Prednisolone Sodium Phosphate

Class: Adrenals
ATC Class: H02AB04
VA Class: HS051
CAS Number: 52438-85-4
Brands: Orapred, Pediapred, Prelone Syrup

Introduction

Synthetic glucocorticoid; minimal mineralocorticoid activity.^{a b c}

Uses for Prednisolone Sodium Phosphate

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.^c

Adrenocortical Insufficiency

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

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.^{a c}

Usually inadequate alone for adrenocortical insufficiency because of minimal mineralocorticoid activity.^{b c}

If prednisolone is used for adrenocortical insufficiency, a mineralocorticoid (e.g., fludrocortisone) must also be administered, particularly in infants.^{a b c d g}

Adrenogenital Syndrome

Lifelong glucocorticoid treatment of adrenogenital syndrome (e.g., congenital adrenal hyperplasia).^{a c d g}

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.^c

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

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

Hypercalcemia

Treatment of hypercalcemia associated with malignancy.^{a c d g}

Usually ameliorates hypercalcemia associated with bone involvement in multiple myeloma.^c

Treatment of hypercalcemia associated with sarcoidosis†.^c

Treatment of hypercalcemia associated with vitamin D intoxication†.^c

Not effective for hypercalcemia caused by hyperparathyroidism†.^c

Thyroiditis

Treatment of granulomatous (subacute, nonsuppurative) thyroiditis.^{a d g}

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

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

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

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.^{a c d e g}

Relieves inflammation and suppresses symptoms but not disease progression.^c

Rarely indicated as maintenance therapy.^c

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.^{a c d g}

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

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.^c

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

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†.^{a c d e} 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.^c

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

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

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.^{a c d e g}

Usually reserved for acute exacerbations unresponsive to conservative therapy.^c

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

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

Chronic skin disorders seldom an indication for systemic glucocorticoid therapy.^c

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

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

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.^{a c d g}

Systemic therapy usually reserved for acute conditions and severe exacerbations.^c

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

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.^c

Ocular Disorders

To suppress a variety of allergic and nonpyogenic ocular inflammations.^c

To reduce scarring in ocular injuries†.^c

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.^{a c d g}

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.^f

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

Asthma

Adjunctively for moderate to severe exacerbations of asthma and for maintenance in persistent asthma.^{c d e}

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.^j

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

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

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.^c

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.^c

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^c (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).^b

Chronic Obstructive Pulmonary Disease

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

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

Sarcoidosis

Management of symptomatic sarcoidosis.^{a c d g}

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

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.^{a d}

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.^{a d f} 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.^d 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.^d

Hypersensitivity Pneumonitis

Used in the management of hypersensitivity pneumonitis.^d

Pulmonary Fibrosis

Used in the management of idiopathic pulmonary fibrosis.^d

Lipid Pneumonitis†

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

>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.^d

Bronchiolitis Obliterans

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

Loeffler’s Syndrome

Symptomatic relief of acute manifestations of symptomatic Loeffler’s syndrome not manageable by other means.^{a g}

Berylliosis

Symptomatic relief of acute manifestations of berylliosis.^{a g}

Aspiration Pneumonitis

Symptomatic relief of acute manifestations of aspiration pneumonitis.^{a g}

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†.^{a d e g}

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

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.^c

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

Pericarditis

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

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†.^{a c d g} Low dosages of glucocorticoids, in conjunction with other supportive therapy, may occasionally be useful for patients unresponsive to usual therapy for chronic conditions.^c

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

Crohn’s Disease

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

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).^{a d e f}

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).^c Acute myeloblastic leukemia, lymphosarcoma, and the blast crisis of chronic myelocytic leukemia may fail to respond or may relapse upon discontinuance of therapy.^c

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

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

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.^{c d}

Liver Disease

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

Multiple Sclerosis

Glucocorticoids are drugs of choice for the management of acute relapses of multiple sclerosis.^{a d} 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.^e

Organ Transplants

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

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

Trichinosis

Treatment of trichinosis with neurologic or myocardial involvement.^{a d}

Nephrotic Syndrome and Lupus Nephritis

Treatment of idiopathic nephrotic syndrome without uremia.^{a d}

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

Treatment of lupus nephritis.^{a d}

Prednisolone Sodium Phosphate Dosage and Administration

General

• 
  

  Route of administration and dosage depend on the condition being treated and the patient response.^a

  
  

Alternate-day Therapy

• 
  

  Alternate-day therapy in which a single dose (twice the usual daily dosage) is administered every other morning is the dosage regimen of choice for long-term oral glucocorticoid treatment of most conditions.^{a c} This regimen provides relief of symptoms while minimizing adrenal suppression, protein catabolism, and other adverse effects.^{a c}

  
  


