Proctocort label

Proctocort

Proctocort Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Proctocort® Suppositories are indicated for use in inflamed hemorrhoids, postirradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani.

History

There is currently no drug history available for this drug.

Other Information

Hydrocortisone Acetate is a corticosteroid designated chemically as pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β) with the following structural formula:

Proctocort Structural Formula

Each rectal suppository contains hydrocortisone acetate, USP 30 mg in a specially blended hydrogenated vegetable oil base.

Proctocort Manufacturers

  • Salix Pharmaceuticals, Inc
    Proctocort | Salix Pharmaceuticals, Inc
    No Recall

    Proctocort | Salix Pharmaceuticals, Inc

    Proctocort | Salix Pharmaceuticals, Inc

    For rectal administration. Detach one suppository from strip of suppositories. Remove the foil wrapper. Avoid excessive handling of the suppository which is designed to melt at body temperature. Insert suppository into the rectum with gentle pressure, pointed end first. Insert one suppository in the rectum twice daily, morning and night for two weeks, in nonspecific proctitis. In more severe cases, one suppository three times a day or two suppositories twice daily. In factitial proctitis, the recommended duration of therapy is six to eight weeks or less, according to the response of the individual case.

  • Salix Pharmaceuticals, Inc
    Proctocort | Salix Pharmaceuticals, Inc
    No Recall

    Proctocort | Salix Pharmaceuticals, Inc

    Proctocort | Salix Pharmaceuticals, Inc

    Topical corticosteroids are generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

    Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

    If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.