Hydrocortisone Rectal Suspension (retention)

Description

Hydrocortisone is a white to practically white, odorless, crystalline powder that is very slightly soluble in water. The chemical name of hydrocortisone is Pregn-4-ene-3,20-dione,11,17,21-tri-hydroxy,(11β)-. Its empirical formula is C21H30O5, with a molecular weight of 362.47. Each disposable unit (60 mL) contains 100 mg of hydrocortisone in an aqueous solution that includes carbomer 934P, polysorbate 80, purified water, sodium hydroxide, and methylparaben at a concentration of 0.18% as a preservative.

Uses and Indications

Hydrocortisone Rectal Suspension, USP is indicated as adjunctive therapy in the treatment of ulcerative colitis, particularly in distal forms. This includes conditions such as ulcerative proctitis, ulcerative proctosigmoiditis, and left-sided ulcerative colitis. Additionally, it has demonstrated efficacy in certain cases involving the transverse and ascending colons.

There are no teratogenic or nonteratogenic effects reported in the available data.

Dosage and Administration

The usual course of therapy with Hydrocortisone Rectal Suspension, USP is one administration nightly for a duration of 21 days, or until the patient achieves clinical and proctological remission. Clinical symptoms typically show improvement within 3 to 5 days; however, enhancement in mucosal appearance, as assessed by sigmoidoscopic examination, may occur later than the clinical improvement.

In challenging cases, treatment may be extended to 2 or 3 months. If the therapy needs to continue beyond 21 days, it is essential to taper the dosage gradually by reducing the administration frequency to every other night for a period of 2 to 3 weeks.

For optimal administration, patients are advised to lie on their left side during the administration of Hydrocortisone Rectal Suspension, USP and to maintain this position for at least 30 minutes post-administration to ensure adequate distribution of the fluid throughout the left colon. Patients should be instructed to retain the enema for a minimum of one hour, with the goal of retention throughout the night. This retention may be aided by the use of prior sedation and/or antidiarrheal medication, particularly in the initial stages of therapy when the urge to evacuate may be pronounced. Detailed patient instructions for the administration of Hydrocortisone Rectal Suspension, USP are provided within each box.

Contraindications

Use is contraindicated in patients with systemic fungal infections due to the potential for exacerbation of the condition. Additionally, the use of this product is contraindicated in individuals who have undergone ileocolostomy during the immediate or early post-operative period, as it may interfere with recovery and healing processes.

Warnings and Precautions

In the management of patients receiving Hydrocortisone Rectal Suspension, USP, several critical warnings and precautions must be observed to ensure safe and effective use.

Surgical Considerations In cases of severe ulcerative colitis, it is imperative to avoid delaying necessary surgical intervention while awaiting a response to medical treatment. Prompt surgical evaluation and intervention may be crucial to prevent complications.

Administration Risks Care must be taken during the insertion of the enema tip, as careless or improper technique can lead to damage to the rectal wall.

Corticosteroid Therapy Patients undergoing corticosteroid therapy who experience unusual stress may require an increased dosage of rapidly acting corticosteroids before, during, and after the stressful event. It is important to note that corticosteroids can mask signs of infection, potentially leading to decreased resistance and difficulty in localizing infections. New infections may emerge during corticosteroid use, necessitating vigilant monitoring.

Ocular Effects Prolonged corticosteroid use is associated with the development of posterior subcapsular cataracts and glaucoma, which may result in optic nerve damage. Additionally, there is an increased risk of secondary ocular infections due to fungi or viruses. Therefore, patients should be monitored for ocular symptoms throughout treatment.

Caution in Specific Conditions Hydrocortisone Rectal Suspension, USP should be administered with caution in patients with conditions such as active or latent peptic ulcer, diverticulitis, renal insufficiency, hypertension, osteoporosis, and myasthenia gravis. The presence of impending perforation, abscess, or other pyogenic infections, as well as fresh intestinal anastomoses, obstruction, or extensive fistulas and sinus tracts, also warrants careful consideration before use.

Surgical Prognosis Corticosteroid therapy may adversely affect surgical outcomes by increasing the risk of infection. If an infection is suspected, appropriate antibiotic therapy should be initiated, typically at higher than usual doses.

Adrenocortical Insufficiency Prolonged therapy with Hydrocortisone Rectal Suspension, USP may lead to drug-induced secondary adrenocortical insufficiency. This risk can be mitigated through gradual dosage reduction. It is important to recognize that relative insufficiency may persist for months following discontinuation of therapy; therefore, hormone therapy should be reinstated during any stress events occurring in this period.

Mineralocorticoid Considerations Due to potential impairment of mineralocorticoid secretion, concurrent administration of salt and/or a mineralocorticoid may be necessary.

Enhanced Effects Corticosteroids may exert an enhanced effect in patients with hypothyroidism or cirrhosis, necessitating careful monitoring and potential dosage adjustments.

Ocular Herpes Simplex Caution is advised when administering corticosteroids to patients with ocular herpes simplex due to the risk of corneal perforation.