• 
  

  If alternate-day therapy is preferred, only use a “short-acting” glucocorticoid that suppresses the HPA axis <1.5 days after a single oral dose (e.g., prednisone, prednisolone, methylprednisolone).^c

  
  


• 
  

  Some conditions (e.g., rheumatoid arthritis, ulcerative colitis) require daily glucocorticoid therapy because symptoms of the underlying disease cannot be controlled by alternate-day therapy.^c

  
  

Discontinuance of Therapy

• 
  

  A steroid withdrawal syndrome consisting of lethargy, fever, myalgia can develop following abrupt discontinuance.^c Symptoms often occur without evidence of adrenal insufficiency (while plasma glucocorticoid concentrations were still high but were falling rapidly).^c

  
  


• 
  

  If used for only brief periods (a few days) in emergency situations, may reduce and discontinue dosage quite rapidly.^{c g}

  
  


• 
  

  Very gradually withdraw systemic glucocorticoids until recovery of HPA-axis function occurs following long-term therapy with pharmacologic dosages.^{c d} (See Adrenocortical Insufficiency under Warnings.)

  
  


• 
  

  Exercise caution when transferring from systemic glucocorticoid to oral or nasal inhalation corticosteroid therapy.^c

  
  


• 
  

  Many methods of slow withdrawal or “tapering” have been described.^c

  
  


• 
  

  In 1 suggested regimen, decrease by 2.5–5 mg every 3–7 days until the physiologic dose (5 mg) is reached.^c

  
  


• 
  

  Other recommendations state that decrements usually should not exceed 2.5 mg every 1–2 weeks.^c

  
  


• 
  

  When a physiologic dosage has been reached, single 20-mg oral morning doses of hydrocortisone can be substituted for whatever glucocorticoid the patient has been receiving.^c After 2–4 weeks, may decrease hydrocortisone dosage by 2.5 mg every week until a single morning dosage of 10 mg daily is reached.^c

  
  


• 
  

  For certain acute allergic conditions (e.g., contact dermatitis such as poison ivy) or acute exacerbations of chronic allergic conditions, glucocorticoids may be administered short term (e.g., for 6 days).^c Administer a high dose on the first day of therapy, then withdraw therapy by tapering the dosage over several days.^c

  
  

Administration

Oral Administration

Administer orally as tablets, syrup, or oral solution.^{a d g}

Dosage

Dosage of prednisolone sodium phosphate is expressed in terms of prednisolone.^{a b d}

After a satisfactory response is obtained, decrease dosage in small decrements to the lowest level that maintains an adequate clinical response, and discontinue the drug as soon as possible.^b

Monitor patients continually for signs that indicate dosage adjustment is necessary, such as remissions or exacerbations of the disease and stress (surgery, infection, trauma).^b

High dosages may be required for acute situations of certain rheumatic disorders and collagen diseases.^c After a response has been obtained, drug often must be continued for long periods at low dosage.^c

High or massive dosages may be required in the treatment of pemphigus, exfoliative dermatitis, bullous dermatitis herpetiformis, severe erythema multiforme, or mycosis fungoides.^c Early initiation of systemic glucocorticoid therapy may be life-saving in pemphigus vulgaris.^c Reduce dosage gradually to the lowest effective level, but discontinuance may not be possible.^c

Pediatric Patients

Base pediatric dosage on severity of the disease and patient response rather than on strict adherence to dosage indicated by age, body weight, or body surface area.^b

Usual Dosage

Oral

Syrup or tablets: Initially, 0.14–2 mg/kg daily or 4–60 mg/m² daily in 4 divided doses.^b

Oral solution: Initially, 0.14–2 mg/kg daily or 4–60 mg/m² daily in 3 or 4 divided doses.^{b d}

Asthma

Oral

For the treatment of refractory bronchial asthma and related bronchospasm (severe persistent asthma) not controlled with high maintenance dosages of an inhaled corticosteroid and a long-acting bronchodilator, add an oral corticosteroid (e.g., prednisone, prednisolone, methylprednisolone) at a dosage of 1–2 mg/kg daily in single or divided doses.^d Continue a short course of oral corticosteroid therapy (usually 3–10 days) until a peak expiratory flow rate of 80% of personal best is achieved or until symptoms resolve.^d May need a longer duration of treatment in some children.^d No evidence that tapering the dosage after improvement will prevent relapse.^d

Nephrotic Syndrome

Oral

Usual dosage: 60 mg/m² given in 3 divided doses for 4 weeks, followed by 4 weeks of alternate-day therapy at single doses of 40 mg/m².^d

Adults

Usual Dosage

Oral

Initially, 5–60 mg daily, depending on the disease being treated; usually administered in 2–4 divided doses.^{b d g}

Acute Exacerbations of Multiple Sclerosis

Oral

Usual dosage: 200 mg daily for 1 week, followed by 80 mg every other day for a month.^{b d}

Cautions for Prednisolone Sodium Phosphate

Contraindications

• 
  

  Known hypersensitivity to prednisolone, any ingredient in the respective formulation, or any other corticosteroid.^{c d}

  
  


• 
  

  Systemic fungal infections.^{a d g}

  
  


• 
  

  Concurrent administration of live or live, attenuated vaccines in patients receiving immunosuppressive doses of corticosteroids.^d (See Specific Drugs under Interactions.)

