Hydrocortisone AC 25mg Rectal Supp
It is used to treat signs of hemorrhoids or rectal irritation.
Drug Class
Anti-inflammatory agent; Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydrocortisone rectal suppositories are a type of medicine called a corticosteroid. They are inserted into the rectum to reduce inflammation, swelling, itching, and discomfort caused by conditions like ulcerative proctitis or hemorrhoids. It works directly on the irritated tissues to calm them down.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, 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.
Continue using the medication as directed, even if your symptoms improve. Before and after handling the medication, wash your hands thoroughly.
To insert the rectal suppository, remove the foil wrapper and gently push the suppository into the rectum, pointed end first. Avoid excessive handling of the suppository. If the suppository is too soft, you can chill it in the refrigerator or run it under cold water to firm it up.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing temperatures. Protect the medication from heat sources and keep it in a secure location, out of the reach of children and pets.
Missing a Dose
If you miss a dose, use it as soon as you remember. However, if it's 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 a missed dose.
To use this medication safely and effectively, 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.
Continue using the medication as directed, even if your symptoms improve. Before and after handling the medication, wash your hands thoroughly.
To insert the rectal suppository, remove the foil wrapper and gently push the suppository into the rectum, pointed end first. Avoid excessive handling of the suppository. If the suppository is too soft, you can chill it in the refrigerator or run it under cold water to firm it up.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing temperatures. Protect the medication from heat sources and keep it in a secure location, out of the reach of children and pets.
Missing a Dose
If you miss a dose, use it as soon as you remember. However, if it's 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 a missed dose.
Lifestyle & Tips
- Maintain good bowel hygiene.
- Avoid straining during bowel movements.
- Follow any dietary recommendations provided by your doctor for your underlying condition (e.g., inflammatory bowel disease).
- Store suppositories in a cool place (refrigerator if specified by manufacturer) as they can melt at room temperature.
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:
25 mg rectally once or twice daily
Dose Range:
25 - 50 mg
Condition-Specific Dosing:
ulcerativeProctitis:
25 mg rectally once or twice daily for 2-6 weeks, or until remission is achieved. May be tapered to alternate-day dosing for maintenance.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not routinely recommended for children under 12 years. If used, dose must be individualized and carefully monitored due to potential for systemic effects.
Adolescent:
Not routinely recommended for children under 12 years. If used, dose must be individualized and carefully monitored due to potential for systemic effects.
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.
Dialysis:
No specific adjustment needed due to 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.
Pharmacology
Mechanism of Action
Hydrocortisone is a corticosteroid that acts by binding to specific glucocorticoid receptors in the cytoplasm, forming a complex that translocates to the nucleus. This complex modulates gene expression, leading to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines). In the rectum, it reduces inflammation, edema, pruritus, and pain associated with inflammatory bowel disease (proctitis) or hemorrhoids.
Pharmacokinetics
Absorption:
Bioavailability:
Variable, generally low (e.g., 10-30% of administered dose may be absorbed systemically)
Tmax:
1-2 hours (for systemically absorbed drug)
FoodEffect:
Not relevant for rectal administration
Distribution:
Vd:
Not specifically quantified for rectal route; if absorbed systemically, widely distributed.
ProteinBinding:
Approximately 90% (to albumin and corticosteroid-binding globulin)
CnssPenetration:
Limited
Elimination:
HalfLife:
80-118 minutes (for systemically absorbed hydrocortisone)
Clearance:
Not specifically quantified for rectal route
ExcretionRoute:
Renal (as metabolites)
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Local anti-inflammatory effects may be noticed within hours to days.
PeakEffect:
Full therapeutic effect may take several days to weeks.
DurationOfAction:
Effects persist as long as treatment continues.
Safety & Warnings
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 notice 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
+ More sputum or change in color of sputum
+ Pain with passing urine
+ Mouth sores
+ Wound that will not heal
Changes in eyesight
Severe headache
Irritation at the site of application
Severe bleeding from the rectum or rectal 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 can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
Burning or stinging
Dryness
* Tingling
If you experience any of these side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice. 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 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
+ More sputum or change in color of sputum
+ Pain with passing urine
+ Mouth sores
+ Wound that will not heal
Changes in eyesight
Severe headache
Irritation at the site of application
Severe bleeding from the rectum or rectal 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 can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:
Burning or stinging
Dryness
* Tingling
If you experience any of these side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice. 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 rectal bleeding or pain.
- Severe abdominal pain or fever.
- Signs of infection (e.g., pus, increased pain, redness, swelling).
- Signs of systemic steroid effects, which are rare but can occur with prolonged use or high doses (e.g., unusual weight gain, swelling in ankles/feet, increased thirst/urination, mood changes, muscle weakness).
- Allergic reaction symptoms (e.g., rash, itching, severe dizziness, trouble breathing).
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 your safety, 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 for you 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 your safety, 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 for you 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, discuss the need for regular eye pressure checks 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 illnesses or been vaccinated against them, consult your doctor promptly.
If you have diabetes, 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 to ensure safe use. Be aware that this medication can stain clothing and fabrics, so take necessary precautions to protect them.
In the event that this medication is swallowed, seek immediate medical attention by calling a doctor or poison control center. Do not use this medication for an extended period beyond the duration prescribed by your doctor, as prolonged use may increase the risk of developing cataracts or glaucoma. Discuss this 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 may affect growth in children and teenagers, necessitating regular growth checks. Consult your doctor to discuss this potential risk.
