Neorice

Approved Indications:

• Acute diarrhea (including cholera): Treatment and prevention of dehydration and electrolyte loss.
• Pediatric diarrhea: Especially effective in children with mild to moderate dehydration, per WHO guidelines.
• Adult diarrheal illnesses: For rehydration in cases of moderate water and electrolyte loss.
• Cholera-associated dehydration: Rice-based ORS is particularly effective in reducing stool output.
• Dehydration due to vomiting, fever, or excessive sweating.

Clinically Accepted Off-label Uses:

• Supportive therapy in viral gastroenteritis (e.g., rotavirus, norovirus).
• Dehydration in elderly patients due to heatstroke or infection.
• Rehydration in malnourished children when intravenous fluids are not immediately available.

Route of Administration: Oral only.

Preparation Instructions:
Dissolve the entire contents of one sachet in exactly 1 liter of clean, preferably boiled and cooled water. Stir until fully dissolved. Do not mix with milk, soup, or sugary drinks.

Adults:

• Administer 200–400 mL after each loose stool.
• Total daily intake: 2–4 liters depending on severity of dehydration.

Children:

• <6 months: 30–50 mL after each stool.
• 6 months–2 years: 50–100 mL after each stool.
• 2–10 years: 100–200 mL after each stool.
• >10 years: Follow adult dosing.

Elderly:

• Same as adults; monitor for signs of fluid overload, especially in patients with cardiac or renal comorbidities.

Special Populations:

• Renal impairment: Use with caution; monitor for hyperkalemia or fluid overload.
• Hepatic impairment: No adjustment typically needed; monitor if ascites is present.
• Malnourished children: Begin with small frequent sips (5–10 mL every 1–2 minutes), increasing as tolerated.

Duration of Use:
Continue until diarrhea resolves and normal hydration is restored, typically within 24–72 hours.

Rice-based oral rehydration solution works by enhancing the sodium and water absorption through the sodium-amino acid co-transport mechanism in the small intestine. When rice starch is broken down in the gut, it produces glucose polymers (maltodextrins), which facilitate the co-transport of sodium across the intestinal mucosa. This process improves water uptake and corrects dehydration more efficiently than glucose-based ORS, especially in cases of secretory diarrhea like cholera, as it avoids excessive osmotic load and maintains low osmolarity in the intestinal lumen.

• Absorption: Sodium and water are actively absorbed in the small intestine via sodium-amino acid co-transport.
• Distribution: Water is distributed to both extracellular and intravascular compartments.
• Metabolism: Rice starch is enzymatically hydrolyzed into glucose polymers locally in the intestine.
• Excretion: Excess water and electrolytes are eliminated through the kidneys.
• Bioavailability: Local gastrointestinal action; systemic absorption is not pharmacologically relevant.
• Onset of Action: Begins within 30–60 minutes of oral administration.
• Half-life: Not applicable (supportive therapy only).

• Pregnancy: Considered safe in all trimesters. No teratogenic or fetal risks identified.
• Lactation: Safe to use while breastfeeding. The drug does not pass into breast milk in significant amounts. Breastfeeding should be continued alongside ORS in infants.

• Primary Class: Oral Electrolyte Replacement Solution
• Subclass: Rice-based, hypoosmolar oral rehydration therapy

• Severe dehydration requiring intravenous fluid replacement
• Intestinal obstruction or paralytic ileus
• Persistent vomiting preventing oral intake
• Known hypersensitivity to any component of the formulation

• Use only with safe, clean water. Contaminated water may worsen illness.
• Not intended for parenteral use.
• In severe dehydration (e.g., shock, unconsciousness), start with IV fluids before initiating ORS.
• Monitor for signs of fluid overload in:
• Patients with heart failure
• Renal impairment
• Discard prepared solution after 24 hours, even if unused.
• Do not mix ORS with milk, soup, or carbonated beverages, which may alter osmolarity.

Common:

• Abdominal bloating or mild distension
• Nausea (especially if taken too quickly)
• Temporary increase in stool frequency

Rare/Serious:

• Hypernatremia or fluid overload (particularly in renal or cardiac patients)
• Electrolyte imbalance (if solution is prepared or consumed improperly)

Onset: Within the first few hours of administration; generally mild and self-limiting.

• Drug-Drug Interactions: No significant interactions reported.
• Drug-Food: Should not be mixed with food, milk, or juices as this alters composition.
• Drug-Alcohol: Not applicable.
• Enzyme Systems Involved: No hepatic metabolism; not affected by CYP450 pathways.

• WHO and UNICEF 2023–2024 guidelines reaffirm that rice-based ORS is superior to glucose-based ORS in reducing stool volume and duration in cholera and pediatric diarrhea.
• Updated global protocols encourage wider use of rice-based ORS in cholera-endemic regions and in resource-limited settings due to enhanced clinical outcomes.
• Emphasis on low osmolarity formulations (≤245 mOsm/L) for improved safety and efficacy.

• Temperature: Store at 15°C to 30°C.
• Humidity: Keep in a dry place, protected from moisture.
• Light Protection: Store away from direct sunlight.
• Handling Instructions:
• Do not refrigerate or freeze the dry sachet.
• Once reconstituted, discard any unused solution after 24 hours.
• Use clean, food-grade containers for preparation.