Nodosis

For the use of a Registered Medical Practitioner, Hospital or Laboratory only.

1. Description

Nodosis is Sodium Bicarbonate tablets which is used as an alkalinizing agent in the treatment of metabolic acidosis. Sodium bicarbonate also may be used as an alkalinizing agent in advanced cardiovascular life support (ACLS) during cardiopulmonary resuscitation (CPR) and in the treatment of certain intoxications (e.g., methyl alcohol, phenobarbital, salicylates) to decrease renal reabsorption of the drug or to correct acidosis.

Sodium Bicarbonate also is used to increase urinary pH in order to increase the solubility of certain weak acids (e.g., cystine, sulfonamides, uric acid) or in the treatment of haemolytic reactions requiring alkalinization of the urine to diminish the nephrotoxic effects of blood pigments. In addition, the drug is used in the treatment of severe diarrhoea accompanied by substantial GI bicarbonate loss and as an adjunct in the treatment of hyperkalaemia to induce the cellular uptake of potassium and return the ratio of intracellular to extra cellular potassium concentration toward normal.

2. Composition

  • Nodosis – Each film coated tablet of Nodosis contains Sodium Bicarbonate IP 500 mg
  • Nodosis DS – Each film-coated tablet contains: Sodium Bicarbonate IP – 1000 mg
  • Nodosis 2G – Each sachet contains: Sodium Bicarbonate IP – 2000 mg; Excipients – q.s.; Colour: Titanium Dioxide IP
  • Nodosis GST – Each Enteric-coated tablet contains: Sodium Bicarbonate IP – 500 mg
  • Nodosis DS GST – Each Enteric-coated tablet contains: Sodium Bicarbonate IP – 1000 mg
  • Nodosis Suspension – Each 15 mL contains: Sodium Bicarbonate IP – 1000 mg, in a flavoured syrupy base of sorbitol; Colour: Tartrazine

3. Dosage Form

  • Nodosis – Tablet
  • Nodosis DS – Tablet
  • Nodosis 2G – Granules (sachet)
  • Nodosis GST – Tablet
  • Nodosis DS GST – Tablet
  • Nodosis Suspension – Oral Suspension

4. Pharmacology

Pharmacodynamics

Sodium bicarbonate is an alkalinising agent that replenishes bicarbonate ions and corrects metabolic acidosis by increasing plasma bicarbonate concentration. It buffers excess hydrogen ions, raises blood pH, and restores the body’s acid-base balance. These effects help reverse the clinical manifestations of metabolic acidosis.

In patients with chronic kidney disease (CKD), sodium bicarbonate reduces the acid load, helping to maintain normal physiological pH and slow the progression of metabolic complications associated with chronic metabolic acidosis. It also increases urinary pH, enhancing the solubility and excretion of weak acids such as uric acid and cystine. Additionally, urinary alkalinisation may reduce renal tubular toxicity from certain drugs and pigments.

Sodium Bicarbonate (Nodosis) therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis. Plasma concentration is regulated by the kidney through acidification of the urine when there is a deficit or by alkalinization of the urine when there is an excess. Bicarbonate anion is considered “labile” since at a proper concentration of hydrogen ion (H+) it may be converted to carbonic acid (H2CO3) and hence to its volatile form, carbon dioxide (CO2) excreted by the lung. Normally a ratio of 1:20 (carbonic acid; bicarbonate) is present in the extra cellular fluid. In a healthy adult with normal kidney function, practically all the glomerular filtered bicarbonate ion is reabsorbed; less than 1% is excreted in the urine.

Pharmacokinetics

Absorption

Sodium bicarbonate is readily absorbed from the gastrointestinal tract following oral administration. After absorption, bicarbonate ions enter the systemic circulation and contribute to the body’s bicarbonate buffering system.

Distribution

Bicarbonate is distributed predominantly within the extracellular fluid, where it serves as the principal physiological buffer. It rapidly equilibrates with carbonic acid and dissolved carbon dioxide, helping maintain systemic acid-base homeostasis.

Metabolism

Sodium bicarbonate is not metabolised. Following absorption, bicarbonate participates directly in the physiological bicarbonate-carbonic acid buffer system. In the presence of hydrogen ions, bicarbonate forms carbonic acid, which is subsequently converted by carbonic anhydrase into carbon dioxide (CO₂) and water (H₂O). The carbon dioxide is eliminated through the lungs.

Elimination

Bicarbonate homeostasis is regulated primarily by the kidneys. Under normal physiological conditions, nearly all filtered bicarbonate is reabsorbed by the renal tubules, with less than 1% excreted unchanged in the urine. When plasma bicarbonate concentrations exceed the renal threshold, excess bicarbonate is excreted in the urine, resulting in urinary alkalinisation. Carbon dioxide generated during buffering reactions is eliminated through pulmonary exhalation.

