Anusol-HC Suppositories 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
Jan 1975
DEA Schedule
Not Controlled
Overview
What is this medicine?
Anusol-HC suppositories contain hydrocortisone, a type of steroid medicine. It works by reducing swelling, itching, and discomfort caused by conditions like hemorrhoids or inflammation in the rectum. It's inserted into the rectum to work directly where it's needed.
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 wrapper and gently push the suppository into the rectum, pointed end first. Avoid excessive handling of the suppository. If it becomes soft, you can chill it in the refrigerator or run it under cold water to firm it up.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures and excessive heat. Keep all medications in a secure location, out of the reach of children and pets.
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 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 wrapper and gently push the suppository into the rectum, pointed end first. Avoid excessive handling of the suppository. If it becomes soft, you can chill it in the refrigerator or run it under cold water to firm it up.
Storage and Disposal
Store this medication at room temperature, avoiding freezing temperatures and excessive heat. Keep all medications in a secure location, out of the reach of children and pets.
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.
Lifestyle & Tips
- Maintain good bowel habits to avoid straining during defecation.
- Increase fiber intake and fluid intake to prevent constipation.
- Avoid prolonged sitting or standing.
- Practice good anal hygiene.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One suppository (25 mg) rectally 2 to 4 times daily, or as directed by physician.
Dose Range:
25 - 100 mg
Condition-Specific Dosing:
hemorrhoids:
One suppository (25 mg) rectally 2 to 4 times daily.
proctitis:
One suppository (25 mg) rectally 2 to 4 times daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established; use only if clearly needed and under strict medical supervision, typically lower doses and shorter duration.
Adolescent:
Not established; use only if clearly needed and under strict medical supervision, typically lower doses and shorter duration.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended due to low systemic absorption.
Moderate:
No specific adjustment recommended due to low systemic absorption.
Severe:
No specific adjustment recommended due to low systemic absorption.
Dialysis:
No specific adjustment recommended due to low systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment recommended due to low systemic absorption.
Moderate:
No specific adjustment recommended due to low systemic absorption.
Severe:
No specific adjustment recommended due to low systemic absorption.
Pharmacology
Mechanism of Action
Hydrocortisone is a corticosteroid that acts as an anti-inflammatory and antipruritic agent. It diffuses across cell membranes and binds to specific cytoplasmic receptors. These complexes then enter the nucleus, bind to DNA (chromatin), and stimulate the transcription of messenger RNA (mRNA) and subsequent protein synthesis of various enzymes thought to be responsible for the anti-inflammatory effects. It inhibits the release of hydrolytic enzymes from leukocytes, prevents the accumulation of macrophages at inflamed sites, interferes with the adhesion of leukocytes to capillary walls, reduces capillary permeability, and antagonizes the activity of histamine and kinin release. It also inhibits the synthesis of prostaglandins and leukotrienes by inhibiting phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (low systemic absorption from rectal route, typically <10% but can be higher with inflamed mucosa or prolonged use)
Tmax:
Not precisely defined for rectal route due to local action and variable systemic absorption.
FoodEffect:
Not applicable for rectal administration.
Distribution:
Vd:
Approximately 0.5-1.5 L/kg (for systemic hydrocortisone, less relevant for local rectal use)
ProteinBinding:
Approximately 90% (primarily to corticosteroid-binding globulin and albumin)
CnssPenetration:
Limited (systemic absorption is low from rectal route)
Elimination:
HalfLife:
Approximately 1.5-2 hours (systemic, but local duration of action is longer)
Clearance:
Approximately 0.5-0.8 L/hr/kg (systemic)
ExcretionRoute:
Renal (primarily as inactive metabolites)
Unchanged:
<1% (systemic)
Pharmacodynamics
OnsetOfAction:
Within hours (for local anti-inflammatory effect)
PeakEffect:
Variable, depends on severity of inflammation and individual response.
DurationOfAction:
Several hours (local effect)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ More sputum or change in color of sputum
+ Pain with passing urine
+ Mouth sores
+ Wound that will not heal
Changes in eyesight
Severe headache
Irritation at the site of application
Severe bleeding from the rectum or rectal pain
Unexplained bruising or bleeding
Swelling
Bone or joint pain
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only 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 or seek medical help:
Burning or stinging
Dryness
* Tingling
This is not an exhaustive list of 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 help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Passing urine more often
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or passing out
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, including:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ More sputum or change in color of sputum
+ Pain with passing urine
+ Mouth sores
+ Wound that will not heal
Changes in eyesight
Severe headache
Irritation at the site of application
Severe bleeding from the rectum or rectal pain
Unexplained bruising or bleeding
Swelling
Bone or joint pain
Skin changes, including:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Thinning of the skin
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only 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 or seek medical help:
Burning or stinging
Dryness
* Tingling
This is not an exhaustive list of 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 rectal pain or bleeding
- Signs of infection (fever, pus, severe pain)
- Severe burning, itching, or irritation at the application site
- Any signs of systemic steroid effects (e.g., unusual weight gain, swelling in ankles/feet, increased thirst/urination, muscle weakness, mood changes) - though rare with rectal 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 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 list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure safe treatment, inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the 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 list is not exhaustive, and it is crucial to discuss all your health problems and medications with your doctor.
