Anucort-HC 25mg Rectal Suppos 12s

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
Category C
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FDA Approved
Jun 1952
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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. They work 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 too 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 to make up for a missed dose.
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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.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Not established
Child: Use with caution; dosage must be individualized based on severity of condition and response. Risk of systemic effects is higher in children.
Adolescent: Use with caution; dosage must be individualized based on severity of condition and response. Risk of systemic effects is higher in adolescents.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for rectal administration, but monitor for systemic effects if prolonged use.
Moderate: No specific adjustment needed for rectal administration, but monitor for systemic effects if prolonged use.
Severe: No specific adjustment needed for rectal administration, but monitor for systemic effects if prolonged use.
Dialysis: No specific adjustment needed for rectal administration, but monitor for systemic effects if prolonged use.

Hepatic Impairment:

Mild: No specific adjustment needed for rectal administration, but monitor for systemic effects due to reduced metabolism.
Moderate: No specific adjustment needed for rectal administration, but monitor for systemic effects due to reduced metabolism.
Severe: No specific adjustment needed for rectal administration, but monitor for systemic effects due to reduced metabolism.

Pharmacology

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Mechanism of Action

Hydrocortisone is a corticosteroid that acts by binding to glucocorticoid receptors in the cytoplasm, leading to a cascade of effects that modulate gene expression. This results in potent anti-inflammatory, antipruritic, and vasoconstrictive actions. It inhibits the release of hydrolytic enzymes from leukocytes, prevents the accumulation of macrophages at sites of inflammation, interferes with the adhesion of leukocytes to capillary walls, reduces the permeability of capillary membranes, and inhibits the formation of edema.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (systemic absorption from rectal route can range from 5% to 50% depending on mucosal integrity and duration of exposure)
Tmax: Approximately 1-2 hours (for systemic absorption)
FoodEffect: Not applicable for rectal administration

Distribution:

Vd: Approximately 0.2-0.5 L/kg
ProteinBinding: Approximately 90% (primarily to corticosteroid-binding globulin and albumin)
CnssPenetration: Limited (systemic absorption can lead to CNS effects, but direct CNS penetration from rectal route is minimal)

Elimination:

HalfLife: Approximately 1.5-2 hours (plasma half-life); biological half-life is longer (8-12 hours)
Clearance: Approximately 0.5-1 L/hr/kg
ExcretionRoute: Renal (as inactive metabolites)
Unchanged: <1% (systemically)
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Pharmacodynamics

OnsetOfAction: Within hours (for local anti-inflammatory effect)
PeakEffect: Variable, depends on local absorption and inflammation severity
DurationOfAction: Several hours (local effect), up to 8-12 hours (biological effect if systemically absorbed)

Safety & Warnings

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Side Effects

Urgent 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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of high blood sugar: confusion, drowsiness, excessive thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, extreme dizziness or fainting, muscle weakness, 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, or excessive hair growth)
Thinning of the skin

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:

Burning or stinging sensation
Dryness
* Tingling

This is not an exhaustive list of potential 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.
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Seek Immediate Medical Attention If You Experience:

  • Worsening of rectal pain, bleeding, or itching.
  • Signs of infection (e.g., fever, pus, severe pain).
  • Severe abdominal pain or cramping.
  • Unusual weight gain or swelling in the face/ankles.
  • Increased thirst or urination (signs of high blood sugar).
  • Mood changes or difficulty sleeping.
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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

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 your safety, 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

It is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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 schedule for 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. Additionally, try to 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 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 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 can affect growth in children and teenagers, making regular growth checks necessary. Discuss this with your doctor.

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. It is crucial to discuss the potential benefits and risks of using this medication during these periods to ensure the best outcome for both 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 (e.g., moon face, buffalo hump, striae, muscle weakness, hyperglycemia, hypertension, fluid retention), adrenal suppression.

What to Do:

Discontinue use. Symptomatic and supportive care. For acute ingestion, call Poison Control Center at 1-800-222-1222. For chronic systemic effects, gradual tapering of the drug may be necessary under medical supervision.

