EFFECTIVE replacement of water and electrolyte losses by oral route
The osmotic concentration is low 24b mmol/I
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COMPOSITION |
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Sodium chloride......... 520 mg Sodium citrate dihydrate........ 580 mg Potassium chloride.........300 mg Anhydrous glucose........2 7 g Excipients q s ..........1 sachet |
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Electrolyte co nee filiation ol |
The newest recommendation of WHO/ UNICEF |
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| Natri | 75 mmol/l | 75 mmol/l |
| Kali | 20 mmol/l | 20 mmol/l |
| Clorid | 65 mmol/l | 65 mmol/l |
| Citrat | 10 mmol/l | 10 mmol/l |
| Glucose | 75 mmol/l | 75 mmol/l |
| Nồng đồ thẩm thấu | 245 mmol/l | 245 mmol/l |
White to off-white powder or crystalline form with a slightly sweetish salty taste.
Box of 20 sachets x 4.1 powder.
Oresol 245 is an oral rehydration therapy. The combination of electrolytes stimulates water and electrolyte absorption from the GI tract and therefore prevents or reverses dehydration in diarrhoea.
Sodium and glucose are actively transported via the membrane into the enterocytes. Sodium is then extruded into the intercellular spaces and the resulting osmotic gradient causes water and electrolytes to be drawn from the gut and then into the circulation.
Oresol 245 could not be expected to affect the ability to drive or use machines.
Oresol 245 is not contra-indicated in pregnancy or lactation.
Medical supervision is recommended for use during pregnancy and lactation.
Food or other fluids containing electrolytes, such as fruit juices or salted foods should be avoided to prevent electrolyte overuse or osmotic diarrhea until treatment is discontinued.
Do not dilute with water because dilution reduces the absorption of glucose-sodium transport system.
There have not been many reports of adverse effects (ADRs) occurring with oral oresol.
Common, ADR > 1/100
Mild vomiting.
Uncommon, 1/1000 < ADR < 1/100
Hypernatremia; excessive rehydration (sunken eyelids).
Rare, ADR < 1/1000
Heart failure due to excessive rehydration.
Treatment of ADRs
Mild vomiting may occur at the beginning of treatment. In order to continue treatment, slow administration of a small amount in many times should be recommended. If the eyelids become severely puffy, the treatment can be temporarily discontinued. Breastfeed or give extra fluids between ORS doses to prevent hypernatremia.
Please inform your doctor of all undesirable effects upon drug administration.
In the event of significant overdose, serum electrolytes should be evaluated as soon as possible, appropriate steps taken to correct an abnormalities and levels monitored until return to normal levels is established. This is particularly important in the very young and in cases of severe hepatic or renal failure.
Store in dry places, not exceeding 30oC, protect from light.
Use with caution in patients with congestive heart failure, edema, or sodium retention, because of the risk of hypernatremia, hyperkalemia, heart failure, or edema.
Patients with severe renal failure or cirrhosis.
During treatment, electrolyte levels and acid-base balance should be carefully monitored.
The infant should be breastfed or given water between doses of fluid and electrolyte solution to avoid hypernatremia.
Patients with rare hereditary problems of glucose-galactose malabsorption should not take this medicine.
For oral administration only. Oresol 245 should not be reconstituted in diluents other than water. Each sachet should always be dissolved in 200 ml of water. A weaker solution than recommended will not contain the optimal glucose and electrolyte concentration and a stronger solution than recommended may give rise to electrolyte imbalance. If diarrhoea persists for longer than 24-48 hours the patient should be seen by a physician. Oresol 245 should not be used for the self treatment of chronic or persistent diarrhoea except under medical supervision. Oresol 245 shall not be used for treatment in infants below the age of 24 months without medical supervision. Infants under the age of 2 years with diarrhoea should be seen by a physician as soon as possible. No specific precautions are necessary in the elderly.
Oresol 245 should not be used for self-treatment by patients:
• with chronic or persistent diarrhea.
• with liver or kidney disease.
• with diabetes.
• on low potassium or sodium diets.
• with an intestinal obstruction.
The use of Oresol 245 in patients with these conditions should be supervised by a physician.
If nausea and vomiting are present with the diarrhoea, small but frequent amounts should be drunk at first.
Oral correction of fluid and electrolyte loss in infants, children, and adults.
Treatment of watery diarrhoea of various aetiologies including gastro-enteritis, in all age groups.
Anuria or oliguria (because normal kidney function is required to remove any excess urine or electrolytes). Patients with anuria or prolonged anuria require intravenous fluid and electrolyte rehydration to ensure accuracy. However, transient oliguria is a characteristic of diarrheal dehydration, so oral rehydration is not contraindicated.
Severe dehydration with shock symptom (because oral rehydration will be too slow, prompt intravenous treatment is required).
Severe diarrhea (when diarrhea exceeds 30 ml/kg body weight per hour, patients should may not be drinking enough water to replace the ongoing fluid loss).
Profuse and prolonged vomiting
Intestinal obstruction, paralytic ileus, intestinal perforation.
Route of administration: Oral.
RECONSTITUTION
The contents of each sachet should be dissolved in 200 ml (approx. 7fl oz) of drinking water. Use fresh drinking water for adults and children. For infants, and where drinking water is unavailable, the water should be freshly boiled and cooled. The solution should be made up immediately before use and may be stored for up 24 hours in a refrigerator, otherwise any solution remaining an hour after reconstitution should be discarded. The solution itself must not be boiled.
A basic principle of treatment of diarrhoea is to replace lost fluid and electrolytes and then to maintain sufficient fluid intake to replace fluid loss from stools. The amount of reconstituted Oresol 245 administered should be adapted to the age and weight of the patient and the stage and severity of the condition.
Severe dehydration may need to be corrected by parenteral fluids initially, followed by oral maintenance if indicated. If the loss of fluid in the diarrhoea is excessive, medical advice should be sought.
Daily intake may be based on a volume of 150 ml/kg body weight for infants up to the age of 2 and 20 - 40 ml/kg body weight for adults and children. A reasonable approximation is:
Infants up to the age of 2: One to one and a half times the usual 24 hour feed volume.
Children: One sachet dissolved in 200ml of water after every loose motion.
Adults (including the elderly): One or two sachets after every loose motion. Each sachet should be dissolved in 200 ml of water.
More may be required initially to ensure early and full volume repletion.
In the initial stages of treatment of diarrhoea all foods, including cow's or artificial milk, should be stopped. However breast milk need not be withheld. In breast-fed infants it is suggested that the infant is given the same volume of Oresol 245 as the bottle fed baby and then put to the breast until satisfied. Expression of residual milk from the breasts may be necessary during this period. After 24 - 48 hours, when symptoms have subsided, the normal diet should be resumed but this should be gradual to avoid exacerbation of the condition.
When vomiting is present with the diarrhoea it is advisable that small amounts of Oresol 245 be taken frequently. However, it is important that the whole of the required volume of Oresol 245 be taken. Where the kidneys are functioning normally, it is difficult to over-hydrate by mouth and where there is doubt about the dosage, more rather than less should be taken. If no improvement is seen within 24 - 48 hours it is recommended that the patient be seen by a physician.
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