SMC Fruity (Orange)

Approved Indications:

• Acute diarrheal dehydration (including cholera): To restore fluid and electrolyte balance.
• Pediatric dehydration due to gastroenteritis: Especially in mild to moderate cases.
• Adult dehydration secondary to diarrhea or vomiting.
• Traveler’s diarrhea.
• Febrile illness with dehydration: To maintain fluid volume.
• Dehydration due to excessive sweating or heat exposure.

Clinically Accepted Off-label Uses:

• Hydration support in athletes and children during high heat or after exercise.
• Supportive care during dengue fever or similar viral infections.
• Initial oral rehydration in malnourished children before initiating specialized feeding protocols.
• Mild dehydration in elderly individuals when IV fluids are not required.

Route: Oral only.

Preparation:
Dissolve the full content of one sachet in 1 liter of clean, safe drinking water. Stir until fully dissolved. Do not mix with milk, juice, or sugary beverages. Discard unused solution after 24 hours.

Adults:

• 200–400 mL after each episode of diarrhea or vomiting.
• Up to 3–4 liters per day as needed.

Children:

• <6 months: 30–50 mL after each loose stool.
• 6 months to 2 years: 50–100 mL per episode.
• 2–10 years: 100–200 mL per episode.
• >10 years: Adult dose.

Elderly:

• Use adult dose with caution; monitor for fluid overload in those with heart or renal conditions.

Special Populations:

• Renal Impairment: Caution in moderate to severe cases; monitor electrolytes.
• Hepatic Impairment: Generally safe; monitor fluid status in ascitic patients.
• Malnourished children: Start with small frequent sips (5–10 mL every few minutes), increasing gradually.

Duration:
Continue until dehydration is corrected or diarrhea/vomiting resolves (typically within 24–72 hours).

Flavored glucose-based ORS acts via the sodium-glucose co-transport mechanism in the small intestine. Glucose enhances the active absorption of sodium through the SGLT-1 transporter located on intestinal epithelial cells. This promotes water uptake through osmotic gradients, leading to effective rehydration even during secretory diarrhea such as cholera. The presence of flavoring agents enhances palatability and compliance, particularly in children, without affecting the core pharmacodynamic mechanism.

• Absorption: Sodium and glucose are absorbed via active transport; water follows osmotically.
• Distribution: Absorbed fluids are distributed in the extracellular and intravascular compartments.
• Metabolism: Glucose is metabolized via glycolysis and cellular respiration.
• Excretion: Excess electrolytes and fluids are excreted through the kidneys.
• Bioavailability: Local effect in the intestine; systemic absorption of water and electrolytes.
• Onset of Action: 30–60 minutes after oral intake.
• Half-life: Not applicable (supportive fluid replacement).

• Pregnancy: Safe for use throughout pregnancy. No teratogenic effects observed. Used to manage dehydration in pregnancy-related gastrointestinal illnesses.
• Lactation: Safe. Not significantly excreted in breast milk. Breastfeeding should be continued alongside ORS use in infants.

• Primary Class: Oral Electrolyte Replacement Therapy
• Subclass: Flavored, glucose-based, hypoosmolar oral rehydration solution (ORS)

• Severe dehydration requiring intravenous fluid therapy
• Bowel obstruction or paralytic ileus
• Persistent vomiting preventing oral administration
• Known hypersensitivity to any component, including artificial flavors or colorants

• Do not exceed recommended concentration — incorrect mixing can lead to hypernatremia or electrolyte imbalances.
• Use only clean, potable water to avoid worsening infection.
• Discard unused solution after 24 hours.
• Caution in:
• Renal impairment (risk of hyperkalemia or volume overload)
• Heart failure
• Elderly patients with comorbidities
• Avoid mixing with soft drinks or juices which alter osmolarity.
• In patients with persistent vomiting, unconsciousness, or shock, initiate IV rehydration.
• Do not exceed recommended concentration — incorrect mixing can lead to hypernatremia or electrolyte imbalances.
• Use only clean, potable water to avoid worsening infection.
• Discard unused solution after 24 hours.
• Caution in:
• Avoid mixing with soft drinks or juices which alter osmolarity.
• In patients with persistent vomiting, unconsciousness, or shock, initiate IV rehydration.

Common:

• Mild nausea
• Bloating or stomach fullness (especially if consumed too fast)
• Temporary increase in stool volume initially

Rare/Serious:

• Hypernatremia (if improperly diluted)
• Fluid overload (in renal or cardiac patients)
• Allergic reactions to flavoring or coloring agents (e.g., rash, itching)

Onset: Usually within the first few hours of administration; symptoms are typically mild and transient.

• Drug–Drug Interactions: No significant interactions reported.
• Drug–Food: Should not be co-administered with milk, carbonated drinks, or fruit juices.
• Drug–Alcohol: Not relevant.
• Enzyme Interactions: Not metabolized by liver enzymes (e.g., CYP450); no hepatic enzyme inhibition or induction.

• WHO 2023–2024 guidelines continue to recommend low-osmolarity glucose-based ORS as the first-line therapy for diarrhea-related dehydration in all age groups.
• Flavored formulations are permitted to improve palatability and adherence, especially in pediatric populations, provided that osmolarity and electrolyte ratios remain within WHO specifications.
• Many national health programs now use flavored ORS as a standard in public health kits.

• Temperature: Store between 15°C and 30°C.
• Humidity: Protect from moisture.
• Light Protection: Store in a dry, shaded area.
• Handling Instructions:
• Keep sachets sealed until use.
• Use clean containers for mixing.
• Do not refrigerate dry powder or prepared solution.
• Discard solution 24 hours after preparation.