In the US, nutraceuticals are marketed under the Dietary Supplement and Health Education Act of 1994 (DSHEA). Consequently, scientific data supporting claimed benefit(s) are not always available for nutraceuticals as they are for traditional pharmaceuticals since nutraceuticals are not regulated as drugs. Consumers should also note that rigid quality control standards are not required for nutraceuticals and substantial variability can occur in both the potency and the purity of these products. Monographs on nutraceuticals are included in CP when reliable clinical data are available. The information presented below is condensed from the best clinical data we could find.
Lactase is a gastointestinal enzyme that aids in the digestion of lactose (milk sugar) found in dairy products. Some children and many adults become lactose intolerant when they do not produce sufficient lactase to digest lactose containing dairy products. This can lead to stomach cramps, bloating, flatulence and diarrhea. Lactase products have been available for decades; the enzyme is not regulated as a drug by the FDA but is regulated as a non-prescription dietary supplement.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Oral Administration
-Take orally at first bite of a meal that includes lactose-containing dairy products. Do not take the enzyme too early or the stomach will degrade the enzyme.
-Because dairy products contain various amounts of lactose and the symptoms of lactose intolerance vary from individual to individual, the lactase dosage needed must be individualized.
There are no documented adverse reactions from the use of lactase.
Lactase has not been evaluated by the Food and Drug Administration. Products containing lactase are not intended to diagnose, treat, cure, or prevent any disease. Consumers should also be informed that rigid quality control standards are not required for nutraceuticals and substantial variability can occur in both the potency and the purity of these products.
There are no documented absolute contraindications to the use of lactase.
Certain dosage forms of lactase may contain aspartame and should be used with caution in patients with phenylketonuria. For example, Lactaid Ultra chewable tablets, vanilla twist flavor, contains aspartame and thus roughly 0.49 mg of phenylalanine per tablet.
There are no data to describe adverse effects of lactase ingestion during pregnancy; the enzyme is found in many dairy food products and is generally recognized as safe (GRAS) for human consumption. Since lactase is not regulated as a drug, no FDA pregnancy risk category has been assigned to this dietary supplement. The lactase enzyme acts locally within the gut and systemic effects from use are not expected. Other strategies for pregnant women who are lactose intolerant, in place of lactase supplements, include ingesting lower-lactose dairy products, such as cheese and yogurt, or products specifically marked as "lactose free".
Lactase is often added to common dairy food products for mass human consumption; the products are generally recognized as safe (GRAS). There are no data to describe adverse effects of lactase ingestion during breast-feeding. The lactase enzyme acts locally within the gut and systemic effects from use are not expected, and thus, adverse effects to the breast-feeding infant or child are not expected. Other strategies for lactating women who are lactose intolerant, in place of lactase supplements, include ingesting lower-lactose dairy products, such as cheese and yogurt, or products specifically marked as "lactose free".
Lactase products are available in many different strengths. Dosage must be individualized according to patient need and response. Representative available products contain lactase as follows:
Dairyease chewable tablets - 3000 FCC lactase units/chewable tablet
Lac-Dos tablets - 3000 FCC lactase units/tablet
Lactaid Original Strength caplets - 3000 FCC lactase units/caplet
Lactaid Extra Strength caplets - 4500 FCC lactase units/ caplet
Lactaid Ultra caplets, tablets or chewable tablets - 9000 FCC lactase units/dosage form
Lactrase capsules - 3750 FCC lactase units/capsule
RiteAid Dairy Relief Original Strength caplets - 3000 FCC lactase units/caplet
RiteAid Dairy Relief Extra Strength caplets - 4500 FCC lactase units/caplet
Surelac chewable tablets - 3000 FCC lactase units/chewable tablet
For aide in digesting dairy foods in patients with symptoms of lactose intolerance (lactase deficiency)*:
NOTE: This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.
NOTE: The standard dose is 3000 FCC units. There are products with larger amounts/dose. The amount of lactose in the meal and the amount of lactose naturally occurring in the body will determine the dosage that will alleviate symptoms.
Oral dosage (chewable tablets containing 3000 FCC units/dose, e.g. Dairyease chewable tablets):
Adults and Adolescents: Chew 1-3 tablets PO with first bite of meal or drink containing lactose.
Oral dosage (caplets or tablets containing 3000 FCC units/dose, e.g. Lac-Dos, Lactaid Original Strength):
Adults and Adolescents: 1-3 caplets or tablets PO with first bite of meal or drink containing lactose.
Oral dosage (capsules containing 3750 FCC units/dose, e.g. Lactrase):
Adults and Adolescents: 1 or 2 capsules PO with first bite of meal or drink containing lactose. May increase dose until symptoms are relieved.
Oral dosage (caplets or tablets containing 4500 FCC units/dose, e.g. Lactaid Extra Strength):
Adults and Adolescents: 1-3 caplets or tablets PO with first bite of meal or drink containing lactose.
Oral dosage (chewable tablets containing 9000 FCC units/dose, e.g. Lactaid Ultra chewable tablets):
Adults and Adolescents: Chew 1-2 tablets PO with first bite of meal or drink containing lactose. No more than 2 tablets per dose.
Oral dosage (caplets or tablets containing 9000 FCC units/dose, e.g. Lactaid Ultra):
Adults and Adolescents: 1-2 caplets or tablets PO with first bite of meal or drink containing lactose. No more than 2 caplets or tablets per dose.
Maximum Dosage Limits:
-Adults
18,000 FCC Units/dose PO is suggested by some manufacturers.
-Elderly
18,000 FCC Units/dose PO is suggested by some manufacturers.
-Adolescents
18,000 FCC Units/dose PO is suggested by some manufacturers.
-Children
Specific guidelines are not available.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Lactase products.
Lactase is a natural enzyme found in the small intestine that breaks down lactose, the complex sugar found in dairy foods, into readily absorbable sugars, glucose and galactose. Without the lactase enzyme, lactose moves through the intestine undigested, creating all the symptoms of lactose intolerance. These symptoms can include stomach cramps, bloating, flatulence and diarrhea. Taking lactase supplements prior to ingesting dairy foods can relieve these symptoms.
Pharmacokinetics:
Lactase is taken orally. The action of the enzyme occurs locally in the gastrointestinal tract. The systemic absorption of lactase is negligible. Gastrointestinal acids appear to breakdown the enzyme within the gut.