5. Indications

Sodium Bicarbonate (Nodosis) is indicated in the treatment of metabolic acidosis; promotion of gastric, systemic, and urinary alkalinization; replacement therapy in severe diarrhoea; used to reduce incidence of chemical phlebitis.

6. Contraindications

Sodium Bicarbonate (Nodosis) is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction and in patients receiving diuretics known to produce a hypochloraemic alkalosis, metabolic and respiratory alkalosis; hypocalcaemia in which alkalosis may produce tetany, hypertension, convulsions or CHF; when administration of sodium could be clinically detrimental.

7. Precautions

Sodium Bicarbonate should not be used if you have certain medical conditions. Before using this product, consult your doctor if you have: a certain breathing problem (pulmonary oedema), congestive heart failure, severe kidney disease (e.g., inability to make urine), severe liver disease (e.g., ascites, cirrhosis), high sodium levels, and swollen ankles/legs/feet due to retaining water (peripheral oedema). If you have any of the following health problems, consult your doctor before using Sodium Bicarbonate: low calcium levels, high blood pressure, heart problems (e.g., irregular heartbeat) and kidney disease.

Because this medication contains salt (sodium), do not use if you are on a salt-restricted diet.

During pregnancy, this medication should be used only when clearly needed. This medication may worsen high blood pressure during pregnancy (toxemia of pregnancy). Discuss the risks and benefits with your doctor.

This medication may pass into breast milk. Consult doctor before breast-feeding.

8. Drug Interactions

Concomitant Therapy: Sodium Bicarbonate can decrease elimination of amphetamine, dextroamphetamine, ephedrine, flecainide, mecamylamine, methamphetamine, pseudoephedrine and quinidine, thus increasing their therapeutic effects.

Sodium Bicarbonate can increase elimination of Chlorpropamide, lithium, methotrexate, salicylates and tetracyclines, thus decreasing their therapeutic effects.

9. Adverse Effects

Some of the side effects although may occur rarely with Sodium Bicarbonate are nausea or vomiting, headache, muscle pain, swelling of feet, ankles or legs, decreased appetite, unusual tiredness, constipation, dry mouth or increased thirst or increased urination.

Some of the common adverse reactions which may occur with Sodium Bicarbonate are Exacerbation of CHF, Rebound hyperacidity, milk-alkali syndrome, Hypernatraemia, alkalosis, Extravasations with cellulitis, tissue necrosis, ulceration, venous irritation, tetany or oedema.

10. Dosage & Administration

The dose of Sodium Bicarbonate will be different for different patients. Usual Adult Dose for Moderate metabolic acidosis is 325 to 2000 mg orally 1 to 4 times a day. (Patients younger than 60 yr of age, max dose 16 g/day; patients older than 60 yr of age max dose 8 g/day).

Nodosis Suspension: shake well before use.

11. Overdosage

Sodium Bicarbonate should be stopped in alkalosis, manage the patient according to the degree of alkalosis present. 0.9% sodium chloride injection intravenous may be given; potassium chloride also may be indicated if there is hypokalaemia. Severe alkalosis may be accompanied by hyperirritability or tetany and these symptoms may be controlled by calcium gluconate. An acidifying agent such as ammonium chloride may also be indicated in severe alkalosis.

12. Storage

Store in a cool, dry place. Protect from light and moisture.

Nodosis 2G and Nodosis Suspension: store in a cool & dry place; protect from moisture. Keep the medicine out of reach of children.

Additional Information

Milliequivalence

5.95 mEq of Sodium & Bicarbonate in 500 mg of Nodosis Tablet, 11.9 mEq of Sodium & Bicarbonate in 1000 mg of Nodosis-DS Tablet, 11.9 mEq of Sodium & Bicarbonate in 15 mL of Nodosis Suspension, 5.95 mEq of Sodium & Bicarbonate in 500 mg of Nodosis-GST Tablet. 23.8 mEq of Sodium & Bicarbonate in 2 g of Nodosis-2G

13. Presentation

  • Nodosis – 15 Tablets in a strip, 10 strips in a Box.
  • Nodosis DS – 15 Tablets in a Strip, 20 Strips in a Box.
  • Nodosis 2G – 2.5 g granules sachet, 15 sachets in a Box.
  • Nodosis GST – 10 Tablets in a Strip, 20 Strips in a Box.
  • Nodosis DS GST – 10 Tablets in a Strip, 20 Strips in a Box.
  • Nodosis Suspension – 300 mL bottle in a Box.

Disclaimer: The information provided herein is not medical advice and is not intended to replace medical advice offered by a health care provider. Please consult your health care provider for advice.