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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
VASCULERA is indicated for the clinical dietary management of the metabolic processes associated with chronic venous insufficiency (CVI). Conditions which occur due to CVI include varicose veins, spider veins, edema, deep vein thrombosis, stasis dermatitis, venous ulcers and hemorrhoids. Symptoms of CVI include heavy leg syndrome (dull aching discomfort, heaviness, cramping, itching and tingling in legs), pain that gets worse when standing, pain that gets better when legs are raised, swelling of the legs (edema), redness of the legs and ankles, skin color changes around the ankles and thickening of the skin on the legs and ankles (stasis dermatitis). VASCULERA must be used under the supervision of a physician.
VASCULERA should be taken as directed by a physician. See Dosage and Administration for additional information.
Interactions with Food
VASCULERA can be taken with or without food.
There is currently no drug history available for this drug.
VASCULERA (diosmiplex) consists of a specially formulated proprietary blend of micronized, highly purified diosmin glycoside in combination with alkaline granules, alka4-complex. Diosmin glycoside manages venous inflammation, accumulation of polymorphonuclear leukocytes, platelets and other thrombotic components as well as edema, caused by a deterioration of venous vessel walls. Alka4-complex works by buffering stomach acid and managing blood pH to affect local metabolic acidosis in veins.
Each VASCULERA tablet contains 600 mg of diosmin glycoside (diosmin), a micronized, highly purified flavonoid fraction (from citrus) with hesperidoside constituents. In clinical trials, this level of intake has been shown to manage chronic venous insufficiency (CVI). Diosmin is chemically described as (7-[[6-O-(6-Deoxy-α-L-mannopyranosyl)-ß-D-glucopyranosyl]oxy]-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one) with a molecular weight of 608.5. The empirical formula for diosmin is C28H32O15. The structural formula is:
Each VASCULERA tablet contains 30 mg of a proprietary, structured, highly alkaline agglomeration of reactive magnesium hydroxide (Mg(OH)2, molecular weight 58.3), potassium chloride (KCl, molecular weight 74.6) and potassium hydroxide (KOH, molecular weight 56.1) held apart from each other in a matrix of calcium carbonate (CaCO3, molecular weight 100.1), microcrystalline cellulose and croscarmellose sodium. The agglomerated particle matrix has the following approximate characteristics:
VASCULERA contains the following other ingredients as fillers and excipients: microcrystalline cellulose, stearic acid, croscarmellose sodium, povidone, silicone dioxide, and water. Tablets do not contain fructose, glucose, sucrose, lactose, gluten, maltodextrin, tree nuts, peanuts, or flavors. VASCULERA is suitable for vegans.
The U.S. Congress defined “medical food” in the Orphan Drug Act and Amendments of 1988 as “a food which is formulated to be consumed or administered enterally under the supervision of a physician, and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” VASCULERA has been developed, manufactured and labeled in accordance with the statutory definition of a medical food. VASCULERA is to be used only under a physician’s supervision.
Generally Recognized As Safe
The ingredients in VASCULERA are Generally Recognized as Safe (GRAS). This is the statutory U.S. safety standard that the U.S. Food and Drug Administration (FDA) requires of all ingredients added to food products. The standard for an ingredient to achieve GRAS status requires technical demonstration of non-toxicity and safety, general recognition of safety through widespread usage and agreement of that safety by experts in the field.