Ursodiol (Page 3 of 4)

Pregnancy Category B

Reproduction studies have been performed in rats and rabbits with ursodiol doses up to 200-fold the therapeutic dose and have revealed no evidence of impaired fertility or harm to the fetus at doses of 20- to 100-fold the human dose in rats and at 5-fold the human dose (highest dose tested) in rabbits. Studies employing 100- to 200-fold the human dose in rats have shown some reduction in fertility rate and litter size. There have been no adequate and well-controlled studies of the use of ursodiol in pregnant women, but inadvertent exposure of 4 women to therapeutic doses of the drug in the first trimester of pregnancy during the ursodiol trials led to no evidence of effects on the fetus or newborn baby. Although it seems unlikely, the possibility that ursodiol can cause fetal harm cannot be ruled out; hence, the drug is not recommended for use during pregnancy.

Nursing Mothers

It is not known whether ursodiol is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ursodiol is administered to a nursing mother.

Pediatric Use

The safety and effectiveness of ursodiol in pediatric patients have not been established.

Geriatric Use

In worldwide clinical studies of ursodiol, approximately 14% of subjects were over 65 years of age (approximately 3% were over 75 years old). In a subgroup analysis of existing clinical trials, patients greater than 56 years of age did not exhibit statistically significantly different complete dissolution rates from the younger population. No age-related differences in safety and effectiveness were found. Other reported clinical experience has not identified differences in response in elderly and younger patients. However, small differences in efficacy and greater sensitivity of some elderly individuals taking ursodiol cannot be ruled out. Therefore, it is recommended that dosing proceed with caution in this population.

ADVERSE REACTIONS

The nature and frequency of adverse experiences were similar across all groups.

The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5% incidence level:

GALLSTONE DISSOLUTION
Ursodiol Placebo
8 — 10 mg/kg/day
(N = 155) (N = 159)
N (%) N (%)
Body as a Whole
Allergy 8 (5.2) 7 (4.4)
Chest Pain 5 (3.2) 10 (6.3)
Fatigue 7 (4.5) 8 (5.0)
Infection Viral 30 (19.4) 41 (25.8)
Digestive System
Abdominal Pain 67 (43.2) 70 (44.0)
Cholecystitis 8 (5.2) 7 (4.4)
Constipation 15 (9.7) 14 (8.8)
Diarrhea 42 (27.1) 34 (21.4)
Dyspepsia 26 (16.8) 18 (11.3)
Flatulence 12 (7.7) 12 (7.5)
Gastrointestinal Disorder 6 (3.9) 8 (5.0)
Nausea 22 (14.2) 27 (17.0)
Vomiting 15 (9.7) 11 (6.9)
Musculoskeletal System
Arthralgia 12 (7.7) 24 (15.1)
Arthritis 9 (5.8) 4 (2.5)
Back Pain 11 (7.1) 18 (11.3)
Myalgia 9 (5.8) 9 (5.7)
Nervous System
Headache 28 (18.1) 34 (21.4)
Insomnia 3 (1.9) 8 (5.0)
Respiratory System
Bronchitis 10 (6.5) 6 (3.8)
Coughing 11 (7.1) 7 (4.4)
Pharyngitis 13 (8.4) 5 (3.1)
Rhinitis 8 (5.2) 11 (6.9)
Sinusitis 17 (11.0) 18 (11.3)
Upper Respiratory
Tract Infection 24 (15.5) 21 (13.2)
Urogenital System
Urinary Tract Infection 10 (6.5) 7 (4.4)
GALLSTONE PREVENTION
Ursodiol Placebo
600 mg
(N = 322) (N = 325)
N (%) N (%)
Body as a Whole
Fatigue 25 (7.8) 33 (10.2)
Infection Viral 29 (9.0) 29 (8.9)
Influenza-like Symptoms 21 (6.5) 19 (5.8)
Digestive System
Abdominal Pain 20 (6.2) 39 (12.0)
Constipation 85 (26.4) 72 (22.2)
Diarrhea 81 (25.2) 68 (20.9)
Flatulence 15 (4.7) 24 (7.4)
Nausea 56 (17.4) 43 (13.2)
Vomiting 44 (13.7) 44 (13.5)
Musculoskeletal System
Back Pain 38 (11.8) 21 (6.5)
Musculoskeletal Pain 19 (5.9) 15 (4.6)
Nervous System
Dizziness 53 (16.5) 42 (12.9)
Headache 80 (24.8) 78 (24.0)
Respiratory System
Pharyngitis 10 (3.1) 19 (5.8)
Sinusitis 17 (5.3) 18 (5.5)
Upper Respiratory
Tract Infection 40 (12.4) 35 (10.8)
Skin and Appendages
Alopecia 17 (5.3) 8 (2.5)
Urogenital System
Dysmenorrhea 18 (5.6) 19 (5.8)

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