Hemmorex-HC 30mg Suppositories

Manufacturer LASER 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
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 medicine called a corticosteroid. They are used to reduce swelling, itching, and discomfort in the rectum caused by conditions like hemorrhoids or inflammation. The medicine works directly where it's needed to calm down the irritation.
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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 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 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.
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Lifestyle & Tips

  • Maintain good anal hygiene.
  • Avoid straining during bowel movements; consider increasing fiber and fluid intake to prevent constipation.
  • Avoid prolonged sitting or standing.
  • Do not use for longer than prescribed by your doctor, typically 2-4 weeks, to avoid potential side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: One 30mg suppository rectally 1 to 2 times daily, usually morning and evening, for 2 weeks. May be reduced to 1 suppository every other day for 2 weeks.
Dose Range: 30 - 60 mg

Condition-Specific Dosing:

proctitis: One 30mg suppository rectally 1 to 2 times daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (use generally not recommended for children under 12 without specific medical advice and careful monitoring due to potential for systemic effects)
Adolescent: Not established (use generally not recommended for children under 12 without specific medical advice and careful monitoring due to potential for systemic effects)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed due to limited systemic absorption.
Moderate: No specific adjustment needed due to limited systemic absorption.
Severe: No specific adjustment needed due to limited systemic absorption.
Dialysis: No specific considerations due to limited systemic absorption.

Hepatic Impairment:

Mild: No specific adjustment needed due to limited systemic absorption.
Moderate: No specific adjustment needed due to limited systemic absorption.
Severe: No specific adjustment needed due to limited systemic absorption.

Pharmacology

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Mechanism of Action

Hydrocortisone is a corticosteroid that acts locally to reduce inflammation, pruritus, and swelling. It binds to glucocorticoid receptors in the cytoplasm, forming a complex that translocates to the nucleus and modulates gene expression. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines).
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Pharmacokinetics

Absorption:

Bioavailability: Limited systemic absorption (typically <10% to 20% of the dose) when administered rectally, but can vary depending on the integrity of the rectal mucosa and duration of use.
Tmax: Not well-defined for rectal administration due to limited systemic absorption; local effect onset is within hours.
FoodEffect: Not applicable for rectal administration.

Distribution:

Vd: If systemically absorbed, hydrocortisone distributes widely. For systemic hydrocortisone, Vd is approximately 0.5-1.5 L/kg.
ProteinBinding: Approximately 90% bound to plasma proteins, primarily transcortin (corticosteroid-binding globulin) and albumin.
CnssPenetration: Limited (if systemically absorbed, can cross blood-brain barrier, but not significant with rectal use).

Elimination:

HalfLife: Systemic half-life of hydrocortisone is approximately 1.5-2 hours (biological half-life is longer, 8-12 hours).
Clearance: Not well-defined for rectal administration due to limited systemic absorption.
ExcretionRoute: Metabolites are primarily excreted in the urine.
Unchanged: <1% of systemically absorbed hydrocortisone is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Local anti-inflammatory effects typically observed within hours to a few days.
PeakEffect: Peak local effect within a few days of consistent use.
DurationOfAction: Effects persist for several hours after administration, requiring twice-daily dosing for sustained relief.

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: 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, 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 adrenal gland problems: 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 non-healing wounds
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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Burning or stinging sensations
Dryness
* Tingling

This is not an exhaustive list of possible side effects. If you have questions or concerns, 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 rectal pain, bleeding, or itching after several days of use.
  • Signs of infection (e.g., fever, pus, severe pain).
  • Any unusual or severe side effects, even if you think they are unrelated.
  • Signs of systemic absorption (e.g., increased thirst, frequent urination, swelling in ankles/feet, unexplained weight gain, mood changes, muscle weakness - these are rare but possible with prolonged or excessive use).
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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 is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to discuss all of your:

Prescription and over-the-counter (OTC) medications
Natural products
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 to confirm that it is safe to do so in conjunction with this medication.
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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. 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 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 they may be at a higher risk of experiencing certain side effects. In some cases, this medication can affect growth in children and teenagers, so regular growth checks may be 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. 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:

  • Acute overdose with rectal hydrocortisone is unlikely due to limited systemic absorption.
  • Chronic excessive use may lead to systemic corticosteroid effects such as Cushing's syndrome (e.g., moon face, central obesity, thin skin, easy bruising), adrenal suppression, hyperglycemia, or hypertension.

