Sodium Bicarbonate BP

1. Name Of The Medicinal Product

Sodium Bicarbonate BP.

2. Qualitative And Quantitative Composition

Sodium Hydrogen Carbonate 100% w/w.

3. Pharmaceutical Form

Powder/granules.

A white crystalline powder or granules.

4. Clinical Particulars

4.1 Therapeutic Indications

1. For the relief of the symptoms of dyspepsia, heartburn and indigestion.

2. As an external lotion for relief of the symptoms of insect bites and sunburn.

4.2 Posology And Method Of Administration

1. Oral.

2. Cutaneous.

1. For relief of the symptoms of dyspepsia, heartburn and indigestion:

Adults and children over 12 years: one level 5ml spoonful dissolved in warm water, to be taken up to 4 times a day.

Not to be taken by children under 12 years old.

2. As an external lotion:

Dissolve one 5ml spoonful in a pint of warm water. Apply with lint or cotton wool.

4.3 Contraindications

For oral use:

Contraindicated in patients with metabolic or respiratory alkalosis, hypocalcaemia, or hypochlorhydria.

Not to be taken by children under 12 years old.

It should be used with extreme caution in patients with congestive heart failure, renal impairment, cirrhosis of the liver, or hypertension, or to patients receiving corticosteroids. Hypersensitivity to sodium bicarbonate.

4.4 Special Warnings And Precautions For Use

Keep all medicines away from children.

Sodium bicarbonate should be avoided in patients on a restricted sodium diet.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

For oral use:

The effects of a number of drugs may be reduced or increased by the alkalinisation of the urine (e.g. aspirin or diflunisal) and reduction in gastric pH brought about by sodium bicarbonate.

The following drugs are reported to be susceptible to inactivation on mixing with sodium bicarbonate solution: adrenaline hydrochloride, benzyl penicillin potassium, carmustine, glycopyrronium bromide, isoprenaline hydrochloride, and suxamethonium chloride.

Sodium-containing preparations should be avoided by patients on lithium because sodium is preferentially absorbed by the kidney resulting in increased lithium excretion and reduced plasma levels.

As a precaution for antacids, in order to minimise the risk of interactions affecting pharmacokinetics of concomitantly administered products, drug administrations should be separated by approximately 2 to 3 hours.

Sodium bicarbonate reduces the absorption of a number of other drugs taken concomitantly. These include ACE inhibitors (captopril, enalapril, and fosinapril), antibacterials and antifungals (azithromycin, cefaclor, cefpodoxime, isoniazid, itraconazole, rifampicin, tetracyclines, ketoconazole and the quinolone group of antibacterials); antivirals (atazanivir, fosamprenavir, tipranavir); antihistamines (fexofenadine); bisphosponates, corticosteroids (deflazacort); digoxin, dipyridamole, antiepileptics (gabapentin and phenytoin), ulcer healing drugs (lansoprazole); levothyroxine, mycophenolate, lipid regulating drugs (rosuvastatin); antipsychotics (sulpiride, phenothiazines), chloroquine, hydrochloroquine, and penicillamine. Antacids should be avoided with nilotinib.

Antacids possibly reduce absorption of bile acids.

4.6 Pregnancy And Lactation

Animal studies are insufficient with respect to effects on pregnancy, embryonal foetal development, parturition and postnatal development. The potential risk for humans is unknown.

Sodium bicarbonate should not be taken in pregnancy or if breastfeeding unless advised by a doctor to do so.

4.7 Effects On Ability To Drive And Use Machines

No or negligible influence.

4.8 Undesirable Effects

Administration by mouth can cause stomach cramps and flatulence.

Additional undesirable effects associated with oral use of sodium bicarbonate include possible increase in blood pressure, exacerbation of hyperkalaemia, and fluid retention and pulmonary oedema may be caused in those at risk.

4.9 Overdose

Excessive administration of bicarbonate may lead to hypokalaemia and metabolic alkalosis, especially in patients with impaired renal function. Symptoms include mood changes, tiredness, shortness of breath, muscle weakness and irregular heart beat. Muscle hypertonicity, twitching and tetany may develop, especially in hypocalcaemic patients. Excessive doses of sodium salts may lead to sodium overloading and hyperosmolality.

Treatment of metabolic alkalosis and hypernatraemia is by correction of fluid and electrolyte balance. Replacement of calcium, chloride, and potassium ions may be of particular importance.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Antacids with sodium bicarbonate A02A H

Sodium bicarbonate is used as an antacid in relief of the symptoms of dyspepsia, heartburn and indigestion caused by excess gastrointestinal acid.

Solutions of sodium bicarbonate when applied topically act to relieve the symptoms of insect bites and sunburn.

5.2 Pharmacokinetic Properties

No information available.

5.3 Preclinical Safety Data

None.

6. Pharmaceutical Particulars

6.1 List Of Excipients

None.

6.2 Incompatibilities

Sodium bicarbonate is incompatible with acids, acidic salts, and many alkaloidal salts.

Sodium bicarbonate solution should not be mixed with calcium or magnesium salts, cisplatin, dobutamine hydrochloride, labetalol hydrochloride, oxytetracycline hydrochloride, as insoluble precipitates may result.

6.3 Shelf Life

36 months unopened

6.4 Special Precautions For Storage

Do not store above 25°C. Store in the original package.

6.5 Nature And Contents Of Container

150g, 300g and 500g: Polypropylene securitainer with LDPE/HDPE white cap

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

L C. M. Ltd.

Linthwaite Laboratories

Huddersfield

HD7 5QH.

8. Marketing Authorisation Number(S)

PL 12965/0033

9. Date Of First Authorisation/Renewal Of The Authorisation

17/09/1993 / 07/04/2004

10. Date Of Revision Of The Text

25.02.2011