Hydrocortisone 1% Rectal Crm 28.4gm
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
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydrocortisone rectal cream is a type of steroid medicine applied to the rectum or around the anus. It works by reducing swelling, itching, and discomfort caused by conditions like hemorrhoids or inflammation in the rectal area.
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. It can also be applied to the skin around the anus as directed.
Use the 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.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing. Keep all medications in a secure 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 disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Managing Missed Doses
If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Avoid using two doses at the same time or taking extra doses.
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. It can also be applied to the skin around the anus as directed.
Use the 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.
Storing and Disposing of Your Medication
Store the medication at room temperature, avoiding freezing. Keep all medications in a secure 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 disposing of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Managing Missed Doses
If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Avoid using two doses at the same time or taking extra doses.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the cream.
- Clean the affected area gently before application.
- For external use, apply a thin layer to the affected skin around the anus.
- For internal use, attach the applicator tip to the tube and gently insert it into the rectum. Squeeze the tube to apply the cream, then remove the applicator and clean it thoroughly with warm water and soap.
- Do not use for longer than prescribed by your doctor, usually no more than 7 days, unless directed otherwise.
- Avoid tight-fitting clothing that may irritate the area.
- Maintain good hygiene to prevent infection.
- Increase fiber and fluid intake to prevent constipation, which can worsen hemorrhoids.
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.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
hemorrhoids:
Apply a small amount to the perianal area and/or insert rectally using an applicator tip, 2 to 4 times daily.
proctitis:
Apply a small amount to the affected area 2 to 4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established, use with caution and under medical supervision due to potential for systemic absorption and adrenal suppression.
Child:
Not established, use with caution and under medical supervision due to potential for systemic absorption and adrenal suppression. Dosing should be individualized and for the shortest duration possible.
Adolescent:
Similar to adult dosing, but use with caution and for the shortest duration possible.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed due to low systemic absorption.
Moderate:
No adjustment typically needed due to low systemic absorption.
Severe:
No adjustment typically needed due to low systemic absorption.
Dialysis:
No specific considerations for rectal application due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment typically needed due to low systemic absorption.
Moderate:
No adjustment typically needed due to low systemic absorption.
Severe:
No adjustment typically needed due to low systemic absorption.
Pharmacology
Mechanism of Action
Hydrocortisone is a corticosteroid that acts by binding to glucocorticoid receptors in the cytoplasm of target cells. This complex then translocates to the nucleus, where it 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). This results in reduced inflammation, pruritus, and vasoconstriction.
Pharmacokinetics
Absorption:
Bioavailability:
Variable; generally low (approximately 1-5% systemically absorbed from intact skin, but can be higher from inflamed or denuded rectal mucosa).
Tmax:
Not well-defined for rectal cream; systemic absorption is slow and variable.
FoodEffect:
Not applicable for rectal administration.
Distribution:
Vd:
Not well-defined for rectal cream; for systemically absorbed hydrocortisone, Vd is approximately 0.2-0.4 L/kg.
ProteinBinding:
Approximately 90% (primarily to corticosteroid-binding globulin and albumin) for systemically absorbed hydrocortisone.
CnssPenetration:
Limited (for systemically absorbed hydrocortisone, crosses BBB to some extent).
Elimination:
HalfLife:
Approximately 1.5-2 hours (for systemically absorbed hydrocortisone).
Clearance:
Approximately 0.5-0.8 L/hr/kg (for systemically absorbed hydrocortisone).
ExcretionRoute:
Primarily renal (as inactive metabolites and a small amount of unchanged drug).
Unchanged:
Less than 10% (for systemically absorbed hydrocortisone).
Pharmacodynamics
OnsetOfAction:
Within hours for local anti-inflammatory effect.
PeakEffect:
Not precisely defined for local effect; symptomatic relief typically within days.
DurationOfAction:
Several hours per application.
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, 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, 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:
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, 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, 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:
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.
- Signs of infection (e.g., pus, fever, increased redness or warmth).
- Severe burning, stinging, or irritation after application.
- Any signs of systemic steroid effects, such as unusual weight gain, swelling in the face or ankles, increased thirst or urination, or muscle weakness (rare with rectal cream but possible with prolonged or excessive 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
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to discuss all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or change the dosage 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
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to discuss all of your:
Prescription and over-the-counter (OTC) medications
Natural products
Vitamins
Health problems
with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or change the dosage 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, discuss the need for regular eye pressure 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 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), inform your doctor, as this medication may cause an increase in blood sugar levels. Monitor your blood sugar levels as instructed by your doctor.
Before using any other medications or products in the rectal area, consult your doctor. Avoid applying this medication to cuts, scrapes, or damaged skin, as it 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, so discuss this potential risk 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 may affect growth in children and teenagers, making regular growth checks necessary. Consult your doctor to determine the appropriate dosage and monitoring schedule for your child. Note that some formulations of this medication may not be suitable for all age groups, so consult your doctor if you have any questions.
