Sodium Citrate/ Citric Acid/ Sodium Bicarbonate/ Tartaric Acid

Registered South African indications:

• Gastric antacid
• Urinary alkalinising agent

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Sodium citrate
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Severe renal impairment
• Dehydration
• Sodium controlled diet
• Untreated Addison's disease
• Hyperkalaemia
• Severe myocardial damage

Cautions

• Breastfeeding
• Hepatic impairment
• Heart failure
• Hypertension
• Peripheral oedema
• Pulmonary oedema
• Shock
• Debilitated patients

Sodium bicarbonate
Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product

Cautions

• Pregnancy
• Renal impairment
• Hepatic impairment
• Low sodium diet
• Congestive cardiac failure
• Hypertension
• Prolonged use

Additional contraindications for this combination product

• Metabolic disturbances: alkalosis, hypochlorhydria, hypocalcaemia
• Coadministration with urinary antispasmodic which requires an acidic urine

Forms avail. in SA and covered in this monograph: gra

Gastric antacid
Urinary alkalinising agent
- Inflammatory conditions of the bladder
Prevention of crystalluria
- During sulphonamide treatment

Sodium citrate/ Sodium bicarbonate/ Tartaric acid/ Citric acid
613/1716/858/702 (mg/4g)

• Oral (gra): Initial: 4-8g, 6-8hrly; Maintenance: 4g, dly

Dissolve granules in half glass of cold water

Take on empty stomach

Dose should be followed with an additional glass of water

Paed. forms avail. in SA and covered in this monograph: gra

Gastric antacid
Urinary alkalinising agent
- Inflammatory conditions of the bladder
Prevention of crystalluria
- During sulphonamide treatment

Sodium citrate/ Sodium bicarbonate/ Tartaric acid/ Citric acid
613/1716/858/702 (mg/4g)

Younger than 6 years

• Not established for use

Between 6-12 years

• Oral (gra): Initial: 4g, 8-12hrly

Older than 12 years

• See adult dosage

Dissolve granules in half glass of cold water

Take on empty stomach

Dose should be followed with an additional glass of water

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• Caution (Sodium citrate, Sodium bicarbonate)
• Use caution with toxaemia of pregnancy
• The safety of sodium bicarbonate during lactation has not been established, but its use during these periods is not considered to constitute a hazard. Antacids containing sodium bicarbonate should not be used during pregnancy due to their potential to cause metabolic alkalosis and fluid overload

Breastfeeding

• Caution; no information available (Sodium citrate)
• Safety of sodium citrate during breastfeeding has not been established
• The safety of sodium bicarbonate during pregnancy has not been established, but its use during these periods is not considered to constitute a hazard

Renal Impairment

• Mild to moderate: Caution; no dose adjustment recommended (Sodium citrate)
• Severe: Contraindicated (Sodium citrate)

Hepatic Impairment

• Caution; no dose adjustment recommended (Sodium citrate, Sodium bicarbonate)

Elderly

• No dose adjustment recommended (Sodium citrate, Sodium bicarbonate)

Porphyria Information

• Not yet classified (NC) (Sodium citrate)

Drugs in Sport

• Permitted - No warnings

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Sodium citrate
Central Nervous System Disorders

• Tetany

Gastrointestinal Disorders

• Diarrhoea
• Nausea and vomiting

Endocrine and Metabolic Disorders

• Metabolic acidosis

Sodium bicarbonate
Gastrointestinal Disorders

• Stomach cramps
• Belching
• Flatulence

Endocrine and Metabolic Disorders

• Metabolic alkalosis
• Hypokalaemia

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Sodium citrate

• Aluminium hydroxide

Sodium bicarbonate

• Angiotensin-converting enzyme inhibitors
• Analgesics
• Antibacterial agents
• Antiepileptic agents
• Antifungal agents
• Antihistamines
• Antimalarial agents
• Antipsychotic agents
• Antiviral agents
• Bisphosphonates
• Digoxin
• Corticosteroids
• Cytotoxic agents
• Dipyridamole
• Lithium
• Penicillinamine
• Levothyroxine
• Lansoprazole

None routine. Specific cases may require

• Renal function
• Hepatic function
• Electrolytes

Sodium Citrate
Sodium citrate is metabolized to sodium bicarbonate and acts as a systemic alkaliser.  

Sodium Bicarbonate
Sodium bicarbonate has antacid properties and neutralises gastric acid with the production of carbon dioxide.

Tartaric Acid
This ingredient has no pharmacological effect.

Citric Acid
This ingredient has no pharmacological effect.

Sodium citrate/ Sodium bicarbonate/ Tartaric acid/ Citric acid is available in several formulations. Please note the list below gives examples of products which are available and is not necessarily comprehensive. The listing of a product does not constitute endorsement of the product by EMGuidance; likewise, failure to list a product does not imply that EMGuidance disapproves of the product. This information is put together on the basis of the National Government's Medicines Price Registry at the time of publication

COMBINATION PREPARATIONS

Sodium citrate/ Sodium bicarbonate/ Tartaric acid/ Citric acid (or Citric acid anhydrous)

Sachet (per 4g) 613mg/1716mg/858mg/702mg

• Citro-soda plain (Adcock)
• Citro-soda cranberry (Adcock)

Granules (per 4g) 613mg/1716mg/858mg/702mg

• Adco-Sodasol (Adcock)
• Alkafizz (Cipla)
• Citro-soda plain (Adcock)
• Citro-soda cranberry (Adcock)

Tablet effervescent 615mg/1362mg/860mg/700mg

• Uri-alk (Medchem)