What to Do:

If systemic effects are suspected from chronic overuse, consult a healthcare professional immediately. Management involves gradual withdrawal of the corticosteroid under medical supervision. For acute accidental ingestion, call a poison control center (1-800-222-1222) or seek emergency medical attention.

Drug Interactions

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Moderate Interactions

  • CYP3A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole, clarithromycin): May increase systemic exposure to hydrocortisone if significant absorption occurs, leading to potential for systemic corticosteroid side effects. Use with caution and monitor for adverse effects.

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.

Exclusion of underlying infections (bacterial, fungal, viral)

Rationale: Corticosteroids can mask or worsen infections.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Symptom improvement (reduction in pain, itching, inflammation)

Frequency: Daily/Weekly

Target: Significant reduction or resolution of symptoms.

Action Threshold: Lack of improvement or worsening symptoms after 7 days may indicate need for re-evaluation or alternative therapy.

Local adverse reactions (burning, itching, irritation, atrophy)

Frequency: Daily

Target: Absence of new or worsening local irritation.

Action Threshold: Persistent or severe local reactions may warrant discontinuation.

Signs of systemic corticosteroid absorption (e.g., Cushing's syndrome symptoms, adrenal suppression)

Frequency: Periodically, especially with prolonged or high-dose use

Target: Absence of systemic effects.

Action Threshold: Presence of systemic effects requires immediate medical evaluation and potential discontinuation/tapering.

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Symptom Monitoring

  • Rectal pain
  • Rectal itching
  • Rectal bleeding
  • Rectal irritation or burning
  • Signs of infection (fever, pus, increased pain)
  • Signs of systemic corticosteroid effects (e.g., increased thirst/urination, swelling, mood changes, weight gain, fatigue, muscle weakness - rare with rectal use)

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. While systemic absorption is limited, corticosteroids can cross the placenta. Studies in animals have shown teratogenic effects.

Trimester-Specific Risks:

First Trimester: Potential for teratogenic effects observed in animal studies; human data limited for rectal use.
Second Trimester: Risk generally considered lower than first trimester, but still Category C.
Third Trimester: Potential for fetal adrenal suppression if significant systemic absorption occurs, especially with prolonged use near term.
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Lactation

L3 (Moderately Safe). Hydrocortisone is excreted in breast milk following systemic administration. While systemic absorption from rectal use is limited, caution is advised. Monitor the infant for potential adverse effects (e.g., growth suppression, adrenal suppression), though unlikely with typical rectal doses.

Infant Risk: Low risk with typical rectal doses due to limited maternal systemic absorption, but theoretical risk of infant adrenal suppression or growth effects with prolonged or high-dose maternal use.
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Pediatric Use

Not generally recommended for children under 12 years of age without specific medical advice and careful monitoring due to the potential for systemic absorption and adverse effects (e.g., growth retardation, adrenal suppression), especially with prolonged use or in infants/young children who may have a higher surface area to weight ratio.

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Geriatric Use

No specific dose adjustments are typically required. However, elderly patients may be more susceptible to systemic corticosteroid side effects if significant absorption occurs, especially with prolonged use, due to age-related thinning of the skin/mucosa or comorbidities. Monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Hydrocortisone rectal suppositories are for local action; systemic absorption is minimal but can occur, especially with prolonged use or damaged mucosa.
  • Emphasize proper administration technique: insert pointed end first, push gently, and remain lying down for a few minutes to ensure retention.
  • Patients should be advised not to use this medication for longer than prescribed (typically 2-4 weeks) to minimize the risk of local and potential systemic side effects.
  • If symptoms do not improve within 7 days or worsen, the patient should contact their healthcare provider for re-evaluation.
  • This medication is not for internal hemorrhoids that are prolapsed or thrombosed, or for infections unless specifically treated concurrently.
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Alternative Therapies

  • Topical anesthetics (e.g., lidocaine, pramoxine)
  • Astringents (e.g., witch hazel pads)
  • Protectants (e.g., zinc oxide, petrolatum)
  • Oral pain relievers (e.g., NSAIDs, acetaminophen)
  • Dietary modifications (fiber supplements, stool softeners) for constipation-related symptoms.
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Cost & Coverage

Average Cost: $30 - $100 per 12 suppositories
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.