Anucort-HC 25mg Rectal Supp 24s

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
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Pharmacologic Class
Corticosteroid, Glucocorticoid
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Pregnancy Category
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?

Hydrocortisone rectal suppositories are a type of steroid medicine used to reduce swelling, itching, and discomfort caused by conditions like hemorrhoids or inflammation in the rectum (proctitis). It works by calming down the body's immune response in the affected area.
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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 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, away from heat sources. Do not freeze the medication. 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.
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Lifestyle & Tips

  • Maintain good anal hygiene.
  • Avoid straining during bowel movements.
  • Increase fiber intake and fluid consumption to prevent constipation.
  • Avoid prolonged sitting or standing.
  • Do not use for longer than prescribed without consulting a doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: One 25 mg suppository rectally, 2 times daily (morning and night) for 2 weeks, or as directed by physician.
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Not established
Child: Not established (use with caution, risk of systemic absorption and growth suppression)
Adolescent: Not established (use with caution, risk of systemic absorption and growth suppression)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment typically needed due to minimal systemic absorption.
Moderate: No adjustment typically needed due to minimal systemic absorption.
Severe: No adjustment typically needed due to minimal systemic absorption.
Dialysis: No specific considerations for rectal administration due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment typically needed due to minimal systemic absorption.
Moderate: No adjustment typically needed due to minimal systemic absorption.
Severe: No adjustment typically needed due to minimal systemic absorption.
Confidence: Medium

Pharmacology

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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.
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Pharmacokinetics

Absorption:

Bioavailability: Variable, generally low (5-20%) after rectal administration, but can increase with inflamed mucosa or prolonged use.
Tmax: Not well-defined for rectal administration; local effect is primary.
FoodEffect: Not relevant for rectal administration.

Distribution:

Vd: Approximately 0.5 L/kg (systemic hydrocortisone)
ProteinBinding: Approximately 90% (primarily to corticosteroid-binding globulin and albumin) for systemic hydrocortisone.
CnssPenetration: Limited for rectal administration; systemic absorption can lead to some CNS penetration.

Elimination:

HalfLife: Approximately 1.5-2 hours (systemic hydrocortisone); biological half-life is longer (8-12 hours).
Clearance: Approximately 10 mL/min/kg (systemic hydrocortisone).
ExcretionRoute: Renal (primarily as inactive metabolites).
Unchanged: <1% (systemic hydrocortisone).
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Pharmacodynamics

OnsetOfAction: Within hours for local anti-inflammatory effect.
PeakEffect: Within 1-2 days of consistent use.
DurationOfAction: Local effect persists for several hours; systemic effects, if any, are short-lived.
Confidence: Medium

Safety & Warnings

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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
Changes in eyesight
Severe headache
Irritation at the site of application
Severe rectal bleeding 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 may only have mild 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 attention:

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, 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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening rectal pain, bleeding, or itching.
  • Signs of infection (e.g., fever, pus, severe pain).
  • New or unusual side effects (e.g., skin thinning, irritation at application site).
  • Signs of systemic absorption (e.g., unexplained weight gain, swelling, increased thirst/urination, mood changes, fatigue).
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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 and its symptoms.
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 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 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 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 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 potential benefits and risks of using this medication to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Unlikely with acute rectal overdose due to limited systemic absorption.
  • Chronic overuse or high doses may lead to systemic corticosteroid effects such as Cushing's syndrome, adrenal suppression, hyperglycemia, fluid retention, and electrolyte imbalances.

What to Do:

Discontinue use and seek medical attention. Symptomatic and supportive treatment. For accidental ingestion, call Poison Control at 1-800-222-1222.

