Boots Oral Rehydration Treatment
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Oral Rehydration Salts (Lemon and Lime Flavour)
Boots Oral Rehydration Treatment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium chloride BP 200.0mg
Potassium chloride BP 300.0mg
Sodium bicarbonate BP 300.0mg
Glucose BP 8.0g
3 PHARMACEUTICAL FORM
Oral powder
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of diarrhoea and fluid loss due to diarrhoea in infants, children and adults.
4.2 Posology and method of administration
Adults, and children over 12 years
One or two reconstituted sachets after each loose bowel movement.
The elderly
Normal adult dose. However, care should be taken when administering to the elderly due to reduced potassium excretion in this category of patient. Consideration should be given to monitoring of potassium levels.
Children 1 - 12 years
One reconstituted sachet after each loose bowel movement.
Infants
Administer with care to infants.
Bottle Fed
Substitute feeds with an equivalent volume of reconstituted solution.
Breast Fed
Administer an appropriate volume of reconstituted solution to that normally consumed prior to breast feeding.
Directions for reconstitution
1. Pour the contents of a sachet into a glass.
2. Add 200ml of fresh drinking water. For infants and where drinking water is not available, use freshly boiled and cooled water. Stir until the powder is completely dissolved.
3. Use within one hour of reconstitution, or within 24 hours stored in a refrigerator.
4. Do not boil the solution after mixing.
4.3 Contraindications
Oral Rehydration Salts are contraindicated in patients exhibiting the following conditions:- cirrhosis of the liver, congestive cardiac failure, nephrotic syndrome, acute and chronic renal failure, ischaemic heart disease, adrenocortical insufficiency, hyperkalaemic periodic paralysis, hyperkalaemia, hypoventilatory states, chloride depletion due to continuous gastric fluid loss, metabolic or respiratory alkalosis, hypocalcaemia, hyperosmolar states in anuria or oliguria, oedematous sodium retaining conditions, hypertension, peripheral or pulmonary oedema or toxaemia of pregnancy, severe vomiting, diarrhoea and dehydration requiring fluid therapy, dextrose malabsorption, in cases of diabetes mellitus, thiamine deficiency, severe under-nutrition, haemodilution, hypophosphataemia, sepsis and trauma.
Oral rehydration salts are also contraindicated for use in patients undergoing treatment with the following:- sodium retaining drugs (e.g. corticosteroids, NSAID’s, carbenoxolone), diuretics known to produce hypochloraemic alkalosis.
4.4 Special warnings and precautions for use
Administer with care in cases of acute dehydration, heat cramps, extensive tissue destruction or if patients are receiving potassium-sparing diuretics. Concurrent use with other potassium containing drugs may precipitate hyperkalaemia.
i) it is very important to dissolve oral rehydration salts in water of the correct volume. A weak solution will not contain optimum glucose and electrolyte concentration and a strong solution may give rise to electrolyte imbalance.
ii) diarrhoea can have very serious consequences in children under 3 years old. Immediate medical advice should be sought.
iii) in other age groups, if symptoms persist for more than 24 - 48 hours, consult your doctor.
iv) if nausea and vomiting are present with the diarrhoea, small and frequent amounts of Oral Rehydration Salts should be drunk first. In infants, immediate medical assistance should be obtained.
v) keep out of the reach of children.
vi) use within one hour of reconstitution, or within 24 hours if stored in a refrigerator.
4.5 Interaction with other medicinal products and other forms of interaction
Sodium Bicarbonate
Increases excretion of lithium, resulting in a reduced plasma-lithium concentration. Potassium Chloride
ACE inhibitors (hyperkalaemia); cyclosporin (increased risk of hyperkalaemia). Potassium sparing diuretics where hyperkalaemia may result. No known interactions to other actives.
4.6 Pregnancy and lactation
Use in patients with pre-eclampsia is contraindicated. The product should only be administered if the expected benefit to the mother is thought to outweigh any possible risk to the foetus or neonate.
4.7 Effects on ability to drive and use machines
None stated.
4.8 Undesirable effects
The following adverse effects have been reported although more commonly following excessive amounts:- hypernatraemia, oedema, nausea, vomiting, diarrhoea, abdominal cramps, thirst, reduced salivation, lachrymation, sweating, fever, tachycardia, renal failure, respiratory arrest, headache, dizziness, restlesness, irritability, weakness, muscular twitching, coma, convulsions, hyperkalaemia, gastro-intestinal ulceration, metabolic alkalosis, muscle hypertonicity, flatulence, dehydration and raised blood pressure.
4.9 Overdose
Iso-osmotic overload is managed by restricting sodium, potassium and water intake plus measures to increase renal sodium, potassium and water output by using “loop diuretics” e.g. frusemide.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
The reconstituted solution contains a mixture of sodium and potassium salts along with glucose, which facilitates the absorption of sodium and potassium from the intestine. Water is drawn from the bowel by the osmotic effect. As well as “drying-up” the stools, the dehydration and loss of electrolytes caused by the diarrhoea is corrected by the water and electrolytes absorbed.
5.2 Pharmacokinetic properties
Glucose
After oral administration glucose is completely absorbed by a sodium dependent uptake mechanism exhibiting saturation kinetics. Blood levels return to normal within two hours of ingestion.
Potassium Chloride
No specific control mechanisms limit absorption of potassium, which is usually complete. Potassium is excreted largely by the kidneys, though 10% is excreted by the colonic mucosa. Potassium excretion is reduced in patients with renal impairment and in the elderly, so extreme caution should be used in treating such patients with potassium salts.
Sodium Bicarbonate
Kinetics are determined by the physiological state of the patient at the time.
Sodium Chloride
Readily absorbed from the gastrointestinal tract. Gut absorption, particularly in the jejunum is enhanced by the addition of glucose. Under conditions of sodium balance, the excretion of sodium in the urine will match intake.
5.3 Preclinical safety data
No relevant information additional to that contained elsewhere in the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
flavour 610477E
6.2 Incompatibilities
None stated.
6.3 Shelf life
36 months unopened. After reconstitution, one hour or 24 hours if stored in a refrigerator.
6.4 Special precautions for storage
Store below 25°C in a dry place.
6.5 Nature and contents of container
2 2
Sachets of laminate comprising 40gm gloss coated paper//12g/m polythene// 8p aluminium//23g/m2 polythene containing 9.015g of product presented in a boxboard carton.
6.6 Special precautions for disposal
Directions for reconstitution
1. Pour the contents of a sachet into a glass.
2. Add 200ml of fresh drinking water. For infants and where drinking water is not available, use freshly boiled and cooled water. Stir until the powder is completely dissolved.
3. Use within one hour of reconstitution, or within 24 hours if stored in a refrigerator.
4. Do not boil the solution after mixing.
7 MARKETING AUTHORISATION HOLDER
Ayrton Saunders Ltd
9 Arkwright Road
Astmoor Industrial Estate
Runcorn
Cheshire
WA7 1NU
8 MARKETING AUTHORISATION NUMBER(S)
PL 16431/0119
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17 November 1997
10 DATE OF REVISION OF THE TEXT
05/03/2011