Ampoules

- MEYLON 84

8.4% Sodium Bicarbonate Intravenous Infusion B.P.
Therapeutic Class

Systemic Alkalinisation Electrolyte Solution

Description and Composition

 

MEYLON

(8.4% Sodium Bicarbonate Intravenous Infusion B.P.)
 
Therapeutic Class
 
Systemic Alkalinisation Electrolyte Solution
 
Description and Composition
 
A clear, colorless, sterile solution each 25 ml. of which contains:
 
Sodium Bicarbonate B.P.        2.1 grams Water for Injections                q.s.
 
Pharmacological Effects
 
  • Bicarbonate is an alkalinizing agent and intravenous bicarbonate containing salts are often used to manage severe metabolic acidosis.
  • Systemic alkali therapy acting as a buffer, helps in correction of acidosis and improves hemodynamic status.
  • Intravenous infusion of sodium bicarbonate can enhance  the excretion of salicylate by elevating intraluminal pH. This helps in secretion and trapping of salicylate in      tubular lumen.
  • Provides the following electrolytes in each liter of fluid:
 
Sodium:              1000 mEq
Bicarbonate:          1000 mEq
 
  • Each ampoule 25 mL provides 25 mEq of sodium and 25 mEq of bicarbonate.
  • The pH range is 7.5 – 9.5
 
Indications
 
  • In management of metabolic acidosis such as ketoacidosis, hyperchloremic acidosis and lactic acidosis.
  • Bicarbonate therapy is also indicated for severe metabolic acidosis after cardiac arrest.
  • Management of overdosage or poisoning with toxins such as salicylate, methanol and ethylene glycol in conjunction with other measures.
 
Dosage and Administration
 
Bicarbonate solution should be used in accordance with the weight and clinical condition of the patient. Generally, sufficient bicarbonate should
 
be   administered     to

achieve    pH   levels    above    7.1.   The   amount    of
 
bicarbonate required varies and also depends upon the rate of ongoing acid production.
 
As  a  general  guideline,  the  amount  of  bicarbonate  administered  is determined as follows:
 
  • Desired increase in bicarbonate concentration x 0.5 x body weight (kg)
 
No more than half of bicarbonate concentration deficit should be corrected over a 3-4 hour period without monitoring arterial blood gases. The response to bicarbonate administration should be closely monitored to avoid volume overload and induction of alkalosis. In severe cases, dialysis with bicarbonate dialysate should be considered.
 
Adverse Effects
 
  • Hypernatremia and hyperosmolarity may occur.
  • Hypokalemia. Correction of acidosis leads to movement of potassium inside the cells causing hypokalemia.
  • Hypercapnia amy occur. Bicarbonate administration can result in a rapid increase in PCO2 that can diffuse across cell membranes worsening intracellular acidosis.
  • Alkalosis, tetany and carpopedal spasm may occur. Rapid correction of metabolic acidosis can lead to tetany as a result of a decrease in ionized calcium concentrations.
 
Contraindications
 
  • Alkalosis.
  • Renal insufficiency
 
Precautions
 
  • The sodium bicarbonate content of Meylon is 84 mg/mL. Care is therefore required in those cases where salt intake is restricted, such as in hypertensive patients, congestive heart failure or pre-eclampsia. Care is required to avoid volume overload.
  • Care is required in patients with preexisting potassium deficiency as it can promote movement of extracellular potassium into the cells and thus worsen hypokalemia. Cardiac monitoring for arrhythmias is essential in such patients.
 
  • Overcorrection of acidosis can lead to alkalosis with the risk of tetany.
  • Care is required in administration as extravasation of the solution may result in tissue necrosis at the site of administration.
 
Overdosage
 
Excessive administration may lead to metabolic alkalosis, hypokalemia and tetany. Symptoms may include tiredness, muscular weakness, shortness of breath and muscle twitching.
 
Management consists mainly of appropriate correction of electrolyte balance. Replacement of potassium, calcium and chloride are of particular importance.
 
Tonicity and Osmolarity
 
Hypertonic solution having a tonicity of 1000. Hyperosmotic solution (~ 2000 mOsm/L)
 
Caloric Value
 
Nil
 
Pharmaceutical Precautions
 
  • Store at room temperature. Protect from sunlight.
  • Do not  use  if  ampoule  is leaking,  solution  is  cloudy or  contains foreign matter.
  • Discard unused portion.
  • Keep all medicines out of the reach of children.
  • Shelf life is three years from the date of manufacturing

Packaging
 
  • 25 mL. in polyethylene, twist-off, plastic ampoules.
 
