Anugesic HC Ointment

(Hydrocortisone Acetate/Pramoxine Hydrochloride/Zinc Sulfate)

The active ingredient in Anugesic HC Ointment is hydrocortisone acetate. Hydrocortisone acetate is a corticosteroid that helps reduce inflammation, swelling, redness, and itching in the affected area. Anugesic HC Ointment also contains additional active ingredients, including pramoxine hydrochloride and zinc sulfate, which help provide local pain relief and soothing protection to irritated tissue in the rectum and anal area.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Anugesic HC Ointment. However, the following is a synopsis of the general guidelines for the use of Anugesic HC Ointment:

• Use Anugesic HC Ointment only as prescribed or directed by a healthcare professional.
• The ointment is typically applied to the affected area up to two to three times daily, often after a bowel movement.
• Before application, gently clean the anal area with mild soap and warm water, then pat dry. Apply a small amount of ointment to the external anal area using a clean finger or applicator if provided. For internal use, an applicator may be used if instructed by your prescriber. Wash hands thoroughly after each application.
• Do not apply large amounts or use more often than directed.
• Avoid prolonged use unless advised by a healthcare professional.
• Do not apply to broken skin, open wounds, or areas with active infection unless directed.

Some mild or common side effects of Anugesic HC Ointment seen in clinical use as compared to placebo include:

• Mild burning or stinging at the application site.
• Itching or irritation in the anal area.
• Dryness or redness of the skin.
• Temporary discomfort after application.

Some individuals may experience serious side effects while using Anugesic HC Ointment. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of an allergic reaction include swelling, severe itching, rash, or difficulty breathing.
• Worsening rectal bleeding or pain.
• Signs of skin thinning or damage in the treated area.
• Persistent irritation or infection symptoms.
• Unusual weight loss or systemic symptoms with prolonged use.

These are not all of the possible side effects of Anugesic HC Ointment. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Anugesic HC Ointment, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Frequent or unexplained rectal bleeding.
• A known allergy to hydrocortisone, pramoxine hydrochloride, zinc sulfate, or any other ingredients.
• Skin infections, fungal infections, or bacterial infections in the affected area.
• A medical condition affecting the rectum or anal area that has not been diagnosed.
• A weakened immune system.

• Known hypersensitivity to hydrocortisone acetate, pramoxine hydrochloride, zinc sulfate, or any other component of the product.
• Untreated skin infections or conditions involving the anal area.
• Use in individuals with certain rectal conditions unless directed by a prescriber.

Many people notice relief of itching, pain, and inflammation within a few hours to a few days of starting treatment. Full symptom improvement may take several days of regular use. If symptoms persist beyond the recommended treatment period, consult a healthcare professional.

When Anugesic HC Ointment is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Other topical corticosteroids may increase the risk of side effects due to cumulative steroid exposure.
• Products applied to the rectum that may irritate the skin and increase absorption of hydrocortisone.

Anugesic HC Ointment is supplied as a topical rectal ointment with 0.5% hydrocortisone acetate combined with 1% pramoxine hydrochloride and 0.5% zinc sulfate.

It should be stored at room temperature, away from the reach of children or pets.

Anugesic HC Ointment is manufactured and distributed by Pfizer under the Anugesic-HC brand name. This product has been discontinued.

Generic versions are available.

Anugesic HC Ointment is usually stopped once symptoms improve or after the prescribed treatment period. Do not continue using the product longer than recommended without consulting a healthcare professional. If symptoms return, seek medical advice before restarting treatment.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. Topical hydrocortisone products should be used during pregnancy only if clearly needed and for the shortest duration possible.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you. It is not known whether hydrocortisone acetate passes into breast milk when used rectally. Avoid applying the ointment to areas that may come into direct contact with the infant.