Formula Each tablet contains biphenyl dimethyl dicarboxylate 25 mg and excipients q.s. (lactose, corn starch, povidone, CMC calcium, magnesium stearate).
Dosage form Tablets.
Presentation Box of 5 blisters x 10 tablets.
Indications Supportive treatment hepatitis due to virus or chemicals (especially antituberculosis drugs).
Contra-indications This drug is contraindicated in patients with known hypersensitivity to any of active or inactive ingredients.
Precautions Caution should be exercised when this drug is administered to patients with chronic active hepatitis or hepatic cirrhosis.
Side effects Such localized allergic manifestations usually resolved when antiallergic agent is administered. -Amaurosis jaundice may occur. It is disappeared when drug was discontinued or jaundice therapeutics are given concomitantly -Rarely nausea may occur. The physician should be informed any side effects during the treatment with FORTEC.
Interactions Galic oil (GO) and biphenyl dimethyl dicarboxylate (BDD), comprised in a pharmaceutical composition for the treatment of patients with viral hepatitis, effectively prevents acute liver injuries, compared to GO or BDD treatment alone.
Pharmacology and characteristics Inhibition of liver cell breakdown: Biphenyl dimethyl dicarboxylate inhibits the lipid peroxidation by free radical scavenging action and inhibits covalent binding with hepatotoxic substance which toxic to lipids of microsomes by stabilizing its membrane. Biphenyl dimethyl dicarboxylate markedly improves impaired liver function and relieves the main symptoms of acute or chronic hepatitis. Liver detoxification: Biphenyl dimethyl dicarboxylate activates liver detoxificant action by inducing hepatic cytochrome P-450 in smooth endoplasmic reticulum which plays a key role in the detoxification mechanisms of the liver. Liver regenerative action: Biphenyl dimethyl dicarboxylate activates liver regeneration by increasing in liver weight and microsomal proteine. Immunobiological responses: Biphenyl dimethyl dicarboxylate has significant therapeutic effect on immunotoxicity induced by CCl4 and ketoconazole. Protective action against drugs or alcohol: It could be expected that biphenyl dimethyl dicarboxylate has protective action agains liver injury induced by drugs (acetaminophen, antibiotics, antifungal, anticancer drug, pills, etc.) Which widely used in clinical practice or alcohol. Rapid drop in ALT: The excellent therapeutic efficacy of biphenyl dimethyl dicarboxylate on reducing abnormal ALT was certainly superior to that of any other drugs.
Dosage and Administration Usually administered 1~2 tablets three times daily. The dose should be appropriately increased according to indication of physician or pharmacist.
Shelf-life 36 months.
Storage Store in a dry and cool place (below 30 degree C). Keep out of reach of children.