DOXYCYCLINE HYCLATE (Page 4 of 4)
HOW SUPPLIED
Doxycycline hyclate tablets USP, are available in yellow colored, round, biconvex film-coated tablets containing doxycycline hyclate equivalent to:
100 mg doxy cy cline
Bottles of 14 (NDC 68788-8464-1
Bottles of 20 (NDC 68788-8464-2
Bottles of 30 (NDC 68788-8464-3
The tablets are imprinted on one side with “CY” and “185” on the other side.
All products are to be Stored at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature] and dispensed in tight, light-resistant containers with a child-resistant closure (USP).
ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY
Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4 , and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4 , and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline.
Minocycline, tetracycline PO4 , methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet.
Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetracycline); and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.
REFERENCES
1. Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149–195.
2. Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89: 524–528.
3. Horne HW Jr and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25: 315–317.
4. Hale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing, 2000: 225–226.
This product’s label may have been updated. For current full prescribing information, please visit www.trispharma.com
Manufactured by:
Changzhou Pharmaceutical Factory
No. 518 Laodong East Road,
Changzhou, Jiangsu, 213018, China
Distributed by:
Tris Pharma, Inc.
Monmouth Junction, NJ 08852 USA
LB8656
Rev. 01Revised November 2021
Repackaged By: Preferred Pharmaceuticals Inc.
PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Label
NDC 68788-8464
Doxycycline Hyclate Tablets, USP
100 mg*
50 Tablets
Rx only
DOXYCYCLINE HYCLATE doxycycline hyclate tablet | ||||||||||||||||||||||||
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Labeler — Preferred Pharmaceuticals Inc. (791119022) |
Registrant — Preferred Pharmaceuticals Inc. (791119022) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Preferred Pharmaceuticals Inc. | 791119022 | REPACK (68788-8464) |
Revised: 06/2023 Preferred Pharmaceuticals Inc.
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