Hydrocortisone Acetate / Zinc Sulfate (Anusol-HC)

1. Health Canada Product Monograph — Hydrocortisone Acetate / Zinc Sulfate

• Hydrocortisone acetate / zinc sulfate suppositories are indicated for the relief of pain and discomfort following anorectal surgery.
• They are indicated for the acute phase of common anorectal disorders, including internal and external hemorrhoids, whether or not complicated by thrombosis or prolapse.
• They are indicated for itching around the anus, inflammation of the rectum, inflammation of the anal crypts, anal fissures, and incomplete fistulas.
• They are indicated for other congestive, allergic, or inflammatory anorectal conditions.

• The safe use of topical corticosteroids during pregnancy has not been fully established, so hydrocortisone acetate / zinc sulfate should not be used in large amounts or for prolonged periods during pregnancy.
• Hemorrhoids occurring during pregnancy are among the conditions this product is indicated to treat, so it may still be used at the lowest effective amount for the shortest necessary time.

• The safe use of topical corticosteroids during breastfeeding has not been fully established, so hydrocortisone acetate / zinc sulfate should not be used in large amounts or for prolonged periods while breastfeeding.

• No specific dosing adjustments for older adults are described in the product monograph.
• Older adults with thinner or more fragile anorectal tissue may be more prone to local irritation, so use should be reviewed with a doctor if symptoms do not improve.

• No specific pediatric dosing or safety information is provided in the product monograph, and a healthcare professional should be consulted before use in children.
• As with other topical corticosteroids, children may absorb proportionally more of the medication relative to body size, so use in children should be supervised by a doctor and limited to the shortest necessary duration.

• Remove the wrapper and insert one suppository into the rectum in the morning, at bedtime, and after each bowel movement, or as directed by a physician.
• No dose adjustment information for kidney or liver impairment is provided in the product monograph.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• The chance of overdose with rectal use is very rare, and no toxic reactions or side effects have been reported.
• If the suppositories are accidentally swallowed, treatment involves gastric lavage followed by a purgative dose of magnesium sulfate.

• Burning on application may occur, especially if the surrounding skin is not intact.
• Local sensitivity reactions have rarely been reported.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Prolonged use could theoretically produce a systemic corticosteroid effect, although none has been noted to date.
• If an idiosyncratic reaction occurs, the medication should be discontinued.
• Very rarely, an allergic hypersensitivity reaction could occur; discontinue use and seek medical advice if swelling, rash, or difficulty breathing develops.
• Seek medical attention if you notice worsening rectal bleeding, severe pain, or signs of infection, since these are not expected effects of this product and need evaluation.

• Use with caution and only after a proper proctologic examination and diagnosis have been completed, since masking symptoms with this product before diagnosis could delay identification of a more serious anorectal condition.
• Use with caution alongside appropriate specific measures for any underlying infection, allergy, or other causal factor, since this product does not replace those treatments.
• Discontinue use if a local, idiosyncratic skin or mucosal reaction develops.
• Use with caution in patients with diabetes or other conditions sensitive to corticosteroid exposure, since some systemic absorption is possible with rectal use, particularly with more frequent or prolonged application than directed.
• Avoid prolonged, uninterrupted use beyond a few days without medical reassessment, consistent with general precautions for topical corticosteroid-containing products.

• Contraindicated in patients with a known sensitivity to any component of the formulation.
• Contraindicated in the presence of untreated tuberculous, fungal, or viral lesions of the skin in the treated area.

• No specific drug interactions are described in the product monograph for hydrocortisone acetate / zinc sulfate.
• Caution is still reasonable when combining with other rectally administered products, to avoid additive local irritation.

• Hydrocortisone acetate / zinc sulfate is inserted rectally, not taken by mouth, so food timing does not apply to its use.

• Insert one suppository in the morning, at bedtime, and after each bowel movement; since it is a rectal product, timing relative to meals is not relevant.

• Store hydrocortisone acetate / zinc sulfate suppositories in a cool place between 15°C and 30°C.

• Use hydrocortisone acetate / zinc sulfate suppositories exactly as directed, and see a doctor for a proper examination before starting if you have not already been diagnosed.
• Insert the suppository into the rectum after removing the wrapper, generally in the morning, at bedtime, and after bowel movements.
• Stop use and tell your doctor if you notice new or worsening burning, irritation, or any signs of infection.
• Do not use this product for longer than directed without checking with your doctor.
• If you are pregnant or breastfeeding, check with your doctor before using this product for more than a few days.