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Potaba Capsules, Potaba Envules, Potaba Tablets (Glenwood)
PRODUCT OVERVIEW
KEY FACTS
Potaba® (Aminobenzoate Potassium, USP) is considered a member of the vitamin B complex. It has been suggested that the antifibrotic action of Potaba® is due to its mediation of increased oxygen uptake at the tissue level.
MAJOR USES
Potaba® offers a means of treatment of serious and often chronic entities, such as scleroderma and Peyronie's Disease.
SAFETY INFORMATION
Contraindicated in patients taking sulfonamides. Anorexia, nausea, fever and rash have occurred infrequently and subside with omission of the drug. Often, desensitization can be accomplished and treatment resumed.
PRESCRIBING INFORMATION
POTABA®Rx
Aminobenzoate Potassium, USP
Systemic ANTIFIBROSIS THERAPY
FORMULA
POTABA® is chemically pure potassium p-aminobenzoate
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.
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.
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. 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.
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.
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.
DOSAGE AND ADMINISTRATION
The average adult daily dose of POTABA® is 12 grams, usually given in four to six divided doses. Tablets and capsules 0.5 gram are given at the rate of 4 tablets or capsules 6 times daily, or 6 given four times daily, usually with meals, and at bedtime with a snack. Tablets must be taken with an adequate amount of liquid to prevent gastrointestinal upset.
POTABA® Envules contain 2 grams pure drug each. 6 Envules are given for a total of 12 grams POTABA® daily.
Children are given 1 gram POTABA® daily in divided doses for each 10 lbs. of body weight. Envules must be dissolved in an adequate amount of liquid to prevent gastrointestinal upset.
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 gm.
NDC 0516-0051-25 Bottle of 250
NDC 0516-0051-10 Bottle of 1000
POTABA Tablets --0.5 gm.
NDC 0516-0054-01 Bottle of 100
NDC 0516-0054-10 Bottle of 1000
POTABA Powder --2.0 gm Envules
NDC 0516-0052-50 Box of 50 × 2.0 gm
Rx only
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