Ursodiol 200 Mg (Page 4 of 4)
OVERDOSAGE
Neither accidental nor intentional overdosing with ursodiol has been reported. Doses of ursodiol in the range of 16-20 mg/kg/day have been tolerated for 6 to 37 months without symptoms by 7 patients. The LD50 for ursodiol in rats is over 5000 mg/kg given over 7 to 10 days and over 7500 mg/kg for mice. The most likely manifestation of severe overdose with ursodiol would probably be diarrhea, which should be treated symptomatically.
DOSAGE AND ADMINISTRATION
Gallstone Dissolution
The recommended dose for ursodiol treatment of radiolucent gallbladder stones is 8-10 mg/kg/day given in 2 or 3 divided doses.
Ultrasound images of the gallbladder should be obtained at 6-month intervals for the first year of ursodiol therapy to monitor gallstone response. If gallstones appear to have dissolved, ursodiol therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months. Most patients who eventually achieve complete stone dissolution will show partial or complete dissolution at the first on-treatment reevaluation. If partial stone dissolution is not seen by 12 months of ursodiol therapy, the likelihood of success is greatly reduced.
Gallstone Prevention
The recommended dosage of ursodiol for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day.
HOW SUPPLIED
Ursodiol Capsules, USP 200 mg are opaque white capsules imprinted with a thick black bar.
Ursodiol 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.
Ursodiol Capsules, USP 200 mg (NDC 0722-7143-01)
Ursodiol Capsules, USP 400 mg (NDC 0722-7144-01)
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
Dispense in tight container (USP).
Rx only
Keep out of reach of children.
Manufactured By:
Nexgen Pharma, Inc.
Irvine, CA 92606
Revised: 05/2020
Package/Label Display Panel
Ursodiol Capsules, USP 200mg (NDC 0722-7143-01) 100 Capsules
Package/Label Display Panel
Ursodiol Capsules, USP 400mg (NDC 0722-7144-01) 100 Capsules
URSODIOL 200 MG usodiol capsule | ||||||||||||||||||
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URSODIOL 400 MG usodiol capsule | ||||||||||||||||||
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Labeler — Nexgen Pharma, Inc (048488621) |
Registrant — Nexgen Pharma, Inc. (048488621) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Nexgen Pharma, Inc. | 160356114 | MANUFACTURE (0722-7143), MANUFACTURE (0722-7144), ANALYSIS (0722-7143), ANALYSIS (0722-7144), PACK (0722-7143), PACK (0722-7144), LABEL (0722-7143), LABEL (0722-7144) |
Revised: 05/2020 Nexgen Pharma, Inc
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