Hydrocortisone rectal foam, enema

The information in this medication guide is specific to hydrocortisone rectal foam or enema.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Call your doctor at once if you have any bleeding from your rectum, feeling short of breath (even with mild exertion), swelling of your ankles or feet, or rapid weight gain.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Wash your hands before and after using this medicine.

Try to empty your bowel and bladder just before using the hydrocortisone rectal.

Use only the applicator provided with the medication to insert it into your rectum.

For best results from the enema, lie down on your left side for at least 30 minutes after using the foam or enema to allow the liquid to distribute throughout your intestines. Try to hold in the enema for at least 1 hour, or all night if possible. Avoid using the bathroom during this time.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

Store at room temperature away from moisture and heat.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Avoid getting a vaccine during your treatment with hydrocortisone rectal. Vaccines may not work as well while you are using a steroid medicine.

Usual Adult Dose for Adrenocortical Insufficiency:

Acute Adrenal Crisis:
100 mg IV followed by IV infusion of 200 mg over 24 hours OR 50 mg IV every 6 hours; then 100 mg IV the following day

Management of Primary Adrenal Insufficiency (PAI):
15 mg to 25 mg orally in 2 or 3 divided doses per day
-Highest dose should be given in the morning, then 2 hours after lunch (2-dose/day regimen) or at lunch and afternoon (3-dose/day regimen)

Prevention of Acute Adrenal Crisis:
Adjust dose according to severity of illness or magnitude of stressor

Comments:
-Fluid status should be managed according to protocols.
-Glucocorticoid replacement therapy should be adjusted based on clinical response.
-Most patients with PAI will require mineralocorticoid supplementation.
-Surgery and other stress inducing situations will require supplemental doses.

Suggested supplemental doses:
-Illness with fever: Double (fever greater than 100.4F [38C]) or triple (fever greater than 102.2F [39C]) oral hydrocortisone doses until recovery (usually 2 to 3 days); increase consumption of electrolyte-containing fluids as tolerated
-Not tolerating oral medication due to gastroenteritis or trauma: 100 mg IM
-Minor to moderate surgical stress: 25 to 75 mg per 24 hours for 1 to 2 days
-Major surgery with anesthesia, trauma, delivery, or ICU care: 100 mg IV followed by 200 mg IV infusion over 24 hours (or 50 mg IV/IM every 6 hours for 24 hours)

Use: For the treatment of adrenocortical insufficiency

Usual Adult Dose for Anti-inflammatory:

Dosing should be individualized on the basis of disease and patient response

Oral:
-Initial dose: 20 mg to 240 mg orally per day
Parenteral:
-Initial dose: 100 mg to 500 mg IV or IM; may repeat doses at intervals of 2, 4, or 6 hours as indicated by response and clinical indication

Maintenance dose: After a favorable initial response, dose should be decreased in small amounts to the lowest dose that maintains an adequate clinical response; if a positive response is not achieved after a reasonable period of time, alternative therapy should be sought.

Comments:
-Lower doses, including doses lower than recommended doses, may suffice in less severe disease; doses in excess of recommended doses may be required in severe disease; in life-threatening situations, doses exceeding multiples of the oral dose may be justified.
-Patients should be closely monitored for signs requiring dose adjustments; if therapy is to be stopped after more than a few days, it should be gradually withdrawn.

Uses: For use when oral therapy is not feasible; it is used as a potent anti-inflammatory agent in managing disorders, diseases, and conditions affecting many organ systems including endocrine, dermatologic, ophthalmic, nervous. gastrointestinal, respiratory, musculoskeletal, and hematologic.

Usual Adult Dose for Sepsis:

200 mg per day by continuous IV infusion

Recommendations from the International Guidelines for Management of Severe Sepsis and Septic Shock 2016:
-IV hydrocortisone should not be used if adequate fluid resuscitation and vasopressor therapy are able to restore hemodynamic stability
-Steroids should not be used in septic patients to prevent septic shock as there is a lack of evidence to support this
-Continuous infusion is recommended over repetitive bolus injections as repetitive boluses have been shown to significantly increase blood glucose
-Taper hydrocortisone treatment when vasopressors no longer required

Use: For the treatment of septic shock when adequate fluid resuscitation and vasopressor therapy are not able to restore hemodynamic stability.

Usual Adult Dose for Asthma:

100 mg IV every 8 hours during surgical period; dose should be rapidly reduced within 24 hours after surgery

Comments:
-Asthma control should be assessed prior to surgery and if lung function is not well controlled, medications to improve lung function should be provided.
-For patients receiving oral corticosteroids in the 6 months prior to surgery, and for selected patients on high dose inhaled corticosteroids (ICS), IV hydrocortisone may be necessary to reduce risk for complications during and after surgery.
-Stress doses of corticosteroids may be considered for select patients with prior high-dose ICS use as clinically important adrenal suppression has been reported in these patients.

Use: To reduce risks of complications during and after surgery in patients with asthma.