  
  

Warnings/Precautions

Warnings

Adrenocortical Insufficiency

When given in supraphysiologic doses for prolonged periods, glucocorticoids may cause decreased secretion of endogenous corticosteroids by suppressing pituitary release of corticotropin (secondary adrenocortical insufficiency).^c

The degree and duration of adrenocortical insufficiency is highly variable among patients and depends on the dose, frequency and time of administration, and duration of glucocorticoid therapy.^c

Acute adrenal insufficiency (even death) may occur if the drugs are withdrawn abruptly or if patients are transferred from systemic glucocorticoid therapy to local (e.g., inhalation) therapy.^c

Withdraw prednisolone very gradually following long-term therapy with pharmacologic dosages.^c (See Discontinuance of Therapy under Dosage and Administration: Dosage.)

Adrenal suppression may persist up to 12 months in patients who receive large dosages for prolonged periods.^c

Until recovery occurs, signs and symptoms of adrenal insufficiency may develop if subjected to stress (e.g., infection, surgery, trauma, illness) and replacement therapy may be required.^{a c d g} Since mineralocorticoid secretion may be impaired, sodium chloride and/or a mineralocorticoid also should be administered.^{c d}

If the disease flares up during withdrawal, may need to increase dosage temporarily and then withdraw drug more gradually.^c

Immunosuppression

Increased susceptibility to infections secondary to glucocorticoid-induced immunosuppression.^d Certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in such patients.^d (See Increased Susceptibility to Infection under Warnings.)

Administration of live virus vaccines, including smallpox, is contraindicated in patients receiving immunosuppressive dosages of glucocorticoids.^{d o} In addition, if inactivated viral or bacterial vaccines are administered to such patients, expected serum antibody response may not be obtained.^{a c d} The USPHS Advisory Committee on Immunization Practices (ACIP) and American Academy of Family Physicians (AAFP)^o state that administration of live virus vaccines usually is not contraindicated in patients receiving corticosteroid therapy under the following circumstances:

• 
  

  short-term (<2 weeks) therapy

  
  


• 
  

  low to moderate dosage

  
  


• 
  

  long-term alternate-day treatment with long-acting preparations

  
  


• 
  

  maintenance physiologic dosages (replacement therapy)

  
  


• 
  

  if it is administered topically, ophthalmically, intra-articularly, bursally, or into a tendon^o

  
  

Increased Susceptibility to Infection

Glucocorticoids, especially in large doses, increase susceptibility to and mask symptoms of infection.^d

Infections with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic infections in any organ system may be associated with glucocorticoids alone or in combination with other immunosuppressive agents.

Infections may be mild, but they can be severe or fatal, and localized infections may disseminate.

Do not use, except in life-threatening situations, in patients with viral infections, or bacterial infections not controlled by anti-infectives.^c

Some infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome, particularly in children.^d

Children and adults who are not likely to have been exposed to varicella or measles should avoid exposure to these infections while receiving glucocorticoids.^d

If exposure to varicella or measles occurs in susceptible patients, treat appropriately (e.g., VZIG, IG, acyclovir).^d

Fatal outcome (e.g., in those developing hemorrhagic varicella) may not always be avoided even if appropriate therapy is initiated aggressively.

Immunosuppression may result in activation of latent infection or exacerbation of intercurrent infections (e.g., those caused by Candida, Mycobacterium, Toxoplasma, Strongyloides, Pneumocystis, Cryptococcus, Nocardia, Ameba).^d

Use with great care in patients with known or suspected Strongyloides (threadworm) infection.^d Immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Not effective and can have detrimental effects in the management of cerebral malaria.^{c d}

Can reactivate tuberculosis.^d Include chemoprophylaxis in patients with a history of active tuberculosis undergoing prolonged glucocorticoid therapy.^{c d} Observe closely for evidence of reactivation.^d Restrict use in active tuberculosis to those with fulminating or disseminated tuberculosis in which glucocorticoids are used in conjunction with appropriate antimycobacterial chemotherapy.^d

Can reactivate latent amebiasis.^{c d} Exclude possible amebiasis in any patient who has been in the tropics or who has unexplained diarrhea prior to initiating therapy.^{c d}

Musculoskeletal Effects

Muscle wasting, muscle pain or weakness, delayed wound healing, and atrophy of the protein matrix of the bone resulting in osteoporosis, vertebral compression fractures, aseptic necrosis of femoral or humeral heads, or pathologic fractures of long bones are manifestations of protein catabolism that may occur during prolonged therapy with glucocorticoids.^{c d} These adverse effects may be especially serious in geriatric or debilitated patients.^c A high protein diet may help to prevent adverse effects associated with protein catabolism.^c

An acute, generalized myopathy can occur with the use of high doses of glucocorticoids, particularly in patients with disorders of neuromuscular transmission (e.g., myasthenia gravis) or in patients receiving concomitant therapy with neuromuscular blocking agents (e.g., pancuronium).^{a d d}

Tendon rupture, particularly of the Achilles tendon.

