VASCULERA- diosmiplex tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIOSMIN (UNII: 7QM776WJ5N) (DIOSMIN - UNII:7QM776WJ5N), CALCIUM MAGNESIUM POTASSIUM CARBONATE CHLORIDE HYDROXIDE (UNII: Z7R65IFU98) (CALCIUM MAGNESIUM POTASSIUM CARBONATE CHLORIDE HYDROXIDE - UNII:Z7R65IFU98)

Available from:

Primus Pharmaceuticals, Inc.

INN (International Name):

DIOSMIN

Composition:

DIOSMIN 600 mg

Administration route:

ORAL

Therapeutic indications:

Indications 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. Usage 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. General CVI and its complications should be diagnosed and management monitored by a physician. Hypersensit

Product summary:

VASCULERA is a grayish-yellow oblong tablet with white flecks on the surface. The tablets are packaged in unit-of-use blister packages : 68040-610-14 contents 30 tablets per carton (30-day supply) 68040-610-10 contents 15 tablets per carton (15-day supply sample) 68040-610-25 contents 3 tablets per carton (3-day supply sample) Storage Store at room temperature 59° – 86°F (15° – 30°C). Protect from light and moisture. Store tablets in original carton until usage. Keep out of reach of children.

Authorization status:

MEDICAL FOOD

Summary of Product characteristics

VASCULERA - DIOSMIPLEX TABLET
PRIMUS PHARMACEUTICALS, INC.
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VASCULERA - DIOSMIPLEX 630MG
DESCRIPTION
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.
DIOSMIN GLYCOSIDE
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 C
H O . The structural formula is:
ALKA4-COMPLEX
Each VASCULERA tablet contains 30 mg of a proprietary, structured,
highly alkaline agglomeration of
reactive magnesium hydroxide (Mg(OH) , 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 (CaCO , molecular weight 100.1),
microcrystalline cellulose and
croscarmellose sodium. The agglomerated particle matrix has the
following approximate
characteristics:
28
32
15
2
3
OTHER INGREDIENTS
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.
MEDICAL FOOD
The U.S