Product Monograph - Anusol-Hc Suppositories
CONTRAINDICATIONS
ANUSOL-HCTM SUPPOSITORIES (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-HCTM SUPPOSITORIES (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-HCTM SUPPOSITORIES (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-HCTM SUPPOSITORIES (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-HCTM SUPPOSITORIES (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
Remove wrapper from the ANUSOL-HCTM SUPPOSITORIES (Hydrocortisone Acetate and Zinc Sulfate Monohydrate) and insert suppository into the rectum in the morning and at bedtime, and after each bowel movement, or as directed by a physician.
Suppository Composition
Each ANUSOL-HCTM SUPPOSITORIES contains: 10 mg hydrocortisone acetate and 10 mg Zinc Sulfate monohydrate in a triglyceride base. Non-medicinal ingredients: calcium phosphate dibasic, magnesium stearate, Hydrogenated Vegetable Oil.
Stability and Storage Recommendations
Store ANUSOL-HCTM SUPPOSITORIES (Hydrocortisone Acetate and Zinc Sulfate Monohydrate) in a cool place between 15°C and 30°C.
AVAILABILITY OF DOSAGE FORMS
ANUSOL-HCTM SUPPOSITORIES (Hydrocortisone Acetate and Zinc Sulfate Monohydrate) is available in box of 24.
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.