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This document outlines important safety information regarding the use of hydrocortisone (Anusol-HC) rectally. Please review the following points carefully and consult your healthcare provider if you have any questions or concerns.

• Hormone Issues and Withdrawal: Long-term use of hydrocortisone (Anusol-HC) can lead to adrenal suppression, a condition where the body reduces or stops producing its own steroid hormones. Abrupt cessation of the medication may result in withdrawal symptoms such as dizziness, fatigue, and nausea. To avoid these complications, your healthcare provider may recommend a rectal exam to ensure this medication is suitable for you. Do not discontinue use suddenly without consulting your provider. Risks increase with prolonged use, excessive dosage, covering the application area with a bandage, and in young children.

• Increased Risk of Skin Infections: Extended use of hydrocortisone (Anusol-HC) can heighten the risk of developing bacterial or fungal infections. Avoid using this medication if you have an existing skin infection, as it may exacerbate your condition. Contact your healthcare provider if you experience symptoms such as redness, swelling, pain, pus, or if there's no improvement in your condition after seven days of treatment, as these could indicate a new infection.

• Potential Skin Problems: Using hydrocortisone (Anusol-HC) for longer than advised can cause skin irritation, such as thinning, stretch marks, spider veins, burning, itching, dryness, inflamed hair follicles, changes in skin color, or rashes. To minimize the risk of severe skin reactions, your provider may request a rectal exam to confirm the necessity of this medication. Report any new or worsening skin issues to your healthcare provider immediately. Risks are associated with excessive and improper use of the medication.

Please follow these guidelines to ensure the safe and effective use of hydrocortisone (Anusol-HC). Always communicate with your healthcare provider regarding any concerns or adverse effects you experience.

Common side effects:

• stinging
• burning
• itching
• skin irritation
• dryness

Less common but important to monitor:

• acne
• excessive hair growth
• folliculitis
• changes in skin color
• development of stretch marks
• skin thinning
• wrinkling

Serious side effects:

• allergic reactions
• rash
• significant itching or swelling
• severe dizziness
• trouble breathing
• long-term fatigue
• muscle weakness
• poor appetite
• weight loss
• abdominal pain

Hydrocortisone acetate, a corticosteroid used to reduce inflammation, can interact with various medications, potentially altering its effectiveness or increasing the risk of side effects. It's important to be aware of these interactions and discuss them with your healthcare provider. Key interactions include:

• Anticoagulants (Blood Thinners): Hydrocortisone may affect the efficacy of blood thinners like Warfarin, necessitating close monitoring of blood clotting parameters to maintain the desired anticoagulant effect.

• Antidiabetic Medications: This corticosteroid can raise blood sugar levels, potentially reducing the effectiveness of antidiabetic drugs. Adjustments to diabetes medication dosages may be required.

• Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Combining hydrocortisone with NSAIDs, such as Ibuprofen or Aspirin, can increase the risk of gastrointestinal issues, including ulcers and bleeding.

• Potassium-Depleting Agents: Concurrent use with medications like certain diuretics or Amphotericin B may lead to low potassium levels (hypokalemia), increasing the risk of heart-related side effects.

• Antibiotics and Antifungals: Drugs like Rifampin can decrease hydrocortisone levels, while others like Ketoconazole may increase its levels, affecting its efficacy and side effect profile.

• Vaccines: Hydrocortisone can weaken the immune response, making live vaccines less effective and increasing the risk of infection. It's advisable to consult your doctor before receiving any vaccinations during treatment.

• Estrogens (Including Oral Contraceptives): Estrogens may decrease the metabolism of hydrocortisone, potentially enhancing its effects and side effects.

• Digitalis Glycosides: Patients on digitalis medications may face an increased risk of heart rhythm issues due to potential low potassium levels when combined with hydrocortisone.

• Cyclosporine: Concurrent use can lead to increased activity of both drugs, with reports of convulsions occurring when used together.

• Cholestyramine: This medication may increase the clearance of hydrocortisone, potentially reducing its effectiveness.

Always inform your healthcare provider about all medications, supplements, and herbal products you are taking to ensure safe and effective use of hydrocortisone acetate.