Hoechst Marion Roussel
Hydrocortisone – Framycetin Sulfate – Cinchocaine HCl – Esculin
Indications And Clinical Uses: The reduction of swelling, pain and inflammation of hemorrhoids and other rectal lesions. The management of acute and chronic nonspecific proctitis, acute internal hemorrhoids, cryptitis, fissures and incomplete fistulas, internal and external pruritus ani. May be used in pre- and postoperative hemorrhoidectomy and repair of fissures.
Contra-Indications: Hydrocortisone must not be used in the presence of tuberculosis, fungal and viral infections. Sensitivity to any of the components.
Precautions: Discontinue use if sensitization occurs. Hydrocortisone should not be used until an adequate proctologic examination is completed and a diagnosis made. Other specific measures against infections, allergy, and other causal factors must not be neglected. The possibility, however rare, that prolonged use of this preparation might produce systemic corticosteroid effects, should be borne in mind. Patients should be advised to inform subsequent physicians of the previous use of hydrocortisone.
Pregnancy: The safe use of topical corticosteroids during pregnancy has not been fully established. Therefore, during pregnancy, they should not be used unnecessarily on extended areas, in large amounts or for prolonged periods of time.
Adverse Reactions: Certain patients may experience burning upon application, especially if the mucous membrane is not intact. tag_DosageDosage
Dosage And Administration: Ointment: For external treatment: Apply a small quantity morning and evening and after each bowel movement, to the affected area. For internal application: attach rectal cannula to tube, insert to full extent and squeeze tube gently from lower end while withdrawing.
Suppositories: 1 suppository morning and evening and after each bowel movement.
Availability And Storage: Ointment: Each g contains: hydrocortisone BP 5 mg (0.5%), framycetin sulfate BP 10 mg (equivalent to 7 mg of framycetin base – 1%), cinchocaine HCl BP 5 mg (0.5%), aesculin 10 mg (1%). Also contains 10% w/w anhydrous lanolin. Tubes of 15 and 30 g with rectal cannula. Store at cool temperature.
Suppositories: Each rectal suppository contains: hydrocortisone BP 5 mg (0.5 %), framycetin sulfate BP 10 mg (equivalent to 7 mg of framycetin base – 1%), cinchocaine HCl BP 5 mg (0.5%), aesculin 10 mg (1%). Boxes of 12 and 24. Store at cool temperature.
PROCTOSEDYL® Hoechst Marion Roussel Hydrocortisone – Framycetin Sulfate – Cinchocaine HCl – Esculin Anorectal Therapy