Hydrocortisone 2.5% Rectal Cream
It is used to treat signs of hemorrhoids or rectal irritation.
Drug Class
Corticosteroid, Anti-inflammatory
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydrocortisone rectal cream is a medicine that helps reduce swelling, itching, and discomfort caused by conditions like hemorrhoids or inflammation in the rectal area. It's a type of steroid that works locally to calm down irritation.
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. It can also be applied to the skin around the anus as directed.
Use this medication as instructed, even if your symptoms improve. Before applying the medication, clean the area if possible, and gently pat it dry with toilet tissue or a soft cloth. Wash your hands before and after use to maintain hygiene.
Storage and Disposal
Store this 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 Instructions
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 the same time or take extra doses.
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. It can also be applied to the skin around the anus as directed.
Use this medication as instructed, even if your symptoms improve. Before applying the medication, clean the area if possible, and gently pat it dry with toilet tissue or a soft cloth. Wash your hands before and after use to maintain hygiene.
Storage and Disposal
Store this 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 Instructions
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 the same time or take extra doses.
Lifestyle & Tips
- Maintain good anal hygiene, gently cleaning the area after bowel movements.
- Avoid straining during bowel movements; consider increasing fiber and fluid intake to prevent constipation.
- Avoid prolonged sitting on the toilet.
- Do not use for longer than recommended by your doctor, typically no more than 7 days, unless advised otherwise.
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:
Apply to the affected area 2 to 4 times daily, preferably after bowel movements and at bedtime.
Condition-Specific Dosing:
Hemorrhoids and Proctitis:
Apply a small amount (approximately 1 inch) to the perianal area or insert rectally using an applicator tip.
Pediatric Dosing
Neonatal:
Not established. Use with extreme caution and under strict medical supervision due to increased risk of systemic absorption and adrenal suppression.
Infant:
Not established. Use with extreme caution and under strict medical supervision due to increased risk of systemic absorption and adrenal suppression.
Child:
Not established. Use with caution and under medical supervision. Risk of systemic absorption and adrenal suppression is higher than in adults.
Adolescent:
Similar to adult dosing, but use with caution and for the shortest duration possible.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required due to minimal systemic absorption.
Moderate:
No specific adjustment typically required due to minimal systemic absorption.
Severe:
No specific adjustment typically required due to minimal systemic absorption.
Dialysis:
No specific adjustment typically required due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment typically required due to minimal systemic absorption.
Moderate:
No specific adjustment typically required due0 to minimal systemic absorption.
Severe:
No specific adjustment typically required due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Hydrocortisone is a corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It acts by inducing phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. It also suppresses the migration of polymorphonuclear leukocytes and reverses increased capillary permeability.
Pharmacokinetics
Absorption:
Bioavailability:
Variable; generally low systemic absorption (less than 5%) from intact rectal mucosa. Absorption can increase with inflammation, mucosal damage, or prolonged use.
Tmax:
Not well-defined for rectal application due to local action and variable systemic absorption.
FoodEffect:
Not applicable for rectal administration.
Distribution:
Vd:
Not well-defined for rectal application; systemically absorbed hydrocortisone distributes widely.
ProteinBinding:
Approximately 90% (primarily to corticosteroid-binding globulin and albumin) when systemically absorbed.
CnssPenetration:
Limited (when systemically absorbed).
Elimination:
HalfLife:
Biological half-life is approximately 8-12 hours (systemic). Plasma half-life is 1.5-2 hours.
Clearance:
Not well-defined for rectal application.
ExcretionRoute:
Renal (as inactive metabolites) when systemically absorbed.
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Within hours for local anti-inflammatory and antipruritic effects.
PeakEffect:
Variable, depends on the severity of inflammation and frequency of application.
DurationOfAction:
Several hours, requiring multiple daily applications.
Safety & Warnings
Side Effects
Serious 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 or seek medical attention immediately:
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, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme 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 a wound that won't heal
Changes in vision
Severe headache
Irritation at the site of application
Severe rectal bleeding or pain
Unexplained bruising or bleeding
Swelling
Bone or joint pain
Skin changes (acne, stretch marks, slow healing, excessive hair growth)
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Burning or stinging
Dryness
* Tingling
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 or seek medical attention immediately:
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, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme 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 a wound that won't heal
Changes in vision
Severe headache
Irritation at the site of application
Severe rectal bleeding or pain
Unexplained bruising or bleeding
Swelling
Bone or joint pain
Skin changes (acne, stretch marks, slow healing, excessive hair growth)
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:
Burning or stinging
Dryness
* Tingling
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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:
- Worsening of rectal pain, itching, or bleeding.
- Severe burning, irritation, or rash in the treated area.
- Signs of infection (e.g., pus, fever, increased redness/swelling).
- Any signs of systemic steroid absorption with prolonged use (e.g., unusual weight gain, swelling in ankles/feet, increased thirst/urination, muscle weakness, mood changes).
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 symptoms you experienced.
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, tell 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 symptoms you experienced.
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, tell 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 have your blood work and bone density checked 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.