Osteoporosis and related fractures are one of the most serious adverse effects of long-term glucocorticoid therapy. The American College of Rheumatology (ACR) currently considers patients receiving or planning to receive the equivalent of at least 5 mg of prednisone (i.e., 5 mg of prednisolone) daily for 3 months or longer to be at risk for bone loss.

To minimize the risk of glucocorticoid-induced bone loss, should use the smallest possible effective dosage and duration and use topical and inhaled preparations whenever possible. Obtain baseline measurement of bone mass density (BMD) at the lumbar spine and/or hip when initiating long-term (e.g., exceeding 6 months) glucocorticoid therapy and initiate appropriate preventive therapy. May repeat longitudinal measurements as often as every 6 months to detect possible bone loss. Less frequent (e.g., annually) follow-up probably is sufficient in patients who are receiving therapy to prevent bone loss.

Before initiating glucocorticoid therapy in postmenopausal women, consider that they are especially prone to osteoporosis.^{c d}

Skeletal wasting is most rapid during the initial 6 months of therapy, and trabecular bone is affected to a greater degree than is cortical bone.

Withdraw glucocorticoids if osteoporosis develops, unless their use is life-saving.^c

Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects.

Calcitonin may be considered as second-line therapy for patients who refuse or do not tolerate bisphosphonate therapy or in whom the drugs are contraindicated.

Fluid and Electrolyte Disturbances

Sodium retention with resultant edema, potassium loss, and elevation of blood pressure may occur but is less common with prednisolone than with average or large doses of cortisone or hydrocortisone.^d Risk is increased with high-dose synthetic glucocorticoids for prolonged periods.^{c d} Edema and CHF (in susceptible patients) may occur.^c

Dietary salt restriction is advisable and potassium supplementation may be necessary.^{c d}

Increased calcium excretion and possible hypocalcemia.^{c d}

Ocular Effects

Prolonged use may result in posterior subcapsular and nuclear cataracts (particularly in children), exophthalmos, and/or increased IOP which may result in glaucoma or may occasionally damage the optic nerve.^d If corticosteroid therapy is continued for >6 weeks, monitor IOP.^d

May enhance the establishment of secondary fungal, bacterial, and viral infections of the eye.^d

Do not use in patients with active ocular herpes simplex infections for fear of corneal perforation.^{c d}

Endocrine and Metabolic Effects

With prolonged therapy, may produce various endocrine disorders including hypercorticism (cushingoid state) and amenorrhea or other menstrual difficulties.^{a c d}

Increased or decreased motility and number of sperm in some men.^c

May decrease glucose tolerance, produce hyperglycemia, and aggravate or precipitate diabetes mellitus, especially in patients predisposed to diabetes mellitus.^{a c g} If glucocorticoid therapy is required in patients with diabetes mellitus, may be necessary to change insulin or oral antidiabetic agent dosage or diet.^{a c g}

Exaggerated response to glucocorticoids in hypothyroidism.^{c d}

Cardiovascular Effects

Use with extreme caution in recent MI since an association between use of glucocorticoids and left ventricular free-wall rupture has been suggested.^c

Sodium retention with resultant edema, potassium loss, hypokalemic alkalosis, and hypertension may occur in patients receiving glucocorticoids.^{c d} Congestive heart failure may occur in susceptible patients.^{a c d g}

Should be used with caution in patients with hypertension or congestive heart failure.^{a c d}

Sensitivity Reactions

Urticaria and other allergic, anaphylactic, or hypersensitivity reactions reported.^{a d}

General Precautions

Monitoring

Prior to initiation of long-term glucocorticoid therapy, perform baseline ECGs, BPs, chest and spinal radiographs, glucose tolerance tests, and evaluations of HPA-axis function in all patients.^{c g}

Perform upper GI radiographs in patients predisposed

Ibu-Tab

In the US, Ibu-Tab is a member of the drug class nonsteroidal anti-inflammatory agents and is used to treat Aseptic Necrosis, Back Pain, Costochondritis, Cystic Fibrosis, Dysautonomia, Fever, Frozen Shoulder, Gout - Acute, Headache, Muscle Pain, Osteoarthritis, Pain, Patent Ductus Arteriosus, Period Pain, Rheumatoid Arthritis, Sciatica and Temporomandibular Joint Disorder.

