive bladder such as frequent or urgent urination, and incontinence (urine leakage).

Gelnique may also be used for purposes not listed in this medication guide.

• Generic Name: prednisolone
• Dosage Forms: n.a.
• Other Brand Names: Flo-Pred, Millipred, Millipred DP, Orapred, Orapred ODT, Pediapred, Veripred 20, Prelone, Hydeltra-TBA, Hydeltrasol, Key-Pred, Cotolone, Depo-Predate, Predicort-50, Predalone 50, Predacort 50, Predate-50, Predaject-50, Pred-Ject-50, Key-Pred SP, Medicort, Predicort RP, Pri-Cortin 50, Predcor, Bubbli-Pred, AsmalPred Plus, Flo-Pred Oral Suspension

Treatment of a wide variety of diseases and conditions, principally for glucocorticoid effects as an anti-inflammatory and immunosuppressant agent and for its effects on blood and lymphatic systems in the palliative treatment of various diseases.

Adrenocortical Insufficiency

Corticosteroids are administered in physiologic dosages to replace deficient endogenous hormones in patients with adrenocortical insufficiency.

Because production of both mineralocorticoids and glucocorticoids is deficient in adrenocortical insufficiency, hydrocortisone or cortisone (in conjunction with liberal salt intake) usually is the corticosteroid of choice for replacement therapy.

Usually inadequate alone for adrenocortical insufficiency because of minimal mineralocorticoid activity.

If prednisolone is used for adrenocortical insufficiency, a mineralocorticoid (e.g., fludrocortisone) must also be administered, particularly in infants.

Adrenogenital Syndrome

Lifelong glucocorticoid treatment of adrenogenital syndrome (e.g., congenital adrenal hyperplasia).

In salt-losing forms, cortisone or hydrocortisone is preferred in conjunction with liberal salt intake; concomitant use of a mineralocorticoid may be necessary until the patient is at least 5–7 years of age.

For long-term therapy after early childhood, a glucocorticoid alone usually is sufficient.

In hypertensive forms, a “short-acting” glucocorticoid with minimal mineralocorticoid activity (e.g., methylprednisolone, prednisone) is preferred. Avoid long-acting glucocorticoids (e.g., dexamethasone) because of tendency toward overdosage and growth retardation.

Hypercalcemia

Treatment of hypercalcemia associated with malignancy.

Usually ameliorates hypercalcemia associated with bone involvement in multiple myeloma.

Treatment of hypercalcemia associated with sarcoidosis.

Treatment of hypercalcemia associated with vitamin D intoxication.

Not effective for hypercalcemia caused by hyperparathyroidism.

Thyroiditis

Treatment of granulomatous (subacute, nonsuppurative) thyroiditis.

Anti-inflammatory actions relieves fever, acute thyroid pain, and swelling.

May reduce orbital edema in endocrine exophthalmos (thyroid ophthalmopathy).

Usually reserved for palliative therapy in severely ill patients unresponsive to salicylates and thyroid hormones.

Rheumatic Disorders and Collagen Diseases

Short-term palliative treatment of acute episodes or exacerbations and systemic complications of rheumatic disorders (e.g., rheumatoid arthritis, juvenile arthritis, psoriatic arthritis, acute gouty arthritis, posttraumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis, ankylosing spondylitis, Reiter's syndrome, rheumatic fever [especially with carditis]) and collagen diseases (e.g., acute rheumatic carditis, systemic lupus erythematosus, systemic dermatomyositis [polymyositis], polyarteritis nodosa, vasculitis) refractory to more conservative measures.

Relieves inflammation and suppresses symptoms but not disease progression.

Rarely indicated as maintenance therapy.

May be used as maintenance therapy (e.g., in rheumatoid arthritis, acute gouty arthritis, systemic lupus erythematosus, acute rheumatic carditis) as part of a total treatment program in selected patients when more conservative therapies have proven ineffective.

Glucocorticoid withdrawal is extremely difficult if used for maintenance; relapse and recurrence usually occur with drug discontinuance.

Controls acute manifestations of rheumatic carditis more rapidly than salicylates and may be life-saving; cannot prevent valvular damage and no better than salicylates for long-term treatment.

Adjunctively for severe systemic complications of Wegener’s granulomatosis, but cytotoxic therapy is the treatment of choice.

Primary treatment to control symptoms and prevent severe, often life-threatening complications of systemic lupus erythematosus, systemic dermatomyositis (polymyositis), polyarteritis nodosa, relapsing polychondritis, polymyalgia rheumatica, Sjogren's syndrome, giant-cell (temporal) arteritis, certain cases of vasculitis, or mixed connective tissue disease syndrome. High dosage may be required for acute situations; after a response has been obtained, the drug must often be continued for long periods at low dosage.

