Hydrocortisone 100mg Enema 7 X 60ml
It is used to treat ulcerative colitis.
Drug Class
Anti-inflammatory agent
Pharmacologic Class
Glucocorticoid; Corticosteroid, Rectal
Pregnancy Category
Category C
FDA Approved
Jun 1978
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydrocortisone enema is a type of steroid medication that is inserted into the rectum. It works by reducing inflammation in the lower part of your bowel, helping to relieve symptoms like bleeding, pain, and urgency caused by conditions like ulcerative colitis or proctitis.
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 designed for rectal use only and should not be taken orally.
Use the medication as directed, even if your symptoms improve.
Wash your hands before and after using the medication.
Shake the container well before each use.
Handle the enema with care, as improper use or incorrect insertion of the enema tip can cause damage to the area.
Storage and Disposal
Store the medication at room temperature, avoiding freezing. Keep all medications in a safe 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 have access to drug take-back programs 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 dose, skip the missed dose and resume your regular schedule. Do not use two doses at once or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is designed for rectal use only and should not be taken orally.
Use the medication as directed, even if your symptoms improve.
Wash your hands before and after using the medication.
Shake the container well before each use.
Handle the enema with care, as improper use or incorrect insertion of the enema tip can cause damage to the area.
Storage and Disposal
Store the medication at room temperature, avoiding freezing. Keep all medications in a safe 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 have access to drug take-back programs 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 dose, skip the missed dose and resume your regular schedule. Do not use two doses at once or take extra doses.
Lifestyle & Tips
- Follow your doctor's instructions carefully regarding diet and other treatments for your bowel condition.
- Maintain good hygiene, especially around the rectal area.
- Report any new or worsening symptoms to your doctor.
- Avoid contact with people who have contagious diseases (e.g., chickenpox, measles) if you are on prolonged or high-dose systemic corticosteroids, as your immune system may be weakened. While rectal absorption is less, caution is still advised.
Available Forms & Alternatives
Available Strengths:
- Hydrocortisone 1% Ointment 28.35gm
- Hydrocortisone 2.5% Cream 30gm
- Hydrocortisone 1% Cream 28.35gm
- Hydrocortisone 2.5% Oint 28.35gm
- Hydrocortisone Val 0.2% Cream 15gm
- Hydrocortisone Val 0.2% Cream 45gm
- Hydrocortisone Val 0.2% Cream 60gm
- Hydrocortisone Val 0.2% Oint 15gm
- Hydrocortisone Val 0.2% Ont 45gm
- Hydrocortisone Val 0.2% Ont 60gm
- Hydrocortisone 2.5% Oint 453.6gm
- Hydrocortisone 1% Ointment 453.6gm
- Hydrocortisone 2.5% Ointment 20gm
- Hydrocortisone 2.5% Cream
- Hydrocortisone AC 25mg Rectal Supp
- Hydrocortisone 1% Cream
- Hydrocort Butyrate 0.1% Soln 60ml
- Hydrocortisone Ace 30mg Suppository
- Hydrocortisone Val 0.2% Cream 45gm
- Hydrocortisone But 0.1% Oint 15gm
- Hydrocortisone But 0.1% Oint 45gm
- Hydrocortisone Val 0.2% Cream 60gm
- Hydrocortisone Val 0.2% Cream 15gm
- Hydrocortisone But 0.1% Cream 15gm
- Hydrocortisone But 0.1% Cream 45gm
- Hydrocortisone 2.5% Ointment 454gm
- Hydrocortisone 2.5% Cream 20gm
- Hydrocort Butyrate 0.1% Soln 20ml
- Hydrocortisone 2.5% Lotion 59ml
- Hydrocortisone 2.5% Lotion 118ml
- Hydrocortisone 2.5% Cream 28.35gm
- Hydrocortisone 100mg Enema 7 X 60ml
- Hydrocortisone 10mg Tablets
- Hydrocortisone 20mg Tablets
- Hydrocortisone 5mg Tablets
- Hydrocortisone Butyr 0.1% Crm 60gm
- Hydrocortisone Butyr 0.1% Crm 45gm
- Hydrocortisone 1% Cream 454gm
- Hydrocortisone 1% Ointment 28gm
- Hydrocortisone 0.5% W/aloe Cream
- Hydrocortisone 2.5% Rectal Cream
- Hydrocortisone 1% Cream 14.2gm
- Hydrocortisone 1% Rectal Crm 28.4gm
