Nesifin

Approved Indications:

• Occasional Constipation:
  Used for short-term relief of functional or dietary-induced constipation.
• Hard or Dry Stools:
  Indicated for stool softening in cases of difficult or painful bowel movements.
• Postoperative or Postpartum Constipation:
  Helps prevent straining during defecation after surgery or childbirth.
• Constipation Associated with Hemorrhoids or Anal Fissures:
  Softens stool to reduce trauma during defecation and aid healing in anorectal conditions.

Clinically Accepted Off-label Uses:

• Bowel Regulation in Patients on Opioids or Iron Supplements:
  Used to prevent constipation caused by medications known to reduce gut motility.
• Preparation for Diagnostic Procedures (e.g., Colonoscopy):
  Occasionally included in bowel preparation regimens in combination with other agents.

Adults:

• Typical Dose: 15–30 mL of oral emulsion once daily at bedtime or in divided doses.
• May be mixed with water or juice to improve palatability.

Pediatrics:

• 6–12 years: 10–15 mL once daily at bedtime or as directed.
• 2–5 years: 5–10 mL once daily. Use only under medical supervision.
• <2 years: Not recommended unless specifically prescribed.

Elderly:

• Same as adults. Use with caution due to increased risk of electrolyte imbalance or aspiration.

Renal Impairment:

• Use cautiously. Magnesium may accumulate, increasing the risk of toxicity. Avoid prolonged use.

Hepatic Impairment:

• Generally safe. No dose adjustment required, but monitor for fat absorption disturbances.

Route of Administration: Oral (emulsion or syrup)

Duration of Use:

• Short-term only (typically ≤5 days).
• Avoid long-term use due to risk of dependence or fat-soluble vitamin malabsorption.

Magnesium Hydroxide + Liquid Paraffin provides a combined osmotic and lubricating laxative effect. Magnesium hydroxide draws water into the intestinal lumen via osmosis, increasing stool fluidity, volume, and triggering peristalsis. Liquid paraffin coats the stool and the intestinal wall, preventing water reabsorption and softening the stool for easier passage. This dual mechanism is effective for relieving hard or impacted stools while minimizing straining during defecation.

Magnesium Hydroxide:

• Absorption: Poorly absorbed; acts locally in the GI tract.
• Metabolism: Not metabolized.
• Excretion: Unabsorbed drug excreted in feces; absorbed magnesium excreted renally.
• Onset: Laxative effect usually within 30 minutes to 6 hours.

Liquid Paraffin:

• Absorption: Not absorbed when used appropriately.
• Metabolism: Not metabolized.
• Excretion: Excreted unchanged in feces.
• Onset: Usually 6 to 8 hours.

• Pregnancy:
  Considered safe for short-term, occasional use during pregnancy. Chronic use should be avoided due to potential for electrolyte imbalance and impaired nutrient absorption.
• Lactation:
  Safe for short-term use. Minimal systemic absorption means negligible excretion in breast milk. Prolonged use may reduce absorption of fat-soluble vitamins (A, D, E, K) in the mother.

• Class: Osmotic and Lubricant Laxative
• Subclass: Saline laxative (Magnesium hydroxide) + Lubricant laxative (Liquid paraffin)
• Generation: Non-absorbable, combination GI agent

• Known hypersensitivity to magnesium hydroxide, liquid paraffin, or any excipients
• Intestinal obstruction or ileus
• Undiagnosed abdominal pain, nausea, or vomiting
• Rectal bleeding or failure to defecate after use
• Severe renal impairment
• Infants under 2 years (unless prescribed)

• Prolonged Use: May result in dependency, electrolyte imbalance, or reduced absorption of fat-soluble vitamins.
• Renal Impairment: Risk of hypermagnesemia; avoid prolonged use.
• Aspiration Risk (Liquid Paraffin): Can cause lipoid pneumonia, particularly in elderly or bedridden patients.
• Pediatric Use: Only under medical advice.
• Fat-soluble Vitamin Absorption: Long-term use may reduce absorption of vitamins A, D, E, and K.
• Use in Elderly: Increased risk of aspiration or bowel atony.

Gastrointestinal:

• Diarrhea
• Abdominal cramping
• Flatulence
• Nausea
• Anal seepage or leakage (from liquid paraffin)

Metabolic:

• Hypermagnesemia: In renal impairment—manifested by drowsiness, hypotension, muscle weakness

Respiratory (Rare):

• Lipoid Pneumonia: Due to aspiration of paraffin in elderly or neurologically impaired

Others:

• Decreased absorption of fat-soluble vitamins with long-term use
• Perianal irritation or soiling

• Fat-Soluble Vitamins (A, D, E, K):
  Reduced absorption with chronic use of liquid paraffin.
• Tetracyclines, Quinolones:
  Magnesium may form chelates, reducing absorption → space doses 2–4 hours apart.
• Iron, Bisphosphonates, Digoxin:
  May reduce bioavailability → administer separately.
• Oral Anticoagulants (e.g., Warfarin):
  Long-term use may lower vitamin K absorption, increasing bleeding risk.

Enzyme Systems:

• Not metabolized via CYP450. Interactions are due to local GI effects.

• No major updates by FDA or EMA.
• Clinical guidelines advise short-term use only, especially in elderly or renally impaired patients.
• Increased awareness of lipoid pneumonia risk in geriatrics has led to more cautious use of liquid paraffin in care homes and hospitals.

• Temperature: Store between 20°C and 25°C; excursions between 15°C and 30°C acceptable.
• Humidity & Light: Protect from direct sunlight and moisture.
• Handling Instructions:
• Shake well before use.
• Keep tightly closed in the original container.
• Do not freeze.
• Keep out of reach of children.
• Discard after the expiration date.