Drug Interactions

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Moderate Interactions

  • Drugs that induce CYP3A4 (e.g., rifampin, phenytoin, barbiturates): May decrease systemic hydrocortisone levels if significant absorption occurs.
  • Drugs that inhibit CYP3A4 (e.g., ketoconazole, ritonavir): May increase systemic hydrocortisone levels if significant absorption occurs.
  • Anticoagulants (e.g., warfarin): Corticosteroids may alter anticoagulant effects; monitor INR if systemic absorption is significant.
  • NSAIDs: Concomitant use may increase risk of GI ulceration if systemic absorption is significant.

Monitoring

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Baseline Monitoring

Assessment of rectal symptoms (pain, itching, bleeding, inflammation)

Rationale: To establish baseline severity and guide treatment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

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

Frequency: Daily/Weekly

Target: Significant reduction or resolution of symptoms.

Action Threshold: Lack of improvement or worsening symptoms after 7 days; consider re-evaluation by physician.

Signs of local irritation or infection

Frequency: Daily

Target: Absence of new or worsening irritation, redness, or discharge.

Action Threshold: Development of new or worsening irritation, signs of infection (e.g., pus, fever); discontinue and consult physician.

Signs of systemic corticosteroid effects (rare with rectal use)

Frequency: Periodically, especially with prolonged use or high doses

Target: Absence of Cushingoid features, hyperglycemia, adrenal suppression.

Action Threshold: Development of systemic symptoms (e.g., unexplained weight gain, swelling, mood changes, fatigue); consult physician.

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Symptom Monitoring

  • Rectal pain
  • Rectal itching
  • Rectal bleeding
  • Rectal inflammation/swelling
  • Signs of infection (e.g., fever, pus, increased pain)
  • Signs of systemic absorption (e.g., increased thirst/urination, unexplained weight gain, mood changes, fatigue, muscle weakness)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Systemic absorption is generally low with rectal use.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though low with topical/rectal use.
Second Trimester: Risk of fetal growth restriction or adrenal suppression with high systemic exposure.
Third Trimester: Risk of fetal adrenal suppression if used close to term with significant systemic absorption.
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Lactation

L3 (Moderately Safe). Hydrocortisone is excreted in breast milk in small amounts after systemic administration. Due to minimal systemic absorption from rectal use, the amount transferred to breast milk is expected to be very low. Use with caution and monitor infant for adverse effects.

Infant Risk: Low risk of adverse effects to the infant with typical rectal dosing. Monitor for signs of adrenal suppression (e.g., poor weight gain) if prolonged or high-dose use.
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Pediatric Use

Use with extreme caution in children, especially infants and young children, due to a larger skin surface area to body weight ratio, which increases the risk of systemic absorption and adverse effects such as growth retardation, Cushing's syndrome, and intracranial hypertension. Not generally recommended for routine use without specific medical guidance.

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Geriatric Use

No specific dose adjustments are typically needed. However, elderly patients may be more susceptible to systemic adverse effects if significant absorption occurs, particularly if they have thinning skin or other comorbidities. Monitor for signs of systemic corticosteroid effects.

Clinical Information

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Clinical Pearls

  • Instruct patients on proper insertion technique for rectal suppositories to ensure maximum local effect.
  • Advise patients not to use for longer than 2 weeks without consulting a healthcare provider, as prolonged use can lead to local irritation or, rarely, systemic effects.
  • Emphasize that this medication is for rectal use only and should not be taken orally.
  • Patients should be aware that while systemic absorption is low, it can increase with inflamed or damaged rectal mucosa, or with occlusive dressings (though not applicable to suppositories).
  • If symptoms do not improve or worsen after 7 days, patients should contact their physician.
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Alternative Therapies

  • Topical anesthetics (e.g., lidocaine, pramoxine)
  • Astringents (e.g., witch hazel pads)
  • Protectants (e.g., zinc oxide, petrolatum)
  • Stool softeners and fiber supplements (for hemorrhoids)
  • Oral corticosteroids (for severe inflammatory bowel disease, not typically for local rectal conditions)
  • Surgical intervention (for severe hemorrhoids)
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Cost & Coverage

Average Cost: $50 - $150 per 24 suppositories
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic or non-preferred generic)
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.