THAMICARB Oral solution Ref.[49927] Active ingredients: Sodium bicarbonate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2020  Publisher: Syri Limited, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK Trading as: Thame Laboratories, Unit 4, Bradfield Road, Ruislip, Middlesex, HA4 0NU, UK. OR Trading as: SyriMed, Unit 4, Bradfield ...

5.1. Pharmacodynamic properties

ATC Code: A02AH, antacids with sodium bicarbonate.

Sodium bicarbonate is used as an antacid in relief of the symptoms of dyspepsia, heartburn and indigestion caused by excess gastrointestinal acid. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide.

Sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses clinical manifestations of metabolic acidosis.

5.2. Pharmacokinetic properties

Absorption

Sodium bicarbonate is readily absorbed from the gastro-intestinal tract.

Sodium bicarbonate exists as a sodium ion and bicarbonate ion within Thamicarb 84mg/ml Oral Solution. Once orally administered, the bicarbonate ion readily binds to hydrochloric acid in the stomach to form sodium chloride, carbon dioxide and water.

Bicarbonate ions which do not react with hydrochloric acid within the stomach are readily emptied into the duodenum via the pylorus. Bicarbonate ions are then readily absorbed through the small intestine where they enter general circulation. A linear dose dependent relationship between sodium bicarbonate supplementation and serum bicarbonate levels has been shown in CKD patients with metabolic acidosis.

Distribution

Sodium bicarbonate is present in all body fluids. Sodium bicarbonate causes neutralisation of gastric acid with the production of carbon dioxide.

The bicarbonate ion is freely soluble in the blood stream and readily crosses the blood brain barrier. The site of action of bicarbonate ions with respect to metabolic acidosis is the blood stream.

Biotransformation

The bicarbonate ion is a simple electrolyte and is therefore not hepatically metabolised but rather eliminated from the body via excretion.

Elimination

Any bicarbonate not involved in the gastric acid neutralisation reaction is absorbed. The bicarbonate ion is excreted through various bodily pathways. Firstly, sodium bicarbonate is excreted via the pulmonary system. This involves the bicarbonate ion binding with a free hydrogen ion to form carbonic acid which is then broken down into carbon dioxide and water in the presence of carbonic anhydrase and excreted through the lungs. Bicarbonate ions readily pass through the renal cortex and are eliminated via urine.

5.3. Preclinical safety data

No further relevant information.

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