1. What is lactobacillus? What does the bacterium do?
Lactobacilli are bacteria that normally live in the human small intestine and vagina. Lactobacillus acidophilus is generally considered to be beneficial because it produces vitamin K, lactase, and antimicrobial substances such as acidolin, acidolphilin, lactocidin, and bacteriocin.* Lactobacillus acidophilus is the most commonly used probiotic, or "friendly" bacteria. Such healthy bacteria inhabit the intestines and vagina and protect against the entrance and proliferation of "bad" organisms that can cause disease. This is accomplished through a variety of mechanisms. For example, the breakdown of food by L. acidophilus leads to production of lactic acid, hydrogen peroxide, and other byproducts that make the environment hostile for undesired organisms. L. acidophilus also produces lactase, the enzyme that breaks down milk sugar (lactose) into simple sugars.
* Cited from Mayo Clinic: http://www.mayoclinic.com/health/lactobacillus/NS_patient-acidophilus
2. Is Lactinex™ the same as acidophilus?
Lactinex products are a blend of Lactobacillus acidophilus and Lactobacillus helveticus (bulgaricus).
3. How is Lactinex supplied?
Each salable unit of the Lactinex Lactobacillus Granules (cat no. 236712) is one carton, which contains 12 packets. Each salable unit of the Lactinex Lactobacillus Tablets (cat. no. 236850) is one bottle, which contains 50 tablets.
4. How do tablets and granules differ? What is the concentration of each?
The tablet may be taken orally (chewed), followed by a small amount of liquid, while the granules can be added to other foods (i.e. cereal) or beverages. At the time of manufacture, each format contains a cumulative colony forming unit count (CFU) of: 1,000,000 CFU/tablet and 100,000,000 CFU/packet; therefore, 100 tablets = 1 package of granules.
5. What other ingredients are in Lactinex?
One packet of Lactinex Lactobacillus Granules (cat no. 236712) contains 380 mg lactose, 24 mg glucose, 34 mg sucrose, 5.0 mg calcium, 5.0 mg sodium, and 20 mg potassium. One tablet of Lactinex Lactobacillus Tablets (cat. no. 236850) contains 240 mg lactose, 12 mg glucose, 125 mg sucrose, 1.3 mg calcium, 1.4 mg sodium and 5.0 mg potassium. Other ingredients are milk, whey powder, soy peptone, talc (tablet) and mineral oil (tablet). For details, please refer to the Lactinex Product Information Sheet.
6. What is the recommended dosage?
The product information sheet recommends taking 4 tablets 3 or 4 times a day of the Lactinex Tablets (cat. no. 236850), or one packet 3 or 4 times a day of the Lactinex Granules (cat. no. 236712).
7. How do I take it?
As the product information sheet recommends, the Lactinex tablets can be chewed and swallowed, and may be followed by a small amount of milk, fruit juice or water. The Lactinex granules can be added to cereal, food or milk.
8. Does Lactinex have any calcium?
One packet of Lactinex Lactobacillus Granules (cat no. 236712) contains 5.0 mg calcium. One tablet of Lactinex Lactobacillus Tablets (cat. no. 236850) contains 1.3 mg calcium.
9. Does Lactinex have sugar?
One packet of Lactinex Lactobacillus Granules (cat no. 236712) contains 24 mg glucose. One tablet of Lactinex Lactobacillus Tablets (cat. no. 236850) contains 12 mg glucose.
10. Does Lactinex have gluten?
No, both Lactinex products are gluten free.
11. Can individuals sensitive to milk products use Lactinex?
Milk products are present in Lactinex. Do not use if sensitive to milk products. A person who exhibits intolerance to lactose may experience some gastrointestinal distress after taking Lactinex.
12. Can individuals sensitive to soy products use Lactinex?
Soy products are present in Lactinex. Do not use if sensitive to soy products.
