Proctosol HC 2.5% Rectal Cream
It is used to treat signs of hemorrhoids or rectal irritation.
Drug Class
Corticosteroid, Anti-inflammatory
Pharmacologic Class
Glucocorticoid receptor agonist
Pregnancy Category
C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydrocortisone rectal cream is a type of steroid medicine that helps reduce swelling, itching, and discomfort caused by conditions like hemorrhoids or inflammation in the rectal area. It works by calming down the body's natural response to irritation.
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.
Continue using 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 have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses to 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. It can also be applied to the skin around the anus as directed.
Continue using 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 have access to drug take-back programs in your area.
Missing a Dose
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Wash hands thoroughly before and after applying the cream.
- Clean the affected area gently before application.
- For external use, apply a small amount to the affected area.
- For internal use, use the provided applicator and follow instructions carefully.
- Do not use for longer than 7 days unless directed by a doctor.
- Avoid tight-fitting clothing that may irritate the area.
- Maintain good hygiene in the anal area.
- Increase fiber and fluid intake to prevent constipation and straining during bowel movements, which can worsen hemorrhoids.
Available Forms & Alternatives
Available Strengths:
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 externally or insert rectally using applicator 2 to 4 times daily, especially after bowel movements.
proctitis:
Insert rectally using applicator 2 to 4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established, use with extreme caution due to potential for systemic absorption and adrenal suppression.
Child:
Not established, use with extreme caution due to potential for systemic absorption and adrenal suppression. If used, limit duration and amount.
Adolescent:
Similar to adult dosing, but limit duration and amount to minimize systemic absorption.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required due to minimal systemic absorption.
Moderate:
No specific adjustment required due to minimal systemic absorption.
Severe:
No specific adjustment required due to minimal systemic absorption.
Dialysis:
No specific adjustment required due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment required due to minimal systemic absorption.
Moderate:
No specific adjustment required due to minimal systemic absorption.
Severe:
No specific adjustment required due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Hydrocortisone is a corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive actions. It acts by inducing phospholipase A2 inhibitory proteins, lipocortins, which control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (typically <5%) through intact skin/mucosa; however, absorption can increase with inflammation, prolonged use, or large surface areas.
Tmax:
Not well-defined for topical/rectal application due to local action and minimal systemic absorption.
FoodEffect:
Not applicable for rectal cream.
Distribution:
Vd:
Not well-defined for topical/rectal application due to minimal systemic absorption.
ProteinBinding:
Approximately 90% (if systemically absorbed, primarily to transcortin and albumin).
CnssPenetration:
Limited (if systemically absorbed).
Elimination:
HalfLife:
Approximately 1.5-2 hours (systemic, if absorbed).
Clearance:
Not well-defined for topical/rectal application.
ExcretionRoute:
Renal (metabolites).
Unchanged:
<1% (systemic, if absorbed).
Pharmacodynamics
OnsetOfAction:
Within hours for local anti-inflammatory and antipruritic effects.
PeakEffect:
Not precisely defined for local effect; continuous with application.
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 or seek medical attention immediately:
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
Change in eyesight
Severe headache
Irritation where the medication was applied
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. Many people may not experience any side effects or only have minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Burning or stinging
Dryness
* Tingling
This is not a complete list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, 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
Change in eyesight
Severe headache
Irritation where the medication was applied
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. Many people may not experience any side effects or only have minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Burning or stinging
Dryness
* Tingling
This is not a complete list of all possible side effects. If you have questions or concerns about side effects, contact 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 symptoms or no improvement after 7 days.
- Increased pain, burning, or irritation at the application site.
- Signs of infection (e.g., pus, fever, severe redness).
- Rectal bleeding that is new, heavy, or persistent.
- Any signs of systemic side effects (e.g., unusual weight gain, swelling in ankles/feet, increased thirst/urination, unusual fatigue), though rare.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Bowel blockage
+ Fistula
+ Fungal infection
+ Holes, sores, or wounds in the rectal area
+ Peritonitis (inflammation of the lining of the abdominal cavity)
+ Recent bowel surgery
Please note that this is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your:
Medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins
Health problems
with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify 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 symptoms you experienced.
