Framycetin/Hydrocortisone/Dibucaine/Esculin Suppository - Rectal

Pronunciation: fram-eye-SEAT-in/hi-dro-KORT-ih-sown/DYE-byoo-kane/ES-kyu-lin

Common Brand Name(s): Proctol , Proctosedyl

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Uses

This combination medication is used to treat pain, itching, swelling, and discomfort caused by hemorrhoids and other problems of the anal area (e.g., anal fissures, itching). It may also be used before and after anal surgery (e.g., hemorrhoid removal and anal fissure repair).

This combination product contains dibucaine (also known as cinchocaine), an anesthetic that works by temporarily numbing the area, and hydrocortisone, a corticosteroid that reduces redness, itching, and swelling. It also contains an aminoglycoside antibiotic called framycetin (also known as neomycin B) that works by stopping the growth of bacteria. Framycetin works only on bacterial infections. It will not work for other types of infections (e.g., infections caused by fungi, viruses). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

This product also contains esculin, a natural substance found in horse chestnut. Esculin is similar to hydroxycoumarin, which is a "blood thinner" (anticoagulant). It has been used to decrease swelling. It may increase the risk of bleeding and may be harmful if swallowed.

How To Use

Use this product in the rectum only.

Unwrap the suppository and moisten it with a few drops of water. Lie down on your left side with your right knee bent. Gently push one suppository into the rectum with your finger. Remain lying down for a few minutes, and avoid having a bowel movement for at least 1 hour so the drug will be absorbed.

This product is usually used twice daily and after each bowel movement or as directed by your doctor. Dosage is based on your medical condition and response to treatment. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.

Do not use more of this product, use it more often, or keep using it longer than prescribed by your doctor. If you have been using this medication for a long time or in high doses, do not suddenly stop using it without your doctor's approval. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Wash hands immediately after use. Avoid getting the product in your eyes, nose, ears or mouth. If the medication gets in these areas, rinse the area immediately with clean water.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Redness, burning, or itching may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these unlikely but serious side effects occur:

  • rectal bleeding
  • change in skin appearance (e.g., color, thickness)
  • skin redness/tenderness/pus or other signs of infection

Rarely, it is possible this medication will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time. Tell your doctor right away if any of the following side effects occur:

  • unusual/extreme tiredness
  • weight loss
  • headache
  • swelling ankles/feet
  • increased thirst/urination
  • vision problems

Tell your doctor right away if any of these rare but very serious side effects occur:

  • easy bleeding/bruising
  • hearing problems (e.g., ringing in the ears)
  • slow/irregular heartbeat
  • signs of serious infection (e.g., fever, persistent sore throat)

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using this product, tell your doctor or pharmacist if you are allergic to dibucaine or other amide anesthetics (e.g., bupivacaine, prilocaine), hydrocortisone or other corticosteroids (e.g., prednisone), or framycetin or other aminoglycoside antibiotics (e.g., neomycin); or to any other ingredient in this product (e.g., esculin); or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have:

  • fungal infection
  • tuberculosis
  • viral infection (e.g., chickenpox, herpes)

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • diabetes
  • eye problems (e.g., glaucoma)
  • infections (especially rectal sores/infections)
  • liver disease
  • stomach/intestinal problems

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may temporarily slow down a child's growth if used for a long time. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. It should not be used for a long time or in large amounts. Discuss the risks and benefits with your doctor.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:

  • antiplatelet medication (e.g., clopidogrel)
  • "blood thinners" (e.g., warfarin)
  • other corticosteroids/immunosuppressant drugs (e.g., prednisone)
  • other rectal products

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Laboratory and/or medical tests (e.g., cortisol levels) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

Missed Dose

If you miss a dose, use it as soon as you remember unless it is almost time for the next dose. In that case, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature between 59-86 degrees F (15-30 degrees C). Do not refrigerate. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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