Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
URSODIOL (UNII: 724L30Y2QR) (URSODIOL - UNII:724L30Y2QR)
Intra-Sana Laboratories
ORAL
PRESCRIPTION DRUG
Reltone™ is a bile acid available as 200 mg and 400 mg capsules suitable for oral administration. Ursodiol (ursodesoxycholic acid) is a naturally occurring bile acid found in small quantities in normal human bile and in the bile of certain other mammals. It is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C24 H40 O4 ). Ursodiol has a molecular weight of 392.57. Its structure is shown below: Inactive Ingredients: Silicon dioxide, magnesium stearate, and corn starch. Gelatin capsules contain gelatin and titanium dioxide and are printed with edible black ink; additionally, the 400 mg capsule also contains FD&C Yellow #6 and D&C Yellow #10.
Reltone™ Capsules, USP 200 mg are opaque white capsules imprinted with a thick black bar. Reltone™ Capsules, USP 400 mg are opaque yellow and white capsules imprinted with a thick black bar. Bottles of 100 are supplied with child-resistant closures. Reltone™ Capsules, USP 200 mg (NDC 80056-143-01) Reltone™ Capsules, USP 400 mg (NDC 80056-144-01) Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F). Dispense in tight container (USP). Rx only Keep out of reach of children. Distributed by: Intra-Sana Laboratories LLC Las Vegas, NV 89113 7143 Rev. 11/2020
Abbreviated New Drug Application
RELTONE 200 MG- URSODIOL CAPSULE RELTONE 400 MG- URSODIOL CAPSULE INTRA-SANA LABORATORIES ---------- RELTONE™ ( URSODIOL CAPSULES, USP ) RX ONLY SPECIAL NOTE GALLBLADDER STONE DISSOLUTION WITH RELTONE™ TREATMENT REQUIRES MONTHS OF THERAPY. COMPLETE DISSOLUTION DOES NOT OCCUR IN ALL PATIENTS AND RECURRENCE OF STONES WITHIN 5 YEARS HAS BEEN OBSERVED IN UP TO 50% OF PATIENTS WHO DO DISSOLVE THEIR STONES ON BILE ACID THERAPY. PATIENTS SHOULD BE CAREFULLY SELECTED FOR THERAPY WITH URSODIOL, AND ALTERNATIVE THERAPIES SHOULD BE CONSIDERED. DESCRIPTION Reltone™ is a bile acid available as 200 mg and 400 mg capsules suitable for oral administration. Ursodiol (ursodesoxycholic acid) is a naturally occurring bile acid found in small quantities in normal human bile and in the bile of certain other mammals. It is a bitter- tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water. The chemical name for ursodiol is 3α,7β-Dihydroxy-5β-cholan-24-oic acid (C H O ). Ursodiol has a molecular weight of 392.57. Its structure is shown below: _Inactive Ingredients: _Silicon dioxide, magnesium stearate, and corn starch. Gelatin capsules contain gelatin and titanium dioxide and are printed with edible black ink; additionally, the 400 mg capsule also contains FD&C Yellow #6 and D&C Yellow #10. CLINICAL PHARMACOLOGY About 90% of a therapeutic dose of Reltone™ is absorbed in the small bowel after oral administration. After absorption, ursodiol enters the portal vein and undergoes efficient extraction from portal blood by the liver (i.e., there is a large “first-pass” effect) where it is conjugated with either glycine or taurine and is then secreted into the hepatic bile 24 40 4 ducts. Ursodiol in bile is concentrated in the gallbladder and expelled into the duodenum in gallbladder bile via the cystic and common ducts by gallbladder contractions provoked by physiologic responses to eating. Only small quantities of ursod Διαβάστε το πλήρες έγγραφο