Cholera Saline

Approved Indications:

• Acute Watery Diarrhea with Severe Dehydration (including Cholera): Primary treatment to rapidly restore fluid and electrolyte balance.
• Cholera in Adults and Children: To replace the massive fluid losses characteristic of cholera.
• Moderate to Severe Dehydration from Other Causes: Used when IV fluids are not available or during transition from IV therapy to oral rehydration.

Off-Label/Clinically Accepted Uses:

• Prophylactic Rehydration in Cholera-Endemic Outbreaks: In high-risk settings (e.g., refugee camps) to prevent dehydration in early diarrheal episodes.
• Maintenance Fluid Therapy Post IV Rehydration in Cholera Patients: Used for continued oral rehydration as oral intake is tolerated.

Dosage Depends on Severity of Dehydration and Body Weight.

Preparation (per WHO standard):
Each sachet (for Cholera Saline) is dissolved in 1 liter of clean water.

Standard WHO Cholera ORS Formula (per liter):

• Sodium chloride: 3.5 g
• Potassium chloride: 1.5 g
• Trisodium citrate dihydrate: 2.9 g
• Glucose (anhydrous): 20 g

Osmolarity: ~245 mOsm/L

Adults (including elderly):

• With cholera: 1,000–2,000 mL per hour initially, adjusted based on fluid loss.
• Ongoing losses: After every loose stool, 200–400 mL or more as needed.

Children:

• <1 year: 50–100 mL per loose stool
• 1–5 years: 100–200 mL per loose stool
• 5–12 years: 200–400 mL per stool
• >12 years: Same as adults

Special Populations:

• Renal impairment: Use cautiously in patients with oliguria or anuria due to sodium and potassium load.
• Severely dehydrated or unconscious patients: Start with IV fluids, then switch to ORS when alert.

Route of Administration: Oral; via cup, spoon, or nasogastric tube if needed.

Duration: Continue until diarrhea stops and rehydration is complete.

Cholera saline works by exploiting the sodium-glucose co-transport mechanism in the small intestine. Glucose facilitates sodium absorption through SGLT1 transporters on enterocytes. As sodium is absorbed, water follows osmotically, leading to effective rehydration. This mechanism remains intact even during cholera toxin-induced secretory diarrhea, making ORS effective despite high fluid losses. The inclusion of potassium and citrate further helps in correcting electrolyte imbalances and metabolic acidosis.

Note: As a non-drug solution, standard pharmacokinetics (ADME) do not apply. However, physiological handling can be described as follows:

• Absorption: Sodium and glucose absorbed in the small intestine via co-transport; water follows passively.
• Distribution: Replaces extracellular fluid volume (plasma and interstitial compartments).
• Metabolism: Glucose is metabolized normally; citrate may be metabolized to bicarbonate, aiding correction of acidosis.
• Excretion: Excess water and electrolytes are excreted via kidneys once balance is restored.

• Pregnancy: Safe for use in pregnancy. No teratogenic or adverse effects reported when used as directed.
• Lactation: Safe during breastfeeding. Helps restore fluid balance in lactating women experiencing diarrhea. No effects on breast milk or infant health.
• Caution: Severe dehydration during pregnancy may require IV fluids; ORS can be used as follow-up therapy.

• Primary Class: Oral Rehydration Solution (ORS)
• Subclass: Electrolyte Replacement / Fluid Therapy for Diarrheal Diseases

• Complete or partial intestinal obstruction
• Inability to drink or absorb oral fluids (e.g., persistent vomiting without nasogastric access)
• Severe dehydration requiring urgent IV rehydration (initially)
• Known hypersensitivity to any component (extremely rare)

• Severe Dehydration or Shock: Use IV fluids (e.g., Ringer’s lactate) initially; switch to ORS when patient can drink.
• Electrolyte Imbalance Risk: Monitor in renal impairment or prolonged diarrhea.
• Cholera Management: ORS alone may not be sufficient for initial fluid resuscitation; should be part of a broader treatment protocol including antibiotics.
• Water Safety: Always mix in clean, boiled, or treated water to prevent introducing further pathogens.
• Discard After 24 Hours: Once prepared, unused solution must be discarded after 24 hours.

Generally well tolerated. Adverse effects are rare and mostly dose-related.

Gastrointestinal:

• Nausea or vomiting (especially if taken too fast)
• Abdominal bloating or cramping (rare)

Electrolyte-related (if used excessively or inappropriately):

• Hypernatremia
• Hyperkalemia (rare; more relevant in renal insufficiency)
• Fluid overload (in infants or patients with renal dysfunction)

Allergic reactions: Very rare; mainly from flavoring agents in commercial preparations.

• Diuretics: May exacerbate electrolyte disturbances when used together.
• Antihypertensives: Electrolyte rebalancing may alter response to medications affecting fluid volume.
• No known significant drug-enzyme interactions.

Drug-Food Interaction:

• Can be taken with or without food; however, patients should be encouraged to resume normal diet early (e.g., BRAT diet or normal weaning foods for children).

Alcohol: Should be avoided in dehydrated states.

• WHO & UNICEF (2023): Reaffirmed low-osmolarity ORS (245 mOsm/L) as the standard, even in cholera, with enhanced sodium and glucose delivery still effective.
• Cholera Outbreak Management (2024): Global cholera task force recommends early initiation of ORS at community level, before hospital presentation, to reduce mortality.
• No changes in formulation; guidelines stress the need for correct reconstitution and prompt use post-preparation.

• Temperature: Store sachets at 20°C to 30°C in a dry, cool place.
• Humidity: Keep in low humidity to prevent clumping or degradation of salts.
• Light Protection: Store away from direct sunlight.
• Handling:
• Do not use damaged or swollen sachets.
• Once prepared, use within 24 hours; discard any remaining solution.
• Reconstitution: Mix 1 sachet in exactly 1 liter of clean water; never in milk, juice, or carbonated drinks.
• Freezing: Not required; do not freeze the solution.