DIOXEL Diosmin / Hesperidin 450mg / 50mg Film-Coated Tablet 1's
RXDRUG-DRP-5423-1pc
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Treatment of symptoms related to venolymphatic insufficiency (heavy legs, pain, early morning restless cramps).
Treatment of functional symptoms related to acute hemorrhoidal attack.
Treatment of functional symptoms related to acute hemorrhoidal attack.
Dosage/Direction for Use
See table.
Overdosage
No overdosage has been reported.
Administration
Should be taken with food: To be taken at midday & evening.
Contraindications
Hypersensitivity to any component of the product.
Special Precautions
Venolymphatic insufficiency: The most effective way of giving this treatment is in combination with a healthy lifestyle such as diet and exercise.
Avoid exposure to sun, heat, excessive standing and being overweight.
Walking and wearing special support stockings stimulate blood circulation.
Acute hemorrhoidal attack: This medicine is no substitute for the specific treatment of other anal disorders.
The treatment must be short-term. If the symptoms do not disappear within 15 days, ask the doctor for advice; proctological examination should be performed and the treatment reviewed.
Avoid exposure to sun, heat, excessive standing and being overweight.
Walking and wearing special support stockings stimulate blood circulation.
Acute hemorrhoidal attack: This medicine is no substitute for the specific treatment of other anal disorders.
The treatment must be short-term. If the symptoms do not disappear within 15 days, ask the doctor for advice; proctological examination should be performed and the treatment reviewed.
Use In Pregnancy & Lactation
Pregnancy: Inform the physician if the patient become pregnant while taking this medicine.
Experimental studies in animals have not demonstrated any teratogenic effect. To date, there have been no reports of adverse effects in humans.
Lactation: Due to lack of information, breastfeeding should be avoided during treatment.
Experimental studies in animals have not demonstrated any teratogenic effect. To date, there have been no reports of adverse effects in humans.
Lactation: Due to lack of information, breastfeeding should be avoided during treatment.
Adverse Reactions
Autonomic: Anxiety, cramps, drowsiness, feeling of discomfort, headache, hypotension, insomnia, palpitation, tiredness, vertigo.
Gastrointestinal: Abdominal pain, diarrhea, dyspepsia, epigastric pain, gastric discomfort, nausea, vomiting.
Gastrointestinal: Abdominal pain, diarrhea, dyspepsia, epigastric pain, gastric discomfort, nausea, vomiting.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Pharmacodynamics: Micronized purified flavonoid fraction (MPFF) is an oral phlebotropic and vascular protective agent consisting of 90% diosmin and 10% hesperidin. It increases venous tone, improves lymphatic drainage and protects the microcirculation from inflammatory processes and apoptosis. By decreasing the expression of some endothelial adhesion molecules, MPFF inhibits the activation, migration and adhesion of leukocytes at the capillary level. This leads to a reduction in the release of inflammatory mediators such as oxygen-free radicals, prostaglandins and thromboxane resulting in a decrease in capillary hyperpermeability.
Pharmacokinetics: Diosmin is rapidly transformed in the intestine by intestinal flora and absorbed as its aglycone, diosmetin, after oral administration.
A study compared the absorption of a single oral dose of radiolabelled MPFF [500 mg tablets containing trace amounts (about 25 nCi) of 14C-diosmin] with that of nonmicronized diosmin in 12 healthy male volunteers. Results showed that about half of an oral 500 mg dose of radiolabelled MPFF was absorbed within 48 hours of administration. Since unabsorbed diosmin was not excreted in the urine, absorption was evaluated based on the urinary elimination of radioactivity. Reduction in the particle size of diosmin led to a significant increase in absorption; mean gastrointestinal absorption of micronized 14C-diosmin was significantly greater than with nonmicronized 14C-diosmin (57.9 vs. 32.7% during 0 to 168 hours postdose; p=0.004).
The time to peak plasma concentration of diosmetin is 1 hour and plasma concentrations decrease slowly after 2 hours; diosmetin is still detectable after 48 hours. The mean volume of distribution of diosmetin is 62.1 liters.
Diosmetin is rapidly and extensively degraded to phenolic acids or their glycine conjugate derivates, which are eliminated in the urine. The predominant metabolite in man is 3-hydroxy-phenylpropionic acid which is mainly eliminated in its conjugated form. Metabolites found in smaller amounts include other phenolic acids corresponding to 3-hydroxy-4-methoxybenzoic acid, 3-methoxy-4-hydroxyphenylacetic acid and 3,4-dihydroxybenzoic acid. It is possible that unidentified metabolites may be responsible for the pharmacological activity of diosmin.
Elimination of micronized diosmin is relatively rapid with ≈34% of the radiolabelled dose of 14C-diosmin excreted in the urine and feces over the first 24 hours and ≈86% over the first 48 hours. Unmetabolized diosmin and diosmetin are not excreted in the urine. The cumulative excretion of the dose in the urine and feces was 100%. About half of the dose was eliminated in the feces as unchanged diosmin and diosmetin.
Pharmacokinetics: Diosmin is rapidly transformed in the intestine by intestinal flora and absorbed as its aglycone, diosmetin, after oral administration.
A study compared the absorption of a single oral dose of radiolabelled MPFF [500 mg tablets containing trace amounts (about 25 nCi) of 14C-diosmin] with that of nonmicronized diosmin in 12 healthy male volunteers. Results showed that about half of an oral 500 mg dose of radiolabelled MPFF was absorbed within 48 hours of administration. Since unabsorbed diosmin was not excreted in the urine, absorption was evaluated based on the urinary elimination of radioactivity. Reduction in the particle size of diosmin led to a significant increase in absorption; mean gastrointestinal absorption of micronized 14C-diosmin was significantly greater than with nonmicronized 14C-diosmin (57.9 vs. 32.7% during 0 to 168 hours postdose; p=0.004).
The time to peak plasma concentration of diosmetin is 1 hour and plasma concentrations decrease slowly after 2 hours; diosmetin is still detectable after 48 hours. The mean volume of distribution of diosmetin is 62.1 liters.
Diosmetin is rapidly and extensively degraded to phenolic acids or their glycine conjugate derivates, which are eliminated in the urine. The predominant metabolite in man is 3-hydroxy-phenylpropionic acid which is mainly eliminated in its conjugated form. Metabolites found in smaller amounts include other phenolic acids corresponding to 3-hydroxy-4-methoxybenzoic acid, 3-methoxy-4-hydroxyphenylacetic acid and 3,4-dihydroxybenzoic acid. It is possible that unidentified metabolites may be responsible for the pharmacological activity of diosmin.
Elimination of micronized diosmin is relatively rapid with ≈34% of the radiolabelled dose of 14C-diosmin excreted in the urine and feces over the first 24 hours and ≈86% over the first 48 hours. Unmetabolized diosmin and diosmetin are not excreted in the urine. The cumulative excretion of the dose in the urine and feces was 100%. About half of the dose was eliminated in the feces as unchanged diosmin and diosmetin.
MedsGo Class
Anorectal Preparations / Phlebitis & Varicose Preparations
Features
Brand
Dioxel
Full Details
Dosage Strength
450 mg / 50 mg
Drug Ingredients
- Diosmin
- Hesperidin
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Diosmin / Hesperidin
Dosage Form
Film-Coated Tablet
Registration Number
DRP-5423
Drug Classification
Prescription Drug (RX)
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