Version October 2024
Hemorrhoids/Rectal lesions: Rectal:
Ointment: Apply a small amount twice daily (morning and evening) and after each bowel movement to the affected external rectal area; may also apply internally with cannula by inserting into rectum and squeezing tube gently.
Suppository: Insert 1 suppository twice daily (morning and bedtime) and after each bowel movement.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
See Dibucaine, Hydrocortisone, and Framycetin monographs.
Hypersensitivity to dibucaine, hydrocortisone, framycetin, esculoside, or any component of the formulation; tuberculosis, fungal, and viral infections.
Concerns related to adverse effects:
• Sensitization: Use has been associated with local sensitization (burning, irritation); discontinue if sensitization is noted.
• Systemic effects: Topical corticosteroids may be absorbed percutaneously. Absorption of topical corticosteroids may cause manifestations of Cushing syndrome, hyperglycemia, or glycosuria. Absorption is increased by the use of occlusive dressings, application to denuded skin, prolonged use, or application to large surface areas.
Other warnings/precautions:
• Appropriate use: Perform an adequate proctologic exam prior to use.
Not available in the United States.
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment, Rectal:
Proctol: Dibucaine 0.5%, hydrocortisone 0.5%, framycetin 1%, and esculoside 1% (15 g, 30 g)
Proctosedyl: Dibucaine 0.5%, hydrocortisone 0.5%, framycetin 1%, and esculoside 1% (15 g, 30 g)
Generic: Dibucaine 0.5%, hydrocortisone 0.5%, framycetin 1%, and esculoside 1% (15 g, 30 g)
Rectal:
Ointment: For topical outside rectal use or internal rectal use. When using internally, attach rectal cannula to the tube and insert to full extent into rectum and while squeezing the tube gently from lower end.
Suppository: Remove plastic wrap from rectal suppository before administration. Insert upright into the rectum.
Note: Not approved in the United States.
Hemorrhoids /rectal lesions: Reduction of swelling, pain, and inflammation of hemorrhoids and other rectal lesions (eg, acute and chronic nonspecific proctitis, acute internal hemorrhoids, cryptitis, fissures and incomplete fistulas, internal and external pruritus ani); pre- and postoperative during hemorrhoidectomy and repair of fissures.
Refer to individual components.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Calcipotriene: Hydrocortisone (Topical) may diminish the therapeutic effect of Calcipotriene. Management: Monitor for reduced calcipotriene efficacy if combined with hydrocortisone valerate. Consider separating the administration of these agents by 10 to 12 hours to minimize the risk of this potential interaction. Risk C: Monitor therapy
Methemoglobinemia Associated Agents: May enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
Conservative measures are preferred for the treatment of hemorrhoids during pregnancy (Fiordaliso 2023). If treatment during pregnancy is necessary, the manufacturer recommends avoiding use of this product on extended areas, in large amounts, or for prolonged periods of time.
Refer to the Hydrocortisone (Topical) monograph for additional information.
See individual agents.
See individual agents.
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