- Hydrocortisone 1%/iodoquinol 1% Crm
- Hydrocortisone 1% Cream 28gm
- Hydrocortisone 10mg Tablets
- Hydrocortisone 20mg Tablets
- Hydrocortisone 5mg Tablets
- Hydrocortisone Val 0.2% Oint 45gm
- Hydrocortisone Val 0.2% Oint 60gm
- Hydrocortisone 1% Cream 28.4gm
- Hydrocortisone 1% Cream 454gm
- Hydrocortisone 2.5% Cream 454gm
- Hydrocortisone 100mg Enema 60ml
- Hydrocortisone But 0.1% Lotion 59ml
- Hydrocortisone 1% W/aloe Cream 28gm
- Hydrocortisone 1% Plus Cream 28.4gm
Dosing & Administration
Adult Dosing
Standard Dose:
100 mg (one enema) rectally once daily at bedtime for 21 days or until remission is achieved.
Dose Range:
100 - 100 mg
Condition-Specific Dosing:
ulcerativeProctitis:
100 mg rectally once daily at bedtime.
ulcerativeColitis:
100 mg rectally once daily at bedtime.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (safety and efficacy not established; use with caution, potential for growth suppression)
Adolescent:
Not established (safety and efficacy not established; use with caution, potential for growth suppression)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but use with caution.
Moderate:
No specific adjustment recommended, but use with caution.
Severe:
No specific adjustment recommended, but use with caution.
Dialysis:
Consider potential for fluid retention and electrolyte imbalance; monitor closely.
Hepatic Impairment:
Mild:
No specific adjustment recommended, but use with caution.
Moderate:
No specific adjustment recommended, but use with caution.
Severe:
No specific adjustment recommended, but use with caution; monitor for increased systemic effects due to reduced metabolism.
Pharmacology
Mechanism of Action
Hydrocortisone is a naturally occurring glucocorticoid. It diffuses across cell membranes and complexes with specific cytoplasmic receptors. These complexes then enter the nucleus, bind to DNA (chromatin), and stimulate transcription of mRNA and subsequent protein synthesis of various enzymes responsible for the anti-inflammatory effects. It inhibits the accumulation of inflammatory cells at sites of inflammation, inhibits phagocytosis, lysosomal enzyme release, and synthesis/release of mediators of inflammation (e.g., prostaglandins, leukotrienes). It also suppresses the immune response.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (approximately 10-50% systemically absorbed after rectal administration, depending on inflammation severity and retention time)
Tmax:
Approximately 1-2 hours (for systemic absorption after rectal administration)
FoodEffect:
Not applicable for rectal administration
Distribution:
Vd:
Approximately 0.2-0.6 L/kg
ProteinBinding:
Approximately 90% (primarily to corticosteroid-binding globulin and albumin)
CnssPenetration:
Limited (systemic absorption can lead to some CNS penetration, but local effect is primary)
Elimination:
HalfLife:
Plasma half-life: 80-118 minutes; Biological half-life: 8-12 hours
Clearance:
Approximately 0.5-1.5 L/hr/kg
ExcretionRoute:
Renal (primarily as inactive metabolites)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
Within hours to days (for anti-inflammatory effect)
PeakEffect:
Days to weeks (for full therapeutic effect in ulcerative colitis)
DurationOfAction:
Approximately 8-12 hours (biological effect)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, extreme dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or non-healing wounds
Changes in vision
Severe headache
Irritation at the application site
Severe rectal bleeding or pain
Unexplained bruising or bleeding
Swelling
Bone or joint pain
Skin changes (acne, stretch marks, slow healing, or excessive hair growth)
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Burning or stinging sensations
Dryness
* Tingling
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: 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, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, extreme dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or discolored sputum, painful urination, mouth sores, or non-healing wounds
Changes in vision
