Prescribing Information

Aminobenzoate Potassium, USP
Systemic Antifibrosis Therapy

ADVANTAGES: Aminobenzoate potassium offers a means of treatment of serious and often chronic entities involving fibrosis and nonsuppurative inflammation.

PHARMACOLOGY: p-Aminobenzoate is considered a member of the vitamin B complex. Small amounts are found in cereal, eggs, milk, and meats. Detectable amounts are normally present in human blood, spinal fluid, urine, and sweat. PABA is a component of several biologically important systems, and it participates in a number of fundamental biological processes.

It has been suggested that the antifibrosis action of aminobenzoate potassium is due to its mediation of increased oxygen uptake at the tissue level. Fibrosis is believed to occur from either too much serotonin or too little monoamine oxidase (MAO) activity over a period of time. Monoamine oxidase requires an adequate supply of oxygen to function properly. By increasing oxygen supply at the tissue level aminobenzoate potassium may enhance MAO activity and prevent or bring about regression of fibrosis.2

CLINICAL USES:

PEYRONIE'S DISEASE: 21 patients with Peyronie's disease were placed on aminobenzoate potassium therapy for periods ranging from 3 months to 2 years. Pain disappeared from 16 of 16 cases in which it had been present. There was objective improvement in penile deformity in 10 of 17 patients, and decrease in plaque size in 16 of 21. The authors suggest that this medication offers no hazard of further local injury as may result from other therapy. There were no significant untoward effects encountered on long term aminobenzoate potassium therapy. 3,7

SCLERODERMA: Of 135 patients with diffuse systemic sclerosis treated with aminobenzoate potassium every patient but one has shown softening of the involved skin if treatment has been continued for 3 months or longer. The responses have been reported in a number of publications.6 The treatment program consists of systemic antifibrosis therapy with aminobenzoate potassium, physical therapy, including deep breathing exercises and dynamic traction splints where indicated, and bethanechol chloride for relief of dysphagia as well as small doses of reserpine for amelioration of Reynaud's phenomena. 1,2

DERMATOMYOSITIS: Five patients with scleroderma and 2 with dermatomyositis were treated with aminobenzoate potassium. There was striking clinical improvement in each patient. Doses of 15-20 grams per day were well tolerated, and patients were easily able to take these doses.4

MORPHEA and LINEAR SCLERODERMA: All 14 patients with localized forms of scleroderma placed on long-term aminobenzoate potassium treatment showed softening of the sclerotic component of their disorder. Treatment is particularly indicated in patients where persistent compressive sclerosis may contribute even greater disfigurement or functional embarrassment from secondary pressure atrophy. 5,6

DOSAGE & ADMINISTRATION: The average adult daily dose of aminobenzoate potassium is 12 grams, usually given in four to six divided doses. Capsules and tablets 0.5 gram are given at the rate of 4 capsules or tablets 6 times daily, or 6 given four times daily, usually with meals, and at bedtime with a snack. Tablets must be dissolved in an adequate amount of liquid to prevent gastrointestinal upset.

Children are given 1 gram aminobenzoate potassium daily in divided doses for each 10 lbs. of body weight.

SIDE EFFECTS: Anorexia, nausea, fever and rash have occurred infrequently and subside with omission of the drug. Often, desensitization can be accomplished and treatment resumed.

USAGE IN PREGNANCY: Safety for use in pregnancy or during lactation has not been established.

PRECAUTIONS: Should anorexia or nausea occur, therapy is interrupted until the patient is eating normally again. This permits prompt subsidence of symptoms and also avoids the possible development of hypoglycemia. Give cautiously to patients with renal disease. If hypersensitivity reaction should occur, aminobenzoate potassium should be stopped.

CONTRAINDICATIONS: Aminobenzoate potassium should not be administered to patients taking sulfonamides.

STORAGE: Store at room temperature 15° - 30° C (59° - 86° F).

HOW SUPPLIED:
Aminobenzoate Potassium Capsules 0.5 gm
NDC 60267-953-01, Bottle of 100
NDC 60267-953-25, Bottle of 250
NDC 60267-953-10, Bottle of 1000
Identification: "HOPE" and "953"

Aminobenzoate Potassium Tablets 0.5 gm
NDC 60267-944-01, Bottle of 100
NDC 60267-944-10, Bottle of 1000
Identification: "HOPE" and "944"

Rx Only.

Keep out of reach of children.

References

1. From: Inflammation and Diseases of Connective Tissue, Edited by Drs. Lewis C. Mills and John H. Moyer. Published by W. B. Saunders Company, Philadelphia, PA 1961.
2. Zarafonetis, Chris J. D.: Treatment of Scleroderma. Annals of Int. Med. 50: 343-365 (1959).
3. Zarafonetis, C. J. D., and Horrax, T. M.: Treatment of Peyronie's Disease. J. of Urology 81: 770-772 (1959).
4. Grace, William J., et al. Therapy of Scleroderma and Dermatomyositis. NY State J. of Med. 63: 140-144 (1963).
5. Zarafonetis, C. J. D.: Treatment of Localized Forms of Scleroderma. Am. J. Med. Sci. 243: 147-158 (1962).
6. Zarafonetis, C. J. D.: Antifibrotic Therapy. Am. J. of Med. Sci. 248: 551-561 (1964).
7. Horrax, T.: Peyronie's Disease, Scientific Exhibit. Am. Urological Assn. Annl. Meet. New Orleans. May 1965.

Manufactured by Anabolic, Inc. in Irvine, CA for Hope Pharmaceuticals.