Proctofoam Hc
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Questions & Answers
Side Effects & Adverse Reactions
Do not insert any part of the aerosol container directly into the anus. Avoid contact with the eyes. Contents of the container are under pressure. Do not burn or puncture the aerosol container. Do not store at temperatures above 120°F (49°C). 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Proctofoam®-HC is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses of the anal region.
History
There is currently no drug history available for this drug.
Other Information
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, polyoxyethylene-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.
Molecular weight: 404.50. Solubility of hydrocortisone acetate in water: 1 mg/100 mL.
Chemical name: pregn-4-ene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11β)-.
Molecular weight: 329.86. Pramoxine hydrochloride is freely soluble in water.
Chemical name: morpholine, 4-[3-(4-butoxyphenoxy) propyl]-, hydrochloride.
Sources
Proctofoam Hc Manufacturers
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Schwarz Pharma
![Proctofoam Hc (Hydrocortisone Acetate And Pramoxine Hydrochloride) Aerosol, Foam [Schwarz Pharma]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Proctofoam Hc | Schwarz Pharma
Apply to affected area 3 to 4 times daily. Use the applicator supplied for anal administration. For perianal use, transfer a small quantity to a tissue and rub in gently.
Directions for Use 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. 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. Pull plunger past the fill line on the applicator barrel. 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. 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. 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. 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. -
Rebel Distributors Corp
Proctofoam Hc | Rebel Distributors Corp
Apply to affected area 3 to 4 times daily. Use the applicator supplied for anal administration. For perianal use, transfer a small quantity to a tissue and rub in gently.
Directions for Use 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. 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. Pull plunger past the fill line on the applicator barrel. 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. 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. 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. 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. -
Alaven Pharmaceutical Llc
Proctofoam Hc | Alaven Pharmaceutical Llc
DOSAGE AND ADMINISTRATION: Apply to affected area 3 to 4 times daily. Use the applicator supplied for anal administration. For perianal use, transfer a small quantity to a tissue and rub in gently.
Directions for Use. 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. 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. Pull plunger past the fill line on the applicator barrel. 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. 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. 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. 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. -
Meda Pharmaceuticals
Proctofoam Hc | Meda Pharmaceuticals
DOSAGE AND ADMINISTRATION: Apply to affected area 3 to 4 times daily. Use the applicator supplied for anal administration. For perianal use, transfer a small quantity 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 (Hydrocortisone Acetate And Pramoxine Hydrochloride) Aerosol, Foam [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=14e43813-665c-4cef-b3b1-60eafc880f41&name=14e43813-665c-4cef-b3b1-60eafc880f41-10.jpg)
![Proctofoam Hc (Hydrocortisone Acetate And Pramoxine Hydrochloride) Aerosol, Foam [Alaven Pharmaceutical Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2cc8803f-51fe-4d66-aab6-9c83096e6cd4&name=proctofoam-figure-10.jpg)
![Proctofoam Hc (Pramoxine Hydrochloride Hydrocortisone Acetate) Aerosol, Foam [Meda Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3831e931-ec0a-11e3-ac10-0800200c9a66&name=proctofoam-figure-10.jpg)
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