1. NAME OF THE MEDICINAL PRODUCT

Sodium Bicarbonate Injection USP 0.5g/10ml & 8.4% w/v Taj Pharma

  1. QUALITATIVE AND QUANTITATIVE COMPOSITION

Sodium Bicarbonate 0.5g/10ml & 8.4% w/v

Each ml solution for injection contains 23.00 mg of sodium.

For the full list of excipients, see section 6.1.

  1. PHARMACEUTICAL FORM

Solution for injection.

A clear, bright, colorless solution

  1. 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 preexisting metabolic acidosis
  • Cardiac arrest associated with hyperkalaemia with pre-existing metabolic acidosis
  • Life threatening 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

Adults:

The usual dose is 1mmol/kg (1ml/kg 8.4% solution) followed by 0.5mmol/kg (0.5ml/kg 8.4% solution) given at 10-minute intervals.

Paediatric population:

The usual dose is 1mmol/kg by slow iv injection. (1ml/kg 8.4% solution)

In premature infants and neonates, the 8.4% solution should be diluted 1:1 with 5% dextrose.

Elderly:

As for adults.

Method of administration

For intravenous administration only.

4.3 Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
  • 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 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.

Sodium Bicarbonate 0.5g/10ml & 8.4% w/v Solution for Injection contains sodium

This medicinal product contains 23.00 mg sodium per ml, equivalent to 1.15% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

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.

4.6 Fertility, 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 haemorrhage (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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 pre-existing hepatic disease. If hypokalaemia is present administer potassium chloride.

  1. 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 Preclinical safety data

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

  1. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Disodium Edetate

Water for Injections.

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.

Administration of sodium bicarbonate is incompatible with allopurinol sodium, amiodarone hydrochloride, anileridine, ascorbic acid injection, carmustine, cefamandole, cefotaxime, codeine phosphate, dobutamine hydrochloride, dopamine hydrochloride, doxapram, epinephrine hydrochloride, esmolol, fenoldopam mesylate, glycopyrrolate, hydromorphone hydrochloride, idarubicin hydrochloride, inamrinone lactate, isoproterenol hydrochloride, labetalol hydrochloride, levofloxacin, levophanon tatrate, magnesium sulfate, methadone, metoclopramide hydrochloride, morphine sulfate, moxalactam, nicardipine hydrochloride, norepinephrine bitartrate, ondasetron hydrochloride, oxytetracycline, pentazocine lactate, sargramostin, secobarbital, streptomycin sulfate, succinylcholine chloride, tetracycline, ticarcillin disodium/clavulanate potassium, trimethaphan, tubocurarine and vinorelbine tartrate.

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

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 Special precautions for disposal and other handling

Discard any unused solution

Any unused product or waste material should be disposed of in accordance with local requirements

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

PACKAGE LEAFLET: INFORMATION FOR THE USER

SODIUM BICARBONATE INJECTION USP
0.5G/10ML & 8.4% W/V
TAJ PHARMA

Sodium Bicarbonate 8.4% w/v

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

This medicine will be referred to as Sodium Bicarbonate Injection in the rest of this leaflet.

WHAT IS IN THIS LEAFLET:

  1. What Sodium Bicarbonate Injection is and what it is used for
  2. What you need to know before you are given Sodium Bicarbonate Injection
  3. How Sodium Bicarbonate Injection is given
  4. Possible side effects
  5. How to store Sodium Bicarbonate Injection
  6. Contents of the pack and other information

    1. WHAT SODIUM BICARBONATE INJECTION IS AND WHAT IT IS USED FOR

Sodium Bicarbonate is one of a group of medicines known as alkalinising agents. It is used to correct the acid-alkaline balance in the body.

Sodium bicarbonate is used to reduce the amount of acid in the body after a heart attack in patients who have the following conditions: too much acid in their body or too much potassium in their blood.

It can also be used to treat patients who have taken too much tricyclic antidepressant medicine. Sodium Bicarbonate will only be used after other resuscitation methods have been attempted.

  1. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN SODIUM BICARBONATE INJECTION

You should not be given Sodium Bicarbonate Injection if:

  • you are allergic to Sodium Bicarbonate or any of the other ingredients of this medicine, (listed in section 6)
  • your breathing is slower or more shallow than usual (hypoventilation)
  • you have any blood abnormalities such as high levels of sodium, low levels of calcium, potassium or chloride, or your blood is less acidic than usual (your doctor will need to check this)
  • you have had kidney stones
  • you have high blood pressure
  • you have kidney failure
  • you have heart failure
  • you suffer from fluid retention

If any of the above apply to you or your child please tell your doctor or nurse before you are given Sodium Bicarbonate Injection.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Sodium Bicarbonate Injection.

