Hemmorex-HC 25mg Rectal Supp 24s

Manufacturer LASER PHARMACEUTICALS 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 medicine called a corticosteroid. They are inserted into the rectum to reduce swelling, itching, and discomfort caused by conditions like hemorrhoids or inflammation of the rectum (proctitis). It works by calming down the body's inflammatory 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 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, 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: Gently clean the area after each bowel movement.
  • Avoid straining during bowel movements: Increase fiber intake and fluid intake to soften stools.
  • Avoid prolonged sitting or standing.
  • Take warm sitz baths to help relieve discomfort.
  • Follow a balanced diet rich in fiber to prevent constipation.
  • Stay well-hydrated.

Dosing & Administration

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Adult Dosing

Standard Dose: One 25 mg suppository rectally 1 to 2 times daily, typically in the morning and at bedtime, or after each bowel movement.
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

hemorrhoids: One 25 mg suppository rectally 1 to 2 times daily.
proctitis: One 25 mg suppository rectally 1 to 2 times daily, for up to 2-4 weeks or as directed by physician.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (use with extreme caution, risk of systemic effects)
Child: Not established (use with caution, risk of systemic effects, consult specialist)
Adolescent: Not established (use with caution, risk of systemic effects, consult specialist)
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific adjustment needed due to minimal systemic absorption.
Moderate: No specific adjustment needed due0 to minimal systemic absorption.
Severe: No specific adjustment needed due to minimal systemic absorption.

Pharmacology

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Mechanism of Action

Hydrocortisone is a corticosteroid that acts locally in the rectum to reduce inflammation, itching, swelling, and discomfort. It works by binding to glucocorticoid receptors, which then modulate the expression of genes involved in inflammatory and immune responses. This leads to inhibition of prostaglandin and leukotriene synthesis, reduction of capillary permeability, and stabilization of lysosomal membranes.
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Pharmacokinetics

Absorption:

Bioavailability: Variable and generally low systemic bioavailability from rectal administration (typically <10-30%), but can be higher with inflamed mucosa or prolonged use.
Tmax: Not well quantified for rectal route due to low systemic absorption; local effect is rapid.
FoodEffect: Not applicable for rectal administration.

Distribution:

Vd: Not well quantified for rectal route; for systemic hydrocortisone, Vd is approximately 0.2-0.4 L/kg.
ProteinBinding: Approximately 90% (primarily to corticosteroid-binding globulin and albumin) for systemically absorbed hydrocortisone.
CnssPenetration: Limited (for systemically absorbed portion).

Elimination:

HalfLife: Approximately 1.5-2 hours (plasma half-life for systemically absorbed hydrocortisone); biological half-life is longer (8-12 hours).
Clearance: Not well quantified for rectal route.
ExcretionRoute: Renal (as inactive metabolites and a small percentage of unchanged drug).
Unchanged: <1% (for systemically absorbed hydrocortisone).
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Pharmacodynamics

OnsetOfAction: Within hours for symptomatic relief.
PeakEffect: Within 1-2 days for significant anti-inflammatory effect.
DurationOfAction: Approximately 8-12 hours (local effect).

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 immediately or seek medical attention:

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, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath
Signs of a weak adrenal gland: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, extreme 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 sputum production or change in sputum color, 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:

Burning or stinging sensation
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 of rectal pain, bleeding, or itching.
  • Signs of infection, such as fever, chills, or pus from the rectal area.
  • Severe burning, irritation, or rash in the rectal area.
  • Any signs of systemic side effects, though rare (e.g., unusual weight gain, swelling in ankles/feet, increased thirst/urination, muscle weakness).
  • If symptoms do not improve within 7 days or worsen, contact your doctor.
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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 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 this with your doctor.

As this medication may increase your risk of developing an 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 illnesses 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. Be aware that this medication can stain clothing and fabrics, so take precautions to protect them.

