MedLibrary.org

Prescription Medications

Doxycycline Monohydrate (Page 4 of 4)

HOW SUPPLIED

Doxycycline Monohydrate Capsules 50 mg have a white opaque body with an ivory opaque cap. The capsule bears the inscription WATSON 410 in brown and 50 mg in brown. Each capsule contains doxycycline monohydrate equivalent to 50 mg of doxycycline, supplied in bottles of 100.

Doxycycline Monohydrate Capsules 75 mg have a white opaque body with a brown opaque cap. The capsule bears the inscription WATSON 2404 in black and 75 mg in black. Each capsule contains doxycycline monohydrate equivalent to 75 mg of doxycycline, supplied in bottles of 100.

Doxycycline Monohydrate Capsules 100 mg have an ivory opaque body with a brown opaque cap. The capsule bears the inscription WATSON 411 in white and 100 mg in brown. Each capsule contains doxycycline monohydrate equivalent to 100 mg of doxycycline, supplied in bottles of 50.

Store at 20° — 25°C (68° -77°F). [See USP controlled room temperature.]
Dispense in a tight light-resistant container as defined in the USP/NF.

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-third Informational Supplement, CLSI document M100-S23. CLSI document M100S23, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2013.

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 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 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 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 Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2012.

6. Clinical and Laboratory Standards Institute (CLSI). Methods for Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard – Second Edition. CLSI document M24-A2, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2011.

7. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline. CLSI document M43-A, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA, 2011.

8. Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press: 2000: 149-195.

9. Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997;89:524-528.

10. Horne HW Jr. and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25:315-317.

11. Hale T. Medications and Mothers Milk. 9th edition. Amarillo, TX: Pharmasoft Publishing 2000; 225-226.

Rx only

For all medical inquiries contact:
ACTAVIS
Medical Communications
Parsippany, NJ 07054
800-272-5525

Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Content Updated: August 203

191157-5

PRINCIPAL DISPLAY PANEL

Doxycycline Monohydrate Capsules100 mg

43063529 Label
(click image for full-size original)
DOXYCYCLINE MONOHYDRATE doxycycline capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43063-529(NDC:0591-0411)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color BROWN (BROWN OPAQUE) , WHITE (IVORY OPAQUE) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code WATSON;411;100;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43063-529-14 14 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:43063-529-28 28 CAPSULE in 1 BOTTLE, PLASTIC None
3 NDC:43063-529-06 6 CAPSULE in 1 BOTTLE, PLASTIC None
4 NDC:43063-529-02 2 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA050641 02/07/2005
Labeler — PD-Rx Pharmaceuticals, Inc. (156893695)
Registrant — PD-Rx Pharmaceuticals, Inc. (156893695)
Establishment
Name Address ID/FEI Operations
PD-Rx Pharmaceuticals, Inc. 156893695 repack (43063-529)

Revised: 09/2013 PD-Rx Pharmaceuticals, Inc.

Page 4 of 4 « 1 2 3 4