Orasol Saline

Approved Indications:

• Acute diarrhea (including cholera): For the prevention and treatment of dehydration and electrolyte loss.
• Pediatric diarrheal illnesses: Effective in infants and children with mild to moderate dehydration.
• Adult infectious or non-infectious diarrhea: Management of fluid and electrolyte loss.
• Traveler’s diarrhea: Supportive oral rehydration.
• Vomiting and fever-associated dehydration: For mild to moderate volume depletion.
• Post-operative fluid loss: As supportive oral hydration in non-critical cases.

Clinically Accepted Off-label Uses:

• Dehydration from intense physical activity or heat exposure.
• Supportive hydration in febrile illnesses such as dengue or viral infections.
• Initial rehydration in malnourished children (under medical supervision).
• Mild dehydration in elderly or debilitated patients when IV therapy is not needed.

Route of Administration: Oral only.

Preparation Instructions:
Dissolve the full contents of one sachet in exactly 1 liter of clean, safe (boiled and cooled) water. Mix thoroughly until fully dissolved. Do not add sugar, salt, milk, or juice.

Dosage:

Adults:

• 200–400 mL after each loose stool or vomiting episode.
• Total daily requirement: Up to 3–4 liters depending on fluid loss severity.

Children:

• <6 months: 30–50 mL after each loose stool.
• 6 months to 2 years: 50–100 mL after each loose stool.
• 2 to 10 years: 100–200 mL after each episode.
• >10 years: Same as adults.

Elderly:

• Use adult dosage.
• Monitor for fluid overload in those with cardiac or renal disease.

Special Populations:

• Renal impairment: Use with caution. Monitor potassium and fluid status.
• Hepatic impairment: Generally safe. Monitor ascitic patients for volume overload.
• Malnourished children: Start with frequent small sips (5–10 mL every 1–2 minutes), gradually increasing.

Duration of Use:
Continue treatment until dehydration is corrected and diarrhea/vomiting stops, typically within 24 to 72 hours.

Glucose-based Oral Rehydration Salt (ORS) acts through the sodium-glucose co-transport mechanism in the small intestine. Specifically, glucose is absorbed via SGLT-1 (Sodium-Glucose Linked Transporter 1), which facilitates concurrent sodium absorption. This active transport of sodium draws water across the intestinal epithelium via osmosis. Even during diarrheal diseases such as cholera, this transport mechanism remains functional, allowing for effective rehydration, electrolyte replenishment, and reduction in stool output.

• Absorption: Sodium and glucose are actively absorbed in the small intestine. Water follows passively via osmotic gradients.
• Distribution: The absorbed fluid is distributed throughout the extracellular and intravascular compartments.
• Metabolism: Glucose is metabolized normally via glycolysis and oxidative phosphorylation.
• Excretion: Excess fluids and electrolytes are excreted by the kidneys.
• Bioavailability: Not systemically relevant; acts locally in the gastrointestinal tract.
• Onset of Action: Rehydration effect begins within 30 to 60 minutes after ingestion.
• Half-life: Not applicable (supportive effect only).

• Pregnancy: Safe in all trimesters. No risk of teratogenicity. May be used to correct dehydration associated with vomiting or diarrhea in pregnancy.
• Lactation: Safe during breastfeeding. Not excreted in clinically significant amounts into breast milk. ORS therapy should be accompanied by continued breastfeeding in infants.

• Primary Class: Oral Electrolyte Replacement Solution
• Subclass: Glucose-based, hypoosmolar oral rehydration therapy (WHO standard)

• Severe dehydration requiring intravenous fluid therapy
• Intestinal obstruction or paralytic ileus
• Persistent or uncontrollable vomiting that prevents oral intake
• Known hypersensitivity to any component of the formulation

• Use only clean, safe water for reconstitution to prevent infection.
• Discontinue if the patient becomes unconscious or develops shock—switch to IV fluids.
• High-risk patients (e.g., renal, cardiac, or elderly) should be monitored for signs of fluid overload or electrolyte imbalance.
• Do not mix with milk, juice, carbonated drinks, or sugary beverages, which may alter osmolarity.
• Discard reconstituted solution after 24 hours to avoid bacterial contamination.
• Monitor for hyperkalemia and fluid overload in renal patients.

Common (generally mild):

• Abdominal bloating or fullness
• Nausea if taken too rapidly
• Temporary increase in stool volume during early treatment

Serious but Rare:

• Hypernatremia or hyperkalemia (especially in renal impairment)
• Fluid overload (notably in elderly or cardiac patients)
• Electrolyte imbalances if improperly prepared or overused

Onset: Within hours of administration; most effects are mild and self-limiting.

• Drug-Drug Interactions: No major clinically significant interactions.
• Drug-Food Interactions: Do not mix with food, milk, or sugary drinks, which may alter efficacy.
• Drug-Alcohol Interactions: Not relevant.
• Enzymatic Interactions: Not metabolized by CYP450 enzymes; no hepatic enzyme interactions.

• WHO and UNICEF (2023–2024): Continue to recommend low-osmolarity glucose-based ORS as the global standard for diarrhea-related dehydration in all age groups.
• Updated molar ratio: A glucose-to-sodium ratio of 1:1 is confirmed as optimal for absorption.
• Reiterated preference over older high-osmolarity formulations, due to lower incidence of vomiting and reduced stool volume.

• Temperature: Store sachets between 15°C and 30°C.
• Humidity: Keep in a dry place, protected from moisture.
• Light: Store away from direct sunlight.
• Reconstitution Guidelines:
• Use immediately after mixing.
• Do not refrigerate powder.
• Discard prepared solution after 24 hours, even if unused.
• Use clean utensils and drinking containers during preparation.