Dexamethasone - Warnings and Precautions

WARNINGS General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS ).

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

Immunosuppression and Increased Risk of Infection Corticosteroids, including Dexamethasone Tablets USP, 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 infection 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 Dexamethasone Tablets USP withdrawal or dosage reduction as needed.

Do not administer Dexamethasone Tablets USP by an intraarticular, intrabursal, intratendinous, or intralesional route in the presence of acute local infection.

Tuberculosis If Dexamethasone Tablets USP are 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 Dexamethasone Tablets USP 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 Dexamethasone Tablets USP.

In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles: If a Dexamethasone Tablet USP-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 Dexamethasone Tablet USP-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 Dexamethasone Tablets USP.

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 Dexamethasone Tablets USP.

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 Dexamethasone Tablets USP, may exacerbate systemic fungal infections; therefore, avoid Dexamethasone Tablet USP use in the presence of such infections unless Dexamethasone Tablets USP are needed to control drug reactions.

For patients on chronic Dexamethasone Tablet USP therapy who develop systemic fungal infections, Dexamethasone Tablets USP withdrawal or dosage reduction is recommended.

Amebiasis Corticosteroids, including Dexamethasone Tablets USP, may activate latent amebiasis.

Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating Dexamethasone Tablets USP in patients who have spent time in the tropics or patients with unexplained diarrhea.

Strongyloides Infestation Corticosteroids, including Dexamethasone Tablets USP, 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.

Cerebral Malaria Avoid corticosteroids, including Dexamethasone Tablets USP, in patients with cerebral malaria.