Lactic acid + Citric acid + Potassium bitartrate

Approved and Clinically Accepted Uses:

• Occasional Constipation (Short-Term Relief):
  – Used as an osmotic laxative to relieve functional or occasional constipation.
  – Helps soften stools and promote bowel movement without causing dependency.
• Bowel Preparation (Off-label Use):
  – May be used in combination regimens to assist bowel cleansing before endoscopy or diagnostic imaging.
• Supportive Acidification (Off-label Use):
  – Occasionally used in metabolic or urinary alkalosis to aid in pH normalization.

Route of Administration: Oral (after reconstitution in water)
Formulation: Effervescent granules

Adults:

• Dose: 1 sachet (containing ~5.9 g powder) dissolved in 200 mL of cold water, once daily.
• Timing: Preferably taken in the morning after a meal.
• Duration: Recommended for up to 7 days. Seek medical advice if constipation persists beyond 3 days.

Pediatrics:

• Not recommended for children under 12 years unless prescribed by a physician.

Elderly:

• Same dosage as adults. Monitor fluid status and renal function due to higher dehydration risk.

Renal Impairment:

• Use with caution. Monitor serum potassium levels to avoid hyperkalemia.

Hepatic Impairment:

• No specific dose adjustment required, but clinical monitoring is advised in severe hepatic disease.

Instructions for Use:

• Dissolve the entire sachet in a glass (at least 200 mL) of cold water.
• Stir well and drink immediately.
• Maintain adequate hydration during use.

Lactic acid and citric acid serve as organic acidifiers that gently lower intestinal pH, stimulating peristalsis and stool movement. Potassium bitartrate functions as an osmotic agent, drawing water into the intestines to soften stool and stimulate defecation. Together, the combination enhances intestinal motility and fluid retention in the colon, enabling a non-stimulant, physiologic laxative effect. The mechanism does not involve neural stimulation, minimizing cramping and irritation compared to stimulant laxatives.

• Absorption: Minimal systemic absorption; primary action is localized in the gastrointestinal tract.
• Distribution: Not significantly distributed systemically due to minimal absorption.
• Metabolism:
  – Lactic acid and citric acid are metabolized via the citric acid cycle.
  – Potassium bitartrate dissociates into potassium and tartrate; excess potassium is renally excreted.
• Excretion:
  – Absorbed components are excreted in urine.
  – Unabsorbed components are eliminated via feces.
• Onset of Action: Typically 6–12 hours after ingestion.
• Bioavailability: Not clinically relevant due to localized action.

• Pregnancy:
  – Not formally assigned an FDA pregnancy category.
  – Considered safe for occasional use when clinically indicated.
  – No teratogenic effects reported in short-term human use. Use caution in early pregnancy.
• Lactation:
  – No significant excretion into breast milk reported.
  – Likely compatible with breastfeeding if used short term and in standard doses.
• Caution:
  – Avoid chronic use during pregnancy or lactation due to the risk of electrolyte imbalance or dehydration.

• Primary Class: Osmotic Laxative
• Sub-class: Non-stimulant acidifier–laxative combination

• Known hypersensitivity to lactic acid, citric acid, potassium bitartrate, or formulation excipients
• Intestinal obstruction or suspected bowel perforation
• Severe dehydration or fluid-electrolyte imbalance
• Hyperkalemia
• Advanced renal failure

• Use with caution in patients with:
  – Renal impairment
  – Congestive heart failure
  – Electrolyte abnormalities
  – Inflammatory bowel disease
• Avoid long-term use:
  – Risk of dependence, electrolyte shifts, or chronic bowel dysfunction.
• Monitor for:
  – Signs of dehydration
  – Electrolyte imbalance, particularly potassium in at-risk populations
• Discontinue and seek medical help if:
  – Severe abdominal pain, nausea, vomiting, or rectal bleeding occurs

Common (≥1%):

• Bloating
• Flatulence
• Mild abdominal discomfort
• Loose stools or diarrhea

Less Common (<1%):

• Nausea
• Excessive thirst
• Transient cramping

Rare/Serious:

• Hyperkalemia
• Allergic reactions (rash, urticaria, angioedema)

Onset: Most mild side effects occur within the first few doses and are dose-dependent.

• Potassium-sparing diuretics (e.g., spironolactone, amiloride): Increased risk of hyperkalemia
• ACE inhibitors or ARBs: Additive potassium elevation risk
• Antacids or alkalinizing agents: May affect acid balance and reduce laxative efficacy
• Drugs sensitive to GI motility (e.g., digoxin): May alter absorption
• CYP450 System: Not involved; systemic metabolism is minimal

Food Interactions:

• No clinically significant food interactions reported.

Alcohol:

• Excessive intake may aggravate dehydration or GI upset.

• No major regulatory updates or labeling changes noted in recent FDA, EMA, or WHO bulletins.
• Continued recommendation for short-term use only in functional constipation, with emphasis on adequate hydration and electrolyte monitoring.

• Temperature: Store below 25°C
• Humidity: Keep in a dry place; protect from moisture
• Light: Store away from direct sunlight
• Handling: Do not open sachet until ready for use
• Reconstitution: Dissolve immediately before use; do not store prepared solution
• Other: Keep out of reach of children