 
 
 
 
 

MEYLON 84
8.4% Sodium Bicarbonate Intravenous Infusion B.P.
Therapeutic Class

Systemic Alkalinisation Electrolyte Solution

Description and Composition

 

MEYLON

(8.4% Sodium Bicarbonate Intravenous Infusion B.P.)
 
Therapeutic Class
 
Systemic Alkalinisation Electrolyte Solution
 
Description and Composition
 
A clear, colorless, sterile solution each 25 ml. of which contains:
 
Sodium Bicarbonate B.P.        2.1 grams Water for Injections                q.s.
 
Pharmacological Effects
 
  • Bicarbonate is an alkalinizing agent and intravenous bicarbonate containing salts are often used to manage severe metabolic acidosis.
  • Systemic alkali therapy acting as a buffer, helps in correction of acidosis and improves hemodynamic status.
  • Intravenous infusion of sodium bicarbonate can enhance  the excretion of salicylate by elevating intraluminal pH. This helps in secretion and trapping of salicylate in      tubular lumen.
  • Provides the following electrolytes in each liter of fluid:
 
Sodium:              1000 mEq
Bicarbonate:          1000 mEq
 
  • Each ampoule 25 mL provides 25 mEq of sodium and 25 mEq of bicarbonate.
  • The pH range is 7.5 – 9.5
 
Indications
 
  • In management of metabolic acidosis such as ketoacidosis, hyperchloremic acidosis and lactic acidosis.
  • Bicarbonate therapy is also indicated for severe metabolic acidosis after cardiac arrest.
  • Management of overdosage or poisoning with toxins such as salicylate, methanol and ethylene glycol in conjunction with other measures.
 
Dosage and Administration
 
Bicarbonate solution should be used in accordance with the weight and clinical condition of the patient. Generally, sufficient bicarbonate should
 
be   administered     to

achieve    pH   levels    above    7.1.   The   amount    of
 
bicarbonate required varies and also depends upon the rate of ongoing acid production.
 
As  a  general  guideline,  the  amount  of  bicarbonate  administered  is determined as follows:
 
  • Desired increase in bicarbonate concentration x 0.5 x body weight (kg)
 
No more than half of bicarbonate concentration deficit should be corrected over a 3-4 hour period without monitoring arterial blood gases. The response to bicarbonate administration should be closely monitored to avoid volume overload and induction of alkalosis. In severe cases, dialysis with bicarbonate dialysate should be considered.
 
Adverse Effects
 
  • Hypernatremia and hyperosmolarity may occur.
  • Hypokalemia. Correction of acidosis leads to movement of potassium inside the cells causing hypokalemia.
  • Hypercapnia amy occur. Bicarbonate administration can result in a rapid increase in PCO2 that can diffuse across cell membranes worsening intracellular acidosis.
  • Alkalosis, tetany and carpopedal spasm may occur. Rapid correction of metabolic acidosis can lead to tetany as a result of a decrease in ionized calcium concentrations.
 
Contraindications
 
  • Alkalosis.
  • Renal insufficiency
 
Precautions
 
  • The sodium bicarbonate content of Meylon is 84 mg/mL. Care is therefore required in those cases where salt intake is restricted, such as in hypertensive patients, congestive heart failure or pre-eclampsia. Care is required to avoid volume overload.
  • Care is required in patients with preexisting potassium deficiency as it can promote movement of extracellular potassium into the cells and thus worsen hypokalemia. Cardiac monitoring for arrhythmias is essential in such patients.
 
  • Overcorrection of acidosis can lead to alkalosis with the risk of tetany.
  • Care is required in administration as extravasation of the solution may result in tissue necrosis at the site of administration.
 
Overdosage
 
Excessive administration may lead to metabolic alkalosis, hypokalemia and tetany. Symptoms may include tiredness, muscular weakness, shortness of breath and muscle twitching.
 
Management consists mainly of appropriate correction of electrolyte balance. Replacement of potassium, calcium and chloride are of particular importance.
 
Tonicity and Osmolarity
 
Hypertonic solution having a tonicity of 1000. Hyperosmotic solution (~ 2000 mOsm/L)
 
Caloric Value
 
Nil
 
Pharmaceutical Precautions
 
  • Store at room temperature. Protect from sunlight.
  • Do not  use  if  ampoule  is leaking,  solution  is  cloudy or  contains foreign matter.
  • Discard unused portion.
  • Keep all medicines out of the reach of children.
  • Shelf life is three years from the date of manufacturing

Packaging
 
  • 25 mL. in polyethylene, twist-off, plastic ampoules.
 
 
 
 
 
 


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