Additionally, 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 breastfeeding, inform your doctor to discuss the potential benefits and risks of using this medication to 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, discuss the need for regular eye pressure checks 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 illnesses or been vaccinated against them, consult your doctor promptly.
If you have diabetes, 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 to ensure safe use. Be aware that this medication can stain clothing and fabrics, so take necessary precautions to protect them.
In the event that this medication is swallowed, seek immediate medical attention by calling a doctor or poison control center. Do not use this medication for an extended period beyond the duration prescribed by your doctor, as prolonged use may increase the risk of developing cataracts or glaucoma. Discuss this 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 may affect growth in children and teenagers, necessitating regular growth checks. Consult your doctor to discuss this potential risk.
Additionally, 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 breastfeeding, inform your doctor to discuss the potential benefits and risks of using this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with rectal administration due to limited systemic absorption.
- If significant systemic absorption occurs, symptoms would be those of systemic corticosteroid excess (e.g., Cushingoid features, hyperglycemia, hypertension, fluid retention, mood disturbances).
What to Do:
Discontinue use and seek medical attention. Management is supportive and symptomatic. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Moderate Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) - potential for increased systemic hydrocortisone levels if significant absorption occurs.
- Anticoagulants (e.g., warfarin) - corticosteroids may alter anticoagulant effects.
- NSAIDs - increased risk of gastrointestinal ulceration.
- Diuretics (thiazide, loop) - enhanced potassium excretion, increased risk of hypokalemia.
- Antidiabetics - corticosteroids can increase blood glucose levels, requiring adjustment of antidiabetic therapy.
Monitoring
Baseline Monitoring
Rectal symptoms (bleeding, pain, urgency, tenesmus)
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation of therapy
Proctoscopic examination
Rationale: To assess extent and severity of inflammation (e.g., in ulcerative proctitis).
Timing: Prior to initiation of therapy
Routine Monitoring
Symptom improvement (reduction in bleeding, pain, urgency)
Frequency: Daily to weekly
Target: Significant reduction or resolution of symptoms
Action Threshold: Lack of improvement or worsening symptoms after 1-2 weeks may indicate need for re-evaluation or alternative therapy.
Signs of systemic corticosteroid effects (e.g., hyperglycemia, hypertension, Cushingoid features, adrenal suppression)
Frequency: Periodically, especially with prolonged use or higher doses
Target: Absence of systemic effects
Action Threshold: Presence of systemic effects may require dose reduction, discontinuation, or alternative therapy.
Rectal irritation or discomfort
Frequency: Daily
Target: Minimal to none
Action Threshold: Persistent or severe irritation may require discontinuation.
Symptom Monitoring
- Rectal bleeding
- Rectal pain or discomfort
- Urgency to defecate
- Tenesmus
- Abdominal pain
- Changes in bowel habits
- Signs of infection (e.g., fever, increased pain, pus)
- Unusual weight gain or swelling (edema)
- Increased thirst or urination
- Mood changes or sleep disturbances
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. While systemic absorption from rectal administration is limited, caution is advised.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of cleft palate in animal studies with high systemic doses; human data are limited for rectal route.
Second Trimester:
Generally considered safer than first trimester, but still Category C.
Third Trimester:
Potential for fetal growth restriction or adrenal suppression with prolonged, high-dose systemic use; unlikely with limited rectal absorption.
Lactation
L3 (Moderately Safe). Hydrocortisone is excreted in breast milk. Due to limited systemic absorption from the rectal route, infant exposure is expected to be minimal. However, monitor the infant for adverse effects (e.g., growth suppression, signs of adrenal suppression).
Infant Risk:
Low risk, but monitor for signs of systemic effects.
Pediatric Use
Use with caution. Children may be more susceptible to systemic effects (e.g., growth retardation, adrenal suppression) due to a larger surface area to body weight ratio. Not recommended for children under 12 years unless specifically indicated and closely monitored by a specialist.
Geriatric Use
No specific dose adjustments are typically needed. However, geriatric patients may have increased susceptibility to systemic corticosteroid side effects (e.g., osteoporosis, diabetes, hypertension) if significant absorption occurs, or if they have pre-existing comorbidities. Monitor closely.
Clinical Information
Clinical Pearls
- Ensure proper insertion technique: Lie on your side, insert the suppository pointed end first, and remain lying down for a few minutes to allow it to dissolve and prevent expulsion.
- Suppositories may stain clothing; consider using a panty liner or pad if leakage is a concern.
- Store suppositories as directed (often in a refrigerator) to prevent melting.
- This medication is for local action in the rectum; significant systemic absorption is generally not expected but can occur, especially with prolonged use, high doses, or compromised rectal mucosa.
- Do not use for prolonged periods without medical supervision, as it can lead to local irritation or, rarely, systemic corticosteroid side effects.
Alternative Therapies
- 5-aminosalicylates (5-ASAs) rectal (e.g., mesalamine suppositories/enemas for ulcerative proctitis)
- Topical anesthetics (e.g., lidocaine cream/ointment for hemorrhoids)
- Oral corticosteroids (for more widespread or severe inflammatory bowel disease)
- Immunomodulators or biologics (for moderate to severe inflammatory bowel disease)
Cost & Coverage
Average Cost:
Variable per suppository
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.