Ingredient matches for Ibu-Tab

Ibuprofen

Ibuprofen is reported as an ingredient of Ibu-Tab in the following countries:

• United States

International Drug Name Search

Arteriovenous Shunting Medications

Topics under Arteriovenous Shunting

• AV Malformations (0 drugs)

Drug List:

E-400

Generic Name: vitamin e (Oral route)

VYE-ta-min E

Commonly used brand name(s)

In the U.S.

• Alpha-E


• Aqua Gem-E


• Aquasol E


• D-Alpha Gems


• E-400


• E-600


• E-Gems


• Formula E 400


• Gamma E-Gems


• Gamma E Plus


• Key-E


• Natural Vitamin Blend E-400IU


• Nutr-E-Sol

Available Dosage Forms:

• Liquid


• Solution


• Tablet


• Capsule, Liquid Filled


• Tablet, Chewable


• Powder for Solution


• Capsule

Therapeutic Class: Nutritive Agent

Pharmacologic Class: Vitamin E (class)

Uses For E-400

Vitamins are compounds that you must have for growth and health. They are needed in only small amounts and are available in the foods that you eat. Vitamin E prevents a chemical reaction called oxidation, which can sometimes result in harmful effects in your body. It is also important for the proper function of nerves and muscles.

Some conditions may increase your need for vitamin E. These include:

• Intestine disease


• Liver disease


• Pancreas disease


• Surgical removal of stomach

Increased need for vitamin E should be determined by your health care professional.

Infants who are receiving a formula that is not fortified with vitamin E may be likely to have a vitamin E deficiency. Also, diets high in polyunsaturated fatty acids may increase your need for vitamin E.

Claims that vitamin E is effective for treatment of cancer and for prevention or treatment of acne, aging, loss of hair, bee stings, liver spots on the hands, bursitis, diaper rash, frostbite, stomach ulcer, heart attacks, labor pains, certain blood diseases, miscarriage, muscular dystrophy, poor posture, sexual impotence, sterility, infertility, menopause, sunburn, and lung damage from air pollution have not been proven. Although vitamin E is being used to prevent certain types of cancer, there is not enough information to show that this is effective.

Lack of vitamin E is extremely rare, except in people who have a disease in which it is not absorbed into the body.

Vitamin E is available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Vitamin E is found in various foods including vegetable oils (corn, cottonseed, soybean, safflower), wheat germ, whole-grain cereals, and green leafy vegetables. Cooking and storage may destroy some of the vitamin E in foods.

Vitamin supplements alone will not take the place of a good diet and will not provide energy. Your body also needs other substances found in food such as protein, minerals, carbohydrates, and fat. Vitamins themselves often cannot work without the presence of other foods. For example, small amounts of fat are needed so that vitamin E can be absorbed into the body.

The daily amount of vitamin E needed is defined in several different ways.

• For U.S.—


• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).


• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—


• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Vitamin E is available in various forms, including d- or dl-alpha tocopheryl acetate, d- or dl-alpha tocopherol, and d- or dl-alpha tocopheryl acid succinate. In the past, the RDA for vitamin E have been expressed in Units. This term has been replaced by alpha tocopherol equivalents (alpha-TE) or milligrams (mg) of d-alpha tocopherol. One Unit is equivalent to 1 mg of dl-alpha tocopherol acetate or 0.6 mg d-alpha tocopherol. Most products available in stores continue to be labeled in Units.

Normal daily recommended intakes in milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) and Units for vitamin E are generally defined as follows:

Persons	U.S.		Canada
	mg alpha-TE	Units	mg alpha-TE	Units
Infants and children Birth to 3 years of age	3–6	5–10	3–4	5–6.7
4 to 6 years of age	7	11.7	5	8.3
7 to 10 years of age	7	11.7	6–8	10–13
Adolescent and adult males	10	16.7	6–10	10–16.7
Adolescent and adult females	8	13	5–7	8.3–11.7
Pregnant females	10	16.7	8–9	13–15
Breast-feeding females	11–12	18–20	9–10	15–16.7

Before Using E-400

If you are taking this dietary supplement without a prescription, carefully read and follow any precautions on the label. For this supplement, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts. You should check with your health care professional if you are giving your baby an unfortified formula. In that case, the baby must get the vitamins needed some other way. Some studies have shown that premature infants may have low levels of vitamin E. Your health care professional may recommend a vitamin E supplement.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	A	Adequate studies in pregnant women have not shown an increased risk of fetal abnormalities.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this dietary supplement, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this dietary supplement with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Dicumarol

Using this dietary supplement with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this dietary supplement. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems—Vitamin E, when taken in doses greater than 800 Units a day for long periods of time, may make this condition worse

Proper Use of vitamin e

This section provides information on the proper use of a number of products that contain vitamin e. It may not be specific to E-400. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral solution dosage form:
  
  • To prevent the following deficiencies in infants:
    
    • Infants receiving a formula high in polyunsaturated fatty acids—15 to 25 Units per day or 7 Units per 32 ounces of formula.
    
