SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Sodium Bicarbonate Injection BP Minijet 4.2% w/v

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium Bicarbonate BP 4.2% w/v

Each 42 mg/ml injection contains 11.5 mg of Na+/ml.

For the full list of excipients,see section 6.1

3.    PHARMACEUTICAL FORM

Sterile aqueous solution for parenteral administration to humans.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

Sodium Bicarbonate Injection is indicated in adults and children for:

•    Correction of metabolic acidosis associated with cardiac arrest in patients with pre-existing metabolic acidosis

•    Cardiac arrest associated with hyperkalaemia with pre-existing metabolic acidosis

•    Life threatening hyperkalaemia with pre-existing metabolic acidosis

•    Tricyclic antidepressant overdose.

Sodium bicarbonate should only be used after other resuscitative measures such as cardiac compression, ventilation, adrenaline and antiarrhythmic agents have been attempted.

In neonates, Sodium Bicarbonate is indicated for:

•    Correction of metabolic acidosis associated with cardiac arrest in patients with pre-existing metabolic acidosis

•    Cardiac arrest associated with hyperkalaemia with pre-existing metabolic acidosis

No benefits have been demonstrated from the routine use of sodium bicarbonate in resuscitation of neonates. In neonates, sodium bicarbonate is recommended in resuscitation only in cases of prolonged cardiac arrest, irresponsive to other therapy, after establishment of adequate ventilation and circulation.

4.2 Posology and method of administration

Posology:

The posology depends largely on the extent of the acid-base imbalance. This should be checked regularly. Administration is via slow intravenous injection.

For intravenous administration only.

Adults:

The usual dose is 1mmol/kg (2ml/kg 4.2% solution) followed by 0.5mmol/kg (1ml/kg 4.2% solution) given at 10 minute intervals.

Children:

The usual dose is 1mmol/kg by slow iv injection. (2ml/kg 4.2% solution

In premature infants and neonates, the 4.2% solution should be used (or the 8.4% solution may be used if diluted 1:1 with 5% dextrose).

Elderly:

As for adults.

4.3. Contra-Indications

Administration of sodium bicarbonate is contraindicated

•    Conditions where sodium intake is restricted (e.g. renal failure, hypertension, oedema, congestive heart failure)

•    Patients with hypoventilation (risk of worsening of acidosis)

•    Metabolic or respiratory alkalosis

•    Patients with a history of urinary calculi

•    Patients with coexistent potassium depletion or chloride depletion, hypocalcaemia and hypernatraemia.

4.4 Special Warnings and Special Precautions For Use

Whenever sodium bicarbonate is used intravenously, arterial blood gas analyses, in particular arterial/venous blood pH and carbon dioxide levels, should be performed before and during the course of treatment to minimise the possibility of overdosage and resultant alkalosis.

Accidental extravascular injection of hypertonic solutions may cause vascular irritation or sloughing. The use of scalp veins should be avoided.

Whenever respiratory acidosis is concomitant with metabolic acidosis, both pulmonary ventilation and perfusion must be adequately supported to get rid of excess

CO2.

Administration of sodium bicarbonate to a patient with inadequate minute ventilation can cause worsening of the acidosis.

The treatment of metabolic acidosis must, if possible, be combined with concurrent treatment to combat the primary cause of the acidosis, for example the administration of insulin in uncomplicated diabetes, or blood volume restoration in shock.

In long-term therapy, care is essential to prevent the risk of overdose and alkalosis. Therefore, repeat administrations of fractional doses, or an infusion, should be given while regularly monitoring the acid-base balance and electrolytes. As soon as the most severe symptoms are under control, the dose and frequency of administration must be reduced until normal values have been restored.

There is no evidence to support the use of bicarbonate therapy in the treatment of hypoperfusion-induced lactic academia associated with sepsis.

Each ml of the 4.2% solution contains 11.5mg of sodium, and a single 2 ml/kg dose administered to a 70 kg adult would provide 81% of the WHO recommended maximum daily intake. This should be considered in patients whose overall intake of sodium must be markedly restricted (see section 4.3).

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 corticotrophin.

Urinary alkalisation will increase the renal clearance of medicinal products which are acid in nature e.g. tetracyclines, especially doxycycline, acetylsalicylic acid, chlorpropamide, lithium, methenamine. It increases the half life and duration of action of basic drugs such as quinidine, amphetamines, ephedrine, pseudoephedrine, memantine and flecainide. Sodium bicarbonate is known to increase renal tubular reabsorbtion of mecamylamine causing hypotention.

Hypochloraemic alkalosis may occur if sodium bicarbonate is used in conjunction with potassium depleting diuretics such as bumetamide, ethacrynic acid, frusemide and thiazides.

Concurrent use in patients taking potassium supplements may reduce serum potassium concentration by promoting an intracellular ion shift.

Pregnancy and Lactation

Safe use in pregnancy has not been established. The use of any drug in pregnant or lactating women requires that the expected benefit be carefully weighed against the possible risk to the mother and child.

Patients requiring i.v. sodium bicarbonate are unlikely to be fit enough to breast feed.

4.7. Effects on Ability to Drive and Use Machines

Not applicable; this preparation is intended for use only in emergencies.

4.8 Undesirable effects

Metabolism and nutrition disorders:

Alkalosis, hypokalaemia, hypernatremia, hyperosmolarity, hypocalcemia, hypoglycemia, paradoxical intracellular acidosis.

Cardiac disorder:

Deterioration of hemodynamic status associated with volume overload.