Severe headache
Irritation at the application site
Severe rectal bleeding or pain
Unexplained bruising or bleeding
Swelling
Bone or joint pain
Skin changes (acne, stretch marks, slow healing, or excessive hair growth)
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
Burning or stinging sensations
Dryness
* Tingling
This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Increased thirst or urination (signs of high blood sugar)
- Swelling in your ankles or feet (fluid retention)
- Unusual weight gain, especially in the face or abdomen (Cushingoid features)
- Muscle weakness or fatigue
- Mood changes, depression, or anxiety
- Difficulty sleeping
- Signs of infection (fever, chills, sore throat, body aches)
- Severe abdominal pain or worsening rectal bleeding
- Black, tarry stools (sign of GI bleeding)
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 you experienced, including any symptoms that occurred.
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
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.
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 you experienced, including any symptoms that occurred.
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
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.
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 swallowed, seek immediate medical attention by calling a doctor or poison control center.
Use this medication only for the duration prescribed by your doctor. 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. Consult your doctor to determine the best approach.
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.
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 swallowed, seek immediate medical attention by calling a doctor or poison control center.
Use this medication only for the duration prescribed by your doctor. 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. Consult your doctor to determine the best approach.
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.
Overdose Information
Overdose Symptoms:
- Fluid retention
- Hypertension
- Hyperglycemia
- Hypokalemia
- Increased systemic side effects (e.g., Cushingoid features, adrenal suppression with prolonged use)
What to Do:
Acute overdose is unlikely with rectal administration. In case of suspected overdose or significant systemic effects, contact a poison control center immediately (Call 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is supportive and symptomatic.
Drug Interactions
Major Interactions
- Live or live attenuated vaccines (risk of disseminated infection)
- Mifepristone (decreased corticosteroid effect)
Moderate Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin): May increase hydrocortisone levels and systemic effects.
- CYP3A4 inducers (e.g., rifampin, phenytoin, phenobarbital): May decrease hydrocortisone levels and efficacy.
- NSAIDs (e.g., ibuprofen, naproxen): Increased risk of GI ulceration/bleeding.
- Diuretics (thiazide, loop): Enhanced potassium depletion, increased risk of hypokalemia.
- Anticoagulants (e.g., warfarin): May alter anticoagulant effect (monitor INR).
- Antidiabetics (e.g., insulin, oral hypoglycemics): May increase blood glucose, requiring dose adjustment of antidiabetics.
- Cardiac glycosides (e.g., digoxin): Increased risk of digitalis toxicity with hypokalemia.
- Cholestyramine, colestipol: May decrease hydrocortisone absorption (separate administration).
Minor Interactions
- Oral contraceptives: May increase hydrocortisone levels.
- Grapefruit juice: May increase hydrocortisone levels (CYP3A4 inhibition).
Monitoring
Baseline Monitoring
Complete Blood Count (CBC)
Rationale: To assess baseline hematologic status and identify potential for leukocytosis or lymphopenia.
Timing: Prior to initiation of therapy
Electrolytes (Potassium, Sodium)
Rationale: To assess baseline electrolyte balance, as corticosteroids can cause fluid retention and potassium loss.
Timing: Prior to initiation of therapy
Blood Glucose
Rationale: To assess baseline glucose levels, as corticosteroids can elevate blood glucose.