    
    • Infants with certain colon problems—15 to 25 Units per kilogram (kg) (6.8 to 11 Units per pound) of body weight per day. The water-soluble form of vitamin E must be used.
    
    
    • Infants of normal birthweight—5 Units per 32 ounces of formula.
    
    
  
  


• For oral dosage forms (capsules, tablets, oral solution):
  
  • To prevent deficiency for individuals (other than infants), the amount taken by mouth is based on normal daily recommended intakes:
    
    • For the U.S.
    
    
    • Adult and teenage males—10 milligrams (mg) of alpha tocopherol equivalents (mg alpha-TE) or 16.7 Units per day.
    
    
    • Adult and teenage females—8 mg alpha-TE or 13 Units per day.
    
    
    • Pregnant females—10 mg alpha-TE or 16.7 Units per day.
    
    
    • Breast-feeding females—11 to 12 mg alpha-TE or 18 to 20 Units per day.
    
    
    • Children 4 to 10 years of age—7 mg alpha-TE or 11.7 Units per day.
    
    
    • Children birth to 3 years of age—3 to 6 mg alpha-TE or 5 to 10 Units per day.
    
    
    • For Canada
    
    
    • Adult and teenage males—6 to 10 mg alpha-TE or 10 to 16.7 Units per day.
    
    
    • Adult and teenage females—5 to 7 mg alpha-TE or 8.3 to 11.7 Units per day.
    
    
    • Pregnant females—8 to 9 mg alpha-TE or 13 to 15 Units per day.
    
    
    • Breast-feeding females—9 to 10 mg alpha-TE or 15 to 16.7 Units per day.
    
    
    • Children 7 to 10 years of age—6 to 8 mg alpha-TE or 10 to 13 Units per day.
    
    
    • Children 4 to 6 years of age—5 mg alpha-TE or 8.3 Units per day.
    
    
    • Children birth to 3 years of age—3 to 4 mg alpha-TE or 5 to 6.7 Units per day.
    
    
  
  
  • To treat deficiency:
    
    • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on the severity of deficiency.
    
    
  
  

For individuals taking the oral liquid form of this dietary supplement:

• This preparation should be taken by mouth even though it comes in a dropper bottle.


• This dietary supplement may be dropped directly into the mouth or mixed with cereal, fruit juice, or other food.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the dietary supplement in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

E-400 Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

With doses greater than 400 Units a day and long-term use

• Blurred vision


• diarrhea


• dizziness


• headache


• nausea or stomach cramps


• unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: E-400 side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More E-400 resources

• E-400 Side Effects (in more detail)
• E-400 Use in Pregnancy & Breastfeeding
• E-400 Drug Interactions
• E-400 Support Group
• 0 Reviews for E-400 - Add your own review/rating

Compare E-400 with other medications

• Alzheimer's Disease
• Anemia, Sickle Cell
• Cystic Fibrosis
• Dietary Supplementation
• Nocturnal Leg Cramps
• Retinopathy Prophylaxis
• Tardive Dyskinesia
• Vitamin E Deficiency

anakinra Subcutaneous

an-a-KIN-ra

Commonly used brand name(s)

In the U.S.

• Kineret

Available Dosage Forms:

• Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Interleukin-1 Inhibitor

Uses For anakinra

Anakinra is used to treat moderate to severe symptoms of rheumatoid arthritis. It may relieve redness, pain, tenderness, and warmth in hands, feet, wrists, shoulders, elbows, and ankles. anakinra is used in patients 18 years of age or older. Anakinra will not cure the disease, but will help with the symptoms as long as you continue to take it.

anakinra is available only with your doctor's prescription.

Before Using anakinra

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For anakinra, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to anakinra or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on anakinra have been done only in adult patients, and there is no specific information comparing use of anakinra in children with use in other age groups.

Geriatric

anakinra has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking anakinra, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using anakinra with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abatacept


• Adalimumab


• Certolizumab Pegol


• Etanercept


• Golimumab


• Infliximab


• Rilonacept

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of anakinra. Make sure you tell your doctor if you have any other medical problems, especially:

• Active infections—May be worsened by anakinra

• Asthma—Patients with asthma may be at higher risk of getting a serious infection when taking anakinra.

• Immunosuppression—Anakinra has not been studied in patients who have immune system problems. The effects of the medicine in these patients is not known

• Kidney disease—Higher blood levels of anakinra may occur

Proper Use of anakinra

Your health care professional will teach you or your caregiver how to give the injection. You must demonstrate the procedure so that your health care professional knows you understand. Before taking the injection, check the medicine to make sure it is clear and doesn't have any particles in it. If it looks cloudy or discolored, or has any particles floating in it, you should throw it away. Do not shake the syringe. Give the entire dose and then throw away the syringe. Your health care professional will tell you how to dispose of your syringes. Do not reuse syringes. Do not keep part of a dose for later use. Take the medicine at the same time each day. If you have questions or problems with the procedure, call your health care professional.

