Hemmorex-HC 25mg Rectal Supp 12s
It is used to treat signs of hemorrhoids or rectal irritation.
Drug Class
Anti-inflammatory agent
Pharmacologic Class
Corticosteroid, Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Jun 1952
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydrocortisone rectal suppositories are a type of medicine called a corticosteroid. They are used to reduce swelling, itching, and discomfort caused by hemorrhoids or other inflammatory conditions in the rectal area. They work by calming down the body's inflammatory response.
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.
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 wrapping and gently push the suppository 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.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures and excessive heat. Keep the medication in a secure location, out of the reach of children and pets, to prevent accidental ingestion or misuse.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses to make up for a missed dose.
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.
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 wrapping and gently push the suppository 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.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures and excessive heat. Keep the medication in a secure location, out of the reach of children and pets, to prevent accidental ingestion or misuse.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Maintain good anal hygiene: Gently clean the area after each bowel movement.
- Avoid straining during bowel movements: Increase fiber intake and drink plenty of water to soften stools.
- Avoid prolonged sitting or standing.
- Take warm sitz baths to soothe the area.
- Do not use for longer than prescribed by your doctor, typically no more than 2 weeks, unless directed otherwise.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One 25 mg suppository rectally 1 to 2 times daily, preferably in the morning and at bedtime, for 2 weeks. May be reduced to 1 suppository every other day for 2 weeks.
Dose Range:
25 - 50 mg
Condition-Specific Dosing:
hemorrhoids:
One 25 mg suppository rectally 1 to 2 times daily.
proctitis:
One 25 mg suppository rectally 1 to 2 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (use with caution, generally not recommended for prolonged use due to potential for systemic effects including growth suppression)
Adolescent:
Not established (use with caution, generally not recommended for prolonged use due to potential for systemic effects including growth suppression)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended due to limited systemic absorption.
Moderate:
No specific adjustment recommended due to limited systemic absorption.
Severe:
No specific adjustment recommended due to limited systemic absorption.
Dialysis:
No specific adjustment recommended due to limited systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment recommended due to limited systemic absorption.
Moderate:
No specific adjustment recommended due to limited systemic absorption.
Severe:
No specific adjustment recommended due to limited systemic absorption.
Pharmacology
Mechanism of Action
Hydrocortisone is a corticosteroid that acts locally to reduce inflammation, pruritus, and swelling associated with hemorrhoids and other anorectal conditions. It binds to glucocorticoid receptors in the cytoplasm, leading to a cascade of events that modulate gene expression. This results in the inhibition of prostaglandin and leukotriene synthesis, stabilization of lysosomal membranes, and suppression of leukocyte migration, thereby reducing inflammatory responses.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (systemic absorption is limited but can occur, especially with inflamed mucosa or prolonged use)
Tmax:
Not well-defined for local rectal effect; systemic Tmax for oral hydrocortisone is 1-2 hours.
FoodEffect:
Not applicable for rectal administration.
Distribution:
Vd:
Approximately 0.5-1.5 L/kg (for systemic hydrocortisone)
ProteinBinding:
Approximately 90% (primarily to corticosteroid-binding globulin and albumin)
CnssPenetration:
Limited (for systemically absorbed hydrocortisone)
Elimination:
HalfLife:
Approximately 1.5-2 hours (plasma half-life for systemic hydrocortisone); biological half-life is longer (8-12 hours)
Clearance:
Approximately 0.5-1 L/min (for systemic hydrocortisone)
ExcretionRoute:
Renal (primarily as inactive metabolites)
Unchanged:
<1% (systemically)
Pharmacodynamics
OnsetOfAction:
Within hours for symptomatic relief
PeakEffect:
Within 1-2 days of regular use
DurationOfAction:
Variable, typically 8-12 hours per dose for local effect
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: 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 adrenal gland problems: 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 don't go away, contact your doctor or seek medical help:
Burning or stinging
Dryness
* Tingling
This is not a comprehensive list of all 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 help right away:
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 adrenal gland problems: 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 don't go away, contact your doctor or seek medical help:
Burning or stinging
Dryness
* Tingling
This is not a comprehensive list of all 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.
- Signs of infection (e.g., pus, fever, severe redness, increased pain).
- Severe burning, irritation, or allergic reaction at the application site.
- Unusual swelling in ankles or feet, unexplained weight gain, increased thirst or urination (signs of systemic absorption, especially with prolonged use).
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 with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting 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 with your doctor.
Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins
It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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 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 what your doctor has prescribed, 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 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, discuss them with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to weigh the 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 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 what your doctor has prescribed, 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 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, discuss them with your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is crucial to weigh the 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:
- 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 (moon face, buffalo hump, central obesity), hyperglycemia, fluid retention, hypertension, and adrenal suppression.
What to Do:
If systemic symptoms of overdose occur, contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. Treatment is supportive and may involve gradual withdrawal of the medication if adrenal suppression is suspected.
Drug Interactions
Moderate Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): May increase systemic exposure to hydrocortisone, though less likely with rectal administration due to limited absorption.
- Non-steroidal anti-inflammatory drugs (NSAIDs): Increased risk of gastrointestinal ulceration/bleeding if significant systemic absorption occurs.
- Anticoagulants (e.g., warfarin): May alter anticoagulant effects if significant systemic absorption occurs.
- Diuretics (e.g., thiazide, loop diuretics): May enhance potassium depletion if significant systemic absorption occurs.
Monitoring
Baseline Monitoring
Symptom assessment (pain, itching, bleeding)
Rationale: To establish baseline severity and track treatment efficacy.
Timing: Prior to initiation of therapy.
Visual inspection of anorectal area
Rationale: To assess extent of inflammation, presence of fissures, or other lesions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom improvement
Frequency: Daily
Target: Reduction in pain, itching, bleeding
Action Threshold: Lack of improvement or worsening symptoms after 7 days; consider alternative diagnosis or treatment.
Local adverse reactions (e.g., irritation, burning, atrophy)
Frequency: Daily
Target: Absence of new or worsening local symptoms
Action Threshold: Development of severe irritation, burning, or signs of skin atrophy; discontinue use.
Signs of systemic corticosteroid absorption (e.g., fluid retention, hyperglycemia, Cushingoid features)
Frequency: Periodically, especially with prolonged use (>2 weeks) or large surface area application
Target: Absence of systemic effects
Action Threshold: Presence of systemic effects; discontinue or reduce frequency.
Symptom Monitoring
- Rectal pain
- Rectal itching
- Rectal bleeding
- Burning sensation at application site
- Irritation or redness around the anus
- Signs of infection (pus, fever)
- Unusual weight gain or swelling (signs of systemic absorption)
- Increased thirst or urination (signs of hyperglycemia from systemic absorption)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Systemic absorption from rectal administration is limited, but prolonged or high-dose use could lead to some systemic exposure.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though data for topical/rectal corticosteroids are limited.
Second Trimester:
Risk of fetal growth restriction or adrenal suppression with high systemic exposure.
Third Trimester:
Risk of fetal growth restriction or adrenal suppression with high systemic exposure; neonatal adrenal insufficiency is a theoretical risk if significant systemic absorption occurs near term.
Lactation
L3 (Moderately Safe). Hydrocortisone is excreted in breast milk in small amounts following systemic administration. Due to limited systemic absorption from rectal suppositories, the amount transferred to breast milk is expected to be very low and unlikely to cause adverse effects in a breastfed infant. Use with caution and monitor the infant for any signs of adverse effects.
Infant Risk:
Low risk of adverse effects due to minimal systemic absorption and low transfer into breast milk.
Pediatric Use
Use in children is generally not recommended for prolonged periods due to the potential for systemic absorption leading to growth retardation, adrenal suppression, and other corticosteroid-related adverse effects. If used, it should be under strict medical supervision and for the shortest duration possible.
Geriatric Use
No specific dose adjustments are typically required. Elderly patients may be more susceptible to the systemic side effects of corticosteroids if significant absorption occurs, particularly if they have pre-existing conditions like diabetes, osteoporosis, or hypertension. Monitor for these effects.
Clinical Information
Clinical Pearls
- Instruct patients on proper insertion technique: Lie on side, insert pointed end first, push in with finger, remain lying down for a few minutes.
- Emphasize that this medication is for local use only and should not be taken orally.
- Advise patients not to use for longer than 2 weeks unless specifically directed by a healthcare provider, to minimize risk of local skin atrophy or systemic effects.
- For best results, use after a bowel movement.
- Store suppositories in a cool place, as they may melt at room temperature.
Alternative Therapies
- Topical anesthetics (e.g., lidocaine, pramoxine)
- Astringents (e.g., witch hazel, zinc oxide)
- Protectants (e.g., petrolatum, mineral oil)
- Stool softeners (e.g., docusate sodium) for constipation-related hemorrhoids
- Dietary fiber supplements
Cost & Coverage
Average Cost:
Variable, typically $20-$100 per 12 suppositories
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (most insurance plans)
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.