Your doctor or nurse may want to regularly check your blood acid levels during the course of treatment with this medicine.

Other medicines and Sodium Bicarbonate Injection

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.

Including:

  • corticosteroids or corticotropin (medicines used to reduce swelling or to treat hormone problems)
  • medicines used to treat infections (tetracyclines) such as doxycycline
  • quinidine, flecainide (medicines used to treat heart problems)
  • amphetamines (medicines used to treat certain mental disorders and drowsiness)
  • ephedrine and pseudoephedrine (medicines used to treat colds and asthma)
  • potassium supplements
  • medicines used to treat water retention and problems with passing urine such as ethacrynic acid, bumetanide, thiazides or frusemide
  • medicines used to treat high blood pressure (e.g mecamylamine)
  • medicines used to treat Alzheimers disease (e.g. memantine)
  • medicines used to treat diabetes mellitus (e.g. chlorpropamide)
  • medicines used to treat mood disorders (e.g. lithium)
  • Aspirin (Acetylsalicylic acid)

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask you doctor or pharmacist for advice before taking this medicine.

Sodium Bicarbonate Injection contains sodium.

This medicinal product contains 23.00 mg sodium per ml, equivalent to 1.15% of the WHO recommended maximum daily intake of 2g sodium for an adult.

Driving and using machines

This medicine is unlikely to affect your ability to drive or use machines.

  1. HOW SODIUM BICARBONATE INJECTION IS GIVEN

Your doctor will give you Sodium Bicarbonate Injection by slow injection into the vein (intravenous injection).

Your doctor will decide on how much Sodium Bicarbonate Injection you should be given.

Adults and the elderly

  • The usual starting dose is 1mmol for every kg you weigh
  • Followed by 0.5 mmol/kg given at 10minute intervals

Children

  • The usual dose is 1 mmol for every kg you weigh given by slow IV injection
  • The medicine should be diluted 1:1 with 5% dextrose for premature infants and new-borns.

If you think you have been given too much Sodium Bicarbonate Injection

As this medicine will be given to you whilst you are in hospital, it is unlikely that you will be given too little or too much. Your doctor has information on how to recognise and treat an overdose. If you are concerned about your treatment please talk to your doctor.

Signs of too much sodium bicarbonate include hyperventilation (over breathing), very sensitive to slight stimuli, twitching and high potassium levels in your blood which may cause you to feel dizzy or tired.

  1. POSSIBLE SIDE EFFECTS

Like all medicines, Sodium Bicarbonate Injection can cause side effects, although not everybody gets them.

Side effects include:

  • Low levels of potassium causing twitching, muscle weakness, ‘pins and needles’ in the hands or feet, irritability or abnormal heart rhythm
  • Low levels of blood sugar and high concentration of sodium in the blood causing feeling hungry, thirsty, nervous, confused, extreme irritation, increased urination, shakiness or sweating
  • Too much acid in the blood, which many cause an increased rate of breathing ( intracellular acidosis)
  • a blood disorder consisting of an increase in the volume of circulating blood
  • Low levels of calcium causing involuntary contraction of your muscles
  • Swelling due to a build-up of fluid under the skin
  • New born babies may have bleeding inside the skull
  • Sodium bicarbonate may leak out of the veins into the surrounding tissue. This may cause pain,redness or irritation to the skin
  • If the medicine is not correctly injected it could cause the skin to die around the injection site.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via you can help provide more information on the safety of this medicine.

5. HOW TO STORE SODIUM BICARBONATE INJECTION

Keep all medicines out of the sight and reach of children.

This Sodium Bicarbonate Injection should not be used after the expiry date which is stated on the carton and ampoule label. The doctor or nurse will check that the expiry date on the label has not been passed before administering the injection to you. The expiry date refers to the last day of that month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. This product should only be used in a hospital environment and will be safely disposed of by your doctor.

  1. CONTENTS OF THE PACK AND OTHER INFORMATION

What Sodium Bicarbonate Injection contains

The active substance is Sodium Bicarbonate 8.4%w/v

The other ingredients are disodium edetate, nitrogen and water for injections.

What Sodium Bicarbonate Injection looks like and contents of the pack

Sodium Bicarbonate Injection is a clear, colourless solution supplied in 5ml and 10ml glass ampoules. Each pack contains 10 ampoules.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com