Seroquel

[Quetiapine]

HOW SUPPLIED

25 mg Tablets (NDC 0310-0275) peach, round, biconvex, film coated tablets, identified with 'SEROQUEL' and '25' on one side and plain on the other side, are supplied in bottles of 100 tablets and 1000 tablets and hospital unit dose packages of 100 tablets.

100 mg Tablets (NDC 0310-0271) yellow, round, biconvex film coated tablets, identified with 'SEROQUEL' and '100' on one side and plain on the other side, are supplied in bottles of 100 tablets and hospital unit dose packages of 100 tablets.

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200 mg Tablets (NDC 0310-0272) white, round, biconvex, film coated tablets, identified with 'SEROQUEL' and '200' on one side and plain on the other side, are supplied in bottles of 100 tablets and hospital unit dose packages of 100 tablets.

300 mg Tablets (NDC 0310-0274) white, capsule-shaped, biconvex, film coated tablets, intagliated with 'SEROQUEL' on one side and '300' on the other side, are supplied in bottles of 60 tablets, and hospital unit dose packages of 100 tablets.

Store at 25º C (77º F); excursions permitted to 15-30º C (59-86º F) [See USP].

ANIMAL TOXICOLOGY

Quetiapine caused a dose-related increase in pigment deposition in thyroid gland in rat toxicity studies which were 4 weeks in duration or longer and in a mouse 2 year carcinogenicity study. Doses were 10-250 mg/ kg in rats, 75-750 mg/ kg in mice; these doses are 0.1-3.0, and 0.1-4.5 times the maximum recommended human dose (on a mg/ m 2 basis), respectively. Pigment deposition was shown to be irreversible in rats. The identity of the pigment could not be determined, but was found to be co-localized with quetiapine in thyroid gland follicular epithelial cells.

The functional effects and the relevance of this finding to human risk are unknown. In dogs receiving quetiapine for 6 or 12 months, but not for 1 month, focal triangular cataracts occurred at the junction of posterior sutures in the outer cortex of the lens at a dose of 100 mg/ kg, or 4 times the maximum recommended human dose on a mg/ m 2 basis. This finding may be due to inhibition of cholesterol biosynthesis by quetiapine. Quetiapine caused a dose related reduction in plasma cholesterol levels in repeat-dose dog and monkey studies; however, there was no correlation between plasma cholesterol and the presence of cataracts in individual dogs.

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