As this medication may increase your risk of developing an infection, it is vital to practice good hygiene by washing your hands frequently and avoiding 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), it is crucial to discuss this with your doctor, as this medication may cause an increase in blood sugar levels. Monitor your blood sugar 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 may cause further irritation. In the event that this medication is ingested, seek immediate medical attention or contact a 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; therefore, it is essential to discuss this 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 may affect growth in children and teenagers, so regular growth checks may be necessary; consult your doctor about this. Additionally, some formulations of this medication may not be suitable for all age groups of children, so if you have any questions or concerns, discuss them with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as it is necessary to weigh the benefits and risks of using this medication to both you and your baby.
Regular monitoring is crucial, so be sure to have your blood work and bone density checked 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.
As this medication may increase your risk of developing an infection, it is vital to practice good hygiene by washing your hands frequently and avoiding 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), it is crucial to discuss this with your doctor, as this medication may cause an increase in blood sugar levels. Monitor your blood sugar 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 may cause further irritation. In the event that this medication is ingested, seek immediate medical attention or contact a 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; therefore, it is essential to discuss this 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 may affect growth in children and teenagers, so regular growth checks may be necessary; consult your doctor about this. Additionally, some formulations of this medication may not be suitable for all age groups of children, so if you have any questions or concerns, discuss them with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as it is necessary to weigh the benefits and risks of using this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose with rectal hydrocortisone is unlikely due to minimal systemic absorption.
- Chronic overuse or use on damaged skin can lead to systemic effects such as Cushing's syndrome (e.g., moon face, central obesity, thin skin, easy bruising, muscle weakness), adrenal suppression, and hyperglycemia.
What to Do:
If systemic symptoms occur, discontinue the medication and seek medical attention. For acute ingestion, call Poison Control at 1-800-222-1222. Management is supportive.
Drug Interactions
Contraindicated Interactions
- None known for rectal formulation due to minimal systemic absorption.
Major Interactions
- None known for rectal formulation due to minimal systemic absorption.
Moderate Interactions
- None known for rectal formulation due to minimal systemic absorption. However, prolonged or extensive use could theoretically lead to systemic absorption and interactions similar to oral corticosteroids (e.g., with CYP3A4 inhibitors like ritonavir, ketoconazole, which could increase systemic exposure).
Minor Interactions
- None known for rectal formulation due to minimal systemic absorption.
Monitoring
Baseline Monitoring
Clinical assessment of affected area (e.g., hemorrhoids, proctitis)
Rationale: To establish baseline severity of symptoms and inflammation.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom improvement (e.g., reduction in pain, itching, inflammation)
Frequency: Daily, by patient self-assessment.
Target: Gradual reduction in symptoms.
Action Threshold: Lack of improvement after 7 days, or worsening symptoms, warrants re-evaluation by a healthcare provider.
Local adverse effects (e.g., irritation, burning, atrophy, secondary infection)
Frequency: Daily, by patient self-assessment.
Target: Absence of new or worsening local reactions.
Action Threshold: Development of severe irritation, signs of infection, or skin changes warrants discontinuation and medical evaluation.
Signs of systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression)
Frequency: Rarely needed for typical use; if prolonged or extensive use, consider periodically.
Target: Absence of systemic effects.
Action Threshold: Any signs (e.g., weight gain, moon face, fatigue, weakness) warrant immediate medical evaluation and discontinuation.
Symptom Monitoring
- Rectal pain
- Rectal itching
- Rectal bleeding
- Inflammation/swelling
- Burning sensation
- Irritation
- Signs of infection (pus, fever)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected with proper use, but prolonged or extensive use should be avoided.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of cleft palate in animal studies with high systemic doses; human data are limited for topical use.
Second Trimester:
Generally considered safer than first trimester, but still use with caution.
Third Trimester:
No specific risks identified beyond general corticosteroid concerns; avoid prolonged use near term.
Lactation
L3 (Moderately Safe). Hydrocortisone is excreted in breast milk in small amounts after systemic administration. With rectal application, systemic absorption is minimal, so infant exposure is expected to be very low. Use with caution, especially avoiding application to the nipple/areola area to prevent direct infant ingestion.
Infant Risk:
Low risk of adverse effects to the infant due to minimal systemic absorption by the mother.
Pediatric Use
Use with caution. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome) than adult patients. Avoid prolonged use, especially in infants and young children. Not recommended for children under 12 years without medical supervision.
Geriatric Use
No specific dosage adjustments are typically required. However, geriatric patients may have thinner skin, which could theoretically increase absorption, and may be more susceptible to skin atrophy. Monitor for local adverse effects.
Clinical Information
Clinical Pearls
- For external hemorrhoids, apply a thin film to the perianal area. For internal hemorrhoids or proctitis, use the applicator tip provided.
- Wash hands thoroughly before and after application.
- Do not use for more than 7 consecutive days unless directed by a healthcare professional.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- If symptoms do not improve within 7 days or worsen, consult a doctor.
- This medication is for rectal use only; do not take by mouth.
Alternative Therapies
- Phenylephrine rectal preparations (e.g., Preparation H)
- Witch hazel pads (e.g., Tucks Medicated Pads)
- Local anesthetics (e.g., lidocaine rectal cream)
- Stool softeners (e.g., docusate sodium) to prevent straining
- Fiber supplements (e.g., psyllium) to promote regular bowel movements
Cost & Coverage
Average Cost:
$20 - $80 per 30g tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (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 details. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.