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Pharmacotherapeutic group: Electrolytes with Carbohydrates ATC Code: A07CA
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 diarrhea is corrected by the water and electrolytes absorbed.
Oral rehydration salt is indicated for the treatment of acute diarrhea and the treatment and prevention of dehydration by replacing fluids and electrolytes lost through diarrhoea.
Posology and method of administration
Adults, the elderly and children over 12 years: The contents of one or two sachets to be taken after each loose motion.
Children 1 to 12 years: The contents of one sachet to be taken after each loose motion.
Infants under 1 year: Not to be given unless instructed by a doctor, in which case one to one and a half the usual 24 hourfeed volume should be given.
During the first 24 hours of illness Replavite should replace normal feeds in bottle fed babies, gradually resuming normal feeds as the baby gets better. In breast fed babies, firstly the recommended amount of Relative should be given and then breast fed until satisfactory.
Reconstitution
The contents of each sachet should be dissolved in 200 ml (7 fluid ounces) of fresh drinking water (adults and children).
Freshly boiled and cooled water should be used for infants and when fresh water is not available.
The solution should be made up immediately before use and used within one hour. If refrigerated the solution can be kept for up to 24 hours. A doctor should be consulted if symptoms persist for longer than 24 – 48 hours.
Method of administration
For oral use
Contraindications
Contraindicated in patients with phenylketonuria or those with hypersensitivity to any of the ingredients.
Oral treatment is inappropriate in such conditions as severe dehydration, which requires parenteral fluid therapy or intestinal obstruction.
Special warnings and precautions for use
Severe and persistent diarrhoea should be treated under medical supervision. If symptoms persist for more than 24 — 48 hours, medical advice should be sought.
Inability to drink or retain fluids requires medical supervision.
Children
- Rehydration treatment should only be given to children under 1 year of age on medical advice.
- If a young child (particularly one under 6 months of age) has diarrhoea and/or vomiting advice should be sought from a pharmacist, doctor or other health care professional. If the diarrhea and/or vomiting is severe the child should be seen by a doctor as soon as possible.
Renal Impairment
- Medical supervision is necessary in patients with renal disease, including anuria and prolonged oliguria.
Hepatic Impairment: Low potassium or Sodium diets: Diabetes
Treatment should be supervised by a physician.
This product contains dextrose. Patients with rare-glucose-galactose malabsorption should not take this medicine.
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 (hyperkalemia); cyclosporine (increased risk of hyperkalemia).Potassium sparing diuretics where hyperkalemia may result. No known interactions to otheractives.
Fertility, pregnancy and lactation
May be used during pregnancy and lactation as there are no known adverse effects.
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
None stated.
Overdose
If significant overdosage occurs, serum and electrolytes should be evaluated.
Corrective measures should be carried out and levels monitored until a return to normal levels is achieved.
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