Dosing

The dose of anakinra will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of anakinra. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form
  
  • For rheumatoid arthritis:
    
    • Adults—100 milligrams (mg) a day injected under the skin.
    
    
    • Children—Use and dose must be determined by your doctor. Anakinra is not usually recommended for use in children.
    
    
  
  

Missed Dose

If you miss a dose of anakinra, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store in the refrigerator. Do not freeze.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using anakinra

It is important that your doctor check your progress at regular visits to make sure that anakinra is working properly and to check for unwanted effects.

Your body's ability to fight infection may be reduced while you are being treated with anakinra, it is very important that you call your doctor at the first signs of any infection (for example, if you get a fever or chills).

While you are being treated with anakinra, do not have any immunizations (vaccinations) without your doctor's approval.

anakinra Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Chest pain


• cough


• diarrhea


• fever or chills


• general feeling of discomfort or illness


• headache


• itching, pain, redness, swelling, tenderness or warmth on skin


• joint pain


• loss of appetite


• muscle aches and pains


• nausea


• pain or tenderness around eyes and cheekbones


• redness, bruising pain at the injection site


• runny nose


• shivering


• shortness of breath


• sneezing


• sore throat


• sweating


• tightness in chest


• trouble sleeping


• unusual tiredness or weakness


• vomiting


• wheezing

Less common or rare

• Black, sticky stools


• difficulty in swallowing


• itching


• lower back pain or side pain


• painful or difficult urination


• pale skin


• rash; hives; swelling of face or lips


• ulcers, sores or white spots in mouth


• unusual bruising or bleeding

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach pain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: anakinra Subcutaneous side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More anakinra Subcutaneous resources

• Anakinra Subcutaneous Side Effects (in more detail)
• Anakinra Subcutaneous Use in Pregnancy & Breastfeeding
• Anakinra Subcutaneous Drug Interactions
• Anakinra Subcutaneous Support Group
• 4 Reviews for Anakinra Subcutaneous - Add your own review/rating

Compare anakinra Subcutaneous with other medications

• Rheumatoid Arthritis
• Schnitzler Syndrome
• Still's Disease

Cutivate

Generic Name: fluticasone topical (floo TIK a sone TOP i kal)

Brand Names: Cutivate

What is Cutivate (fluticasone topical)?

Fluticasone is a steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Fluticasone topical (for the skin) is used to treat the inflammation and itching caused by a number of skin conditions such as allergic reactions, eczema, and psoriasis.

Fluticasone topical should not be used to treat rosacea, severe acne, or viral skin infections such as chickenpox or herpes.

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

What is the most important information I should know about Cutivate (fluticasone topical)?

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body. Do not use fluticasone topical in larger amounts, or for longer than recommended by your doctor. Do not apply to your face, underarms, or groin area unless your doctor tells you to.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with fluticasone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Do not use this medication on a child without medical advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Do not use fluticasone topical for longer than 2 weeks. Talk with your doctor if your symptoms do not improve, or if you develop signs of a bacterial, fungal, or viral skin infection.

What should I discuss with my healthcare provider before using Cutivate (fluticasone topical)?

You should not use this medication if you are allergic to fluticasone or formaldehyde.

To make sure you can safely use fluticasone topical, tell your doctor if you have any type of skin infection.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

FDA pregnancy category C. It is not known whether fluticasone topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether fluticasone topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child without medical advice. Children are more likely to absorb large amounts of a topical steroid through the skin. Steroid absorption in children may cause unwanted side effects, or a delay in growth with long-term use. Talk with your doctor if you think your child is not growing at a normal rate while using this medication.

How should I use Cutivate (fluticasone topical)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Wash your hands before and after using fluticasone topical, unless you are using the medication to treat the skin on your hands.

Apply a small amount to the affected area and rub it gently into the skin. Do not apply the medication over a large area of skin, or use it long-term on the face. Do not use fluticasone topical on broken or infected skin. Also avoid using this medication in open wounds.

If you are treating your scalp, part the hair and apply the medicine directly to the scalp, rubbing in gently. Avoid washing or rubbing the treated scalp area right away. Wait until the medicine has dried thoroughly.

Do not cover treated skin areas with a bandage or other covering unless your doctor has told you to. If you are treating the diaper area of a baby, do not use plastic pants or tight-fitting diapers. Covering the skin that is treated with fluticasone topical can increase the amount of medicine your skin absorbs, which may lead to unwanted side effects. Do not use fluticasone topical for longer than 2 weeks without your doctor's advice. Talk with your doctor if your symptoms do not improve, or if you develop signs of a bacterial, fungal, or viral skin infection.

