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PREDNISONE 5mg
Prednisone
is a white to practically white, odorless, crystalline powder and has a
molecular weight of 358.44. It melts at about 230°C with some decomposition.
Prednisone is very slightly soluble in water, slightly soluble in alcohol,
chloroform, dioxane, and methanol.
Each
tablet, for oral administration, contains 5 mg or 10 mg of prednisone.
Inactive
ingredients:
5
mg: anhydrous
lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline
cellulose, sodium starch glycolate, and talc.
10
mg: anhydrous
lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline
cellulose, sodium starch glycolate, and talc.
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.
While on corticosteroid therapy, patients should not be vaccinated against smallpox. Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high doses, because of possible hazards of neurological complications and a lack of antibody response.
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 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 antituberculous 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 that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox 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 chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intravenous immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. Similarly, corticosteroids should be used with great care in patients with known or suspected Stronglyoides (threadworm) infestation. In such patients, corticosteroids-induced immunosuppression may lead to Stronglyoides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.
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