Generic drug from Delursan
Therapeutic class: Gastro-Entero-Hepatology
active ingredients: Ursodeoxycholic acid
laboratory: Teva Sante
Box of 20
· Primary biliary cirrhosis.
Primary sclerosing cholangitis.
· Chronic cholestasis of cystic fibrosis.
· Progressive familial intrahepatic cholestasis of type III.
· Symptomatic cholestasis.
· Biliary lithiasis of LPAC syndrome (Low Phospholipid Associated Cholelithiasis).
· Symptomatic cholestérolic biliary lithiasis: in a non-sclero-atrophic, normal-walled, symptomatic vesicle in patients with a contraindication to surgery.
Dosage URSODESOXYCHOLIC ACID TEVA 250 mg Film-coated tablet Box of 20
Primary biliary cirrhosis: 13 to 15 mg / kg / day.
Primary sclerosing cholangitis: 15 to 20 mg / kg / day. Do not exceed the dosage of 20 mg / kg / day.
Chronic cystic fibrosis: 20 to 30 mg / kg / day
Genetic cholestasis: 20 to 30 mg / kg / day
The initial dosage is in the range of 13 to 15 mg / kg / day. It is recommended to gradually increase the dose in stages to obtain the optimal dosage after 4 and 8 weeks of treatment without exceeding the dose of 20 mg / kg / day in primary sclerosing cholangitis (see section Warnings and precautions for use). special warnings).
Symptomatic cholestasis: 10 to 20 mg / kg / day in continuous treatment until delivery. The maximum daily dose in pregnancy cholestasis should not exceed 1000 mg / day, divided into 2 doses morning and evening, at mealtimes.
Cholesterol biliary lithiasis
The recommended dosage is in the range of 5 to 10 mg / kg / day depending on the weight of the patient.
It is recommended to take the treatment either one in the evening or two in the morning and evening.
This medicine should not be used in the following cases:
· Acute cholecystitis,
· Obstruction of the bile ducts,
· Sclero-atrophic vesicle,
Hypersensitivity to the active substance or to any of the excipients.
Adverse effects Ursodesoxycholic acid Teva
The side effects are listed below, listed by organ class and frequency. Frequencies are defined as very common (≥1 / 10), frequent (≥1 / 100 to <1/10), uncommon (≥1 / 1, 000 to <1/100), rare (1/10, 000) <1/1, 000) and very rare (<1/10, 000) including isolated cases. Very frequent and frequent effects have generally been described in clinical trials. Rare and very rare side effects are usually from spontaneous post-marketing reports.
Frequent: pasty stools, diarrhea
Very rare: pain of the right hypochondrium during treatment of primary biliary cirrhosis
Very rare: Calcified gallstones, decompensation of hepatic cirrhosis, partially regressive at the end of treatment, in case of initiation of treatment of advanced biliary cirrhosis
Skin and subcutaneous tissue disorders
Very rare: urticaria
"Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals declare any suspected adverse reaction via the national reporting system: National Agency for the Safety of Medicines and Health Products (Ansm) and the network of Regional Pharmacovigilance Centers Website: www.ansm.sante.fr ».