If you use this medication long-term, your blood may need to be tested. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using fluticasone topical. Store at room temperature away from moisture, heat, and light. Do not freeze. Keep the tube or bottle tightly closed when not in use.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of fluticasone topical is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Cutivate (fluticasone topical)?

Do not use fluticasone topical to treat any skin condition that has not been checked by your doctor.

Do not use this medication to treat skin conditions around your mouth, rectum, or genital areas. Do not apply to your face, underarms, or groin area unless your doctor tells you to.

Avoid getting this medication in your eyes. If this does happen, rinse with water.

Avoid using other steroid medications on the areas you treat with fluticasone topical unless you doctor tells you to.

Cutivate (fluticasone topical) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when fluticasone topical is applied to the skin, side effects can occur if the medication is absorbed into your bloodstream.

Stop using this medicine and call your doctor at once if you have signs of absorbing fluticasone topical through your skin, such as:

• 
  

  blurred vision, or seeing halos around lights;

  
  


• 
  

  headache, back ache, weakness, confusion, mood changes;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  weight gain, puffiness in your face;

  
  


• 
  

  muscle weakness, feeling tired; or

  
  


• 
  

  high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

  
  

Less serious side effects may include:

• 
  

  mild skin itching, burning, peeling, or dryness;

  
  


• 
  

  changes in color of treated skin;

  
  


• 
  

  thinning or softening of your skin;

  
  


• 
  

  skin rash or irritation around your mouth;

  
  


• 
  

  redness or crusting around your hair follicles;

  
  


• 
  

  blisters, pimples, or crusting of treated skin; or

  
  


• 
  

  stretch marks.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Cutivate (fluticasone topical)?

It is not likely that other drugs you take orally or inject will have an effect on topically applied fluticasone topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Cutivate resources

• Cutivate Side Effects (in more detail)
• Cutivate Use in Pregnancy & Breastfeeding
• Cutivate Drug Interactions
• Cutivate Support Group
• 4 Reviews for Cutivate - Add your own review/rating

• Cutivate Prescribing Information (FDA)


• Cutivate Advanced Consumer (Micromedex) - Includes Dosage Information


• Cutivate Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Cutivate with other medications

• Atopic Dermatitis
• Dermatologic Lesion
• Lichen Sclerosus

Where can I get more information?

• Your pharmacist can provide more information about fluticasone topical.

See also: Cutivate side effects (in more detail)

Lotrimin

Generic Name: clotrimazole topical (kloe TRIM a zole)

Brand Names: Desenex AF Prescription Strength, Fungoid Solution, Lotrimin, Lotrimin Jock Itch Powder, Mycelex, Mycelex OTC

What is Lotrimin (clotrimazole topical)?

Clotrimazole topical is an antifungal medication. Clotrimazole topical prevents fungus from growing on your skin.

Clotrimazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, and yeast infections.

Clotrimazole topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Lotrimin (clotrimazole topical)?

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

Who should not use Lotrimin (clotrimazole topical)?

Do not use clotrimazole topical if you have had an allergic reaction to it in the past.

Clotrimazole topical is in the FDA pregnancy category B. This means that it is unlikely to harm an unborn baby. Do not use clotrimazole topical without first talking to your doctor if you are pregnant. It is not known whether clotrimazole passes into breast milk. Do not use clotrimazole topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Lotrimin (clotrimazole topical)?

Use clotrimazole topical exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication, unless you are using it to treat a hand infection.

Clean and dry the affected area. Apply a small amount of the cream (usually twice daily) for 2 to 4 weeks.

Do not take this medication by mouth.

If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor.

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth. Store clotrimazole topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of clotrimazole topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of clotrimazole topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used, or that clotrimazole topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using Lotrimin (clotrimazole topical)?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear clothing made of loose cotton and other natural fibers until the infection is healed.

Lotrimin (clotrimazole topical) side effects

Serious side effects of clotrimazole topical use are not expected. Stop using clotrimazole topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, swelling, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Lotrimin (clotrimazole topical)?

Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of clotrimazole topical.

Drugs other than those listed here may also interact with clotrimazole topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines.

More Lotrimin resources

• Lotrimin Side Effects (in more detail)
• Lotrimin Use in Pregnancy & Breastfeeding
• Lotrimin Support Group
• 0 Reviews for Lotrimin - Add your own review/rating

• Lotrimin Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Lotrimin Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Gyne-Lotrimin Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Mycelex Prescribing Information (FDA)

Compare Lotrimin with other medications

• Tinea Corporis
• Tinea Pedis

Where can I get more information?

• Your pharmacist has additional information about clotrimazole topical written for health professionals that you may read.

See also: Lotrimin side effects (in more detail)