For the treatment of diarrhoea and fluid loss due to diarrhoea in infants, children and adults.

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.

Oralite is 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. - Oralite is 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.

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.

 

1.      It is very important to dissolve oralite 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.

2.      Diarrhea can have very serious consequences in children under 3 years old. Immediate medical advice should be sought.

3.      In other age groups, if symptoms persist for more than 24 - 48 hours, consult your doctor.

4.      If nausea and vomiting are present with the diarrhoea, small and frequent amounts of Oralite should be drunk first. In infants, immediate medical assistance should be obtained.

5.      Keep out of the reach of children.

6.      Use within one hour of reconstitution, or within 24 hours if stored in a refrigerator.

Potassium Chloride

ACE inhibitors (hyperkalaemia); cyclosporin (increased risk of hyperkalaemia).

Potassium sparing diuretics where hyperkalaemia may result. No known interactions to other actives.

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.

None stated.

 

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.

 

Reporting of suspected adverse reactions

§ Saudi Arabia

 

The National Pharmacovigilance and Drug Safety Centre (NPC) § Fax: +966-11-205-7662 § Call NPC at: +966-11-2038222, Ext.: 2317-2356-2340. § Reporting hotline:19999 § E-mail: npc.drug@sfda.gov.sa § Website: www.sfda.gov.sa/npc

 

§ Other countries

For reporting adverse drug reactions, please refer to the health authorities

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.

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.

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 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.

No relevant information additional to that contained elsewhere in the SPC.

The excipients in each sachet are:

 

1-	Citric Acid Anhydrous
2-	Saccharin Sodium
3-	Orange Flavour

None stated.

3 years from the manufacturing date. The expiry date refers to the last day of the month. Use within one hour of reconstitution or 24 hours if stored in a refrigerator.

§ Keep in a safe place, out of the reach and sight of children.

§ Store the sachet below 30° C, protect from direct light and moisture.

Oralite is available in Triple Layered Laminate sachets comprising of inside Polyethylene layer, middle Aluminum layer and Outside Polyester layer.

Oralite is available in pack of 10 Sachets, each containing 28.5 g of powder.

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.