Anusol-HC Suppositories 24s

Hydrocortisone is a corticosteroid that acts as a glucocorticoid receptor agonist. It exerts its anti-inflammatory and antipruritic effects by inhibiting the release of lysosomal enzymes, preventing the accumulation of macrophages in inflamed areas, reducing leukocyte adhesion to capillary endothelium, reducing dilation and permeability of capillaries, and decreasing edema formation. It also inhibits the synthesis and release of various inflammatory mediators (e.g., prostaglandins, leukotrienes).

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
Changes in eyesight
Severe headache
Irritation at the site of application
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. Many individuals 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 or seek medical help if they bother you or do not go away:

Burning or stinging
Dryness
* Tingling

Reporting Side Effects

This is not an exhaustive list of 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.

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 symptoms you experienced as a result of the allergy.
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 with your doctor.

Additionally, provide your doctor and pharmacist with a comprehensive list of all the medications you are taking, including:
Prescription medications
Over-the-counter (OTC) medications
Natural products
Vitamins

It is vital to verify that it is safe to take this medication in combination with all your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.

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, discuss the need for regular eye pressure checks 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 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 necessary 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 this risk with your doctor.

When administering this medication to children, exercise caution, as they may be more susceptible to certain side effects. In some cases, this medication may affect growth in children and teenagers, necessitating regular growth checks. Consult your doctor to determine the appropriate monitoring schedule.

Note that some formulations of this medication may not be suitable for all age groups of children, so if you have any questions or concerns, discuss them with 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.

• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir): May increase systemic exposure to hydrocortisone if significant absorption occurs, leading to potential for systemic corticosteroid effects.
• Anticoagulants (e.g., warfarin): May alter anticoagulant effects, though less likely with rectal administration.

• Rectal pain
• Rectal itching
• Rectal bleeding
• Rectal irritation
• Burning sensation
• Signs of infection (e.g., pus, fever)
• Signs of systemic corticosteroid effects (e.g., increased thirst/urination, swelling, mood changes, if used long-term or in high doses)

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is limited, but corticosteroids can cross the placenta. High doses or prolonged use may be associated with fetal growth restriction or adrenal suppression.

L3 (Moderately safe). Hydrocortisone is excreted in breast milk in small amounts after systemic administration. Due to limited systemic absorption from rectal use, the amount transferred to breast milk is expected to be very low. Monitor infant for adverse effects (e.g., growth suppression).

Use with extreme caution, especially in infants and children, due to the potential for systemic absorption and adverse effects such as growth retardation, Cushing's syndrome, and intracranial hypertension. Not generally recommended for routine use in children without specific medical guidance.

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 or pre-existing conditions (e.g., osteoporosis, diabetes). Monitor for adverse effects.

• Instruct patients to insert the suppository pointed end first, and to remain lying down for 15-20 minutes to allow it to melt and spread.
• Advise patients to use after a bowel movement for best efficacy.
• Prolonged use (beyond 7 days) should be under medical supervision due to potential for local irritation, atrophy, or systemic absorption.
• Not for use in the presence of fungal, viral, or bacterial infections of the rectum without appropriate concomitant antimicrobial therapy.
• Patients should be advised that this product is for short-term symptomatic relief and does not cure the underlying cause of hemorrhoids or proctitis.

• Topical local anesthetics (e.g., lidocaine, pramoxine)
• Astringents (e.g., witch hazel)
• Protectants (e.g., zinc oxide, petrolatum)
• Stool softeners (e.g., docusate sodium)
• Dietary fiber supplements
• Sitz baths

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.