Lactaid (Lactase)

LACTAID®

McNeil Consumer Products

Lactase Enzyme

Lactose Digestant

Action And Clinical Pharmacology: Converts the disaccharide lactose via hydrolysis into its monosaccharide components, glucose and galactose.

Tablets: In vivo activity has been demonstrated with drug administration at time of milk consumption and at time of consumption of other lactose containing solid and liquid foods.

Drops: Fifteen drops will hydrolyze nearly all of the lactose in 1 L of milk at refrigerator temperature (6°C) in 24 hours. 1 L of any type of milk will contain approximately 50 g lactose prior to lactose hydrolysis.

Indications And Clinical Uses: Lactase insufficiency either suspected because of gastrointestinal disturbances (bloating, flatulence, diarrhea) after consumption of milk or milk products or identified by a lactose tolerance test, or a breath hydrogen test after lactose challenge.

Precautions: Lactase deficient diabetics should be made aware that milk sugar (lactose) which was previously indigestible by them will now be metabolized and provide calories which must be accounted for in their diet (e.g., 50 g of lactose will yield 25 g of glucose and 25 g of galactose sugar each of which may be converted to energy by metabolism).

Galactosemics may not have milk in any form, lactase enzyme modified or not.

Drug Interactions: No drug interactions reported.

Adverse Reactions: The most frequently reported adverse effects to the tablets are gastrointestinal in nature, sometimes mimicking the symptoms of lactose intolerance. No reactions of any kind were observed from the liquid drops. Total reactions were estimated at under 0.1% of users.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Overdose has not been reported with this drug.

Dosage And Administration: Drops: Add up 15 drops to each L of milk to convert nearly all of the lactose.

Tablets: Extra Strength: 2 tablets to be taken just before eating a meal or food which contains lactose. The tablet can either be swallowed or chewed.

Regular Strength: 3 tablets to be taken just before eating a meal or food which contains lactose. The tablet can either be swallowed or chewed. Dosage requirements may vary substantially between individuals and between situations.

Ultra Caplets: 1 caplet to be taken just before eating a meal or food which contains lactose. The caplet must be swallowed whole.

Availability And Storage: Drops: Each mL of solution contains: lactase (b-D-galactosidase derived from Kluyveromyces lactis yeast). Nonmedicinal ingredients: glycerin and water. Dropper bottles of 6.5 and 15.5 mL. Sufficient to treat 30 and 75 L respectively, with doses of 5 drops/L. Treats 10 and 25 L respectively, with doses of 15 drops/L.

Tablets: Extra Strength: Each tablet contains: at least 4 500 FCC lactase units of b-D-galactosidase from Aspergillus oryzae. Nonmedicinal ingredients: cellulose, dextrose, magnesium stearate, mannitol and sodium citrate. Packages of 12, 40 and 80.

Regular Strength: Each tablet contains: at least 3 000 FCC lactase units of b-D-galactosidase from Aspergillus oryzae. Nonmedicinal ingredients: cellulose, dextrose, magnesium stearate, mannitol and sodium citrate. Packages of 15, 50 and 100.

Ultra Caplets: Each caplet contains: at least 9 000 FCC lactase units of b-D-galactosidase from Aspergillus oryzae. Nonmedicinal ingredients: cellulose, colloidal silicon dioxide, dextrose, magnesium stearate and sodium citrate. Packages of 2, 20 and 40.

Container provided with a child-resistant closure. (Shown in Product Recognition Section)

LACTAID® McNeil Consumer Products Lactase Enzyme Lactose Digestant

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