PRAMOXINE/HYDROCORTISONE AEROSOL FOAM - RECTAL

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PRAMOXINE/HYDROCORTISONE AEROSOL FOAM - RECTAL

PHONETIC PRONUNCIATION: (pram-OX-een/hi-dro-KOR-tih-sown)

COMMON BRAND NAME(S): Proctofoam-HC

GENERIC NAME(S): hydrocortisone acetate/pramoxine HCl

Uses

USES: This combination medication is used to treat minor pain, itching, swelling, and discomfort caused by hemorrhoids and other problems of the anal area (e.g., anal fissures). This medication contains pramoxine, an anesthetic that works by temporarily numbing the area. This product also contains hydrocortisone, a corticosteroid that reduces redness, itching, and swelling.


How to use PRAMOXINE/HYDROCORTISONE AEROSOL FOAM - RECTAL

HOW TO USE: Read the Patient Instruction Sheet if one is available from your pharmacist before you start using this product and each time you get a refill. Follow all instructions in the product package for filling and using the applicator (if one is provided). If any of the information is unclear, consult your doctor or pharmacist. If possible, clean the affected area with mild soap and water, rinse well, and pat dry. Shake the foam canister well before using. After filling the applicator, hold it by the barrel and gently insert the applicator tip just 1/2 to 1 inch (1.5 to 2.5 centimeters) inside the anus. Push the plunger to release the foam, then gently withdraw the applicator. Take the applicator apart and clean it thoroughly with warm water. Do not insert any part of the foam canister into the anus, and do not insert the applicator more than 1/2 to 1 inch (1.5 to 2.5 centimeters) inside the anus. Do not use your finger or a tissue to apply this product inside the anus. To apply the product to the outside of the anus, spray a small amount of foam onto a tissue and gently pat onto the affected area. Do not cover the area with plastic or waterproof bandages unless directed to do so by your doctor. Covering the treated area may increase the absorption of the medication through the skin. This may improve how well the drug works, but it may also increase the risk of side effects. 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. This product is usually used 3 to 4 times daily, or after each bowel movement, or as directed by your doctor. Dosage is based on your medical condition and response to therapy. 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. Inform your doctor if your condition does not improve or if it worsens after 2 to 3 weeks.

Side Effects

SIDE EFFECTS: Redness, burning, or itching at the application site may occur. If any of these effects persist or worsen, contact 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: 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

PRECAUTIONS: Before using this product, tell your doctor or pharmacist if you are allergic to pramoxine; or to hydrocortisone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, eye problems, 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. Caution is advised when using this drug in children. Do not use this product over a large area or use tight-fitting diapers/plastic pants unless directed by your doctor. Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. 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 long periods of time or in large amounts. Discuss the risks and benefits with your doctor. It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Interactions

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: other corticosteroids/immunosuppressants (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

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.

Images

PROCTOFOAM-HC 1%-1% FOAM
PROCTOFOAM-HC 1%-1% FOAM
PROCTOFOAM-HC 1%-1% FOAM
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Faq for PRAMOXINE/HYDROCORTISONE AEROSOL FOAM - RECTAL

- Pramoxine/Hydrocortisone aerosol foam is a medication used rectally to relieve itching, swelling, and discomfort caused by hemorrhoids or other anorectal conditions. It contains pramoxine, which is a local anesthetic, and hydrocortisone, which is a corticosteroid. Pramoxine numbs the affected area, while hydrocortisone reduces inflammation and itching.

- Shake the canister well before use. Hold the canister upright and insert the applicator tip into the rectum. Press down on the canister to release the foam, then remove the applicator. Make sure to use the foam after bowel movements and at bedtime, or as directed by your healthcare provider. Be sure to follow the instructions provided with the medication.

- Common side effects may include mild burning, stinging, or irritation at the application site. These symptoms are often temporary and should go away on their own. However, if you experience severe irritation, allergic reactions, or any other unusual symptoms, consult your doctor immediately.

- It is important to discuss the use of this medication with your healthcare provider if you are pregnant or breastfeeding. They can evaluate the potential risks and benefits and determine if it is safe for you to use.

- Inform your doctor about all the medications you are currently taking, including prescription, over-the-counter, and herbal products. Certain drugs may interact with Pramoxine/Hydrocortisone aerosol foam and affect its effectiveness or increase the risk of side effects. Additionally, inform your doctor about any medical conditions you have, especially infections in the rectal area or any open wounds.

- This medication should be used as directed by your healthcare provider or as indicated on the packaging. Do not use it for longer than recommended, unless specifically instructed by your doctor. Prolonged use of corticosteroids can lead to skin thinning or other complications, so it is important to follow the recommended treatment duration.

- The safety and effectiveness of this medication in pediatric patients have not been established. Consult your child's healthcare provider before using Pramoxine/Hydrocortisone aerosol foam in children.

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Disclaimer

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.