Doxycycline (Page 4 of 4)

HOW SUPPLIED

Doxycycline capsules USP, 75 mg are opaque brown cap/opaque white body hard gelatin capsules size “2” having imprinting “A” on cap with black ink and “241” on body with black ink filled with yellow to brown granular powder. Each capsule contains doxycycline monohydrate equivalent to 75 mg doxycycline.

NDC 46708-249-30 bottle of 30 capsules

NDC 46708-249-31 bottle of 100 capsules

Doxycycline capsules USP, 100 mg are opaque brown cap/opaque yellow body hard gelatin capsules size “1” having imprinting “A” on cap with white ink and “242” on body with brown ink filled with yellow to brown granular powder. Each capsule contains doxycycline monohydrate equivalent to 100 mg doxycycline.

NDC 46708-250-30 bottle of 30 capsules

NDC 46708-250-50 bottles of 50 capsules

NDC 46708-250-60 bottle of 60 capsules

NDC 46708-250-61 bottle of 250 capsules

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Seventh Informational Supplement, CLSI document M100-S27 [2017]. CLSI document M100S23, Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA.

2. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard –Tenth Edition. CLSI document M07-A10 [2015], Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA.

3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard –Twelfth Edition. CLSI document M02-A12 [2015], Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA.

4. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline –Third Edition. CLSI document M45­A3 [2015], Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA.

5. Clinical and Laboratory Standards Institute (CLSI). Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard – Eighth Edition. CLSI document M11-A8 [2012], Clinical Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne Pennsylvania 19087, USA.

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

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

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.

Manufactured by:

Alembic Pharmaceuticals Limited

(Formulation Division),

Village Panelav, P.O. Tajpura,
Near Baska, Taluka-Halol,
Panchmahal 389350, Gujarat, India

Revised: 04/2017

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 75 mg

Doxycycline Capsules, USP 75 mg (30’s bottle pack)
Each capsule contains doxycycline monohydrate, equivalent to 75 mg of doxycycline USP . 46708-249-30

30's bottle pack
(click image for full-size original)

30’s bottle pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 100 mg

Doxycycline Capsules, USP 100 mg (30’s bottle pack)
Each capsule contains doxycycline monohydrate, equivalent to 100 mg of doxycycline USP . 46708-250-30

30's bottle pack
(click image for full-size original)
DOXYCYCLINE doxycycline capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-249
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 75 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
SILICON DIOXIDE
MAGNESIUM STEARATE
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
GELATIN
SODIUM LAURYL SULFATE
SHELLAC
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
Product Characteristics
Color BROWN (opaque browncap opaque white body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code A;241
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-249-30 30 CAPSULE in 1 BOTTLE None
2 NDC:46708-249-31 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209165 07/31/2017
DOXYCYCLINE doxycycline capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-250
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
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
SILICON DIOXIDE
MAGNESIUM STEARATE
FERROSOFERRIC OXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
GELATIN
SODIUM LAURYL SULFATE
SHELLAC
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
BROWN IRON OXIDE
Product Characteristics
Color BROWN (opaque brown cap opaque yellow body) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code A;242
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-250-30 30 CAPSULE in 1 BOTTLE None
2 NDC:46708-250-50 50 CAPSULE in 1 BOTTLE None
3 NDC:46708-250-60 60 CAPSULE in 1 BOTTLE None
4 NDC:46708-250-61 250 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209165 07/31/2017
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-249), MANUFACTURE (46708-250)

Revised: 09/2019 Alembic Pharmaceuticals Limited

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