Dosage Management The lowest effective dose of corticosteroids should be utilized to manage the underlying condition. When a dosage reduction is feasible, it should be implemented gradually to minimize withdrawal effects.

Psychiatric Effects Corticosteroid therapy may lead to a range of psychiatric effects, including euphoria, insomnia, mood swings, personality changes, severe depression, and even psychotic manifestations. Existing emotional instability or psychotic tendencies may be exacerbated by corticosteroid use.

Use of Aspirin Aspirin should be used with caution in conjunction with corticosteroids in patients with hypoprothrombinemia, as this combination may increase the risk of bleeding complications.

Healthcare professionals are advised to monitor patients closely for these potential risks and to adjust treatment protocols accordingly to ensure patient safety.

Side Effects

Patients receiving corticosteroids may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Local reactions are commonly reported and may include local pain or burning at the site of administration. Rare occurrences of rectal bleeding and apparent exacerbations or sensitivity reactions have also been noted.

Fluid and electrolyte disturbances are significant concerns, particularly sodium and fluid retention, which may lead to congestive heart failure in susceptible patients. Other disturbances include potassium loss, hypokalemic alkalosis, and hypertension.

Musculoskeletal adverse reactions can be serious, with reports of muscle weakness, steroid myopathy, and loss of muscle mass. Patients may also experience osteoporosis, vertebral compression fractures, aseptic necrosis of the femoral and humeral heads, and pathologic fractures of long bones.

Gastrointestinal effects may include peptic ulceration with potential for perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis.

Dermatologic reactions are also common, including impaired wound healing, thin and fragile skin, petechiae and ecchymoses, facial erythema, and increased sweating. Corticosteroids may suppress reactions to skin tests.

Neurological adverse reactions can manifest as convulsions, increased intracranial pressure with papilledema (pseudo-tumor cerebri), vertigo, and headache.

Endocrine effects may include menstrual irregularities, the development of a Cushingoid state, suppression of growth in pediatric patients, and secondary adrenocortical and pituitary unresponsiveness, particularly during periods of stress such as trauma, surgery, or illness. Patients may also experience decreased carbohydrate tolerance and manifestations of latent diabetes, necessitating increased insulin or oral hypoglycemic agents in diabetic individuals.

Ophthalmic adverse reactions include posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos.

Metabolic effects may present as a negative nitrogen balance due to protein catabolism.

Corticosteroids may mask signs of infection, leading to decreased resistance and difficulty localizing infections. Prolonged use can result in posterior subcapsular cataracts, glaucoma with potential optic nerve damage, and an increased risk of secondary ocular infections due to fungi or viruses.

Psychic derangements may occur, ranging from euphoria, insomnia, mood swings, and personality changes to severe depression and frank psychotic manifestations. Existing emotional instability or psychotic tendencies may be exacerbated by corticosteroid use.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

The table below lists all NDC Code configurations of Hydrocortisone Rectal Suspension (retention) (hydrocortisone), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Therefore, caution is advised when considering treatment in this population.

Particular attention should be given to the growth and development of pediatric patients undergoing prolonged corticosteroid therapy, as these factors may be adversely affected. Regular monitoring is recommended to ensure appropriate management of any potential impacts on growth.

Geriatric Use

Elderly patients, particularly those aged 65 and older, should be treated with caution when prescribed corticosteroids. Special attention is warranted in individuals with renal insufficiency, as this may affect drug clearance and increase the risk of adverse effects.

In geriatric patients with osteoporosis, the use of corticosteroids is also approached with caution, given the potential for exacerbation of this condition. It is recommended that the lowest effective dose of corticosteroid be utilized to manage the underlying conditions, and any dosage reductions should be implemented gradually to minimize the risk of withdrawal symptoms.

Prolonged therapy with corticosteroids may lead to drug-induced secondary adrenocortical insufficiency, which can persist for months following discontinuation of the medication. Therefore, in situations of stress during this period, it is crucial to reinstitute hormone therapy to prevent complications.

Additionally, elderly patients with hypothyroidism or cirrhosis may experience an enhanced effect from corticosteroids, necessitating careful monitoring and potential dose adjustments. Caution is also advised for those with existing emotional instability or psychotic tendencies, as corticosteroids may exacerbate these psychiatric conditions. Regular assessment and monitoring of these patients are essential to ensure safe and effective treatment.

Pregnancy

The use of corticosteroids during pregnancy, nursing, or in women of childbearing potential requires careful consideration of the potential benefits against the risks to the mother and the developing embryo or fetus, as adequate human reproduction studies have not been conducted. Pregnant patients receiving substantial doses of corticosteroids should be monitored closely for signs of hypoadrenalism in neonates, as these infants may be at risk for this condition.

Corticosteroids, including hydrocortisone and cortisone, can lead to adverse effects such as elevated blood pressure, salt and water retention, and increased potassium excretion, particularly at average and large doses. While synthetic derivatives may present a lower risk of these effects, caution is still warranted when they are used in high doses. Dietary modifications, including salt restriction and potassium supplementation, may be necessary to mitigate these risks.

