Deltasone

In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated.

Corticosteroids may mask some signs of infection, and new infections may appear during their use. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, in any location of the body, may be associated with the use of corticosteroids alone or in combination With other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function.1

These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.2 There may be decreased resistance and inability to localize infection when corticosteroids are used. Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses.

Usage in pregnancy: Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism.

Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in, large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids Increase calcium excretion.

Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids.

The use of DELTASONE (prednisone) Tablets in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate anti-tuberculous regimen.

If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chicken pox develops, treatment with antiviral agents may be considered. Similarly, corticosteroids. should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

No information provided.

Serious side effects have been reported with prednisone. See “Drug Precautions” section.

Common side effects of prednisone include:

• dizziness
• hypertension
• slow healing
• retention of fluid resulting in swelling
• acne
• electrolyte imbalances
• decreased immune system function
• decreased bone density
• depression
• inappropriate happiness
• nausea
• joint and muscle pain
• blurred vision
• headache
• abnormal distribution of body fat

This is not a complete list of prednisone side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• amphotericin B (Ambisome and Amphotec)
• potassium depleting diuretics such as acetazolamide (Diamox) and methazolamide (Neptazane)
• anticholinesterases such as neostigmine (Prostigmin) and pyridostigmine (Mestinon)
• warfarin (Coumadin)
• medications to treat diabetes
• isoniazid
• bupropion (Zyban and Wellbutrin)
• cholestyramine (Prevalite)
• cyclosporine (Neoral, Sandimmune, Gengraf)
• digoxin (Lanoxin)
• estrogens and oral contraceptives
• fluoroquinolone antibiotics such as ciprofloxacin (Cipro) and levofloxacin (Levaquin)
• barbituates such as phenobarbital (Donnatal)
• phenytoin (Dilantin)
• carbamazepine (Tegretol, Carbatrol, Equetro, Teril, Epitol)
• rifampin (Rifadin, Rimactane)
• ritonavir (Norvir)
• indinavir (Crixivan)
• macrolide antibiotics such as erythromycin and azithromycin (Zithromax)
• non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil) and aspirin (Ecotrin)
• quetiapine (Seroquel)
• thalidomide (Thalomid)
• vaccines

This is not a complete list of prednisone drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are breastfeeding or plan to breastfeed.

You should not take prednisone if you are breastfeeding unless instructed otherwise. It may be excreted in your breast milk and may harm your nursing child.

• Take prednisone exactly as prescribed.
• This medication comes in tablet and oral solution forms and is usually taken one to four times a day or every other day, with food or milk.
• If prednisone upsets your stomach, you should take the medication along with food or milk.
• If you miss a dose, consult your doctor or pharmacist to determine the appropriate course of treatment.  Do not take two doses of prednisone at the same time.

If you take too much prednisone, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Sodium retention
Fluid retention
Congestive heart failure in susceptible patients
Potassium loss
Hypokalemic alkalosis
Hypertension

Muscle weakness
Steroid myopathy
Loss of muscle mass
Osteoporosis
Tendon rupture, particularly of the Achilles tendon
Vertebral compression fractures
Aseptic necrosis of femoral and humeral heads
Pathologic fracture of long bones

Peptic ulcer with possible perforation and hemorrhage
Pancreatitis
Abdominal distention
Ulcerative esophagitis
Increases in alanine transaminase (ALT, SGPT), aspartate
transaminase (AST, SGOT) and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.

Impaired wound healing
Thin fragile skin
Petechiae and ecchymoses
Facial erythema
Increased sweating
May suppress reactions to skin tests

Negative nitrogen balance due to protein catabolism

Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment
Convulsions
Vertigo
Headache

Menstrual irregularities
Development of Cushingoid state
Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness
Suppression of growth in children
Decreased carbohydrate tolerance
Manifestations of latent diabetes mellitus
Increased requirements for insulin or oral hypoglycemic agents in diabetics

Posterior subcapsular cataracts
Increased intraocular pressure
Glaucoma
Exophthalmos

Urticaria and other allergic, anaphylactic or hypersensitivity reactions

Read the entire FDA prescribing information for Deltasone (Prednisone)

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems.

Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli.

General Precautions

Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis.

Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation.

The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids.

Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis.

Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed.

Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy. Discontinuation of corticosteroids may result in clinical remission.

Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that corticosteroids affect the ultimate outcome or natural history of the disease. The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect. (See DOSAGE AND ADMINISTRATION.)

Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin. Since concurrent use of these agents results in a mutual inhibition of metabolism, it is possible that adverse events associated with the individual use of either drug may be more apt to occur.

Drug Interactions

The pharmacokinetic interactions listed below are potentially clinically important. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity. Corticosteroids may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia. The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

Information for the Patient

Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Fluid and Electrolyte Disturbances
  Sodium retention
  Fluid retention
  Congestive heart failure in susceptible patients
  Potassium loss
  Hypokalemic alkalosis
  Hypertension

Musculoskeletal
  Muscle weakness
  Steroid myopathy
  Loss of muscle mass
  Osteoporosis
  Tendon rupture, particularly of the Achilles tendon
  Vertebral compression fractures
  Aseptic necrosis of femoral and humeral heads
  Pathologic fracture of long bones

Gastrointestinal
  Peptic ulcer with possible perforation and hemorrhage
  Pancreatitis
  Abdominal distention
  Ulcerative esophagitis
  Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT) and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation.

Dermatologic
  Impaired wound healing
  Thin fragile skin
  Petechiae and ecchymoses
  Facial erythema
  Increased sweating
  May suppress reactions to skin tests

Metabolic
  Negative nitrogen balance due to protein catabolism

Neurological
  Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment
  Convulsions
  Vertigo
  Headache

Endocrine
  Menstrual irregularities
  Development of Cushingoid state
  Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness
  Suppression of growth in children
  Decreased carbohydrate tolerance
  Manifestations of latent diabetes mellitus
  Increased requirements for insulin or oral hypoglycemic agents in diabetics

Ophthalmic
  Posterior subcapsular cataracts
  Increased intraocular pressure
  Glaucoma
  Exophthalmos

Additional Reactions
  Urticaria and other allergic, anaphylactic or hypersensitivity reactions