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 ensure the best possible outcome for 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 infections, 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), inform your doctor, as this medication may cause an increase in blood sugar levels. Monitor your blood sugar levels as instructed by your doctor.
Before using any other medications or products in the rectal area, consult your doctor. Avoid applying this medication to cuts, scrapes, or damaged skin, as it 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, so discuss this potential risk 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 may affect growth in children and teenagers, making regular growth checks necessary. Consult your doctor to determine the appropriate dosage and monitoring schedule for your child. Note that some formulations of this medication may not be suitable for all age groups, so consult your doctor if you have any questions.
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 ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose with rectal hydrocortisone cream is unlikely due to low systemic absorption.
- Chronic excessive use may lead to systemic corticosteroid effects, including Cushing's syndrome (e.g., moon face, buffalo hump, central obesity), adrenal suppression, hyperglycemia, hypertension, and growth retardation in children.
What to Do:
If you suspect an overdose or experience systemic symptoms, discontinue use and contact your doctor or poison control center immediately. For the US, call 1-800-222-1222. Treatment is supportive and symptomatic.
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of rectal/perianal symptoms (e.g., pain, itching, bleeding, inflammation)
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Symptom improvement (e.g., reduction in pain, itching, inflammation)
Frequency: Daily to weekly, based on patient report.
Target: Significant reduction or resolution of symptoms.
Action Threshold: Lack of improvement or worsening of symptoms after 7 days may indicate need for re-evaluation or alternative therapy.
Local adverse reactions (e.g., irritation, burning, atrophy, secondary infection)
Frequency: Daily, during application.
Target: Absence of new or worsening local symptoms.
Action Threshold: Development of new or worsening local irritation, signs of infection, or skin changes (e.g., thinning) warrants discontinuation and medical evaluation.
Signs of systemic corticosteroid effects (e.g., weight gain, moon face, edema, hyperglycemia, adrenal suppression)
Frequency: Periodically, especially with prolonged use or in pediatric patients.
Target: Absence of systemic effects.
Action Threshold: Any signs of systemic absorption warrant immediate medical evaluation and discontinuation.
Symptom Monitoring
- Rectal pain
- Rectal itching
- Rectal bleeding
- Inflammation/swelling in the perianal area
- Burning sensation
- Irritation
- Signs of infection (e.g., pus, fever)
- Changes in skin appearance (e.g., thinning, discoloration)
Special Patient Groups
Pregnancy
Hydrocortisone is Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is generally low, but prolonged or extensive use should be avoided.
Trimester-Specific Risks:
First Trimester:
Limited data; theoretical risk of teratogenicity with high systemic doses, but unlikely with topical/rectal use.
Second Trimester:
Generally considered safer than first trimester, but still use with caution.
Third Trimester:
No specific risks identified for topical/rectal use, but monitor for signs of systemic absorption.
Lactation
Hydrocortisone is considered L3 (Moderately Safe) for lactation. Minimal amounts are expected to be excreted into breast milk due to low systemic absorption. Use with caution, and apply to the affected area only, avoiding application to the breast area.
Infant Risk:
Low risk of adverse effects in breastfed infants due to minimal systemic absorption by the mother.
Pediatric Use
Use with extreme caution in pediatric patients, especially infants and young children, as they may absorb proportionally larger amounts of topical corticosteroids and are therefore more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, growth retardation). Use the smallest effective dose for the shortest possible duration. Close monitoring for systemic effects is crucial.
Geriatric Use
No specific dose adjustments are typically needed. Elderly patients may have thinner skin, which could theoretically increase absorption, but generally, the safety profile is similar to younger adults. Use with caution if co-morbidities that could be exacerbated by systemic corticosteroids are present, although systemic absorption is minimal.
Clinical Information
Clinical Pearls
- This cream is for external and rectal use only; do not take by mouth.
- Do not use for more than 7 consecutive days unless specifically directed by a healthcare provider, as prolonged use can lead to local side effects (e.g., skin thinning) or, rarely, systemic absorption.
- If symptoms do not improve within 7 days, or if they worsen, consult a doctor.
- Proper hygiene and dietary changes (e.g., increased fiber, fluids) are important adjuncts for managing hemorrhoids.
- Clean the applicator thoroughly after each use to prevent infection.
Alternative Therapies
- Other topical corticosteroids (e.g., fluocinolone rectal foam)
- Local anesthetics (e.g., lidocaine, pramoxine)
- Astringents (e.g., witch hazel)
- Protectants (e.g., zinc oxide, petrolatum)
- Sitz baths
- Dietary modifications (fiber supplements, stool softeners)
- Surgical interventions for severe hemorrhoids
Cost & Coverage
Average Cost:
$20 - $60 per 28.4gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 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.