Usual Adult Dose for Ulcerative Colitis:

100 mg rectally (retention enema) nightly for 21 days or until both clinical and protological remission occurs
-Difficult cases may require 2 or 3 months of treatment

Comments:
-Clinical symptoms should subside within 3 to 5 days; improvement in appearance of the mucosa (as viewed by sigmoidoscopic exam) may lag behind; discontinue use if no improvement observed within 2 to 3 weeks.
-Some patients may require 2 to 3 months of therapy; if therapy lasts more than 21 days, do not stop abruptly
-Therapy has shown to benefit distal forms of ulcerative colitis including ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis; it has been useful in some cases involving the transverse and ascending colons.

Use: As adjunctive therapy in the treatment of ulcerative colitis, especially distal forms.

Usual Adult Dose for Ulcerative Proctitis:

1 applicatorful rectally once or twice daily for 2 to 3 weeks, then every second day thereafter

Comments:
-Satisfactory response generally occurs within 5 to 7 days with a marked decreased in symptoms; symptomatic improvement should be verified with sigmoidoscopy to best judge dose adjustment, duration of therapy, and rate of improvement.
-Therapy should be individualized and the proper maintenance dose determined by decreasing the initial dose in small decrements at appropriate time intervals until the lowest effective dose is reached.
-After long-term therapy, this drug should be gradually withdrawn.

Use: As adjunctive therapy in the topical treatment of ulcerative proctitis of the distal portion of the rectum in patients who cannot retain hydrocortisone or other corticosteroid enemas.

Usual Adult Dose for Multiple Sclerosis:

Acute exacerbation: 800 mg oral/IV/IM once a day for 1 week followed by 320 mg oral/IV/IM every other day for 1 month

Comments:
-Short-term high-dose corticosteroids are an accepted standard of care for treating relapses of multiple sclerosis; chronic daily corticosteroids are not recommended.
-IV methylprednisolone, oral prednisone and prednisolone are the corticosteroids most studied and cited in clinical guidelines; while this drug has been used, efficacy studies and comparative data are lacking.

Use: For the treatment of acute exacerbations of multiple sclerosis.

Usual Pediatric Dose for Adrenocortical Insufficiency:

Acute Adrenal Crisis:
Initial dose: 2 to 3 mg/kg IV or intraosseous (IO) over 3 to 5 minutes; Maximum dose: 100 mg
Follow with:
-Infants: 1 to 5 mg/kg IV/IO every 6 hours
-Children: 12.5 mg/m2 IV/IO every 6 hours OR 50 mg/m2 IV followed by 50 to 100 mg/m2 IV in divided doses every 6 hours or via 24-hour continuous IV infusion

Management of Primary Adrenal Insufficiency (PAI):
8 mg/m2 orally in 3 or 4 divided doses per day
-Highest dose should be administered in morning

Prevention of Acute Adrenal Crisis:
Adjust dose according to severity of illness or magnitude of stressor

Comments:
-It is important not to under dose during an adrenal crisis.
-Glucocorticoid replacement therapy should be adjusted based on clinical response including growth velocity, body weight, blood pressure, and energy levels.
-Most patients with PAI will require mineralocorticoid supplementation; infants will require up to 12 months of sodium chloride supplements.
-Surgery and other stress inducing situations will require supplemental doses.

Suggested supplemental doses:
-Illness with fever: Double (fever greater than 100.4F [38C]) or triple (fever greater than 102.2F [39C]) oral hydrocortisone doses until recovery (usually 2 to 3 days); increase consumption of electrolyte-containing fluids as tolerated
-Not tolerating oral medication due to gastroenteritis or trauma: 50 mg/m2 IM or estimate (e.g., infants: 25 mg; school-age: 50 mg; adolescents 100 mg)
-Minor to moderate surgical stress: 50 mg/m2 IM or double or triple oral replacement dose
-Major surgery with anesthesia, trauma, delivery, or ICU care: 50 mg/m2 IM followed by 50 to 100 mg/m2 IM in divided doses every 6 hours; rapidly taper and switch to oral regimen as soon as clinical state allows

Use: For the treatment of adrenocortical insufficiency

Usual Pediatric Dose for Anti-inflammatory:

Dosing should be individualized on the basis of disease and patient response

-Initial dose: 0.56 to 8 mg/kg/day oral or IV in 3 or 4 divided doses (20 to 240 mg/m2/day)

Maintenance dose: After a favorable initial response, dose should be decreased in small amounts to the lowest dose that maintains an adequate clinical response; if a positive response is not achieved after a reasonable period of time, alternative therapy should be sought.

Comments:
-Lower doses, including doses lower than recommended doses, may suffice in less severe disease; doses in excess of recommended doses may be required in severe disease; in life-threatening situations, doses exceeding multiples of the oral dose may be justified.
-Patients should be closely monitored for signs requiring dose adjustments; if therapy is to be stopped after more than a few days, it should be gradually withdrawn.

Uses: For use as a potent anti-inflammatory agent in managing disorders, diseases, and conditions affecting many organ systems including endocrine, dermatologic, ophthalmic, nervous, gastrointestinal, respiratory, musculoskeletal, and hematologic.