Sodium Bicarbonate Injection 8.4%W/V
Product Summary
1. NAME OF THE MEDICINAL PRODUCT
Sodium Bicarbonate Injection BP 8.4% w/v
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Bicarbonate BP 8.4% w/v
3. PHARMACEUTICAL FORM
Solution for injection.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
For the control of severe metabolic acidosis, such as renal failure, diabetic coma, or foliowing cardiac arrest.
4.2 Posology and method of administration
Adults, the elderly and children.
By slow intravenous injection or infusion.
An amount appropriate to the body - base deficiency up to 300 mmol. Plasma pH should be measured at regular intervals.
4.3 Contraindications
Not to be administered to patients with metabolic or respiratory alkalosis, hypocalcaemia, hypochlorhydria, hypertension, hypoventilation, chloride depletion or hyperosmolar states such as anuria or oliguria, edematous sodium retaining conditions such as hepatic cirrhosis, congestive heart failure and toxemia of pregnancy.
Administration of sodium bicarbonate is contraindicated in patients taking diuretics known to produce hypochloremic alkalosis.
4.4 Special warnings and special precautions for use
Overtreatment with bicarbonate must be avoided. Frequent monitoring of serum electrolytes and acid-base status is essential.
Sodium bicarbonate should be administered with extreme caution to patients with oedema, aldosteronism, potassium depletion or respiratory acidosis.
4.5 Interaction with other medicinal products and other forms of interaction
Caution should be used when administering sodium ions to patients receiving corticosteroids or corticotropin.
Urinary alkalisation will increase renal clearance of tetracyclines, especially doxycycline. It will increase the half-lives and duration of action of basic drugs such as quinidine, amphetamines, ephedrine and pseudoephedrine.
Concurrent use in patients taking potassium supplements decreases serum potassium concentrations by promoting an intracellular ion shift. Hypochloremic alkalosis may occur if used in conjunction with potassium-depleting diuretics such as bumetanide, etacrynic acid, furosemide and thiazides.
4.6 Pregnancy and lactation
Use with caution, under the supervision of a physician.
Safe use during pregnancy has not been established. Patients requiring intravenous infusions of sodium bicarbonate are unlikely to be in a fit condition to breast-feed.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Undiluted sodium bicarbonate injection is hypertonic. Tissue necrosis, ulceration or sloughing has been reported following extravasation at the site of injection.
4.9 Overdose
Excessive administration of bicarbonate may lead to metabolic alkalosis especially in patients with impaired renal function.
Symptoms: Compensatory hyperventilation, paradoxical acidosis in the cerebrospinal fluid, severe
hypokalemia, volume overload, pulmonary oedema, shortness of breath, muscle weakness (associated with potassium depletion). Muscle hypertonicity, twitching, hyperirritability and tetany may develop especially in hypocalcaemic patients. Seizures may be exacerbated or precipitated in epileptic patients.
Excessive doses of sodium salts may also lead to sodium overloading and hyperosmolality.
Treatment: Discontinue the administration of sodium bicarbonate. The control of symptoms may be
temporarily alleviated by rebreathing expired air. Treatment of metabolic alkalosis associated with bicarbonate consists mainly of correction of fluid levels and electrolyte balance as well as any hypernatraemia associated with excessive sodium intake.
If more severe calcium gluconate can be administered. In severe alkalosis, an intravenous infusion of 2.14% ammonium chloride is recommended, except in patients with preexisting hepatic disease.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The pH of plasma is normally maintained at around 7.4, the plasma-bicarbonate concentration in the range 22 to 30 mmol per litre and the partial pressure of carbon dioxide (pCO2) at 40 mm Hg by means of respiratory, renal and buffering mechanisms.
The most important buffer system is the bicarbonate-carbonic acid system, which operates on a compensatory basis in the regulation of the acid- base balance.
Pharmacokinetic properties
5.2
Carbonic acid, the principal acidic end product of metabolism, exists in a dynamic equilibrium with carbon dioxide and water in body fluids, which in turn are in equilibrium with bicarbonate and hydrogen ions as shown in the equation.
H2CO3 <> H2O + CO2 <> H+ + HCO3 -
5.3 Preclinical safety data
None stated.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Disodium Edetate and Water for Injections.
6.2 Incompatibilities
Precipitant haze will occur when added to parenteral solutions containing calcium.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
None stated.
6.5 Nature and contents of container
5 ml in type 1 colourless glass ampoules. Fusion sealed. 10 ml in type 1 colourless glass ampoules. Fusion sealed. Packed into cartons of 10 ampoules.
6.6 Instructions for use and handling
None stated.
Administrative Data
7. MARKETING AUTHORISATION HOLDER
Macarthys Laboratories Ltd t/a Martindale Pharmaceuticals Bampton Road,
Harold Hill,
Romford,
RM3 8UG
MARKETING AUTHORISATION NUMBER
8.
PL 1883/0023
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
First authorised: 10 August 1983 Last renewed: 10 November 1999
10. DATE OF (PARTIAL) REVISION OF TEXT
July 2004