For the use of a Registered Medical Practitioner, Hospital or Laboratory only.
1. Description
AddNa contains sodium chloride. Sodium chloride (halite) is an ionic compound with the chemical formula NaCl, which has 1:1 ratio of sodium and chloride ions, having rock-salt crystal structure. In sodium chloride the molar masses of sodium and chloride is 22.99 g/mol and 35.45 g/mol respectively. Sodium chloride contributes to the salinity of seawater. It is the major component of extracellular fluid of many organisms. It has been enlisted important in model list of essential medicines by World Health Organisation. Sodium chloride is majorly used in the form of dietary salt in regular household and has an important role to play in food preservation.
Chemistry: The melting point of sodium chloride is 801°C. pH of sodium chloride solution remains 7 because of the weak basicity chloride ions.
Structure: [keep existing structure image]
2. Composition
Each film coated tablet contains:
- Sodium Chloride USP – 1 g
- Excipients – q.s.
Colour: Titanium Dioxide USP
3. Dosage Form
Tablet
4. Pharmacology
Pharmacodynamics
Supplies sodium (Na⁺) and chloride (Cl⁻) ions to replace losses caused by conditions such as vomiting, diarrhoea, excessive sweating, or certain medical disorders.
Sodium is the primary extracellular cation and helps maintain extracellular fluid volume and osmotic pressure.
Chloride works with sodium to maintain electrolyte balance and contributes to acid–base regulation.
Restoring sodium and chloride levels supports normal nerve impulse transmission, muscle contraction, and cardiovascular function.
Pharmacology and Biochemistry: Sodium is the major cation of the extracellular fluid. The major function involves maintaining the fluid volume balance, distribution of water and osmotic pressure of body fluids. Sodium is closely related with chloride and bicarbonate in the regulation of the acid-base balance of the body fluid. Chloride is the major anion present in extracellular fluid. It accompanies the metabolism of sodium and the acid-base changes that happen because of changes in chlorine concentration.
Mechanism of action: Sodium and chloride both the major components of extracellular fluid, present in the fluid compartment present outside the cells; work in synergy with each other to control the volume and pressure. Any disturbance in sodium concentrations leads to disorders of water balance. In hyponatraemia sodium chloride replenishes the deficit of sodium thereby bringing the serum sodium levels back to normal.
Pharmacokinetics
Absorption: Sodium chloride is readily absorbed from the gastrointestinal tract after oral administration, allowing effective replacement of sodium and chloride ions.
Distribution: After absorption, sodium is distributed mainly in the extracellular fluid, while chloride accompanies sodium to maintain electrical neutrality and fluid balance.
Metabolism: Sodium chloride is a naturally occurring electrolyte and is not metabolised by the body.
Elimination: Excess sodium and chloride are primarily excreted by the kidneys. Renal excretion is regulated by hormones such as aldosterone to maintain normal electrolyte and fluid balance. Small amounts are also lost through sweat and faeces.
Half-life: Sodium chloride does not have a fixed pharmacokinetic half-life because its concentration is continuously regulated by the body’s homeostatic mechanisms rather than drug metabolism.
5. Indications
It is indicated in hyponatraemia caused because of kidney, liver and heart conditions. It is indicated in SIADH (Syndrome of inappropriate antidiuretic hormone). Any patient who presents with neurologic compromise or seizures as a result of hyponatraemia requires urgent correction of serum sodium level, regardless of the rate of fall in sodium. Hyponatraemia associated with surgeries, and in intensive care units.
6. Contraindications
It is patients with hypernatraemia. Hypersensitivity to sodium chloride or any component of the formulation.
7. Precautions
Usage in special population
Paediatrics: Sodium chloride is not known to cause any unwanted side-effects. In case children become short of breath, and their face becomes puffy, doctor should be contacted. Sodium chloride should be refrained until advised.
Pregnancy: Animal reproduction studies have not been conducted. Sodium requirements do not change during pregnancy.
8. Drug Interactions
Lithium: Sodium Chloride may increase the excretion of Lithium.
Tolvaptan: Sodium Chloride may enhance the adverse/toxic effect of Tolvaptan.
9. Adverse Effects
Frequency not defined:
- Cardiovascular: Hypotension, localized phlebitis, peripheral oedema, venous thrombosis
- Central nervous system: Chills
- Dermatologic: Pruritus, skin rash, urticaria
- Endocrine & metabolic: Acid-base imbalance, electrolyte disturbance (dilution of electrolytes), hyperchloraemia, hyperchloraemic metabolic acidosis, hypernatraemia, hypervolaemia, hyponatraemia
- Neuromuscular & skeletal: Tremor
- Respiratory: Pulmonary oedema
- Miscellaneous: Fever
10. Dosage & Administration
Usual dosage for NaCl tablets are 6-9 g, daily in divided doses (e.g., 2-3 g two or three times per day) calculated according to the below mentioned formula:
Amount of Na needed to raise the Na : (Targeted concentration of Na – Current Na concentration) x (0.6 x weight in kg)
11. Overdosage
No data available.
12. Storage
Store in a dry place at a temperature not exceeding 30°C. Protect from light. Keep the medicine out of reach of children.
Additional Information
Additional pharmacokinetic information
Metabolism: Sodium chloride that reaches gastro intestinal tract remains unabsorbed for most of the parts. The liquid content passes through small intestine and bowel. On reaching the colon, the salt is taken into the blood along with the water. There is always a balance that is maintained as the excess absorbed is always being excreted by kidney. This helps the body maintain an equilibrium of dissociated ions by retaining 300 grams of salt dissolved in fluid and blood.
Absorption, distribution and excretion: Sodium absorption has a role to play in the absorption of chloride, amino-acids, glucose and water. Chloride, as HCl (hydrochloric acid), is an important component of gastric juice. Sodium in absorbed rapidly in gastro-intestinal tract. Through the sodium-potassium-adenosine-triphosphate pump the absorption occurs at the intestinal walls.
The volume of distribution is 0.64 L/kg
Sodium doesn’t bind to plasma protein
The kidney eliminates sodium through the glomerulus, but the reabsorption percentage is 60% to 70% the proximal tubules accompanied by bicarbonate and water. Additional 25% to 30% is reabsorbed in the loop of Henle accompanied by chloride and water. In the distal tubules, aldosterone facilitates the reabsorption of sodium and chloride. The renal threshold for sodium is 110 to 130 mEq/L. Less than 1% of the filtered sodium is excreted in the urine.
Half-life: Sodium chloride has no fixed elimination half-life; serum sodium is maintained by homeostatic (renal and hormonal) regulation.
13. Presentation
10 tablets in a strip, 5 strips in a Box.