Timing: Prior to initiation of therapy
Blood Pressure
Rationale: To assess baseline cardiovascular status, as corticosteroids can cause hypertension.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical Symptoms (e.g., rectal bleeding, urgency, stool frequency)
Frequency: Daily/Weekly during treatment
Target: Improvement or resolution of symptoms
Action Threshold: Lack of improvement or worsening symptoms may indicate treatment failure or need for re-evaluation.
Electrolytes (Potassium, Sodium)
Frequency: Periodically, especially with prolonged use or concomitant diuretics
Target: Within normal limits
Action Threshold: Significant deviations (e.g., hypokalemia, hypernatremia) require intervention.
Blood Glucose
Frequency: Periodically, especially in diabetic patients or with prolonged use
Target: Within target range for patient
Action Threshold: Persistent hyperglycemia requires intervention (e.g., antidiabetic adjustment).
Blood Pressure
Frequency: Periodically
Target: Within patient's target range
Action Threshold: Significant hypertension requires intervention.
Signs of Systemic Absorption (e.g., Cushingoid features, adrenal suppression)
Frequency: Throughout therapy, especially with prolonged use
Target: Absence of signs
Action Threshold: Development of signs requires re-evaluation of therapy and potential tapering.
Symptom Monitoring
- Rectal bleeding
- Abdominal pain
- Diarrhea/constipation
- Urgency
- Tenesmus
- Fluid retention (swelling in ankles/feet)
- Increased thirst or urination (signs of hyperglycemia)
- Mood changes, insomnia
- Muscle weakness
- Unusual weight gain
- Signs of infection (fever, chills, sore throat)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy 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 variable.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of cleft palate in animal studies; human data limited.
Second Trimester:
Generally considered safer than first trimester, but still Category C.
Third Trimester:
May cause fetal growth restriction, adrenal suppression in the neonate, or premature delivery. Monitor neonates for signs of hypoadrenalism.
Lactation
Hydrocortisone is excreted in breast milk. While systemic absorption from rectal administration is variable and generally lower than oral/IV, caution is advised. The amount transferred to breast milk is generally low and unlikely to cause significant adverse effects in the infant with typical doses. Monitor the infant for signs of adrenal suppression (e.g., poor weight gain).
Infant Risk:
Low to Moderate (L3)
Pediatric Use
Safety and efficacy not established in pediatric patients. Use with caution, as corticosteroids can cause growth retardation in children. If used, monitor growth and development closely. Adrenal suppression is a concern.
Geriatric Use
Elderly patients may be at increased risk of adverse effects, including osteoporosis, fluid retention, hypertension, and diabetes, due to age-related changes in metabolism and increased sensitivity to corticosteroids. Use with caution and monitor closely.
Clinical Information
Clinical Pearls
- Instruct patients to administer the enema at bedtime and retain it for as long as possible (preferably overnight) for maximal therapeutic effect.
- Ensure patients understand proper administration technique to maximize retention and minimize leakage.
- While systemic absorption is less than oral corticosteroids, prolonged use or use in patients with extensive mucosal inflammation can lead to systemic side effects, including adrenal suppression.
- This formulation is primarily for distal ulcerative colitis and proctitis, not for extensive or severe pancolitis.
- Patients should be advised not to discontinue therapy abruptly, especially after prolonged use, to avoid withdrawal symptoms or adrenal crisis.
Alternative Therapies
- 5-aminosalicylates (5-ASAs) rectal (e.g., mesalamine enema, suppositories)
- Oral 5-aminosalicylates (e.g., mesalamine, sulfasalazine)
- Oral corticosteroids (e.g., prednisone, budesonide)
- Immunomodulators (e.g., azathioprine, 6-mercaptopurine)
- Biologic agents (e.g., infliximab, adalimumab, vedolizumab)
- Janus kinase (JAK) inhibitors (e.g., tofacitinib)
- Surgery (e.g., proctocolectomy in severe cases)
Cost & Coverage
Average Cost:
$100 - $300 per 7 x 60ml enema kit
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred brand or non-preferred brand/generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.