How does this medication work? What will it do for me?
This is a combination product containing two medications: pramoxine and hydrocortisone. It is used for the temporary relief of rectal inflammation, itching, pain, and swelling associated with hemorrhoids, fissures, cryptitis, proctititis, and other conditions of the anus and rectum.
Pramoxine works by numbing the area that is treated, while hydrocortisone works by reducing inflammation in the area.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each application provides 375 mg of mucoadhesive base containing 1% hydrocortisone acetate USP (3.75 mg per dose) and 1% pramoxine HCl USP (3.75 mg per dose). Nonmedicinal ingredients: cetyl alcohol, emulsifying wax, methylparaben, propylene glycol, propylparaben, steareth-10, triethanolamine, water, and inert propellants (isobutane and propane).
How should I use this medication?
Shake the aerosol container well before using. Insert one full applicator into the anus 2 or 3 times daily and after each bowel movement. You may also place some of the foam on a perianal pad and apply to the external area of the anus as needed to relieve pain and itching.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.
It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, apply it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication upright at room temperature and away from sources of heat. Protect it from sunlight by storing it in its original packaging and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not use this medication if you:
- are allergic to hydrocortisone, pramoxine, or any ingredients of the medication
- have an active infection, abscess, extensive fistulas, or sinus tracts in the bowel
- have tuberculosis, varicella (chickenpox), vaccinia, acute herpes simplex, or fungal infections
Do not give this medication to children or adolescents under 18 years of age.
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- burning, dryness, irritation, itching, or redness of skin
- feeling the urge to have a bowel movement when the medication is inserted
- loss of skin colour
Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- increased blood pressure
- lack of healing of a skin condition
- pain when the medication is inserted
- skin infection
- symptoms of absorption of corticosteroids into the body (e.g., weight gain, rounding of the face, abnormal hair growth, thinning of skin with easy bruising)
- symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
Stop taking the medication and seek immediate medical attention if any of the following occur:
- symptoms of an allergic reaction (e.g., swelling of the hands, feet, ankles, face, lips, mouth, or throat; difficulty breathing or swallowing)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Allergies or sensitization: Stop using this medication and call your doctor if irritation, allergic reaction, or sensitization occurs. Inform all health professionals involved in your care that you have been using corticosteroids.
Cautions regarding the container: Contents are flammable and the aerosol container may explode if heated.
The contents of the container are under pressure. Do not use in the presence of an open flame or spark and do not place in hot water or near radiators, stoves, or other sources of heat. Do not puncture or incinerate the container or store it at temperatures over 50°C.
Do not insert any part of the aerosol container into the anus.
Diabetes: Hydrocortisone may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.
If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Excessive use: Prolonged or excessive use of this product could produce effects similar to those seen after taking corticosteroids by mouth for prolonged periods of time (such as thin skin, easy bruising, thin bones, or increased risk of infections). To minimize this possibility when long-term therapy is anticipated, your doctor may instruct you to periodically interrupt treatment.
General precautions: Advise all doctors involved in your care that you have been using this medication.
Infected areas: Do not use this medication on infected lesions unless you are also using appropriate anti-infective medications as recommended by your doctor.
Infections: Corticosteroids may hide the symptom of new infections and infections may occur more frequently due to the effect corticosteroids have on the immune system. If you experience skin infections around the affected area or other infections, let your doctor know as soon as possible.
Mood changes and mental health: The use of corticosteroids may cause mood swings, a sense of euphoria, depression, or anxiety. If you have a history of mental health concerns, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Ulcerative bowel disease: People with severe ulcerative bowel disease who use rectal hydrocortisone may be at increased risk of perforation of the bowel wall. If you have ulcerative bowel disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using this medication, contact your doctor immediately.
Breast-feeding: It is not known if this medication passes into breast milk. If you are a breast-feeding mother and are using this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
What other drugs could interact with this medication?
If you are applying additional medications to the area being treated, speak with your doctor or pharmacist.
There may be an interaction between hydrocortisone - pramoxine and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.