Nervous system disorders:

Intracranial hemorrhage (in neonates), hyperirritability or tetany.

General disorders and administration site conditions: Extravasation.

Incorrect administration (intra-arterial, paravenous) may cause tissue necrosis.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Symptoms: metabolic alkalosis accompanied by compensatory hyperventilation, paradoxical acidosis of the cerebrospinal fluid, severe hypokalaemia, hyperirritability and tetany.

Treatment: discontinue the administration of sodium bicarbonate, rebreathe expired air or, if more severe administer calcium gluconate especially if tetany is present. In severe alkalosis, an infusion of 2.14% ammonium chloride is recommended, except in patients with pe-existing hepatic disease. If hypokalaemia is present administer potassium chloride.

5. PHARMACOLOGICAL PROPERTIES

5.1. Pharmacodynamic Properties

Sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses clinical manifestations of metabolic acidosis.

5.2. Pharmacokinetic Properties

Sodium bicarbonate is eliminated principally in the urine and effectively alkalises it.

5.3. Pre-clinical Safety Data

Not applicable since sodium bicarbonate has been used in clinical practice for many years and its effects in man are well known.

6.    PHARMACEUTICAL PARTICULARS

6.1. List of Excipients

Water for Injection

6.2 Incompatibilities

The addition of sodium bicarbonate to parenteral solutions containing calcium should be avoided except where compatibility has been previously established; precipitation or haze may result, should this occur, the solution should not be used.

Due to the physical incompatability (colour change, particulates/microparticulates formation, haze/precipitate formation, gas production) and/or chemical instability (decomposition, instability), the

administration of sodium bicarbonate is incompatible with allopurinol sodium, amiodarone hydrochloride, amoxicillin sodium, amphotericin B cholesteryl (Amphotec), amphotericin B colloidal, amphotericin B lipid complex (Abelcet), amphotericin B liposome (AmBisome), ampicillin sodium, anidulafungin, anileridine, ascorbic acid injection, atracurium besylate, azacitidine, azathioprine sodium, buprenorphine hydrochloride, butorphanol tartrate, calcium chloride, calcium gluconate, carboplatin, carmustine, , caspofungin acetate cefamandole, cefotaxime, , cefotetan disodium, cefoxitin, cefuroxime, chlorpromazine hydrochloride, ciprofloxacin, cisplatin, clonazepam codeine phosphate, dantrolene sodium, daunorubicin citrate liposome, diazepam, diphenhydramine hydrochloride, diazoxide, dimenhydrinate dobutamine hydrochloride, dopamine hydrochloride, doxapram, doxorubicin hydrochloride liposomal, doxycycline hyclate epinephrine hydrochloride, epirubicin hydrochloride, ertapenem sodium, esmolol, etidocaine hydrochloride fenoldopam mesylate, glycopyrrolate, ganciclovir sodium haloperidol lactate, hetastarch 6% (Hextend), hydromorphone hydrochloride, hydroxyzine hydrochloride idarubicin hydrochloride, imipenem-cilastatin sodium inamrinone lactate, isoproterenol hydrochloride, , ketamine hydrochloride labetalol hydrochloride, lansoprazole, leucovorin calcium, levobupivacaine hydrochloride levofloxacin, levophanol tartrate, magnesium sulfate, meperidine hydrochloride, meropenem methadone, metoclopramide hydrochloride, midazolam hydrochloride, minocycline hydrochloride morphine sulfate, moxalactam, mycophenolate mofetil hydrochloride, nalbuphine hydrochloride nicardipine hydrochloride, norepinephrine bitartrate, ondasetron hydrochloride, oxytetracycline, pantoprazole sodium, papaverine hydrochloride, pentamidine isethionate pentazocine lactate, pentobarbital sodium, phenytoin sodium, procaine hydrochloride, prochlorperazine edisylate, promethazine hydrochloride, propacetamol, quinidine gluconate, quinupristin-dalfopristin, rituximab sargramostin, secobarbital, sodium lactate additive, streptomycin sulfate, succinylcholine chloride, , sulfamethoxazole-trimethoprim, tetracycline, thiamine hydrochloride, thiopental sodium ticarcillin disodium/clavulanate potassium, trimethaphan, tubocurarine verapamil hydrochloride, vindesine sulfate vinorelbine tartrate. vitamin B complex with vitamin C, and voriconazole.

It is also incompatible with the solutions of: alcohol 5% in dextrose 5%, dextrose 5% in lactated Ringer’s injection, ionosol(R) B in invert sugar 10%, ionosol(R) D, modified in invert sugar 10%, isonosol(R) D in invert sugar 10%, and ionosol(R) G in invert sugar 10%

6.3. Shelf-Life

36 months.

6.4. Special Precautions for Storage

Store below 25°C.

6.5. Nature and Content of Container

The solution is contained in a USP type I glass vial with an elastomeric closure which meets all the relevant USP specifications.

The 4.2% w/v product is available as 10ml and the 8.4% w/v is available as 10 or 50ml.

6.6. Instructions for Use, Handling and Disposal

The container is specially designed for use with the IMS Minijet injector.

7    MARKETING AUTHORISATION HOLDER

International Medication Systems (UK) Ltd

21 St Thomas Street

Bristol

United Kingdom BS1 6JS

8. MARKETING AUTHORISATION NUMBER

PL 3265/0001R

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

Date first granted: 28 February 1991 Date renewed:    26 November 1996

10 DATE OF REVISION OF THE TEXT

23/11/2016