PROCTOSEDYL®
Hoechst-Roussel
Hydrocortisone - Framycetin Sulfate - Cinchocaine HCl -
Aesculin Anorectal Therapy
Indications: 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.
Contraindications: 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 Effects: Certain
patients may experience burning upon application, especially
if the mucous membrane is not intact.
Dosage:
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.
Supplied: 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
