Introduction
Tilactase is a beta-D-galactosidase obtained from Aspergillus oryzae. It is produced as a chewable tablet that has to be taken before the consumption of a lactose-containing meal. The beta-D-galactosidase us a large monomeric multi-domain enzyme of 985 residues that presents a catalytic (alpha/beta)8-barrel domain. It is considered by the WHO as part of the International Nonpropietary Names for Pharmaceutical Substances.
Uses
Tilactase is a beta-D-galactosidase use to treat lactose intolerance.
Tilactase is indicated for the symptomatic treatment of lactose intolerance in infants and older patients requiring a parenteral nutrition or fluid diet.
Lactose intolerance occurs when there is an existence of an inability to break down lactose which is commonly found in dairy products. This inability occurs when the lactase levels are reduced and thus there is no via to digest and break down the lactose. The undigested lactose moves into the large intestine where normal flora bacteria can interact with it and cause bloating, gas and diarrhea.
Associated Conditions
Pharmacodynamics
The use of a single oral administration of tilactase has been shown to be highly effective in decreasing the symptoms and hydrogen excretion of hypolactasia in tests of lactose H(2)-breath. The analysis has shown a decrease of approximately 80% in both malabsorbers and intolerants.The administration of tilacatase also decreases the presence of bloating and flatus.
Mechanism of Action
Lactose is the primary disaccharide found in dairy products. Tilactase is a type of lactase which is the enzyme that is in charge of the breakdown of lactose to glucose and galactose which can be used by the body. Basically, tilactase acts by replacing the missing lactase in the body and allows avoidance of the reach of lactose to the small intestine and the normal bacteria and thus, preventing the symptoms of the lactose intolerance. Once tilactase has metabolized the lactose, the metabolism products are reabsorbed by the normal process of digestion.
Absorption
Tilactase is not absorbed in the GI tract and thus the pharmacokinetic parameters related to absorption are not relevant.
Volume of Distribution
Tilactase is not absorbed and thus the volume of distribution is not relevant.
Protein Binding
Tilactase is not absorbed and thus the plasma protein binding is not possible.
Route of Elimination
Tilactase is completely eliminated in the feces either unchanged or as metabolites.
Half Life
Tilactase half-life at 35ºC is registered to be 123.77 min. This half-life can be affected by temperature in an inversely proportional manner.
Clearance
Tilactase is not absorbed and thus the clearance rate is not relevant.
Toxicity
Tilactase is known to present a low acute oral toxicity in preclinical trials. The lowest toxic dose for subcutaneous exposure is of 26 g/kg administered over 30 days. There have not been performed enough studies regarding the use of pregnancy or related to the fetal development. There are no reports of overdose with tilactase.
Food Interactions
- Take before a meal. Take tilactase before eating food containing lactose.
Dosage
Paediatric drops: Add lactase enzyme to breast milk or formula in the following directions-
Breast Milk:
- Express a few tablespoons (2-3 tablespoons) of breast milk into sterilized container
- Add 4 drops of lactase paediatric drops
- Give mixture to infant on a spoon or oral syringe before initiating breastfeeding
- Breast feed as normal
- Add 4 drops of lactase paediatric drops to warm (not hot) formula
- Wait 30 minutes, shaking formula occasionally
- Add 2 drops of lactase paediatric drops to warm formula
- Store in refrigerator for minimum 4 hours
- Feed Infant as normal
- Use within 12 hour
- Discard any unused formula.
