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Hydrocortisone 100mg Enema 60ml

Manufacturer CHARTWELL Active Ingredient Hydrocortisone Enema(hye droe KOR ti sone) Pronunciation hye-droe-KOR-ti-sone
It is used to treat ulcerative colitis.
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Drug Class
Corticosteroid
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Hydrocortisone enema is a medicine that contains a steroid, which is a strong anti-inflammatory drug. It is used to treat inflammation in the lower part of your bowel (rectum and lower colon) caused by conditions like ulcerative colitis. It works by reducing swelling, redness, and pain directly where it's needed.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for rectal use only and should not be taken by mouth. Continue using the medication as directed, even if your symptoms improve. Before and after use, wash your hands thoroughly. Shake the container well before administering the medication.

When using the enema, exercise caution to avoid damaging the rectal area. Insert the enema tip correctly to prevent injury. If you are unsure about the proper technique, consult your doctor or pharmacist for guidance.

Storage and Disposal

Store this medication at room temperature, avoiding freezing. Keep all medications in a secure location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

Missed Dose

If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Follow your doctor's instructions carefully regarding diet and other medications for your bowel condition.
  • Maintain good hygiene to prevent infection.
  • Report any new or worsening symptoms to your healthcare provider.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 100 mg (one 60 mL enema) rectally once daily, preferably at bedtime, for 21 days or until remission is achieved.
Dose Range: 100 - 100 mg

Condition-Specific Dosing:

ulcerativeProctitis: 100 mg rectally once daily
ulcerativeColitis: 100 mg rectally once daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established; use with extreme caution and only if benefits outweigh risks due to potential for systemic effects including growth suppression.
Adolescent: Not established; use with extreme caution and only if benefits outweigh risks due to potential for systemic effects including growth suppression.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed due to limited systemic absorption.
Moderate: No specific adjustment needed due to limited systemic absorption.
Severe: No specific adjustment needed due to limited systemic absorption; however, monitor for signs of systemic corticosteroid effects if renal function is severely compromised and significant absorption occurs.
Dialysis: No specific adjustment needed; limited systemic absorption.

Hepatic Impairment:

Mild: No specific adjustment needed due to limited systemic absorption.
Moderate: No specific adjustment needed due to limited systemic absorption.
Severe: No specific adjustment needed due to limited systemic absorption; however, monitor for signs of systemic corticosteroid effects as hepatic metabolism is the primary route of elimination for absorbed drug.

Pharmacology

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Mechanism of Action

Hydrocortisone is a naturally occurring glucocorticoid that exerts its anti-inflammatory and immunosuppressive effects by binding to intracellular glucocorticoid receptors. This binding leads to the modulation of gene expression, inhibiting the synthesis of inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines) and suppressing the migration of inflammatory cells to the site of inflammation. When administered rectally, it acts locally on the inflamed colonic mucosa to reduce inflammation and edema associated with ulcerative colitis and proctitis.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (10-50%) rectally, depending on the integrity of the rectal mucosa and duration of retention.
Tmax: Variable, typically 1-4 hours after rectal administration.
FoodEffect: Not applicable for rectal administration.

Distribution:

Vd: Not specifically quantified for rectal administration; systemic distribution is limited due to first-pass metabolism.
ProteinBinding: Approximately 90% bound to plasma proteins (transcortin and albumin).
CnssPenetration: Limited systemic penetration from rectal administration; however, systemic corticosteroids can cross the blood-brain barrier.

Elimination:

HalfLife: Plasma half-life: 80-118 minutes (systemic); biological half-life is longer.
Clearance: Primarily hepatic clearance.
ExcretionRoute: Mainly renal excretion of inactive metabolites.
Unchanged: <1% (systemic)
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Pharmacodynamics

OnsetOfAction: Rapid local anti-inflammatory effect, clinical improvement typically within days.
PeakEffect: Variable, often within 1-2 weeks of consistent use.
DurationOfAction: Several hours locally; systemic effects are transient due to rapid metabolism.