Additionally, all corticosteroids are known to increase calcium excretion, which may have implications for maternal and fetal bone health. Therefore, healthcare professionals should weigh these considerations when prescribing corticosteroids to pregnant patients.

Lactation

The use of these drugs in lactating mothers requires careful consideration of the potential benefits versus the risks to both the mother and the breastfed infant. It is essential to evaluate the possible hazards to the nursing mother and the infant when prescribing these medications.

Neonates born to mothers who have received substantial doses of corticosteroids during pregnancy should be closely monitored for signs of hypoadrenalism. This observation is critical to ensure the health and safety of the breastfed infant.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any unusual physiological changes.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or toxicology specialist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

Nonclinical Toxicology

The use of corticosteroids during pregnancy, nursing, or in women of child-bearing potential necessitates careful consideration of the potential benefits against the risks to the mother and the developing embryo or fetus, as adequate human reproduction studies have not been conducted. Neonates born to mothers who received substantial doses of corticosteroids during pregnancy should be closely monitored for signs of hypoadrenalism.

Corticosteroids, including hydrocortisone and cortisone, can lead to non-teratogenic effects such as elevated blood pressure, salt and water retention, and increased potassium excretion, particularly at average and high doses. These effects are generally less pronounced with synthetic derivatives unless administered in large doses. Additionally, all corticosteroids are associated with increased calcium excretion.

Prolonged therapy with Hydrocortisone Rectal Suspension, USP, may result in drug-induced secondary adrenocortical insufficiency, which can be mitigated through gradual dosage reduction. This relative insufficiency may persist for months following the cessation of therapy; therefore, in instances of stress during this period, it is advisable to reinstate hormone therapy. Due to potential impairment of mineralocorticoid secretion, concurrent administration of salt and/or a mineralocorticoid is recommended. Furthermore, the effects of corticosteroids may be enhanced in patients with hypothyroidism or cirrhosis.

No specific information regarding animal pharmacology and toxicology is available.

Postmarketing Experience

Reports of local pain or burning, as well as rectal bleeding, attributed to Hydrocortisone Rectal Suspension, USP, have been documented rarely. Additionally, instances of apparent exacerbations or sensitivity reactions have also been reported infrequently.

When corticosteroids are administered rectally, the following adverse reactions should be considered:

Fluid and Electrolyte Disturbances: Sodium retention, fluid retention, congestive heart failure in susceptible patients, potassium loss, hypokalemic alkalosis, and hypertension.

Musculoskeletal: Muscle weakness, steroid myopathy, loss of muscle mass, osteoporosis, vertebral compression fractures, aseptic necrosis of femoral and humeral heads, and pathologic fractures of long bones.

Gastrointestinal: Peptic ulcer with potential perforation and hemorrhage, pancreatitis, abdominal distention, and ulcerative esophagitis.

Dermatologic: Impaired wound healing, thin fragile skin, petechiae and ecchymoses, facial erythema, increased sweating, and possible suppression of reactions to skin tests.

Neurological: Convulsions, increased intracranial pressure with papilledema (pseudo-tumor cerebri) typically following treatment, vertigo, and headache.

Endocrine: Menstrual irregularities, development of a Cushingoid state, suppression of growth in pediatric patients, secondary adrenocortical and pituitary unresponsiveness, particularly during periods of stress such as trauma, surgery, or illness, decreased carbohydrate tolerance, manifestations of latent diabetes, and increased requirements for insulin or oral hypoglycemic agents in diabetic patients.

Ophthalmic: Posterior subcapsular cataracts, increased intraocular pressure, glaucoma, and exophthalmos.

Metabolic: Negative nitrogen balance due to protein catabolism.

Patient Counseling

Healthcare providers should advise patients that optimal results from the enema are achieved when the bowel is emptied immediately prior to administration. It is important for patients to shake the bottle well to ensure that the suspension is homogeneous before use.

Patients should be instructed to remove the protective sheath from the applicator tip and to hold the bottle at the neck to prevent any discharge of the medication during preparation. For administration, the best position is lying on the left side with the left leg extended and the right leg flexed forward for balance. Alternatively, patients may adopt the "knee-chest" position if preferred.

When inserting the lubricated applicator tip into the rectum, patients should be guided to point it slightly toward the navel (umbilicus). They should grasp the bottle firmly, tilt it slightly so that the nozzle is aimed toward the back, and squeeze slowly to instill the medication. Steady hand pressure will help discharge most of the solution. After administration, patients should withdraw the applicator and discard the used unit.

It is essential to inform patients to remain in the chosen position for at least 30 minutes to allow for thorough distribution of the medication internally. If possible, they should retain the enema overnight.

Additionally, patients should be counseled to seek medical advice promptly if they are exposed to chicken pox or measles.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature ranging from 20° to 25°C (68° to 77°F) to ensure optimal stability and efficacy. Proper container requirements must be adhered to, and special handling needs should be observed to maintain the integrity of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Hydrocortisone Rectal Suspension (retention) as submitted by Chartwell RX LLC. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)