Hydrocortisone Ace 30mg Suppository
It is used to treat signs of hemorrhoids or rectal irritation.
Drug Class
Anti-inflammatory agent; Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydrocortisone rectal suppositories are a type of steroid medicine inserted into the rectum. They work by reducing inflammation, swelling, itching, and pain in the rectal area, often used for conditions like hemorrhoids or certain types of inflammatory bowel disease (e.g., proctitis).
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.
Use the medication as directed, even if your symptoms improve.
Wash your hands before and after handling the medication.
To insert the rectal suppository, remove the foil wrapper and gently push it into the rectum, pointed end first. Avoid excessive handling of the suppository.
If the suppository is soft, you can chill it in the refrigerator or run it under cold water to firm it up before use.
Storing and Disposing of Your Medication
Store the medication at room temperature, away from heat sources.
Do not freeze the medication.
Keep all medications in a secure location, out of reach of children and pets.
Missing a Dose
If you miss a dose, use it as soon as you remember.
If it's 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 make up for a missed one.
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.
Use the medication as directed, even if your symptoms improve.
Wash your hands before and after handling the medication.
To insert the rectal suppository, remove the foil wrapper and gently push it into the rectum, pointed end first. Avoid excessive handling of the suppository.
If the suppository is soft, you can chill it in the refrigerator or run it under cold water to firm it up before use.
Storing and Disposing of Your Medication
Store the medication at room temperature, away from heat sources.
Do not freeze the medication.
Keep all medications in a secure location, out of reach of children and pets.
Missing a Dose
If you miss a dose, use it as soon as you remember.
If it's 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 make up for a missed one.
Lifestyle & Tips
- Maintain good anal hygiene.
- Increase fiber and fluid intake to prevent constipation and straining during bowel movements.
- Avoid prolonged sitting or standing.
- Do not use for longer than prescribed by your doctor, typically 2-6 weeks, to avoid potential side effects.
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:
One 25 mg or 30 mg suppository rectally, once or twice daily, for 2 to 6 weeks.
Dose Range:
25 - 60 mg
Condition-Specific Dosing:
ulcerative_colitis:
One 25 mg or 30 mg suppository once or twice daily for 2 to 6 weeks.
hemorrhoids_proctitis:
One 25 mg or 30 mg suppository once or twice daily for 2 to 6 weeks.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not generally recommended; use with extreme caution and under specialist supervision due to risk of systemic effects (e.g., growth suppression, adrenal suppression). Dosing must be individualized.
Adolescent:
Not generally recommended; use with caution and under specialist supervision. Dosing must be individualized.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment typically required due to limited systemic absorption.
Moderate:
No specific adjustment typically required due to limited systemic absorption.
Severe:
No specific adjustment typically required due to limited systemic absorption.
Dialysis:
No specific adjustment typically required due to limited systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment typically required due to limited systemic absorption, though metabolism is hepatic.
Moderate:
No specific adjustment typically required due to limited systemic absorption, though metabolism is hepatic.
Severe:
No specific adjustment typically required due to limited systemic absorption, though metabolism is hepatic.
Pharmacology
Mechanism of Action
Hydrocortisone is a corticosteroid that diffuses across cell membranes and binds to specific cytoplasmic glucocorticoid receptors. These complexes then translocate into the cell nucleus, bind to DNA (glucocorticoid response elements), and modulate gene expression. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of the synthesis and release of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines, adhesion molecules). This action results in reduced inflammation, pain, and itching.
Pharmacokinetics
Absorption:
Bioavailability:
Variable, generally low systemic bioavailability (approximately 10-30%) due to significant first-pass metabolism in the liver after rectal absorption.
Tmax:
Not well-defined for rectal administration; systemic peak concentrations are low and variable.
FoodEffect:
Not applicable for rectal administration.
Distribution:
Vd:
Approximately 0.5-1.5 L/kg (systemic)
ProteinBinding:
Approximately 90% (primarily to albumin and transcortin)
CnssPenetration:
Limited (systemic)
Elimination:
HalfLife:
Approximately 80-118 minutes (systemic, for parent drug)
Clearance:
Approximately 10-15 mL/min/kg (systemic)
ExcretionRoute:
Renal (as inactive metabolites)
Unchanged:
<1% (systemic)
Pharmacodynamics
OnsetOfAction:
Within hours for local anti-inflammatory effect.
PeakEffect:
Variable, typically within 1-2 days for symptomatic relief.
DurationOfAction:
Approximately 12-24 hours for local effect.
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 immediately or seek 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, difficulty 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, or excessive hair growth)
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you're bothered by any of the following side effects or if they persist, contact your doctor:
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 immediately or seek 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, difficulty 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, or excessive hair growth)
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you're bothered by any of the following side effects or if they persist, contact your doctor:
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, bleeding, or irritation.
- Signs of infection (e.g., fever, pus, severe pain).
- Development of new or unusual symptoms such as significant weight gain, swelling in ankles/feet, increased thirst/urination, muscle weakness, or mood changes (these could indicate systemic absorption and side effects).
- Allergic reaction symptoms (e.g., rash, itching/swelling, 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 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
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 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
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 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 regularly. Discuss the frequency of these checks with your doctor.
As this medication may increase your risk of developing infections, it is vital to practice good hygiene by washing your hands frequently. 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 advised 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 precautions to protect them.
In case of accidental ingestion, seek immediate medical attention or contact a 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 these potential risks with your doctor.
When administering this medication to children, exercise caution, as they may be more susceptible to certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Consult 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 concerns or questions, discuss them with 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, you should also have your eye pressure checked regularly. Discuss the frequency of these checks with your doctor.
As this medication may increase your risk of developing infections, it is vital to practice good hygiene by washing your hands frequently. 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 advised 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 precautions to protect them.
