Doxycycline Hyclate (Page 5 of 5)

HOW SUPPLIED

Doxycycline Hyclate Tablets, USP equivalent to 100 mg doxycycline: Round, orange film-coated tablet engraved with “3626” on one side, and plain on the other side

NDC 57237-105-50 Bottles of 50 tablets
NDC 57237-105-01 Bottles of 100 tablets
NDC 57237-105-25 Bottles of 250 tablets
NDC 57237-105-05 Bottles of 500 tablets

Dispense in a tight, light resistant container as defined in the USP, with a child resistant closure (as required).

Store at 20° to 25° C (68° to 77° F) (see USP controlled room temperature)

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.
Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Fourth Informational Supplement, CLSI document M100-S24. CLSI document M100-S24, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2014.
2.
Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard — Ninth Edition. CLSI document M07-A9, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
3.
Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Eleventh Edition. CLSI document M02-A11, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
4.
Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline -Second Edition. CLSI document M45-A2, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2010.
5.
Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard — Eighth Edition. CLSI document M11-A8. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA, 2012.
6.
Clinical and Laboratory Standards Institute. Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard-Second Edition. CLSI document M24-A2. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA, 2011.
7.
Clinical and Laboratory Standards Institute. Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline. CLSI document M43-A. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA, 2011.
a
Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149-195.
b
Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89: 524-528.
c
Horne HW Jr and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25: 315-317.
d
Hale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing, 2000:225-226.

Manufactured for:

Citron Pharma LLC
Suite -1101
2 Tower Center Blvd
East Brunswick NJ 08816

Made in USA

Issued: 10/2014

Rev: 02

PRINCIPAL DISPLAY PANEL — 100 Tablet Bottle Label

100 Tablets
NDC 57237-105-01

Doxycycline Hyclate Tablets USP

100 mg*

Rx only
Citron
Pharma

PRINCIPAL DISPLAY PANEL -- 100 Tablet Bottle Label
(click image for full-size original)
DOXYCYCLINE HYCLATE
doxycycline hyclate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57237-105
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Doxycycline Hyclate (Doxycycline Anhydrous) Doxycycline Anhydrous 100 mg
Inactive Ingredients
Ingredient Name Strength
anhydrous lactose
silicon dioxide
FD&C Red No. 40
FD&C Yellow No. 6
hypromelloses
magnesium stearate
cellulose, microcrystalline
polyethylene glycols
stearic acid
titanium dioxide
METHYLCELLULOSE (400 MPA.S)
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 3626
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57237-105-01 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:57237-105-25 250 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:57237-105-50 50 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:57237-105-05 500 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062505 09/11/1984
Labeler — Citron Pharma LLC (078731527)

Revised: 01/2015 Citron Pharma LLC

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