CORTENEMA Enema (2018)

Βιβλιογραφική αναφορά

Συγγραφείς

ANI Pharmaceuticals, Inc.

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1. Description

Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione,11,17,21-trihydroxy,(11β)-and the following ...

2. Clinical Pharmacology

Hydrocortisone is a naturally occurring glucocorticoid (adrenal corticosteroid), similar to its acetate and sodium hemisuccinate derivatives, is partially absorbed following rectal administration. Absorption ...

3. Indications and Usage

CORTENEMA is indicated as adjunctive therapy in the treatment of ulcerative colitis, especially distal forms, including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. ...

4. Contraindications

Systemic fungal infections; and ileocolostomy during the immediate or early post-operative period.

5. Warnings

In severe ulcerative colitis, it is hazardous to delay needed surgery while awaiting response to medical treatment. Damage to the rectal wall can result from careless or improper insertion of an enema ...

6.1. General

CORTENEMA hydrocortisone retention enema should be used with caution where there is a probability of impending perforation, abscess or other pyogenic infection; fresh intestinal anastomoses; obstruction; ...

6.2. Information for Patients

Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should ...

6.7. Pregnancy

Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of child-bearing potential requires that the possible benefits ...

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Growth and development of pediatric patients on prolonged corticosteroid therapy should be carefully observed.

7. Adverse Reactions

Local pain or burning, and rectal bleeding attributed to CORTENEMA have been reported rarely. Apparent exacerbations or sensitivity reactions also occur rarely. The following adverse reactions should be ...

10. Dosage and Administration

The use of CORTENEMA hydrocortisone retention enema is predicated upon the concomitant use of modern supportive measures such as rational dietary control, sedatives, antidiarrheal agents, antibacterial ...

11. How Supplied

CORTENEMA, hydrocortisone 100 mg retention enema, is supplied as disposable single-dose bottles with lubricated rectal applicator tips, in boxes of seven x 60 mL (NDC 62559-111-07) and boxes of one x 60 ...

12. Storage and Handling

Store at controlled room temperature 20°-25°C (68°-77°F). [See USP Controlled Room Temperature.]