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
 Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
 Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while passing urine
+ Mouth sores
+ Wounds that will not heal
 Changes in eyesight
Severe headache
 Irritation at the site of application
Severe rectal bleeding or pain
 Unexplained bruising or bleeding
Swelling
 Bone or joint pain
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
 Thinning of the skin

Other Possible Side Effects

Like all medications, this drug may cause side effects in some people. Many individuals experience no side effects or only mild ones. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help if they bother you or do not go away:

Burning or stinging
 Dryness
* Tingling

This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Increased rectal bleeding or pain
  • Severe abdominal pain
  • Signs of infection (fever, chills)
  • Unusual weight gain or swelling in the face/ankles
  • Increased thirst or urination
  • Muscle weakness
  • Mood changes, depression, or anxiety
  • Vision problems
  • Any signs of allergic reaction (rash, itching, severe dizziness, trouble breathing)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
 Certain health conditions, including:
+ Bowel blockage
+ Fistula
+ Fungal infection
+ Holes, sores, or wounds in the rectal area
+ Peritonitis (inflammation of the lining of the abdominal cavity)
+ Recent bowel surgery

Please note that this list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.

To ensure safe treatment, inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
 Any natural products or vitamins you are using
* All your health problems

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Regular monitoring is crucial, so be sure to undergo blood tests and bone density checks as directed by your doctor. If you are using this medication long-term, you should also have your eye pressure checked periodically. Discuss this with your doctor to determine the best schedule for these checks.

As this medication may increase your risk of developing infections, it is vital to practice good hygiene by washing your hands frequently. Additionally, try to avoid close contact with individuals who have infections, colds, or flu. If you are exposed to someone with chickenpox or measles and you have not had these diseases or been vaccinated against them, consult your doctor promptly.

If you have diabetes (high blood sugar), inform your doctor, as this medication may cause an increase in blood sugar levels. Monitor your blood sugar levels as instructed by your doctor.

Before using any other medications or products in the rectal area, consult your doctor. Avoid applying this medication to cuts, scrapes, or damaged skin, as this can cause further irritation. In the event that this medication is ingested, seek immediate medical attention or contact a poison control center.

Do not use this medication for an extended period beyond what your doctor has prescribed. Long-term use may increase the risk of developing cataracts or glaucoma, so discuss this potential risk with your doctor.

When administering this medication to children, exercise caution, as the risk of certain side effects may be higher in this age group. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Discuss this with your doctor to determine the best course of action.

Note that some formulations of this medication may not be suitable for all age groups of children. If you have any questions or concerns, consult your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication during these periods to ensure the best possible outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is unlikely due to limited systemic absorption.
  • Chronic overdose or prolonged use may lead to systemic corticosteroid effects such as Cushingoid features (moon face, buffalo hump), hyperglycemia, fluid retention, hypertension, adrenal suppression, and increased susceptibility to infection.

What to Do:

Discontinue medication gradually under medical supervision. Symptomatic and supportive care. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Major Interactions

  • Live or live attenuated vaccines (risk of disseminated infection in immunosuppressed patients)
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) - theoretical risk of increased systemic hydrocortisone levels if significant absorption occurs.
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Moderate Interactions

  • CYP3A4 inducers (e.g., rifampin, phenytoin, carbamazepine, phenobarbital) - theoretical risk of decreased systemic hydrocortisone levels if significant absorption occurs.
  • Non-steroidal anti-inflammatory drugs (NSAIDs) - increased risk of gastrointestinal ulceration.
  • Diuretics (thiazide or loop) - enhanced potassium depletion.
  • Anticoagulants (warfarin) - corticosteroids may alter anticoagulant effects (increase or decrease).
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Minor Interactions

  • Oral contraceptives/estrogens - may increase hydrocortisone levels by altering protein binding.
  • Antidiabetic agents - corticosteroids may increase blood glucose, requiring adjustment of antidiabetic therapy.

Monitoring

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Baseline Monitoring

Baseline symptoms of ulcerative colitis/proctitis (e.g., rectal bleeding, urgency, stool frequency)

Rationale: To assess disease activity and monitor treatment response.

Timing: Prior to initiation of therapy.

Electrolytes (Potassium, Sodium)

Rationale: To monitor for potential electrolyte imbalances, especially with prolonged use or significant systemic absorption.