In case of accidental ingestion, this medication can be harmful, so immediately contact a doctor or 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 this 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, necessitating regular growth checks; consult your doctor about this. Additionally, some formulations of this medication may not be suitable for all age groups of children, so if you have any questions, discuss them with your doctor.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor, as it is necessary to weigh the benefits and risks of using this medication for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Systemic overdose is unlikely with rectal administration due to low absorption.
  • If significant systemic absorption occurs (e.g., with prolonged high-dose use or damaged mucosa), symptoms could include fluid retention, high blood pressure, muscle weakness, mood changes, or hyperglycemia.

What to Do:

If accidental ingestion or suspected systemic overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic.

Drug Interactions

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Moderate Interactions

  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin): May increase systemic exposure to hydrocortisone if significant absorption occurs, leading to potential for systemic corticosteroid side effects. However, this is less likely with rectal administration due to low systemic absorption.
  • Anticoagulants (e.g., warfarin): Corticosteroids may alter the effects of anticoagulants; monitor INR if significant systemic absorption occurs.

Monitoring

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Baseline Monitoring

Symptom assessment (pain, itching, bleeding, swelling)

Rationale: To establish baseline severity and guide treatment.

Timing: Prior to initiation of therapy.

Visual inspection of affected area

Rationale: To assess local inflammation, fissures, or other pathology.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Symptom improvement

Frequency: Daily to weekly

Target: Reduction in pain, itching, bleeding, swelling.

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

Local adverse effects (e.g., irritation, burning, atrophy)

Frequency: Weekly or as symptoms arise

Target: Absence of new or worsening local irritation.

Action Threshold: Persistent or severe local irritation may require discontinuation.

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

Frequency: Rarely needed for typical use; consider if prolonged high-dose use or signs of systemic absorption.

Target: Normal physiological parameters.

Action Threshold: Any signs of systemic effects warrant immediate medical evaluation.

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Symptom Monitoring

  • Rectal pain or discomfort
  • Rectal itching or burning
  • Rectal bleeding
  • Swelling in the anal area
  • Signs of infection (e.g., pus, fever, increased pain)
  • Worsening of original symptoms
  • Any new or unusual symptoms

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is generally low, but prolonged or high-dose use should be avoided.

Trimester-Specific Risks:

First Trimester: Limited data, but generally considered low risk due to minimal systemic absorption.
Second Trimester: Generally considered low risk due to minimal systemic absorption.
Third Trimester: Generally considered low risk due to minimal systemic absorption, but monitor for signs of systemic effects in mother and fetus.
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Lactation

L3 (Moderately Safe). Hydrocortisone is excreted in breast milk, but the amount is likely very small with rectal administration due to minimal systemic absorption. Risk to the infant is considered low.

Infant Risk: Low risk. Monitor infant for any unusual effects, though unlikely.
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Pediatric Use

Not generally recommended for infants and young children due to potential for increased systemic absorption and adrenal suppression. Use with extreme caution and under specialist supervision if necessary. Dosing is not well-established.

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Geriatric Use

No specific dose adjustments are typically needed. However, elderly patients may be more susceptible to systemic side effects if significant absorption occurs, and may have underlying conditions that could be exacerbated. Use with caution and monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Instruct patients to insert the suppository pointed end first, and to remain lying down for 15-20 minutes after insertion to prevent expulsion.
  • Emphasize that this medication is for local use only and should not be taken by mouth.
  • Advise patients that prolonged use (beyond 2-4 weeks) should be avoided unless directed by a physician, due to potential for local side effects (e.g., skin atrophy) and theoretical risk of systemic absorption.
  • For best results, use after a bowel movement.
  • Store suppositories in a cool place, preferably refrigerated, as they may melt at room temperature.
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Alternative Therapies

  • Topical anesthetics (e.g., lidocaine, benzocaine)
  • Astringents (e.g., witch hazel pads)
  • Protectants (e.g., zinc oxide, petrolatum)
  • Stool softeners/fiber supplements (for constipation-related hemorrhoids)
  • Surgical interventions (for severe hemorrhoids)
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Cost & Coverage

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