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Potaba® Potassium P-Aminobenzoate, U.S.P.
Prescribing Information

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  • long term oral therapy
  • low in incidence of drug interaction
  • available by prescription from any pharmacy
  • highly soluble in water, readily absorbed
  • not limiting to normal activities
  • no cumulative side effects
  • low toxicity

FORMULA:

POTABA is chemically pure Potassium P-Aminobenzoate.

DESCRIPTION:

Aminobenzoate Potassium. Potaba is available in the following forms: Capsules and Tablets. Each Capsule contains the following inactive ingredients: Colloidal Silicon Dioxide, Stearic Acid. Capsule Shell contains: Gelatin and Titanium Dioxide. The imprinting ink contains Titanium Dioxide. Each Tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Magnesium Stearate, Microcrystalline Cellulose, and Sodium Starch Glycolate.

INDICATIONS:

Based on a review of this drug by the National Academy of Sciences-National Research Council and/or other information, FDA has classified the indications as follows:

“Possibly” effective: Potassium aminobenzoate is possibly effective in the treatment of scleroderma, dermatomyositis, morphea, linear scleroderma, pemphigus, and Peyronie’s disease. Final classification of the less-than-effective indications requires further investigation.

ADVANTAGES:

POTABA 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 POTABA 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, POTABA 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 POTABA 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 POTABA therapy.3,7

SCLERODERMA: Of 135 patients with diffuse systemic sclerosis treated with POTABA, 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 POTABA, 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 Raynaud’s phenomena. 1,2

DERMATOMYOSITIS: Five patients with scleroderma and 2 with dermatomyositis were treated with POTABA. 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 Potaba 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

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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, Phila. 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 with POTABA, Journ. of Urology 81:770-772 (June 1959).
  4. Grace. William J., Kennedy, Richard J., Formato, Anthony: Therapy of Scleroderma and Dermatomyositis, N.Y. 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, Chris J. D.: Antifibrotic Therapy With POTABA, Amer. Jrnl. of Med. Sci. 248: No. 5/551-561 (Nov. 1964).
  7. Horrax, Trudeau M.: Peyronie’s Disease, Scientific Exhibit, Amer. Urological Assn. Annl. Meet., New Orleans, May 1965.

DOSAGE INFORMATION

POTABA therapy is most acceptable when taken in conjunction with meals or snacks. There are no specific foods to avoid but a normal dietary intake should be maintained. The Average Daily Adult Dosage is 12 Grams of POTABA.

DOSAGE & ADMINISTRATION:

The average adult daily dose of POTABA is 12 grams, usually given in four to six divided doses. Capsules 0.5 gram are given at the rate of 4 capsules 6 times daily, or 6 given four times daily, usually with meals, and at bedtime with a snack.

Children are given 1 gram POTABA 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. 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 a hypersensitivity reaction should occur, Potaba should be stopped.

CONTRAINDICATIONS:

POTABA should not be administered to patients taking sulfonamides.

HOW SUPPLIED:

  • POTABA Capsules 0.5 grams are supplied as number 0 white/white opaque hard gelatin capsules printed "Potaba 51" in black ink.
    Bottle of 1000 - NDC-0516-0051-10
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Page Last Updated: Monday, December 1, 2014
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