13. How does Lactinex compare to an ounce of buttermilk in Lactobacillus content?
We have no equivalency data on the Lactobacillus content of buttermilk changes as it ages. However, there are approximately 4,000,000 cells of the (mixed) lactobacilli in 4 tablets at time of manufacture and a package of granules contains 100 million cells at time of manufacture.
14. What is the stability (shelf life) of Lactinex tablets or granules if not stored at 2-8 ºC?
While 2 - 8°C (refrigerated) storage is strongly recommended, it may not always be realistic, especially during times of transport. Internal studies have shown that organism counts are relatively unaffected during shipment for distribution (24 - 48 hrs) at ambient temperature, if product is refrigerated immediately upon arrival. Product should be stored at refrigerator temperatures to retain maximum stability. We have no claims or stability data for the product if it has been left outside of this storage condition for extended periods of time.
15. Are Lactobacillus resistant to antibiotics?
No, the Lactobacillus cultures in Lactinex are not resistant to antibiotics. Consult with your healthcare provider if you are on antibiotic therapy and are considering Lactinex as a dietary supplement.
16. Can Lactinex be used as a source of L. acidophilus to treat vaginal infections taken orally or inserted vaginally?
Lactinex is not recommended as a source of L. acidophilus to treat this condition.
17. Can Lactinex be given to an infant or child? If so, how much?
A pediatrician should always be consulted prior to the use of Lactinex in infants or children.
18. Can pregnant women take Lactinex?
A pregnant woman should consult with her physician before using Lactinex.
19. Can Lactinex be used as a starter for yogurt?
This is not recommended. There is no data to support this.
20. Is Lactinex useful in preventing or treating cold sores?
Use of this product in treatment of fever blisters and cold sores was based on reports published between 1958 and 1965. There have been unsolicited testimonials to add additional support. More recently, well-controlled evaluations have not produced substantial evidence of its effectiveness. Accordingly, BD discontinued this claim in late 1986 and the labeling was changed.
21. Does Lactinex have tamper-proof packaging?
Each Lactinex product has safety seals. The tablets have a foil seal over the mouth of the bottle, and the granules are packaged inside foil-sealed pouches. Both types are "tamper evident".
22. Where can I buy it?
Most drug stores carry Lactinex products. Please note that as Lactinex products require refrigeration, therefore Lactinex is not accessible directly to consumers from the shelf. You need to ask your pharmacist to obtain Lactinex.
23. Is there an NDC number for Lactinex?
As Lactinex is considered a dietary supplement or food supplement by the FDA, there is no valid National Drug Code (NDC) for any of the Lactinex products.
24. Can I take it with food or on an empty stomach?
The product information sheet recommends taking the Lactinex granules with cereal, food, or milk, and chewing the Lactinex tablets, and may be followed by a small amount of milk, fruit juice or water.
25. Where can I find the expiry?
Product expiry is clearly printed on each bottle of the Lactinex Lactobacillus Tablets (cat. no. 236850), and on each packet of the Lactinex Lactobacillus Granules (cat no. 236712).
26. Are there other precautions?
If you are allergic to milk, soy or sensitive to lactose, you should avoid the use of Lactinex.
27. What about allergies?
People who have known allergies or asthma may be at an increased risk for a reaction from any new treatment. The physician should always know a patient's allergy history. Signs of an allergic reaction are skin rash, hives or itching.
28. How long should I take lactobacillus?
The Lactinex products are generally harmless. Consult with your physician for extended period of use.
29. How about side effects?
There are no known side effects of lactobacillus.
30. Who is responsible for ensuring the safety and efficacy of dietary supplements?
Manufacturers of dietary supplements are responsible for making sure their products are safe before they go to market. They are also responsible for determining that the claims on their labels are accurate and truthful. Dietary supplement products are not reviewed by the government before they are marketed, but FDA has the responsibility to take action against any unsafe dietary supplement product that reaches the market. If FDA can prove that claims on marketed dietary supplement products are false and misleading, the agency may take action against products with such claims. (www.cfsan.fda.gov/~dms/ds-savvy.html)
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