Prescribing Information

Tears Again^® HYDRATE^™

NDC 54799-918-17
Rx Only

DESCRIPTION:
Tears Again^® HYDRATE^™ is a Medical Food specially formulated for the Dietary Management of Dry Eye Syndrome and is intended to be used under the supervision of a physician. Tears Again^® HYDRATE^™ is formulated to contain the omega-3 fatty acid, Flaxseed Oil, but has also included Evening Primrose Oil (EPO), a substance having exceptionally high content of the even rarer essential fatty acid, gamma linolenic acid (omega-6). These essential fatty acids (EFA) have been combined with Bilberry Extract (BBE), all of which provide anti-inflammatory properties – a component in Dry Eye Syndrome. The clinically supported ingredients in Tears Again^® HYDRATE^™ improve Dry Eye Syndrome and provide faster relief by encapsulating a unique combination of ingredients utilizing Hypersorb^®*, a proprietary liposome process that has been proven to enhance the absorption of orally administered ingredients for better bioavailability.

This delivery system is especially suited for oral delivery of drugs with poor bioavailability such as newly discovered drugs, proteins and peptides that are not soluble with conventional technologies. HyperSorb^®* is one of the most significant developments in oral pharmaceutics within the last decade.

Tears Again^® HYDRATE^™ Contains:

Flaxseed Oil 1000 mg
Evening Primrose Oil 500 mg
Bilberry Extract 40 mg

Flaxseed Oil is derived from the seeds of the flax plant and is one of the richest sources of the omega-3 fatty acid, Alpha-Linoleic Acid (ALA). Recent reports have linked dietary Flaxseed Oil to increased comfort when used to manage Dry Eye Syndrome.¹ Essential Fatty acids such as Flaxseed Oil work throughout the body to protect cell membranes. Omega-3 Fatty Acids (Flaxseed Oil) have a competitive inhibitory effect on the arachidonic acid (omega-6 derivative) inflammatory cascade and a modular effect on immune cells.^2,3 Flaxseed Oil also improves meibomian gland secretion by increasing its fluidity, thereby ‘unplugging’ the gland orifices. A recent study demonstrated that increased intake of omega-3 fatty acids improved the profile of the polar lipid fraction of meibomian secretions in patients with Dry Eye Syndrome. By enhancing the lipid fraction of the tear film, evaporative loss will decrease.⁴ Chronic blepharitis has associated meibum abnormalities that explain defects in the tear lipid layer that may result in a frankly unstable tear film and that explain the frequently associated evaporative dry eye.⁵

Evening Primrose Oil is an omega-6 gamma linolenic acid (GLA) that is a downstream metabolite of omega-6 linoleic acid. This compound is a necessary component in the downstream metabolism of omega-6 fatty acid to the series one anti-inflammatory prostaglandins (PGE1s), which are associated with healthy mucosal tissue and tear film. The human body cannot metabolize omega-3 fatty acids to these specifics anti-inflammatory prostaglandins.⁶ Omega-6 fatty acids that are successfully metabolized or those that have the metabolic advantage of containing GLA reduce inflammation after further metabolizing to dihomo-gamma-linoenic acid (DGLA), which also blocks, when appropriate, the pro-inflammatory arachidonic acid conversion. They also enhance the delta-6 and delta-5 desaturase enzymatic conversion of omega-3 alpha-linolenic-acid to EPA/DHA and the series 3 anti-inflammatory prostaglandins.⁷ The body requires all of the essential fatty acids for optimal health. They are particularly important for the patient that has Dry Eye Syndrome because PGE1s from omega-6 (EPO) interrupt the inflammatory loop associated with chronic Dry Eye Syndrome.

Bilberry Extract is a botanical source of an important bioflavanoid for eye health. Bioflavanoids are water-soluble plant-based antioxidants that have additional beneficial effects on eye health. The eyes are supplied with oxygen and nutrients through minute capillaries; bioflavonoids may increase the integrity of these blood vessels, enhancing their function. Research has also demonstrated improvements in patients with retinopathy by supporting blood vessels of the eyes and thereby reducing exudations (fluid seeping through blood vessels).