Drug Interactions

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Major Interactions

  • Live or live attenuated vaccines (risk of disseminated infection with systemic absorption)
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) - may increase systemic hydrocortisone levels and risk of adverse effects.
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Moderate Interactions

  • NSAIDs (e.g., ibuprofen, naproxen) - increased risk of gastrointestinal ulceration/bleeding if significant systemic absorption occurs.
  • Anticoagulants (e.g., warfarin) - corticosteroids may alter anticoagulant effects; monitor INR.
  • Diuretics (e.g., thiazides, loop diuretics) - increased risk of hypokalemia.
  • Antidiabetic agents (e.g., insulin, oral hypoglycemics) - corticosteroids may increase blood glucose levels, requiring dose adjustments.
  • Cardiac glycosides (e.g., digoxin) - increased risk of toxicity if hypokalemia occurs.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Rectal symptoms (pain, itching, bleeding, inflammation)

Rationale: To establish baseline severity and assess treatment efficacy.

Timing: Prior to initiation of therapy

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Routine Monitoring

Rectal symptoms (pain, itching, bleeding, inflammation)

Frequency: Daily or as needed

Target: Reduction or resolution of symptoms

Action Threshold: Worsening symptoms or no improvement after 7 days may require re-evaluation.

Signs of systemic corticosteroid absorption (e.g., fluid retention, hyperglycemia, adrenal suppression)

Frequency: Periodically, especially with prolonged use or high doses

Target: Absence of systemic effects

Action Threshold: Presence of systemic effects warrants dose reduction or discontinuation.

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Symptom Monitoring

  • Rectal pain
  • Rectal itching
  • Rectal bleeding
  • Inflammation/swelling in the rectal area
  • Signs of infection (e.g., fever, pus)
  • Signs of systemic corticosteroid effects (e.g., increased thirst/urination, swelling in ankles/feet, unusual weight gain, mood changes, muscle weakness)

Special Patient Groups

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Pregnancy

Category C. Use 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 can occur.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though data are limited for topical/rectal use.
Second Trimester: Risk of fetal growth restriction or adrenal suppression with prolonged or high-dose systemic exposure.
Third Trimester: Risk of fetal growth restriction or adrenal suppression with prolonged or high-dose systemic exposure; neonatal adrenal insufficiency possible if used close to term.
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Lactation

L3 (Moderately Safe). Hydrocortisone is excreted in breast milk in small amounts. While systemic effects on the infant are unlikely with typical rectal doses, caution is advised. Monitor infant for signs of adrenal suppression (e.g., poor weight gain).

Infant Risk: Low risk of adverse effects with typical rectal doses; theoretical risk of growth suppression or other corticosteroid effects with prolonged high-dose maternal use.
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Pediatric Use

Use with caution. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity, including HPA axis suppression and Cushing's syndrome. Prolonged use should be avoided. Not recommended for infants.

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Geriatric Use

Use with caution. Elderly patients may be more susceptible to the systemic adverse effects of corticosteroids, especially with prolonged use, due to age-related thinning of the skin and potential for co-morbidities (e.g., diabetes, osteoporosis, glaucoma).

Clinical Information

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Clinical Pearls

  • Instruct patients on proper insertion technique for rectal suppositories.
  • Advise patients to lie down for 15-20 minutes after insertion to ensure retention.
  • Emphasize that this medication is for short-term use (typically up to 7 days) unless directed otherwise by a physician, to minimize risk of systemic absorption and adverse effects.
  • Warn patients about potential for local irritation or burning upon insertion.
  • If symptoms do not improve within 7 days, or worsen, patients should contact their healthcare provider.
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Alternative Therapies

  • Topical anesthetics (e.g., lidocaine, pramoxine)
  • Astringents (e.g., witch hazel)
  • Protectants (e.g., zinc oxide, petrolatum)
  • Oral stool softeners or fiber supplements (for hemorrhoids)
  • Other corticosteroids (e.g., budesonide rectal foam for proctitis)
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Cost & Coverage

Average Cost: Not available (varies widely by pharmacy and insurance) per 12 suppositories
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (for generic), Tier 3 or 4 (for brand)
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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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.