Polymyositis associated with malignancy and childhood dermatomyositis may not respond well.

Rarely indicated in psoriatic arthritis, diffuse scleroderma (progressive systemic sclerosis), or osteoarthritis; risks outweigh benefits.

Dermatologic Diseases

Treatment of pemphigus and pemphigoid, bullous dermatitis herpetiformis, severe erythema multiforme (Stevens-Johnson syndrome), exfoliative dermatitis, uncontrollable eczema, cutaneous sarcoidosis, mycosis fungoides, lichen planus, severe psoriasis, and severe seborrheic dermatitis.

Usually reserved for acute exacerbations unresponsive to conservative therapy.

Early initiation of systemic glucocorticoid therapy may be life-saving in pemphigus vulgaris and pemphigoid, and high or massive doses may be required.

For control of severe or incapacitating allergic conditions (e.g., contact dermatitis, atopic dermatitis) refractory to adequate trials of conventional treatment.

Chronic skin disorders seldom an indication for systemic glucocorticoid therapy.

Used for severe psoriasis but rarely indicated systemically; if used, exacerbation may occur when the drug is withdrawn or dosage is decreased.

Rarely indicated systemically for alopecia areata, alopecia totalis, or alopecia universalis. May stimulate hair growth, but hair loss returns when the drug is discontinued.

Allergic Conditions

For control of severe or incapacitating allergic conditions unresponsive to adequate trials of conventional treatment; for control of acute manifestations, including angioedema, serum sickness, allergic symptoms of trichinosis, urticarial transfusion reactions, drug hypersensitivity reactions, and severe seasonal or perennial rhinitis.

Systemic therapy usually reserved for acute conditions and severe exacerbations.

For acute conditions, usually used in high dosage and with other therapies (e.g., antihistamines, sympathomimetics).

Reserve prolonged treatment of chronic allergic conditions to disabling conditions unresponsive to more conservative therapy and when risks of long-term glucocorticoid therapy are justified.

Ocular Disorders

To suppress a variety of allergic and nonpyogenic ocular inflammations.

To reduce scarring in ocular injuries.

For the treatment of severe acute and chronic allergic and inflammatory processes involving the eye and adnexa, including allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis.

Acute optic neuritis optimally treated with initial high-dose IV (e.g., methylprednisolone) therapy followed by chronic oral corticosteroid therapy. Aids in recovery of vision and slows progression to clinically definite multiple sclerosis. In a randomized, placebo-controlled trial, oral corticosteroid (e.g., prednisone) monotherapy did not improve the rate of vision recovery and was associated with an increased risk of new episodes of optic neuritis in either eye.

Less severe allergic and inflammatory allergic conditions of the eye are treated with topical ophthalmic corticosteroids.

Systemically in stubborn cases of anterior segment eye disease and when deeper ocular structures are involved.

Asthma

Adjunctively for moderate to severe exacerbations of asthma and for maintenance in persistent asthma.

Corticosteroids used systemically (oral or IV) for treatment of moderate to severe acute exacerbations of asthma (oral prednisone usually preferred); speeds resolution of airflow obstruction and reduces rate of relapse.

Because onset of effects is delayed, do not use alone for emergency treatment.

Early systemic glucocorticoid therapy particularly important for asthma exacerbations in infants and children.

Orally as an adjunct to other therapy to speed resolution of all but the mildest exacerbations of asthma when response to a short-acting inhaled β2-agonist is not prompt or sustained after 1 hour or in those who have a history of severe exacerbations.

Oral glucocorticoids with minimal mineralocorticoid activity and relatively short half-life (e.g., prednisone, prednisolone, methylprednisolone) are preferred.

In hospital management of an acute asthma exacerbation, use systemic adjunctive glucocorticoids if response to oral inhalation therapy is not immediate, if oral corticosteroids were used as self-medication prior to hospitalization, or if the episode is severe.

For severe persistent asthma once initial control is achieved, high dosages of inhaled corticosteroids are preferable to oral glucocorticoids for maintenance because inhaled corticosteroids have fewer systemic effects.

Maintenance therapy with low doses of an orally inhaled corticosteroid is preferred treatment for adults and children with mild persistent asthma (i.e., patients with daytime symptoms of asthma more than twice weekly but less than once daily, and nocturnal symptoms of asthma more than twice per month).

