Anucort-HC 25mg Rectal Supp

Manufacturer G & W Active Ingredient Hydrocortisone Rectal Suppositories(hye droe KOR ti sone) Pronunciation Hye-droe-KOR-ti-sone
It is used to treat signs of hemorrhoids or rectal irritation.
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Drug Class
Anti-inflammatory agent; Corticosteroid
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Anucort-HC contains hydrocortisone, a type of steroid medicine. It works by reducing swelling, itching, and discomfort caused by conditions like hemorrhoids or inflammation in the rectum.
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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 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 administer the rectal suppository, remove the foil wrapper and insert it into the rectum with the 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.

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.
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Lifestyle & Tips

  • Maintain good bowel habits to avoid straining.
  • Increase fiber and fluid intake.
  • Avoid prolonged sitting or standing.
  • Practice good anal hygiene.

Dosing & Administration

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Adult Dosing

Standard Dose: One 25 mg suppository rectally 2-3 times daily, or as directed by physician.
Dose Range: 25 - 75 mg

Condition-Specific Dosing:

hemorrhoids: One 25 mg suppository rectally 2-3 times daily.
proctitis: One 25 mg suppository rectally 2-3 times daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not generally recommended without specific medical guidance due to potential for systemic effects and increased susceptibility.
Adolescent: Not generally recommended without specific medical guidance due to potential for systemic effects and increased susceptibility.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (limited systemic absorption).
Moderate: No adjustment needed (limited systemic absorption).
Severe: No adjustment needed (limited systemic absorption).
Dialysis: No specific considerations (limited systemic absorption).

Hepatic Impairment:

Mild: No adjustment needed (limited systemic absorption).
Moderate: No adjustment needed (limited systemic absorption).
Severe: No adjustment needed (limited systemic absorption).

Pharmacology

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Mechanism of Action

Hydrocortisone is a corticosteroid that diffuses across cell membranes and binds to specific cytoplasmic receptors. These complexes then enter the nucleus, bind to DNA, and modify gene expression. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines). Locally, it reduces inflammation, pruritus, and swelling associated with anorectal conditions.
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Pharmacokinetics

Absorption:

Bioavailability: Highly variable, generally low (e.g., 5-20% systemically) from rectal mucosa; can increase with inflamed or denuded mucosa.
Tmax: Variable, typically within 1-2 hours if systemically absorbed.
FoodEffect: Not applicable for rectal administration.

Distribution:

Vd: Approximately 0.5-1.5 L/kg (if systemically absorbed).
ProteinBinding: Approximately 90% (primarily to corticosteroid-binding globulin and albumin).
CnssPenetration: Limited with rectal administration.

Elimination:

HalfLife: Approximately 1.5-2 hours (plasma half-life); biological half-life is longer (8-12 hours).
Clearance: Rapid.
ExcretionRoute: Primarily renal (as inactive metabolites).
Unchanged: Minimal.
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Pharmacodynamics

OnsetOfAction: Within hours for local anti-inflammatory effect.
PeakEffect: Variable, typically within 1-2 days of consistent use.
DurationOfAction: Effects persist for several hours after administration.

Safety & Warnings

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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, 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 may cause side effects in some people. While many individuals may not experience any side effects or only minor ones, it's essential to contact your doctor or seek medical help if you notice any of the following:

Burning or stinging
Dryness
* Tingling

If you experience any of these side effects or any other unusual symptoms that bother you or do not go away, consult your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Worsening rectal pain or bleeding
  • Signs of infection (e.g., fever, pus)
  • Severe irritation or burning at the application site
  • Signs of systemic steroid effects (e.g., unusual weight gain, swelling in ankles/feet, increased thirst/urination, mood changes - rare but possible with prolonged use or high absorption).
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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 and medications with your doctor.

To ensure safe treatment, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* All your health problems

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe for you to do so.
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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 have your blood work and bone density checked 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 infection, 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 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 may affect growth in children and teenagers, necessitating regular growth checks. Consult your doctor about 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 questions or concerns, discuss them with 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 outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Fluid retention
  • High blood pressure
  • Muscle weakness
  • Hyperglycemia
  • Cushingoid features (with prolonged, significant systemic absorption)

What to Do:

Discontinue use, provide supportive care. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Moderate Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) - theoretical increase in systemic hydrocortisone levels if significant absorption occurs.
  • Anticoagulants (e.g., warfarin) - theoretical alteration of anticoagulant effects.
  • NSAIDs - theoretical increased risk of GI ulceration if significant systemic absorption occurs.
  • Potassium-depleting diuretics (e.g., thiazides, loop diuretics) - theoretical increased risk of hypokalemia if significant systemic absorption occurs.

Monitoring

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Baseline Monitoring

Anorectal examination

Rationale: To assess the extent and nature of the condition (e.g., hemorrhoids, proctitis) and rule out other pathologies.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Symptom improvement (e.g., reduction in pain, itching, inflammation, bleeding)

Frequency: Daily

Target: Gradual reduction in symptoms.

Action Threshold: If symptoms worsen or do not improve within 7 days, re-evaluate diagnosis.

Local adverse reactions (e.g., burning, itching, irritation, atrophy)

Frequency: Daily

Target: Absence of new or worsening local reactions.

Action Threshold: Discontinue if severe irritation or signs of atrophy occur.

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Symptom Monitoring

  • Rectal bleeding
  • Rectal pain
  • Rectal itching
  • Burning sensation at application site
  • Irritation at application site
  • Signs of infection (e.g., fever, pus)
  • Signs of systemic corticosteroid absorption (e.g., fluid retention, hyperglycemia, mood changes - rare with rectal use)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Limited systemic absorption reduces risk, but caution is advised.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of oral clefts with systemic corticosteroids, but risk with rectal hydrocortisone is considered low due to limited absorption.
Second Trimester: Generally considered safer than first trimester, but still use with caution.
Third Trimester: Potential for fetal growth restriction or adrenal suppression with prolonged, high-dose systemic use; risk is low with rectal hydrocortisone due to limited absorption.
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Lactation

L3. Hydrocortisone is excreted in breast milk systemically. While rectal absorption is limited, caution is advised. Use lowest effective dose for shortest duration.

Infant Risk: Low risk of adverse effects to the infant due to limited systemic absorption and low levels in breast milk. Monitor infant for signs of adrenal suppression (e.g., poor weight gain) or other corticosteroid effects, though highly unlikely.
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Pediatric Use

Use with caution. Children may be more susceptible to systemic absorption and adverse effects (e.g., growth retardation, Cushing's syndrome) due to a larger skin surface area to body weight ratio. Not recommended for routine use without specific medical guidance.

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Geriatric Use

No specific dose adjustments 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. Monitor for signs of systemic effects.

Clinical Information

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Clinical Pearls

  • For rectal suppositories, ensure proper insertion technique: remove wrapper, moisten suppository with water, insert pointed end first gently past the anal sphincter.
  • Lie down for 15-20 minutes after insertion to prevent expulsion.
  • Wash hands thoroughly before and after use.
  • Do not use for more than 7 days unless directed by a physician, as prolonged use can lead to local atrophy or systemic effects.
  • Not for use in the presence of fungal, viral, or bacterial infections of the anorectal area without appropriate concomitant antimicrobial therapy.
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Alternative Therapies

  • Other topical agents for hemorrhoids (e.g., phenylephrine, witch hazel, zinc oxide)
  • Stool softeners
  • Fiber supplements
  • Sitz baths
  • Surgical interventions for severe cases
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Cost & Coverage

Average Cost: $50-$100 per 12 suppositories (25mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic); Tier 2 or 3 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.