Doxycycline Hyclate (Page 4 of 4)
HOW SUPPLIED
Doxycycline Hyclate Capsules, USP equivalent to 50 mg doxycycline: No. 2 Blue/White Opaque Hard Gelatin Capsule Printed “West-ward 3141” in Black Ink.
NDC 0143-9802-50 : Bottle of 50 Capsules
Doxycycline Hyclate Capsules, USP equivalent to 100 mg doxycycline: No. 0 Blue/Blue Opaque Hard Gelatin Capsule Printed “West-ward 3142” in Black Ink.
NDC 0143-9803-50 : Bottle of 50 Capsules
NDC 0143-9803-05 : Bottle of 500 Capsules
Store at 20° to 25°C (68° to 77°F), [See USP Controlled Room Temperature]. Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
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
- Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149–195.
- Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89: 524–528.
- Horne HW Jr and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25: 315–317.
- Hale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing, 2000: 225–226.
Manufactured by:
Hikma Pharmaceuticals
P.O. Box 182400
Amman, 11118 — Jordan
Distributed by:
Hikma Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922
2INDOXY-E
Revised 02/2022
PRINCIPAL DISPLAY PANEL
NDC 0143-9803-50
Doxycycline Hyclate Capsules, USP
100 mg 50 capsules
PRINCIPAL DISPLAY PANEL
NDC 0143-9802-50
Doxycycline Hyclate Capsules, USP
50 mg 50 capsules
PRINCIPAL DISPLAY PANEL
NDC 0143-9803-05
Doxycycline Hyclate Capsules, USP
100 mg 500 capsules
DOXYCYCLINE HYCLATE doxycycline hyclate capsule | ||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||
|
DOXYCYCLINE HYCLATE doxycycline hyclate capsule | ||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||
| ||||||||||||||||||||||||||||||
|
Labeler — Hikma Pharmaceuticals USA Inc. (001230762) |
Revised: 12/2023 Hikma Pharmaceuticals USA Inc.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/doxycycline-hyclate-119/page/4/