In case of accidental ingestion, seek immediate medical attention or contact a 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 these potential risks with your doctor.
When administering this medication to children, exercise caution, as they may be more susceptible to certain side effects. In some cases, this medication can affect growth in children and teenagers, making regular growth checks necessary. Consult 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 concerns or questions, discuss them with 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:
- Acute overdose with rectal hydrocortisone is unlikely due to limited systemic absorption.
- Chronic overuse or high doses may lead to systemic corticosteroid effects such as Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), adrenal suppression, hyperglycemia, hypertension, fluid retention, and osteoporosis.
What to Do:
If systemic symptoms of overdose occur, contact a poison control center or emergency medical services immediately. Call 1-800-222-1222. Treatment is supportive and symptomatic; gradual withdrawal of the drug may be necessary if chronic overdose is suspected.
Drug Interactions
Moderate Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin): May increase systemic exposure to hydrocortisone if significant absorption occurs, leading to potential for systemic corticosteroid effects.
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Increased risk of gastrointestinal ulceration or bleeding if significant systemic absorption occurs, though less common with rectal use.
- Diuretics (thiazide, loop): Increased risk of hypokalemia due to potassium-wasting effects.
Minor Interactions
- Anticoagulants (e.g., warfarin): May alter anticoagulant effects; monitor INR.
- Antidiabetic agents: May increase blood glucose levels; monitor blood glucose.
Monitoring
Baseline Monitoring
Rectal symptoms (pain, bleeding, itching, inflammation)
Rationale: To assess severity and establish a baseline for treatment efficacy.
Timing: Prior to initiation of therapy.
Blood pressure
Rationale: To monitor for potential systemic effects, especially with prolonged use or higher doses.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom improvement (rectal pain, bleeding, itching)
Frequency: Daily to weekly, depending on severity.
Target: Reduction or resolution of symptoms.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation or alternative therapy.
Signs of local irritation or infection
Frequency: Daily to weekly.
Target: Absence of new or worsening irritation, redness, or discharge.
Action Threshold: Development of new or worsening irritation, pain, or signs of infection (e.g., fever, purulent discharge) requires medical attention.
Signs of systemic corticosteroid effects (e.g., weight gain, edema, hyperglycemia, mood changes, adrenal suppression)
Frequency: Periodically, especially with prolonged use (>2-4 weeks) or higher doses.
Target: Absence of new or worsening systemic effects.
Action Threshold: Development of systemic effects may necessitate dose reduction, discontinuation, or alternative therapy.
Symptom Monitoring
- Rectal pain
- Rectal bleeding
- Rectal itching
- Rectal irritation or burning
- Changes in bowel habits
- Unusual weight gain or swelling (edema)
- Increased thirst or urination (signs of hyperglycemia)
- Mood changes (e.g., irritability, depression)
- Muscle weakness
- Fatigue (potential adrenal suppression)
Special Patient Groups
Pregnancy
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. While systemic absorption from rectal administration is limited, corticosteroids can cross the placenta. Observe neonates for signs of hypoadrenalism if the mother received significant doses.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of cleft palate in animal studies, but human data are inconclusive. Limited systemic absorption from rectal route reduces concern.
Second Trimester:
Generally considered safer than first trimester for systemic corticosteroids, but still Category C. Limited systemic absorption from rectal route.
Third Trimester:
Potential for fetal growth restriction, adrenal suppression, and premature delivery with prolonged systemic use. Limited systemic absorption from rectal route reduces this risk.
Lactation
Hydrocortisone is excreted in breast milk, but systemic levels following rectal administration are generally low. Considered L3 (moderately safe). Monitor breastfed infants for signs of adverse effects (e.g., growth suppression, unusual weight gain). Use lowest effective dose for shortest duration.
Infant Risk:
Low risk with typical rectal use due to limited systemic absorption by the mother.
Pediatric Use
Use with extreme caution. Children may be more susceptible to systemic corticosteroid effects (e.g., growth retardation, adrenal suppression, Cushing's syndrome) due to a larger skin surface area to body weight ratio and potential for higher systemic absorption. Not generally recommended for routine use; if used, monitor closely for systemic effects.
Geriatric Use
Use with caution. Elderly patients may be more susceptible to the systemic side effects of corticosteroids, such as osteoporosis, fluid retention, and hypertension, even with limited systemic absorption. Monitor closely for these effects.
Clinical Information
Clinical Pearls
- Hydrocortisone rectal suppositories are primarily for local anti-inflammatory effects in the rectum and lower colon.
- They are typically used for short-term treatment (e.g., 2-6 weeks) to manage acute flares of conditions like ulcerative proctitis or severe hemorrhoids.
- Proper administration technique is crucial: insert the suppository pointed end first, and try to retain it for at least 1-3 hours for optimal absorption and effect.
- Advise patients to lie down for 15-20 minutes after insertion to help retain the suppository.
- While systemic absorption is limited, prolonged or high-dose use can lead to systemic corticosteroid side effects, including adrenal suppression. Tapering may be necessary after prolonged use.
- Not intended for long-term maintenance therapy without careful medical supervision.
Alternative Therapies
- Topical anesthetics (e.g., lidocaine rectal cream/ointment for pain/itching)
- Astringents (e.g., witch hazel pads for hemorrhoids)
- Stool softeners or fiber supplements (to prevent straining)
- Oral 5-aminosalicylates (e.g., mesalamine for ulcerative proctitis)
- Oral corticosteroids (for more widespread or severe inflammatory bowel disease)
- Surgical interventions (for severe hemorrhoids or other structural issues)
Cost & Coverage
Average Cost:
Varies, typically $50 - $200 per 12-24 suppositories
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic or non-preferred brand)
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's a good idea 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.