How Long Should I Wait to Use Proctofoam Again

What is Proctofoam HC and how is it used?

Proctofoam HC is a prescription medicine used to treat the symptoms of Topical Inflammation and Hemorrhoids. Proctofoam HC may exist used lone or with other medications.

Proctofoam HC belongs to a grade of drugs chosen Anesthetics/Corticosteroid Combos; Corticosteroids, Gastrointestinal; Corticosteroids, Topical.

What are the possible side effects of Proctofoam HC?

Proctofoam HC may cause serious side furnishings including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• blurred vision,
• eye pain,
• seeing halos around lights,
• mood changes,
• slumber problems (insomnia),
• increased thirst or urination,
• hunger,
• dry out oral fissure,
• fruity jiff odor,
• weight loss,
• weight gain,
• puffiness in your face up up,
• muscle weakness, and
• tiredness

Get medical assistance correct away, if you take whatsoever of the symptoms listed college upwardly.

The virtually common side furnishings of Proctofoam HC include:

• mild redness or swelling of treated peel,
• thinning of treated skin, and
• numbness on areas where the medicine is accidentally applied

Tell the doc if y'all take whatever side effect that bothers you or that does non go abroad.

These are not all the possible side furnishings of Proctofoam HC. For more information, ask your dr. or pharmacist.

Phone call your dr. for medical communication nearly side effects. Yous may written report side furnishings to FDA at 1-800-FDA-1088.

Description

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

Proctofoam®-HC contains a constructed corticosteroid used as an anti-inflammatory/antipruritic amanuensis and a local coldhearted.

Hydrocortisone acetate

Molecular weight: 404.50. Solubility of hydrocortisone acetate in water: 1 mg/100 mL. Chemical proper noun: pregn-iv-ene-3,twenty-dione, 21-(acetyloxy)-11,17-dihydroxy-, (11β)-.

Pramoxine hydrochloride

Molecular weight: 329.86. Pramoxine hydrochloride is freely soluble in h2o. Chemical proper noun: morpholine, 4-[three-(iv-butoxyphenoxy) propyl]-, hydrochloride.

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INDICATIONS

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

DOSAGE AND ADMINISTRATION

Apply to afflicted expanse 3 to 4 times daily. Use the applicator supplied for anal administration. For perianal utilise, transfer a pocket-sized quantity to a tissue and rub in gently.

Directions for Use

1. Place cap on peak of container. Shake cream container vigorously for five-10 seconds before each apply. Practice not remove container cap during utilise of the production.
2. Agree 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 Catamenia OF MEDICATION.
3. Pull plunger by the brand total 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 pollex below the container. Support the applicator with your other hand. Prime number the container by pressing down firmly on flanges and and so release. With initial priming, a outburst of air may come up out of the container. Information technology ordinarily requires ane-2 pumps for foam to appear.
5. To fill up applicator butt, press downwardly firmly on cap flanges, hold for 1-ii seconds, and release. Wait 5-10 seconds to allow cream to aggrandize in applicator barrel. Repeat until foam reaches fill up line. Information technology commonly requires 3-4 pumps for foam to reach fill up line. Remove applicator from container cap. Note: If foam goes across fill up line, it volition keep to aggrandize and menstruation backwards resulting in cream build-upwardly under cap.
6. Concord applicator firmly past barrel, making certain thumb and center finger are positioned securely underneath and resting confronting butt wings. Place alphabetize finger over the plunger. Gently insert tip into anus. One fourth dimension in identify, push push plunger to expel cream, and then withdraw applicator. Caution: Practise not insert whatsoever office of the aerosol container direct into the anus. Apply to anus only with enclosed applicator. Do non insert any part of the applicator past the anus into rectum.
7. Later each use, applicator parts should be pulled apart for thorough cleaning with warm water. Since some foam will appear nether the cap, the cap and underlying tip should be pulled apart and rinsed to assistance forestall build-up of cream and possible blockage.

HOW SUPPLIED

Proctofoam®-HC is supplied in an aerosol container with a special anal applicator. When used correctly, the droplets container will evangelize a minimum of 14 applications. Store upright at controlled room temperature twenty°-25°C (68°-77°F). Practise Non Air-condition.

NDC 0091-0690-1010 chiliad

Schwarz Pharma, Milwaukee, WI 53201, Us.

QUESTION

Ringworm is caused by a mucus. Come up across Respond

Side Furnishings & Drug Interactions

SIDE EFFECTS

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

DRUG INTERACTIONS

No data provided.

WARNINGS

Do not insert any role of the aerosol container directly into the anus. Avert contact with the optics. Contents of the container are nether pressure level. Do not burn down or puncture the droplets container. Do not shop at temperatures to a higher identify 120°F (49°C). If there is no evidence of clinical comeback inside ii or iii weeks afterward starting Proctofoam®-HC therapy, or if the patient's status worsens, discontinue the drug. Keep this and all medicines out of the attain of children.

