POTABA Powder for oral solution Ref.[108421] Active ingredients: 4-Aminobenzoic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2022  Publisher: Neon Healthcare Ltd., 8 The Chase, John Tate Road, Hertford, SG13 7NN, United Kingdom

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Other dermatological preparations, Other dermatologicals
ATC code: D11AX23

Mechanism of action

Potassium para-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. The pharmacological action of this chemical has not been clearly established, but it has been suggested that the antifibrosis activity of potassium para-aminobenzoate is brought about by the drug increasing oxygen uptake at the tissue level. Fibrosis is believed to occur from either too much serotonin or too little monoamine oxidase activity over a period of time. The activity of monoamine oxidase is dependent on an adequate oxygen supply. By increasing oxygen supply at tissue level potassium para-aminobenzoate enhances monoamine oxidase activity thereby preventing or bringing about regression of fibrosis.

5.2. Pharmacokinetic properties

Absorption

Aminobenzoate is well absorbed after oral administration.

Oral administration of 3 g Potassium para-aminobenzoate to healthy volunteers resulted in maximum plasma levels of 29-74 μg/mL after 41-90 min. followed by rapid decrease to less than 10 μg/mL after 4 h.

Elimination

Potassium and conjugated aminobenzoate are eliminated by the kidney.

5.3. Preclinical safety data

In-vitro bacterial tests with para-aminobenzoate revealed no mutagenic potential. There are no long-term tests for carcinogenic potential. Adequate reproductive toxicity tests are not available for potassium para-aminobenzoate. In limited studies in pregnant rats, oral administration of 50 mg/kg/day para-aminobenzoate reduced foetal weights. In animal experiments, para-aminobenzoate crosses the placenta.

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