Okebo (Page 4 of 4)

HOW SUPPLIED

Okebo™ (Doxycycline Monohydrate USP) Capsules, 50 mg are brown opaque cap and yellow opaque body imprinted with “LU” on cap in white ink and “M71” on the body in black ink filled with light yellow to grey colored blend.

Each capsule contains doxycycline monohydrate USP equivalent to 50 mg doxycycline.
Okebo™ (Doxycycline Monohydrate USP) Capsules, 50 mg is available in:
Bottle of 100 capsules NDC 69482-400-99

Okebo™ (Doxycycline Monohydrate USP) Capsules, 75 mg are brown opaque cap and light yellow opaque body imprinted with “LU” on cap in white ink and “M72” on the body in black ink filled with light yellow to grey colored blend.

Each capsule contains doxycycline monohydrate USP equivalent to 75 mg doxycycline.
Okebo™ (Doxycycline Monohydrate USP) Capsules, 75 mg is available in:
Bottle of 100 capsules NDC 69482-475-99

Okebo™ (Doxycycline Monohydrate USP) Capsules, 100 mg are brown opaque cap and yellow opaque body imprinted with “LU” on cap in white ink and “M73” on the body in black ink filled with light yellow to grey colored blend.

Each capsule contains doxycycline monohydrate USP equivalent to 100 mg doxycycline.
Okebo™ (Doxycycline Monohydrate USP) Capsules, 100 mg is available in:
Bottle of 50 capsules NDC 69482-450-50

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP controlled room temperature]. Protect from light.

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-seventh Informational Supplement, CLSI document M100-S27 [2017]. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
  2. Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard — Tenth Edition. CLSI document M07- A10 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
  3. Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard — Twelfth Edition. CLSI document M02-A12 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
  4. Clinical and Laboratory Standards Institute. Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline — Third Edition. CLSI document M45-A3 [2015], Clinical and 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 and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, PA 19087 USA.
  6. Clinical and Laboratory Standards Institute. Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard — Second Edition. CLSI document M24-A2 [2011], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.
  7. Clinical and Laboratory Standards Institute. Methods for Antimicrobial Susceptibility Testing for Human Mycoplasmas; Approved Guideline. CLSI document M43-A [2011], Clinical and 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.

Distributed by:
Encore Dermatology, Inc.
5 Great Valley Parkway,
Malvern, PA 19355 USA
1-844-848-6543
www.encorederm.com

Manufactured by:
Lupin Limited
Goa 403 722
INDIA.

June 2017

ID#: XXXXXX
DOX1133 06/17

PRINCIPAL DISPLAY PANEL — NDC: 69482-450-50 — 50-Count Bottle Label

NDC 69482-450-50

Rx only

Okebo (Doxycycline Monohydrate USP)

100 mg* Capsules

*Each capsule contains doxycycline monohydrate USP equivalent to 100 mg doxycycline.

50 Capsules

100-Count Bottle Label
(click image for full-size original)
OKEBO doxycycline capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69482-450
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
MICROCRYSTALLINE CELLULOSE
SODIUM STARCH GLYCOLATE TYPE A POTATO
FERROSOFERRIC OXIDE
GELATIN
FERRIC OXIDE RED
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
Product Characteristics
Color BROWN (brown opaque cap) , YELLOW (yellow opaque body) Score no score
Shape CAPSULE Size 20mm
Flavor Imprint Code LU;M73
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69482-450-50 50 CAPSULE in 1 BOTTLE None
2 NDC:69482-450-06 6 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204234 11/20/2017
Labeler — Encore Dermatology Inc. (079629654)

Revised: 01/2020 Encore Dermatology Inc.

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