Product Monograph - Anusol-Hc Ointment
CONTRAINDICATIONS
ANUSOL-HC TM OINTMENT (Hydrocortisone Acetate and Zinc Sulfate Monohydrate) is contraindicated in patients with a sensitivity to any of the components. Not to be used in the presence of existing tuberculous, fungal and viral lesions of the skin.
PRECAUTIONS
Until an adequate proctologic examination is completed and diagnosis made, ANUSOL-HC TM OINTMENT (Hydrocortisone Acetate and Zinc Sulfate Monohydrate) or any preparation containing hydrocortisone should not be used. In addition, specific measures against infection, allergy and other causal factors must not be neglected. Prolonged use of this medication could produce systemic corticosteroid effect although none have noted to date. As with all medication that is applied locally, if idiosyncratic reactions occur, medication should be discontinued.
Pregnancy and Lactation:
The safe use of topical corticosteroids during pregnancy and lactation has not been fully established. Therefore, during pregnancy, ANUSOL-HC TM OINTMENT (Hydrocortisone Acetate and Zinc Sulfate Monohydrate) should not be used unnecessarily in large amounts, or for prolonged periods of time.
ADVERSE REACTIONS
Occasionally, patients may experience burning upon application of the ANUSOL-HC TM OINTMENT (Hydrocortisone Acetate and Zinc Sulfate Monohydrate) especially if the anoderm is not intact. Local sensitivity reactions have been rare.
SYMPTOMS AND TREATMENT OF OVERDOSAGE
The chances of overdosage are very rare, and no toxic reactions or side effects have been reported with ANUSOL-HC TM OINTMENT (Hydrocortisone Acetate and Zinc Sulfate Monohydrate).
Treatment: In case of accidental ingestion, perform gastric lavage, followed by a purgative dose of magnesium sulfate.
DOSAGE AND ADMINISTRATION
Apply ANUSOL-HC TM OINTMENT (Hydrocortisone Acetate and Zinc Sulfate Monohydrate) internally and on the exterior surface of the anus in the morning and at bedtime, and after each bowel movement, or as directed by a physician.
Ointment Composition
Each tube of ANUSOL-HC TM OINTMENT contains: 0.5% hydrocortisone acetate and 0.5% zinc sulfate monohydrate in a petrolatum ointment base. Non-medicinal ingredients: calcium phosphate dibasic, mineral oil, petrolatum white, Polyoxyethylene (2) oleyl-ether.
Stability and Storage Recommendations
Store ANUSOL-HC TM OINTMENT ( Hydrocortisone Acetate and Zinc Sulfate Monohydrate) in a cool place between 15 and 30°C.
AVAILABILITY OF DOSAGE FORMS
ANUSOL-HC TM OINTMENT (Hydrocortisone Acetate and Zinc Sulfate Monohydrate) is available in 30 g aluminum tube co-packaged with a plastic applicator.
PHARMACEUTICAL INFORMATION
Drug Substance
Proper Name: Hydrocortisone Acetate and Zinc Sulfate Monohydrate
Chemical Name: Hydrocortisone Acetate - Pregn-4-ene-3,20-dione, 21-(acetyloxy)-11,17- dihydroxy-, (11ß)-.
Zinc Sulfate – Zinc sulfate (1:1) monohydrate
Empirical Formula: Hydrocortisone Acetate - C23H32O6
Zinc Sulfate monohydrate - ZnSO4•H2O
Molecular weight: Hydrocortisone Acetate - 404.50
Zinc Sulfate monohydrate - 179.4
Structural Formula for Hydrocortisone Acetate:
Description: Hydrocortisone Acetate: White to practically white, odorless, crystalline powder. Slightly soluble in alcohol and in chloroform; insoluble in water.
Zinc Sulfate monohydrate: Colorless, transparent prisms, or small needles. The monohydrate is practically insoluble in alcohol.