ProctoFoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) is a topical aerosol foam for anal use containing hydrocortisone acetate 1% and pramoxine hydrochloride 1% in a hydrophilic base containing cetyl alcohol, emulsifying wax, methylparaben, polyoxyetlheylene-10 stearyl ether, propylene, glycol, propylparaben, purified water, trolamine, and inert propellants: isobutane and propane.

PROCTOFOAM^®-HC contains a synthetic corticosteroid used as an anti-inflammatory/antipruritic agent and a local anesthetic.

Hydrocortisone Acetate

Pramoxine Hydrochloride

ProctoFoam HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.

Apply to affected area 3 to 4 times daily. Use the applicator supplied for anal administration. For perianal use, transfer a small quantily, to a tissue and rub in gently.

Directions for Use

1. Place cap on top of container. Shake foam container vigorously for 5-10 seconds before each use. Do not remove container cap during use of the product.
2. Hold container upright on a level surface and gently place the tip of the applicator onto the nose of the container cap. CONTAINER MUST BE HELD UPRIGHT TO OBTAIN PROPER FLOW OF MEDICATION.
3. Pull plunger past the fill line on the applicator barrel.
4. Hold the container and applicator at eye level. Place the index and middle fingers on the container cap flanges and the thumb beneath the container. Support the applicator with your other hand. Prime the container by pressing down firmly on flanges and then release.With initial priming, a burst of air may come out of the container. It usually requires 1-2 pumps for foam to appear.
5. To fill applicator barrel, press down firmly on cap flanges, hold for 1-2 seconds, and release. Wait 5-10 seconds to allow foam to expand in applicator barrel. Repeat until foam reaches fill line. It usually requires 3-4 pumps for foam to reach fill line. Remove applicator from container cap. Note: If foam goes beyond fill line, it will continue to expand and flow backwards resulting in foam build-up under cap.
6. Hold applicator firmly by barrel, making sure thumb and middle finger are positioned securely underneath and resting against barrel wings. Place index finger over the plunger. Gently insert tip into anus. Once in place, push plunger to expel foam, then withdraw applicator. CAUTION: Do not insert any part of the aerosol container directly into the anus. Apply to anus only with enclosed applicator. Do not insert any part of the applicator past the anus into rectum.
7. After each use, applicator parts should be pulled apart for thorough cleaning with warm water. Since some foam will appear under the cap, the cap and underlying tip should be pulled apart and rinsed to help prevent build-up of foam and possible blockage.

PROCTOFOAM®-HC is supplied in an aerosol container with a special anal applicator. When used correctly, the aerosol container will deliver a minimum of 14 applications.

Store upright at controlled room temperature 15°-30°C (59°-86°F) Do not refrigerate.

NDC 0091-0690-10..................................10g

CAUTION: Federal law prohibits dispensing without prescription.

SCHWARZ PHARAMA
Milwaukee, WI 53201, USA

PC2585K
Rev. 08/04

The following local adverse reactions are reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

No information provided.

Do not insert any proof of the aerosol container directly into the anus. Avoid contact with the eyes. Contents of the container are under pressure. Do not incinerate or puncture the aerosol container. Do not store at temperatures above 39°C (120°F). If there is no evidence of clinical improvement within two or three weeks after starting ProctoFoam HC therapy, or if the patient's condition worsens discontinue the drug. Keep this and all medicines out of the reach of children.

General

Systemic absorption of topical corticosteriods has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use and the addition of occlusive dressings. Therefore patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug to reduce the frequency of application or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (see Pediatric Use below.)

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Laboratory Tests

The following tests may be helpful in evaluating the HPA axis suppression:

Urinary free cortisol test
ACTH stimulation test

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy

Teratogenic Effects: Pregnancy Category C. Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate well-controlled studies of teratogenic effects from topically applied corticosteroids in pregnant women. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

Topical corticosteroid products are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vaso-constrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pramoxine hydrochloride is a surface or local anesthetic which is not chemically related to the ''caine'' types of local anesthetics. Its unique chemical structure is likely to minimize the danger of cross-sensitivity reactions in patients allergic to other local anesthetics.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin increase the percutaneous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (See DOSAGE AND ADMINISTRATION ).

Once absorbed through the skin topical corticosteroids are handled through pharmacokinetic pathways similar to systemically adminstered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for anal or perianal use only. Avoid contact with eyes.
2. Be advised not to use this medication for any disorder other than for which it has been prescribed.
3. Report any signs of adverse reactions.

Also see DOSAGE AND ADMINISTRATION for Directions for Use

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

PRAMOXINE/HYDROCORTISONE AEROSOL FOAM - RECTAL

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

COMMON BRAND NAME(S): Proctofoam-HC

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: 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: 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 immediately 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.

Tell your doctor immediately 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, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

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.

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.

Though very unlikely, it is possible that the hydrocortisone in this medication will be absorbed into your bloodstream. This may have undesirable effects that may require additional corticosteroid treatment. Children and those using this drug for an extended time may be at higher risk, especially if they also have serious medical problems such as severe infections, injuries, or surgeries. This precaution applies for up to 1 year after stopping use of this drug.

Tell your doctor immediately if any of the following side effects occur: vision problems, persistent headache, increased thirst /urination, unusual weakness, unusual weight loss, dizziness.

Consult your doctor or pharmacist for more details, and inform them that you use (or have used) this medication.

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.

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.

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: This medicine may be harmful if swallowed. If overdose or swallowing is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline 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 and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the foam canister upright at room temperature between 68-77 degrees F (20-25 degrees C). Do not refrigerate. Do not store at temperatures above 120 degrees F (49 degrees C). The contents of this container are under pressure. Do not burn or puncture the aerosol container. 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.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.