Chronic Obstructive Pulmonary Disease

For severe exacerbations of chronic obstructive pulmonary disease (COPD), a short (e.g., 1–2 weeks) course of oral glucocorticoids can be added to existing therapy.

Much less dramatic effects in stable COPD than in asthma, and the role of glucocorticoids is limited to very specific indications.

Sarcoidosis

Management of symptomatic sarcoidosis.

Systemic glucocorticoids are indicated for hypercalcemia; ocular, CNS, glandular, myocardial, or severe pulmonary involvement; or severe skin lesions unresponsive to intralesional injections of glucocorticoids.

Advanced Pulmonary and Extrapulmonary Tuberculosis

Used systemically as adjunctive therapy with effective antimycobacterial agents (e.g., streptomycin, isoniazid) to suppress manifestations related to the host’s inflammatory response to the bacillus (Mycobacterium tuberculosis) and ameliorate complications in severe pulmonary or extrapulmonary (disseminated) tuberculosis.

In advanced pulmonary tuberculosis, adjunctive glucocorticoid therapy may enhance short-term resolution of disease manifestations (e.g., clinical and radiographic abnormalities).

In certain forms of extrapulmonary disease (e.g., meningitis, pericarditis), also may reduce mortality.

In moderate to severe tuberculous meningitis, systemic adjunctive glucocorticoids may reduce sequelae (e.g., intellectual impairment) and/or improve survival. Used concurrently with appropriate antituberculous chemotherapy in the treatment of tuberculous meningitis with subarachnoid block or impending block. Speeds resolution of abnormal CSF parameters (e.g., elevated intracranial pressure, basal exudate, CNS tuberculomas).

In acute tuberculous pericarditis, systemic adjunctive glucocorticoid therapy rapidly reduces the size of pericardial effusions and the need for drainage procedures and decreases mortality (probably through control of hemodynamically threatening effusion).

In tuberculous pleurisy, hastens the resolution of pain, dyspnea, and fever.

Used adjunctively with antimycobacterial agents for the treatment of tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty. The safety and efficacy of adjunctive glucocorticoid therapy in patients with tuberculous lymphadenitis, miliary or laryngeal tuberculosis, or HIV-associated tuberculosis has not been fully elucidated.

Eosinophilic Pneumonias

Used in the management of idiopathic eosinophilic pneumonias.

Hypersensitivity Pneumonitis

Used in the management of hypersensitivity pneumonitis.

Pulmonary Fibrosis

Used in the management of idiopathic pulmonary fibrosis.

Lipid Pneumonitis

Promotes the breakdown or dissolution of pulmonary lesions and eliminates sputum lipids.

>Pneumocystis carinii Pneumonia

Used adjunctively with appropriate anti-infective therapy in the management of moderate to severe Pneumocystis carinii pneumonia in patients with acquired immunodeficiency syndrome (AIDS) to decrease the likelihood of deterioration of oxygenation, respiratory failure, and/or death.

Allergic Bronchopulmonary Aspergillosis

Used in the management of allergic bronchopulmonary aspergillosis.

Bronchiolitis Obliterans

Used in the management of idiopathic bronchiolitis obliterans with organizing pneumonia.

Loeffler’s Syndrome

Symptomatic relief of acute manifestations of symptomatic Loeffler’s syndrome not manageable by other means.

Berylliosis

Symptomatic relief of acute manifestations of berylliosis.

Aspiration Pneumonitis

Symptomatic relief of acute manifestations of aspiration pneumonitis.

Anthrax

Adjunct to anti-infective therapy in the treatment of anthrax in an attempt to ameliorate toxin-mediated effects associated with Bacillus anthracis infections.

Used for cutaneous anthrax if there are signs of systemic involvement or extensive edema involving the neck and thoracic region. Has been used for anthrax meningitis, and inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism if extensive edema, respiratory compromise, or meningitis is present.

Hematologic Disorders

Management of acquired (autoimmune) hemolytic anemia, idiopathic thrombocytopenic purpura (ITP), secondary thrombocytopenia, erythroblastopenia, congenital (erythroid) hypoplastic anemia (Diamond-Blackfan anemia), or hemolysis.

High or even massive dosages decrease bleeding tendencies and normalize blood counts; does not affect the course or duration of hematologic disorders.

Glucocorticoids, immune globulin IV (IGIV), or splenectomy are first-line therapies for moderate to severe ITP, depending on the extent of bleeding involved.

May not affect or prevent renal complications in Henoch-Schoenlein purpura.

Insufficient evidence of effectiveness in aplastic anemia in children, but widely used.

