Lactase

Approved Indications:

• Lactose Intolerance (Primary and Secondary):
  • For the prevention and relief of gastrointestinal symptoms such as bloating, flatulence, abdominal discomfort, and diarrhea caused by lactose malabsorption due to lactase deficiency.
  • For use in individuals with congenital, primary (adult-type hypolactasia), or secondary lactase deficiency (e.g., due to gastroenteritis, celiac disease, or inflammatory bowel disease).

Clinically Accepted Off-Label Uses:

• Infantile Colic (due to Transient Lactase Deficiency):
  • Used as oral drops in infants with colic symptoms presumed to be caused by transient lactase deficiency.
• Dairy Reintroduction Therapy:
  • Used during dietary counseling to help reintroduce dairy in lactose-intolerant individuals gradually.

General Instructions:
• Administer immediately before or with the first bite or sip of any lactose-containing meal or beverage.
• Do not exceed the recommended number of doses per day.
• Oral use only.

Adults and Adolescents (≥12 years):
• Tablet/Capsule: 3000 to 9000 FCC units immediately before eating dairy.
• May repeat if additional lactose is consumed after 30–45 minutes.

Children (1–11 years):
• 3000 to 6000 FCC units before lactose-containing meals or snacks. Adjust dose based on symptom response.

Infants (0–12 months):
• Oral Drops: 4 drops (typically 300 FCC units) added to each feed of milk or formula. Let sit for 30 minutes at room temperature or refrigerate for 4 hours before feeding.

Elderly:
• No specific dose adjustment required. Use standard adult dose.

Renal/Hepatic Impairment:
• No dosage adjustment necessary as lactase is not systemically absorbed.

Lactase is a β-galactosidase enzyme that hydrolyzes lactose—a disaccharide sugar found in milk—into its absorbable monosaccharides, glucose and galactose, in the small intestine. In individuals with lactase deficiency, unabsorbed lactose reaches the colon where bacterial fermentation produces gas and short-chain fatty acids, leading to symptoms like bloating and diarrhea. Supplemental oral lactase digests lactose in the upper small intestine, preventing these symptoms and improving lactose tolerance.

Absorption:
• Not systemically absorbed; acts locally in the gastrointestinal tract.

Distribution:
• Not applicable; remains in the intestinal lumen.

Metabolism:
• May be degraded by digestive enzymes or gastric acid if not protected by formulation.

Excretion:
• Not excreted in active form; degraded and eliminated through the gastrointestinal tract.

Onset of Action:
• 15 to 30 minutes after oral intake.

Duration of Action:
• Typically effective for 30 to 45 minutes post-administration.

Bioavailability:
• Not systemically bioavailable.

Half-life:
• Not applicable (acts locally and transiently).

Pregnancy:
• Not assigned a specific FDA pregnancy category.
• Considered safe for use during pregnancy as the enzyme is not absorbed systemically.

Lactation:
• Safe for use during breastfeeding.
• No expected excretion into breast milk and no known adverse effects on nursing infants.

Caution:
• Though not systemically absorbed, always consult a healthcare provider before use during pregnancy or lactation.

• Class: Digestive Enzyme Supplement
• Subclass: Disaccharidase Enzyme Replacement (Lactase Enzyme)

• Hypersensitivity to lactase or any component of the formulation
• Patients with galactosemia (condition requiring strict avoidance of galactose and lactose)
• Known allergy to microbial fermentation-derived enzymes (e.g., from Aspergillus oryzae)

• Not effective for milk protein allergy. Do not use as a substitute for avoidance in allergic patients.
• Use with caution in infants under medical care for persistent diarrhea or unexplained colic.
• Enzyme activity may decrease in very acidic gastric environments; administer at the beginning of meals.
• Formulations vary in strength (measured in FCC units); always follow product-specific dosing instructions.
• Monitor for allergic reactions (rash, swelling, pruritus) in sensitive individuals.

Common (Mild and Transient):
• Gastrointestinal: Gas, bloating, abdominal discomfort (often due to incomplete digestion or underlying condition)

Uncommon to Rare:
• Skin: Rash, urticaria, itching (rare hypersensitivity)
• Oral irritation (with chewable tablets in sensitive users)

Severe Reactions:
• Rare anaphylaxis has been reported with microbial enzyme exposure, though extremely uncommon with oral lactase.

Note:
Lactase is generally very well-tolerated with a low incidence of side effects due to lack of systemic absorption.

Major Drug-Drug Interactions:
• None known.

Drug-Food Interactions:
• Required to be taken with lactose-containing foods to be effective.
• High gastric acidity may reduce enzyme activity. Avoid simultaneous intake with strongly acidic foods if possible.

Drug-Alcohol Interactions:
• None directly reported. However, alcohol may alter gastric motility, which could impact timing of enzyme activity.

Enzyme Pathways:
• Not metabolized via cytochrome P450 enzymes (e.g., CYP3A4); no known interaction with hepatic enzyme systems.

• Clinical guidelines recommend oral lactase supplementation as a first-line strategy for managing dietary lactose intolerance.
• Pediatric practice increasingly supports the off-label use of lactase drops in infants with suspected transient lactase deficiency.
• Product labeling updates in many countries now emphasize FCC unit standardization for consistent dosing.
• No recent FDA or EMA safety warnings or guideline changes as of the latest review.

Tablets/Capsules:
• Store below 25°C (77°F)
• Protect from moisture and light
• Do not freeze

Oral Drops:
• Store as directed on the label
• Some products require refrigeration after opening
• Shake well before each use
• Do not expose to high temperatures

General Precautions:
• Keep tightly closed in original container
• Avoid humidity and direct sunlight
• Check product expiration and discard if color, odor, or consistency changes