Hijuven

Hijuven

tocopheryl nicotinate

Manufacturer:

Eisai

Distributor:

DKSH
Full Prescribing Info
Contents
dl-α-tocopheryl nicotinate.
Description
Each orange soft capsule contains 200 mg of dl-α-tocopheryl nicotinate.
(See Table 1.)

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Excipients/Inactive Ingredients: L-aspartic acid, FD&C Yellow No.6 (Sunset Yellow - FCF), carnauba wax, glycerol esters of fatty acids, titanium oxide, gelatin, D-sorbitol solution, medium chain fatty acid triglyceride, concentrated glycerin, ethyl parahydroxybenzoate and propyl parahydroxybenzoate.
Action
Pharmacology: Pharmacodynamics: Improvement of lipid metabolism: In aged or cholesterol-loaded rats, dl-α-tocopheryl nicotinate decreases serum total cholesterol concentrations by increasing the turnover rate of cholesterol, which is considered to be due to enhanced catabolism/excretion of cholesterol. dl-α-Tocopheryl nicotinate also decreases lipid peroxide and triglyceride concentrations.
dl-α-Tocopheryl nicotinate decreases total serum cholesterol and triglyceride levels in humans, while it increases the serum levels of high-density lipoprotein (HDL) cholesterol in lipoprotein metabolism.
Enhancement of microcirculation: In an experiment with unanesthetized rabbits, dl-α-tocopheryl nicotinate has been demonstrated to maintain vasomotion and increase peripheral blood flow in the ear conchae by directly acting on the blood vessel walls, not via the nervous system.
In a clinical trial, dl-α-tocopheryl nicotinate is more significantly effective in alleviating peripheral circulatory disturbances than coadministration of vitamin E and nicotinic acid.
Strengthening of blood vessels: dl-α-Tocopheryl nicotinate mitigates capillary hyperpermeability in humans and decreases the number of purpura spots.
Inhibition of platelet aggregation: dl-α-Tocopheryl nicotinate inhibits the aggregation induced by epinephrine, arachidonic acid, collagen and ADP in stimulated human platelets.
dl-α-Tocopheryl nicotinate is more potent than tocopherol and tocopherol acetate in inhibiting the aggregation induced by arachidonic acid and collagen in human platelet-rich plasma.
Restoration of arterial oxygen partial pressure: dl-α-Tocopheryl nicotinate restores the decreased partial pressure of oxygen in human arterial blood.
Clinical Studies: Clinical efficacy: Hyperlipidemia: In open labeled clinical trials, it has been shown that statistically significant reduction for the patients of high total cholesterol before administrations, and shown that significant increase for the patients of low HDL-cholesterol before administrations. And statistically significant reduction in serum lipid peroxides was observed in patients with hyperlipidemia.
Peripheral circulatory disturbances: In double-blind and open labeled clinical trials, dl-α-tocopheryl nicotinate has been demonstrated to be useful in patients with peripheral circulatory disturbances such as arteriosclerosis obliterans.
Pharmacokinetics: Blood concentrations: dl-α-Tocopheryl nicotinate was administered orally to 12 healthy adult male volunteers at a single dose of 600 mgnote) after a meal, and plasma concentrations of dl-α-tocopheryl nicotinate (the unchanged drug) and tocopherol were determined. The plasma peak concentration (Cmax=0.615 μg/mL) of the unchanged drug was reached 6 hr after administration,and thereafter declined rapidly with an elimination half-life of 4.3 hr. The peak plasma tocopherol concentration (except endogenous tocopherol) (Cmax=1.62 μg/mL) was reached 10 hr after administration and declined gradually with an elimination half-life of 38.5 hr. (See figure.)
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Effect of meal: When dl-α-tocopheryl nicotinate was administered orally to 4 healthy adult male volunteers at a single dose of 600 mgnote), the peak plasma concentration was 32 times higher and the AUC was 29 times larger after a meal than during fasting. The absorption of dl-α-tocopheryl nicotinate is significantly influenced by food intake.
Note: A single dose of 600 mg is unapproved.
Indications/Uses
Hyperlipidemia. Peripheral circulatory disturbances accompanying arteriosclerosis obliterans.
Dosage/Direction for Use
The usual adult dosage for oral use is 3 capsules daily in three divided doses.
The dosage may be adjusted depending on the patient's age and symptoms.
The usual adult dosage of dl-α-tocopheryl nicotinate for oral use is 300 - 600 mg daily in three divided doses.
Overdosage
There is insufficient information on overdose.
Contraindications
Hijuven is contraindicated in patients with hypersensitivity to any of the active or inactive ingredients in Hijuven.
Special Precautions
Caution in handing over drug: For drugs that are dispensed in a press-through package (PTP), in-struct the patient to remove the drug from the package prior to use. [It has been reported that, if the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa, causing perforation and resulting in serious complications such as mediastinitis.]
Use In Pregnancy & Lactation
No clinical data on fertility and excretion in human milk have been reported. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy. There is a very limited amount of data from the use in pregnant women. As a precautionary measure, it is preferable to avoid the use in such cases.
Adverse Reactions
Adverse reactions were reported in 105 of 5,621 patients 1.87%). (Sum of the clinical trials). (See Table 2.)

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Drug Interactions
No data to date.
Storage
Hijuven should be stored at room temperature.
PTP packaged soft capsules should be protected from high temperature and moisture after opening aluminum bag. (Capsule shells may be softened.)
Soft capsules should be protected from high temperature and high humidity to be prepared and administered for a long period of time (Capsule shell may cause adhesion.).
ATC Classification
A11HA03 - tocopherol (vit E) ; Belongs to the class of other plain vitamin preparations. Used as dietary supplements.
Presentation/Packing
Softcap 200 mg (orange) x 100's.
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