Drugs List

Therapeutic Indications

Uses

Peyronie's disease
Scleroderma

Administration

For oral administration with food. One sachet should be dissolved in cold water or fruit juice.

Contraindications

Children under 18 years
Breastfeeding
Hyperkalaemia
Pregnancy
Renal impairment
Severe hepatic impairment

Precautions and Warnings

Nausea
Prolonged fasting
Vomiting
Anorexia nervosa
Cardiovascular disorder
Diabetes mellitus

Advise ability to drive/operate machinery may be affected by side effects
Correct hyperkalaemia before starting treatment
Consider discontinuing treatment until hyperkalaemia has been corrected
Monitor closely for skin reactions
Monitor hepatic function regularly
Monitor serum potassium periodically
Increased risk of hypoglycaemia with low food intake
Discontinue and do not restart if severe cutaneous adverse reactions occur
Discontinue permanently if severe hypersensitivity reactions occur
Interrupt treatment if patient is not eating enough
Advise patients of the warning signs of hypoglycaemia

Before initiating treatment an anamnestic survey of pre-existing hyperkalaemia risk factors including an initial serum potassium determination should be performed for all patients. Serum potassium should be measured at least monthly or at closer intervals (depending on risk assessment and monitoring requirements due to other risk factors) in patients with an increased risk of hyperkalaemia. Patients with an increased initial serum potassium level, the underlying cause should be identified and serum potassium levels should be corrected before the start of treatment. For these patients, monitoring after the start of treatment should also be performed monthly until long-term normal serum potassium levels are established. Monitoring is recommended at least quarterly.

Pregnancy and Lactation

Pregnancy

Potassium aminobenzoate is contraindicated during pregnancy.

The manufacturer does not recommend using potassium aminobenzoate during pregnancy. There is limited data from the use of potassium aminobenzoate in pregnancy.

Lactation

Potassium aminobenzoate is contraindicated during breastfeeding.

The manufacturer does not recommend using potassium aminobenzoate during breastfeeding. It is unknown whether potassium aminobenzoate is excreted in human breast milk. A risk to the newborns/infants cannot be excluded.

Side Effects

Anorexia
Chills
Diarrhoea
Drug rash with eosinophilia and systemic symptoms (DRESS)
Drug-induced liver injury
Elevation of liver enzymes
Hepatic failure
Hepatitis
Hepatotoxicity
Hypersensitivity reactions
Hypoglycaemia
Nausea
Pruritus
Pyrexia
Rash
Severe cutaneous adverse reactions
Stomach discomfort
Vomiting

Presentation

Oral formulations of potassium aminobenzoate.

Drugs List

Therapeutic Indications

Uses

Peyronie's disease
Scleroderma

Dosage

Adults

Administration

For oral administration with food. One sachet should be dissolved in cold water or fruit juice.

Contraindications

Children under 18 years
Breastfeeding
Hyperkalaemia
Pregnancy
Renal impairment
Severe hepatic impairment

Precautions and Warnings

Nausea
Prolonged fasting
Vomiting
Anorexia nervosa
Cardiovascular disorder
Diabetes mellitus

Advise ability to drive/operate machinery may be affected by side effects
Correct hyperkalaemia before starting treatment
Consider discontinuing treatment until hyperkalaemia has been corrected
Monitor closely for skin reactions
Monitor hepatic function regularly
Monitor serum potassium periodically
Increased risk of hypoglycaemia with low food intake
Discontinue and do not restart if severe cutaneous adverse reactions occur
Discontinue permanently if severe hypersensitivity reactions occur
Interrupt treatment if patient is not eating enough
Advise patients of the warning signs of hypoglycaemia

Before initiating treatment an anamnestic survey of pre-existing hyperkalaemia risk factors including an initial serum potassium determination should be performed for all patients. Serum potassium should be measured at least monthly or at closer intervals (depending on risk assessment and monitoring requirements due to other risk factors) in patients with an increased risk of hyperkalaemia. Patients with an increased initial serum potassium level, the underlying cause should be identified and serum potassium levels should be corrected before the start of treatment. For these patients, monitoring after the start of treatment should also be performed monthly until long-term normal serum potassium levels are established. Monitoring is recommended at least quarterly.

Pregnancy and Lactation

Pregnancy

Potassium aminobenzoate is contraindicated during pregnancy.

The manufacturer does not recommend using potassium aminobenzoate during pregnancy. There is limited data from the use of potassium aminobenzoate in pregnancy.

Lactation

Potassium aminobenzoate is contraindicated during breastfeeding.

The manufacturer does not recommend using potassium aminobenzoate during breastfeeding. It is unknown whether potassium aminobenzoate is excreted in human breast milk. A risk to the newborns/infants cannot be excluded.

Side Effects

Anorexia
Chills
Diarrhoea
Drug rash with eosinophilia and systemic symptoms (DRESS)
Drug-induced liver injury
Elevation of liver enzymes
Hepatic failure
Hepatitis
Hepatotoxicity
Hypersensitivity reactions
Hypoglycaemia
Nausea
Pruritus
Pyrexia
Rash
Severe cutaneous adverse reactions
Stomach discomfort
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: July 2021

Reference Sources

Summary of Product Characteristics: Potaba 3g Powder Sachets. Neon Healthcare Limited. Revised May 2021.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 July 2021