Certain health conditions, including:
+ Bowel blockage
+ Fistula
+ Fungal infection
+ Holes, sores, or wounds in the rectal area
+ Peritonitis (inflammation of the lining of the abdominal cavity)
+ Recent bowel surgery
Please note that this is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your:
Medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins
Health problems
with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify 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 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, 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, so 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, as it is essential to weigh the benefits and risks of using this medication 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, 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 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, 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, so 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, as it is essential to weigh the benefits and risks of using this medication to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Prolonged or excessive use, especially over large areas or broken skin, can lead to systemic absorption and symptoms of Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, thin skin, easy bruising, muscle weakness).
- Adrenal suppression (fatigue, weakness, nausea, vomiting, low blood pressure) can occur with chronic misuse.
What to Do:
Discontinue use and seek medical attention. Symptomatic and supportive treatment. For acute ingestion, call a Poison Control Center (1-800-222-1222) or emergency services immediately, though oral overdose is unlikely with a rectal cream.
Drug Interactions
Monitoring
Baseline Monitoring
Assessment of affected area
Rationale: To establish baseline severity of inflammation, pruritus, or pain.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in symptoms)
Frequency: Daily to weekly, depending on severity.
Target: Symptom resolution or significant improvement.
Action Threshold: Lack of improvement after 7 days, worsening symptoms, or development of new symptoms.
Local adverse reactions (e.g., irritation, burning, atrophy)
Frequency: Daily.
Target: Absence of adverse reactions.
Action Threshold: Presence of significant irritation, burning, or signs of skin/mucosal atrophy.
Signs of infection
Frequency: Daily.
Target: Absence of redness, pus, fever.
Action Threshold: Development of signs of infection; discontinue use and treat infection.
Signs of systemic absorption (rare, with prolonged/excessive use)
Frequency: Periodically, especially with prolonged use or in children.
Target: Absence of Cushing's syndrome features, growth retardation (in children), or adrenal suppression.
Action Threshold: Any suspicion of systemic effects; consider discontinuation and medical evaluation.
Symptom Monitoring
- Rectal pain
- Itching
- Inflammation
- Bleeding (if related to hemorrhoids)
- Burning sensation at application site
- Irritation
- Signs of infection (e.g., pus, fever, increased pain)
- Unusual fatigue or weakness (rare, signs of systemic absorption)
- Weight gain or swelling (rare, signs of systemic absorption)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Category C. Avoid prolonged use or large amounts.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity with high doses of systemic corticosteroids; risk with topical/rectal is low due to minimal absorption but caution advised.
Second Trimester:
Low risk with appropriate use; monitor for fetal growth if prolonged/high dose use.
Third Trimester:
Low risk with appropriate use; monitor for fetal growth if prolonged/high dose use.
Lactation
Use with caution. It is not known whether topically administered corticosteroids are excreted in human milk. Systemic corticosteroids are excreted in human milk and could potentially cause adverse effects in the infant. Minimize exposure to the infant.
Infant Risk:
Low risk with short-term, limited use due to minimal systemic absorption. Avoid applying to areas where the infant might ingest it.
Pediatric Use
Use with extreme caution. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (e.g., HPA axis suppression, Cushing's syndrome, growth retardation) than adults. Limit duration of therapy and amount applied. Not recommended for prolonged use.
Geriatric Use
No specific dosage adjustments are generally required. However, elderly patients may have thinner skin, which could potentially increase absorption, though this is less of a concern with rectal application. Monitor for local adverse effects and efficacy.
Clinical Information
Clinical Pearls
- Instruct patients on proper application technique, especially when using the applicator for internal use.
- Emphasize that this is for short-term use (typically up to 7 days) unless otherwise directed by a healthcare professional, to minimize risk of local and systemic side effects.
- Advise patients to seek medical attention if symptoms do not improve or worsen, or if new symptoms like bleeding or signs of infection appear.
- Remind patients that while effective for symptom relief, it does not cure the underlying cause of hemorrhoids or proctitis; lifestyle modifications (e.g., fiber, fluids) are crucial for long-term management.
Alternative Therapies
- Topical anesthetics (e.g., lidocaine, benzocaine)
- Astringents (e.g., witch hazel, zinc oxide)
- Protectants (e.g., petrolatum, mineral oil)
- Stool softeners (for hemorrhoids)
- Dietary fiber supplements (for hemorrhoids)
- Sitz baths
Cost & Coverage
Average Cost:
$15 - $50 per 30g tube of 2.5% cream
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. 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 details about the medication taken, the amount, and the time it happened.