Pericarditis

To reduce the pain, fever, and inflammation of pericarditis, including that associated with MI.

Glucocorticoids can provide effective symptomatic relief, but aspirin considered the treatment of choice for postmyocardial infarction pericarditis because of greater evidence establishing benefit.

Important to distinguish between pain caused by pericarditis and that caused by ischemia since management will differ.

Consider possibility that cardiac rupture may account for recurrent pain since use of glucocorticoids may be a risk factor in its development.

Glucocorticoids may cause thinning of developing scar and myocardial rupture.

Management of tuberculous pericarditis. (See Advanced Pulmonary and Extrapulmonary Tuberculosis under Uses.)

GI Diseases

Short-term palliative therapy for acute exacerbations and systemic complications of ulcerative colitis or regional enteritis, or celiac disease. Low dosages of glucocorticoids, in conjunction with other supportive therapy, may occasionally be useful for patients unresponsive to usual therapy for chronic conditions.

Do not use if a probability of impending perforation, abscess, or other pyogenic infection.

Crohn’s Disease

Management of mildly to moderately active and moderately to severely active Crohn’s disease.

Some experts state that conventional glucocorticoids should not be used for the management of mildly to moderately active disease because of their high incidence of adverse effects, and their use should be reserved for patients with moderately to severely active disease.

Parenteral glucocorticoids recommended for patients with severe fulminant Crohn’s disease. Once patients respond to parenteral therapy, they should gradually be switched to an equivalent regimen of an oral glucocorticoid.

Glucocorticoids should not be used for maintenance therapy of Crohn’s disease because they usually do not prevent relapses and the drugs may produce severe adverse reactions with long-term administration.

Glucocorticoids have been used in the management of moderately to severely active Crohn’s disease and in mild esophageal or gastroduodenal Crohn’s disease in pediatric patients.

Neoplastic Diseases

Alone or as a component of various chemotherapeutic regimens in the palliative treatment of neoplastic diseases of the lymphatic system (e.g., leukemias and lymphomas in adults and acute leukemias in children).

In adults, acute lymphocytic (lymphoblastic) leukemia, chronic lymphocytic leukemia, and Hodgkin’s disease respond well to combination regimens that include a glucocorticoid (usually prednisone or prednisolone). Acute myeloblastic leukemia, lymphosarcoma, and the blast crisis of chronic myelocytic leukemia may fail to respond or may relapse upon discontinuance of therapy.

Treatment of breast cancer: Glucocorticoids alone not as effective as other agents (e.g., cytotoxic agents, hormones, antiestrogens) and should be reserved for unresponsive disease.

Glucocorticoids alone or as a component of various combination chemotherapeutic regimens for palliative treatment of advanced, symptomatic (i.e., painful) hormone-refractory prostate cancer.

Cerebral Malaria

Glucocorticoids are not effective and can have detrimental effects in the management of cerebral malaria caused by Plasmodium falciparum; no longer recommended for this condition.

Liver Disease

In patients with subacute hepatic necrosis and chronic active hepatitis, high-dose glucocorticoids can decrease serum bilirubin, ascites, and mortality rate. In nonalcoholic cirrhosis in women, the drugs increase survival rate in the absence of ascites, but not when ascites is present. May decrease mortality rate in patients with alcoholic cirrhosis with hepatic encephalopathy, but should not be used in less seriously ill patients.

Multiple Sclerosis

Glucocorticoids are drugs of choice for the management of acute relapses of multiple sclerosis. Have replaced corticotropin as the therapy of choice because of a more rapid onset of action, more consistent effects, and fewer adverse effects.

Anti-inflammatory and immunomodulating effects accelerate neurologic recovery by restoring the blood-brain barrier, reducing edema, and possibly improving axonal conduction.

Shortens the duration of relapse and accelerates recovery; remains to be established whether the overall degree of recovery improves or the long-term course is altered.

Myasthenia Gravis

Management of myasthenia gravis, usually when there is an inadequate response to anticholinesterase therapy.

Organ Transplants

Used in massive dosage with or without other immunosuppressive drugs to prevent rejection of transplanted organs.

Incidence of secondary infections is high with immunosuppressive drugs; limit to clinicians experienced in their use.

Trichinosis

Treatment of trichinosis with neurologic or myocardial involvement.

Nephrotic Syndrome and Lupus Nephritis

Treatment of idiopathic nephrotic syndrome without uremia.

Can induce diuresis or remission of proteinuria in nephrotic syndrome secondary to primary renal disease, especially when there is minimal renal histologic change.

Treatment of lupus nephritis.