THAM Solution for injection Ref.[10255] Active ingredients: Trometamol

Source: FDA, National Drug Code (US)  Revision Year: 2020 

2. Clinical Pharmacology

When administered intravenously as a 0.3 M solution, tromethamine act as a proton acceptor and prevents or corrects acidosis by actively binding hydrogen ions (H+). It binds not only cations of fixed or metabolic acids, but also hydrogen ions of carbonic acid, thus increasing bicarbonate anion (HCO3‾). Tromethamine also acts as an osmotic diuretic, increasing urine flow, urinary pH, and excretion of fixed acids, carbon dioxide and electrolytes. A significant fraction of tromethamine (30% at pH 7.40) is not ionized and therefore is capable of reaching equilibrium in total body water. This portion may penetrate cells and may neutralize acidic ions of the intracellular fluid.

The drug is rapidly eliminated by the kidney; 75% or more appears in the urine after eight hours. Urinary excretion continues over a period of three days.

Water is an essential constituent of all body tissues and accounts for approximately 70% of total body weight. Average normal adult daily requirement ranges from two to three liters (1.0 to 1.5 liters each for insensible water loss by perspiration and urine production).

Water balance is maintained by various regulatory mechanisms. Water distribution depends primarily on the concentration of electrolytes in the body compartments and sodium (Na+) plays a major role in maintaining physiologic equilibrium.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies with THAM Solution have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

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