To ensure safe treatment, inform your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems
Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Regular monitoring is crucial, so be sure to undergo blood tests and bone density checks as directed by your doctor. If you are using this medication long-term, you should also have your eye pressure checked periodically. 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 the risk of certain side effects may be higher in this age group. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks. Consult your doctor to discuss the potential effects on growth and the need for monitoring.
Note that some formulations of this medication may not be suitable for all age groups of children. If you have any questions or concerns, consult your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the 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, you should also have your eye pressure checked periodically. 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 the risk of certain side effects may be higher in this age group. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks. Consult your doctor to discuss the potential effects on growth and the need for monitoring.
Note that some formulations of this medication may not be suitable for all age groups of children. If you have any questions or concerns, consult your doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the benefits and risks of using this medication to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Acute overdose is unlikely due to low systemic absorption.
- Chronic overuse or use on damaged mucosa may lead to systemic corticosteroid effects such as Cushing's syndrome, adrenal suppression, hyperglycemia, fluid retention.
What to Do:
Discontinue use. Symptomatic and supportive treatment. For suspected systemic effects, consult a healthcare professional immediately. Call 1-800-222-1222 for poison control.
Drug Interactions
Moderate Interactions
- CYP3A4 inhibitors (e.g., ritonavir, cobicistat, ketoconazole, itraconazole): May increase systemic exposure to hydrocortisone, potentially leading to systemic corticosteroid effects, though less likely with rectal administration due to low absorption.
Monitoring
Baseline Monitoring
Assessment of anorectal symptoms (pain, itching, inflammation)
Rationale: To establish baseline severity and guide treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Resolution of anorectal symptoms
Frequency: Daily
Target: Reduction or elimination of pain, itching, inflammation.
Action Threshold: If symptoms worsen or do not improve within 7 days, re-evaluate diagnosis and treatment.
Signs of local irritation (burning, itching, dryness)
Frequency: Daily
Target: Absence of new or worsening irritation.
Action Threshold: If severe or persistent, discontinue use and consult physician.
Signs of systemic corticosteroid effects (e.g., fluid retention, hyperglycemia, adrenal suppression)
Frequency: Periodically, especially with prolonged or high-dose use, or in patients with compromised skin barrier.
Target: Absence of systemic effects.
Action Threshold: If present, discontinue use and manage symptoms; consider alternative therapy.
Symptom Monitoring
- Rectal pain
- Rectal itching
- Rectal bleeding
- Inflammation/swelling
- Burning sensation at application site
- Dryness at application site
- Skin atrophy (with prolonged use)
- Signs of infection (if underlying condition worsens)
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Systemic absorption is low, but prolonged or high-dose use could lead to systemic effects.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though risk is low with topical/rectal use.
Second Trimester:
Potential for fetal growth restriction or adrenal suppression with high systemic exposure.
Third Trimester:
Potential for fetal growth restriction or adrenal suppression with high systemic exposure; neonatal adrenal insufficiency if used close to term.
Lactation
Hydrocortisone is excreted in breast milk following systemic administration. While systemic absorption from rectal suppositories is low, caution should be exercised. L3 (Moderately Safe). Monitor infant for adverse effects.
Infant Risk:
Low risk of adverse effects to the infant due to low systemic absorption by the mother, but theoretical risk of growth suppression or other corticosteroid effects with prolonged or high-dose maternal use. Monitor infant for unusual weight gain or developmental changes.
Pediatric Use
Safety and efficacy not established in children. Use only if clearly needed and under strict medical supervision, typically with lower doses and shorter duration due to increased risk of systemic absorption and adrenal suppression in infants and children.
Geriatric Use
No specific dosage adjustments are generally needed. Elderly patients may be more susceptible to systemic adverse effects if significant absorption occurs, due to age-related thinning of skin/mucosa or comorbidities. Use with caution and monitor for adverse effects.
Clinical Information
Clinical Pearls
- Anusol-HC suppositories are for rectal use only; do not take by mouth.
- Wash hands thoroughly before and after use.
- Remove the wrapper before inserting the suppository.
- Lie on your side with one leg straight and the other bent toward your chest. Gently insert the suppository pointed end first into the rectum.
- Try to remain lying down for a few minutes after insertion to allow the suppository to melt and spread.
- Do not use for more than 7 days unless directed by a physician.
- Prolonged use, especially in children or on damaged mucosa, can lead to systemic absorption and adverse effects like adrenal suppression.
- If symptoms do not improve within 7 days or worsen, consult a healthcare provider to re-evaluate the condition.
Alternative Therapies
- Topical anesthetics (e.g., lidocaine, pramoxine) for symptomatic relief
- Astringents (e.g., witch hazel, zinc oxide) for soothing and drying effects
- Stool softeners/laxatives to prevent straining
- Surgical intervention for severe hemorrhoids
Cost & Coverage
Average Cost:
Varies, typically $50-$150 per 12 suppositories
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (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 this 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, including the amount taken and the time it happened, to ensure you receive the best possible care.