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This document outlines crucial safety information and warnings associated with the use of Proctofoam HC (hydrocortisone / pramoxine). It is essential to understand these risks and precautions to ensure safe usage. Please review these points carefully and seek advice from your healthcare provider if any concerns arise.

• Fire Hazard: Proctofoam HC contains a flammable propellant. Handle with care to prevent fire risks:

  • Avoid storing the can in high temperatures or above 120°F.
  • Do not puncture or damage the can.
  • Steer clear of open flames and avoid smoking during and after application.

• Hormone-related Side Effects: Prolonged use of topical steroids like Proctofoam HC can lead to adrenal suppression, where your body reduces its own steroid hormone production. Sudden discontinuation might cause withdrawal symptoms such as skin swelling, rash, and burning.

  • Risks increase with long-term use, excessive application, or if the affected area is covered with a bandage.
  • Young children are particularly susceptible.

• Skin Problems: Extended use beyond medical advice can lead to skin thinning or bruising. Your healthcare provider will aim to prescribe the minimal effective dose for the shortest duration.

  • Report any new or worsening skin issues immediately.

• Infections: Long-term use heightens the risk of fungal or bacterial skin infections. Avoid using Proctofoam HC on infected skin as it may exacerbate the condition.

  • Notify your healthcare team if you experience redness, swelling, pain, or pus, or if symptoms do not improve within 2 to 3 weeks. These could indicate a new infection.

This medication has no listed contraindications. Always follow your healthcare provider's instructions for safe use of Proctofoam HC.

When using Proctofoam HC, it's important to be aware of potential interactions with other medications and certain health conditions. Proctofoam HC contains Hydrocortisone, a corticosteroid, and Pramoxine, a local anesthetic.

Drug Interactions:

Proctofoam HC may interact with various medications, potentially altering their effects or increasing the risk of side effects. Notably, when used alongside certain diabetes medications like Metformin or albiglutide, the hydrocortisone in Proctofoam HC can be absorbed into the bloodstream and may interfere with blood sugar control, reducing the effectiveness of these diabetes treatments. This risk is heightened if the medication is applied over large areas, used for extended periods, or applied to damaged skin. Therefore, individuals with diabetes should monitor their blood sugar levels closely and consult their healthcare provider for possible adjustments to their diabetes medication regimen.

Additionally, Proctofoam HC may interact with other medications, including Acetaminophen, Ibuprofen, Prednisone, Tramadol, and Xanax. It's crucial to inform your healthcare provider about all prescription and over-the-counter medications, vitamins, minerals, herbal products, and supplements you are currently taking to prevent potentially harmful interactions.

Disease Interactions:

Certain health conditions can influence how your body responds to Proctofoam HC:

• Diabetes: Corticosteroids like hydrocortisone can raise blood glucose levels by interfering with insulin action. While topical corticosteroids rarely produce these effects, caution is advised for individuals with diabetes or glucose intolerance. Monitoring blood sugar levels and consulting with a healthcare provider is recommended.

• Infections: Topical corticosteroids may suppress the immune response, potentially worsening existing infections or increasing susceptibility to new infections. If you have a current infection, especially in the area of application, consult your healthcare provider before using Proctofoam HC.

• Ocular Conditions: Prolonged use of corticosteroids can lead to eye issues such as cataracts or glaucoma. If you have a history of eye problems, use Proctofoam HC with caution and under medical supervision.

• Hyperadrenocorticism (Cushing's Syndrome): Systemic absorption of topical corticosteroids can potentially exacerbate conditions like Cushing's syndrome. Use Proctofoam HC cautiously if you have this condition.

• Diaper Rash: The use of topical corticosteroids is generally not recommended for treating diaper rash due to the increased risk of systemic absorption and potential side effects in infants.

General Precautions:

To minimize the risk of interactions and side effects:

• Use Proctofoam HC exactly as prescribed, avoiding prolonged use or application over large areas unless directed by a healthcare provider.

• Avoid covering the treated area with occlusive dressings unless instructed, as this can increase absorption of the medication.

• Inform your healthcare provider of all existing health conditions and medications to ensure Proctofoam HC is safe for you.

Always consult your healthcare provider if you have concerns about potential interactions or side effects related to Proctofoam HC.