Panafil Ointment (Healthpoint)

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DESCRIPTION

PANAFIL Ointment is an enzymatic healing-debriding ointment which contains papain, USP (not less than 405,900 USP units of activity based on Lot I0C389 per gram of ointment); urea, USP 10%; and chlorophyllin copper complex sodium, USP 0.5% in a hydrophilic base composed of boric acid, chlorobutanol (anhydrous) as a preservative, polyoxyl 40 stearate, propylene glycol, purified water, sodium borate, sorbitan monostearate, stearyl alcohol, and white petrolatum.

CLINICAL PHARMACOLOGY

Papain, the proteolytic enzyme derived from the fruit of carica papaya, is a potent digestant of nonviable protein matter, but is harmless to viable tissue. It has the unique advantage of being active over a wide pH range, 3 to 12. Despite its recognized value as a digestive agent, papain is relatively ineffective when used alone as a debriding agent, primarily because it requires the presence of activators to exert its digestive function. Urea is combined with papain to provide two supplementary chemical actions: 1) to expose by solvent action the activators of papain (sulfhydryl groups) which are always present, but not necessarily accessible, in the nonviable tissue or debris of lesions, and 2) to denature the nonviable protein matter in lesions and thereby render it more susceptible to enzymatic digestion. In pharmacologic studies involving digestion of beef powder, Miller ¹ showed that the combination of papain and urea produced twice as much digestion as papain alone.

Chlorophyllin Copper Complex Sodium adds healing action to the cleansing action of the proteolytic papain-urea combination. The basic wound-healing properties of Chlorophyllin Copper Complex Sodium are promotion of healthy granulations, control of local inflammation and reduction of wound odors. ² Specifically, Chlorophyllin Copper Complex Sodium inhibits the hemagglutinating and inflammatory properties of protein degradation products in the wound, including the products of enzymatic digestion, thus providing an additional protective factor. ^1,3 The incorporation of Chlorophyllin Copper Complex Sodium in PANAFIL Ointment permits its continuous use for as long as desired to help produce and then maintain a clean wound base and to promote healing.

INDICATIONS AND USES

PANAFIL Ointment is suggested for treatment of acute and chronic lesions such as varicose, diabetic and decubitus ulcers, burns, postoperative wounds, pilonidal cyst wounds, carbuncles and miscellaneous traumatic or infected wounds.

PANAFIL Ointment is applied continuously throughout treatment of these conditions (1) for enzymatic debridement of necrotic tissue and liquefaction of fibrinous, purulent debris, (2) to keep the wound clean, and simultaneously (3) to promote normal healing.

CONTRAINDICATIONS

Do not use if you are allergic to or have known or suspected hypersensitivity to any ingredient in this product.

PRECAUTIONS

See Dosage and Administration . Not to be used in eyes.

ADVERSE REACTIONS

PANAFIL Ointment is generally well tolerated and nonirritating. A small percentage of patients may experience a transient "burning" sensation on application of the ointment. Occasionally, the profuse exudate resulting from enzymatic digestion may cause irritation. In such cases, more frequent changes of dressings until exudate diminishes will alleviate discomfort.

DOSAGE AND ADMINISTRATION

Cleanse the wound with ALLCLENZ® Wound Cleanser or saline. Avoid cleansing with hydrogen peroxide solution as it may inactivate the papain. Apply PANAFIL Ointment directly to the wound, cover with appropriate dressing, and secure into place. Note: Papain may also be inactivated by the salts of heavy metals such as lead, silver and mercury. Contact with medications containing these metals should be avoided. When practicable, daily or twice daily changes of dressings are preferred. Longer intervals between redressings (two or three days) have proved satisfactory, and PANAFIL Ointment may be applied under pressure dressings.

HOW SUPPLIED

30g tube, 6g tube. Store at controlled room temperature 20°-25°C (68°-77°F).

1. Miller, J.M.: The Interaction of Papain, Urea and Water-Soluble Chlorophyll in a Proteolytic Ointment for Infected Wounds, Surgery 43:939, 1958.
2. Smith, L.W.: The Present Status of Topical Chlorophyll Therapy, New York J. Med. 55:2041, 1955.
3. Barnard, R.D.: Elucidation of Chemically Defined Haptens For Competitive Inhibition of Aggressin Activity, Immunol. 8:78, 1954.

PANAFIL Ointment is a registered trademark of Healthpoint, Ltd.

ALLCLENZ Wound Cleanser is a registered trademark of Healthpoint, Ltd.

Marketed by:

Healthpoint®

Healthpoint, Ltd.

Fort Worth, Texas 76107

1-800-441-8227

www.Healthpoint.com

Manufactured by:

DPT Laboratories, Ltd.

San Antonio, Texas 78215

128156-1204

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