Prednisolone - Warnings and Precautions

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

Cardio-renal 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.

Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment.

Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients.

Changes in thyroid status of the patient may necessitate adjustment in dosage.

Immunosuppression and Increased Risk of Infection Corticosteroids, including prednisolone sodium phosphate oral solution, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens.

Corticosteroids can: Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal.

The rate of infectious complications increases with increasing corticosteroid dosages.

Monitor for the development of infection and consider prednisolone sodium phosphate oral solution withdrawal or dosage reduction as needed.

Tuberculosis If prednisolone sodium phosphate oral solution is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur.

Closely monitor such patients for reactivation.

During prolonged prednisolone sodium phosphate oral solution therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis.

Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including prednisolone sodium phosphate oral solution.

In corticosteroid-treated patients who have not had these diseases or are nonimmune, particular care should be taken to avoid exposure to varicella and measles: If a prednisolone sodium phosphate oral solution-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated.

If varicella develops, treatment with antiviral agents may be considered.

If a prednisolone sodium phosphate oral solution-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.

Hepatitis B Virus Reactivation Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including prednisolone sodium phosphate oral solution.

Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection.

Screen patients for hepatitis B infection before initiating immunosuppressive (e.g., prolonged) treatment with prednisolone sodium phosphate oral solution.

For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy.

Fungal Infections Corticosteroids, including prednisolone sodium phosphate oral solution, may exacerbate systemic fungal infections; therefore, avoid prednisolone sodium phosphate oral solution use in the presence of such infections unless prednisolone sodium phosphate oral solution is needed to control drug reactions.

For patients on chronic prednisolone sodium phosphate oral solution therapy who develop systemic fungal infections, prednisolone sodium phosphate oral solution withdrawal or dosage reduction is recommended.