Oral correction of fluid and electrolyte loss in infants aged 3 months upwards, children and adults.

Treatment of watery diarrhoea of various aetiologies including gastroenteritis in all age groups from 3 months upwards.

ORS New is particularly recommended in the case of too loose or frequent stools where t enables over-loose stools to revert to normal.

Method of use

1.     Cut open the sachet and empty the powder in 200 ml of drinking water & mix well. Do not boil the solution.

2.     Orally feed the solution to the patient in small amounts as per the need. In case of vomiting, wait for 10 minutes and give again.

3.     Refer the patient to a doctor in case of persistent vomiting and or continuous diarrhea

4.     In between the feeds, supplement by other liquids (breast milk in case of infants), fruit juice and light food.

5.     The reconstituted ORS solution is to be stored in a refrigerator for not more than 24 hours due to the possibility of bacterial contamination.  Discard unused solution after 24 hours and make up fresh solution if required.

Adults:

Daily dose to be adjusted based on the requirement for replacement and maintenance of fluid losses of patients or as directed by physician.

Route of Administration: Oral

For oral administration only. ORS New should not be reconstituted in diluents other than water.

Each sachet should always be dissolved in 200 ml water.

ORS should not be administered to infants under 3 months and for those aged 3 months to 1 year under medical advice.

If diarrhoea persists unremittingly for longer than 36 hours the patient should be reassessed by the physician.

No  specific  precautions  are  necessary  in  the  elderly. However,  care  should  be  taken  when administering.

ORS New solution in cases of severe renal or hepatic impairment or other conditions where normal electrolyte balance may be disturbed.

None known

ORS New is not contraindicated in pregnancy or lactation but should be used on medical advice

ORS New could not be expected to affect the ability to drive or use machines.

None known

In the event of significant overdose, serum electrolytes should be evaluated as soon as possible, appropriate steps taken to correct any abnormalities and levels monitored until return to normal levels is established. This is particularly important in the very young.

ATC code: Electrolyte with carbohydrates A07C

ORS New contains a balanced amount of electrolytes, starch and proteins in water. Oral rehydration therapy with ORS New enables a dehydrated subject to be rehydrated rapidly.

The advantages of ORS are bound with its composition.

• Water: the appropriate amount is essential to correct dehydration.
• Starch: low osmotic capacity (unlike pure glucose) thus preventing any additional loss of fluid through the stools. Rice starch contains 20% amylase and 80% amylopectin.
•  Proteins:  specific nutritional properties.
• Electrolytes:  essential for restoring the iconic equilibrium. The role of citrate is to correct the acidosis that occurs as a result of diarrhoea. Citrate also enhances the absorption of Na+ and is more stable than bicarbonate

Content of electrolytes in the reconstituted preparation:

Na+                                            60 mmol/l

Cl-                                               50 mmol/l

K+                                               20 mmol/l

Citrate                                  10 mmol/l (or 30 meq/l)

Osmolarity                              140 mosm/l

Not applicable

Sodium Saccharine

Orange dry flavor

None known

Store below 25°C.  Protect from light & moisture.

Carton containing sachet of ORS sachets powder.

ORS New 200 ml is supplied in pack size of 10’s sachet and 50’s sachets

The primary packaging material is a printed trilaminate sachet foil.

The reconstituted solution should be used immediately within 24hrs and should not to be stored.