OTHER INGREDIENTS: Safflower Oil, Lecithin (Precept 8120), d-alpha Tocopheryl Acetate, Gelatin, Glycerin, Purified Water, Caramel Powder.

Contains Soy or Soy derivatives.

CONTRAINDICATIONS:
Should not be used by the patient without physician supervision, or in those persons showing hypersensitivity to any component of this preparation. Avoid taking at the same time with other medications and/or supplements. Pregnant women should not take evening Primrose Oil due to increased risk of pregnancy complications. Evening Primrose Oil may lower the seizure threshold and precipitate seizures in patients taking phenothiazines.

WARNINGS:

• Before taking, tell your doctor if you are pregnant or breastfeeding.
• Flaxseed Oil may cause ileus (intestinal blockage).
• Flaxseed Oil may cause a thyroid problem.
• Flaxseed Oil and Evening Primrose Oil reduce blood vessel platelet aggregation. If already taking aspirin or blood thinners consult your physician – you may need to have your clotting time checked.
• Evening Primrose Oil may lower the seizure threshold and precipitate seizures in patients taking phenothiazines.

PRECAUTIONS:

Information for Patients:
Keep this and all drugs out of the reach of children. In case of emergency contact a Poison Control Center Immediately.
Avoid taking at the same time with other medications and/or supplements.

Pregnancy Category C:
It is not known whether this Medical Food can cause fetal harm when administered to a pregnant woman or affect reproduction.

Pediatric Use:
Safety and effectiveness in children have not been established.

Other than the possibility for allergic reaction in susceptible individuals, no serious side effects are associated with consumption of normal amounts. Flaxseed Oil increases stool bulk and frequency of defecation, it is not recommended for those with bowel obstruction, irritable bowel syndrome or diverticular disease. Stop taking immediately and talk to your doctor if you have any of the following side effects: Breathing problems or tightness in your throat or chest, chest pain, skin hives, rash, or itchy or swollen skin, headache, GI upset, nausea.

DOSAGE:
Take 4 soft gels daily. May be taken directly or during meals or snacks. Avoid taking at the same time with other medications and/or supplements.

HOW SUPPLIED:
Tears Again^® HYDRATE^™ is supplied as 120 Soft Gels in a caramel color. NDC 54799-918-17

STORAGE:
Store at a controlled room temperature, 15 –30 degree Celsius (59-86 degree Fahrenheit) Keep container tightly closed.

Manufactured By:
Best Formulations, Inc.
City of Industry, CA 91748

Distributed By:
OCuSOFT INC.
P.O. Box 429
Richmond TX 77406
U.S. Patent 6610322 B1

REFERENCES:

1. Ambrioso RJ, Stelzner SK, Boerner CF, Honan PR, McIntyre DJ. Nutrition and Dry Eye: The Role of Lipids. Review of Refractive Surgery, August 2002; 29-32.
2. Calder PC. N-3 polyunsaturated fatty acids and immune cell function. Adv Enzyme Regul. 1997; 37:197-237.
3. Calder PC. Omega-3 polyunsaturated fatty acids, inflammatory and immunity. World Rev Nutr. Diet 2001; 88:109-116.
4. Sullivan BD, Cermak JM, Sullivan RM, Papas AS, Evans JE, Dana MR, Sullivan DA. Correlations between nutrient intake and the polar lipid profiles of meibomian gland secretions in women with Sjogren’s Sydrome. Adv Exp Med Biol 2002; in press.
5. McCulley JP, Shine WE. Eyelid disorders: the meibomian gland, blepharitis, and contact lenses. Eye Contact Lens. 2003 Jan; 29(1Suppl): S93-5: discussion S115-8, S192-4.
6. Barabino S, Rolando M, Camicione P, et al. Systemic linolenic and gamma linolenic acid therapy in dry eye syndrome with an inflammatory component. Cornea 2003 Mar; 22(2); 97-101
7. Furse RK, Rossetti RG, Zurier RB. Gamma linolenic acid, an unsaturated fatty acid with anti-inflammatory properties, blocks amplififcation of IL-1 beta production by human monocytes. J Immunol 2001 Jul 1; 167 (1); 490-6.
   
   

Learn More About Dry Eye