PRECAUTIONS

Full general

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

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

Recovery of HPA centrality office 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 exist more susceptible to systemic toxicity. (run into PRECAUTIONS - Pediatric use.)

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

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

Information for patients

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

1. This medication is to be used equally directed past the physician. Information engineering is for anal or perianal utilize only. Avoid contact with eyes.
2. Exist advised not to utilise this medication for any disorder other than for which data technology has been prescribed.
3. Report any signs of agin reactions. Laboratory tests

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

Urinary free cortisol test
ACTH stimulation exam

Carcinogenesis, mutagenesis, impairment of fertility

Long-term animate being studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to decide mutagenicity with prednisolone and hydrocortisone take revealed negative results.

Pregnancy

Teratogenic Effects. Pregnancy Category C.

Corticosteroids are by and large teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more stiff corticosteroids have been shown to be teratogenic subsequently dermal awarding in laboratory animals. At that place are no adequate, well-controlled studies of teratogenic effects from topically applied corticosteroids in pregnant women. Therefore, topical corticosteroids should exist used during pregnancy simply if the potential benefit justifies the potential chance to the fetus. Drugs of this class should non exist used extensively on significant patients, in large amounts, or for prolonged periods of fourth dimension.

Nursing mothers

It is not known whether topical assistants of corticosteroids could event in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities non probable to accept a deleterious outcome on the infant. Still, caution should exist exercised when topical corticosteroids are administered to a nursing woman.

Pediatric use

Pediatric patients may demonstrate greater susceptibility to topical cortico-steroid-induced HPA axis suppression and Cushing'southward syndrome than mature patients considering of a larger peel expanse 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 absenteeism 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 to the lowest degree corporeality compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.

Geriatric use

Reported clinical experience has not identified differences in responses between the elderly and younger patients. In full general, dose selection for an elderly patient should exist cautious using the to the lowest degree amount compatible with an effective therapeutic regimen and reflecting the greater frequency of decreased hepatic, renal or cardiac office, and of concomitant disease or other drug therapy.

Overdosage & Contraindications

OVERDOSE

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

CONTRAINDICATIONS

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

CLINICAL PHARMACOLOGY

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

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor 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 authorization and therapeutic efficacy in human being. 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 probable to minimize the danger of cross-sensitivity reactions in patients allergic to other local anesthetics.

Pharmacokinetics

The extent of percutaneous assimilation of topical corticosteroids is determined past many factors including the vehicle, the integrity of the epidermal barrier, and the employ of occlusive dressings.

Topical corticosteroids can exist captivated through normal intact pare. Inflammation and/or other disease processes in the peel increase the percutaneous absorption of topical corticosteroids. Occlusive dressings essentially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for handling of resistant dermatoses. (Run into DOSAGE AND ADMINISTRATION.)

Once captivated through the pare, topical corticosteroids are handled through pharmacokinetic pathways like to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are and so excreted past the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

PATIENT Information

Delight READ CAREFULLY Before USING

PATIENT INSTRUCTIONS FOR

proctofoam® HC
(hydrocortisone acetate ane% and pramoxine hydrochloride i%)

TOPICAL Droplets

Keep this insert. It contains important information about the use of procotofoam® HC.

1. Place cap on top of container. Milkshake cream container vigorously for 5-10 seconds before each employ. Practise 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 Exist HELD UPRIGHT TO OBTAIN PROPER Catamenia OF MEDICATION.



3. Pull plunger by the fill line on the applicator butt.



4. Hold the container and applicator at middle level. Place the index and heart fingers on the container cap flanges and the thumb below the container. Support the applicator with your other paw. Prime the container by pressing downwardly firmly on flanges and then release. With initial priming, a burst of air may come out of the container. It unremarkably requires 1-2 pumps for foam to announced.
5. To fill up applicator barrel, press downward firmly on cap flanges, concur for 1-2 seconds, and release. Wait 5-10 seconds to allow cream to expand in applicator barrel. Repeat until foam reaches fill line. Information technology unremarkably requires 3-4 pumps for foam to achieve make full line. Remove applicator from container cap. Notation: if foam goes beyond make full line, information technology volition continue to aggrandize and flow backwards resulting in foam build-up under cap.



6. Concord applicator firmly by butt, making sure thumb and center finger are positioned securely underneath and resting confronting butt wings. Place index finger over the plunger. Gently insert tip into anus. One time in place, push plunger to expel cream, then withdraw applicator. Caution: Practice not insert whatsoever office of the aerosol container directly into the anus. Utilise to anus only with enclosed applicator. Exercise not insert any part of applicator past the anus into rectum.



7. After each utilize, 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 exist pulled autonomously and rinsed to assist prevent build-up of cream and possible blockage.

From

Written report Bug to the Food and Drug Administration

You lot are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call ane-800-FDA-1088.

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