Timing: Prior to initiation, especially if patient has pre-existing electrolyte abnormalities or is on concomitant diuretics.

Blood pressure

Rationale: To monitor for potential fluid retention and hypertension, especially with prolonged use or significant systemic absorption.

Timing: Prior to initiation.

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Routine Monitoring

Clinical symptoms (rectal bleeding, urgency, stool frequency)

Frequency: Daily to weekly during treatment, then as clinically indicated.

Target: Reduction or resolution of symptoms.

Action Threshold: Lack of improvement or worsening symptoms may indicate need for alternative therapy.

Signs of systemic corticosteroid effects (e.g., fluid retention, hyperglycemia, adrenal suppression, mood changes)

Frequency: Periodically, especially with prolonged use or if patient reports new symptoms.

Target: Absence of systemic side effects.

Action Threshold: Presence of significant systemic effects may require dose reduction, discontinuation, or alternative therapy.

Electrolytes (Potassium)

Frequency: Periodically, especially if prolonged use or risk factors for hypokalemia.

Target: Within normal limits.

Action Threshold: Hypokalemia may require potassium supplementation or dose adjustment.

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Symptom Monitoring

  • Rectal bleeding
  • Abdominal pain
  • Diarrhea
  • Urgency to defecate
  • Fever
  • Weight changes
  • Swelling in ankles/feet
  • Increased thirst/urination (signs of hyperglycemia)
  • Mood changes
  • Difficulty sleeping

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Systemic absorption from rectal administration is limited, which may reduce risk compared to systemic routes.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cleft palate in animal studies; human data are limited.
Second Trimester: Generally considered safer than first trimester, but still Category C.
Third Trimester: May cause fetal growth restriction or adrenal suppression in the neonate if used systemically and for prolonged periods. Risk is lower with rectal administration due to limited absorption.
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Lactation

Hydrocortisone is excreted in breast milk in small amounts. Due to limited systemic absorption from rectal administration, the amount transferred to breast milk is expected to be low. Generally considered compatible with breastfeeding, but monitor the infant for signs of adverse effects (e.g., growth suppression).

Infant Risk: Low risk; monitor for signs of adrenal suppression or growth effects, especially with prolonged maternal use or high doses.
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Pediatric Use

Not routinely recommended for children due to potential for systemic effects, including growth suppression and adrenal suppression. Use only under strict medical supervision and if benefits clearly outweigh risks. Dosage must be carefully individualized.

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Geriatric Use

No specific dose adjustments are generally required. However, elderly patients may be more susceptible to the systemic side effects of corticosteroids (e.g., osteoporosis, fluid retention, hypertension, diabetes), even with limited systemic absorption. Monitor closely for these effects.

Clinical Information

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Clinical Pearls

  • Instruct patients to administer the enema preferably at bedtime, after a bowel movement, and to retain it for as long as possible (ideally overnight or for at least one hour) for maximum local effect.
  • Ensure proper administration technique is demonstrated or clearly explained to the patient.
  • Hydrocortisone enema is for local treatment of distal ulcerative colitis and proctitis; it is not effective for more extensive colonic disease.
  • While systemic absorption is limited, prolonged use or use in patients with severely inflamed mucosa may lead to systemic corticosteroid effects, including adrenal suppression. Tapering may be necessary after prolonged use.
  • Patients should be advised not to discontinue therapy abruptly, especially after prolonged use, to avoid withdrawal symptoms or adrenal insufficiency.
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Alternative Therapies

  • 5-aminosalicylates (5-ASAs) such as mesalamine (rectal suppositories, enemas, or oral formulations)
  • Budesonide rectal foam/enema (another corticosteroid with high first-pass metabolism, leading to less systemic absorption)
  • Oral corticosteroids (e.g., prednisone) for more extensive or severe disease
  • Immunomodulators (e.g., azathioprine, mercaptopurine) for maintenance therapy
  • Biologic agents (e.g., infliximab, adalimumab) for moderate to severe disease
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Cost & Coverage

Average Cost: Varies widely, typically $100-$500 per 7-enema pack
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often covered by most plans)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it was taken.