Sodium Bicarbonate Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sodium Bicarbonate B.P.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium Bicarbonate B.P. 100% w/w
3 PHARMACEUTICAL FORM
Powder.
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
Dosage:
1) Oral.
2) Cutaneous.
1) For the relief of the symptoms of dyspepsia, heartburn and indigestion Adults, elderly 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) To use externally as a 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.
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.
Not to be taken by children under 12 years old.
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 excretion of lithium (reduced plasma concentration).
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 Fertility, 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 heartbeat. 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 known.
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.
6.4 Special precautions for storage
None.
6.5 Nature and contents of container
NATURE CONTENTS
A. Cardboard Little John Drum or 100gm, 200gm
Robinsons with a plastic cap............... or 5002gm.
B. Foodgrade paper bag in a
printed oardboard carton.................... 200gm.
6.6 Special precautions for disposal and other handling
None stated.
7 MARKETING AUTHORISATION HOLDER
Cox Pharmaceutical Ltd
788-790 Finchley Road, London NW11 7TJ United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 42671/0007
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15/05/90
10 DATE OF REVISION OF THE TEXT
22/06/2016