Doxycycline Hyclate (Page 4 of 4)

HOW SUPPLIED

Product: 50090-5825

NDC: 50090-5825-4 30 CAPSULE in a BOTTLE

NDC: 50090-5825-0 14 CAPSULE in a BOTTLE

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. Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149–195.
  2. Cziezel AE and Rockenbauer M. Teratogenic study of doxycycline. Obstet Gynecol 1997; 89: 524–528.
  3. Horne HW Jr and Kundsin RB. The role of mycoplasma among 81 consecutive pregnancies: a prospective study. Int J Fertil 1980; 25: 315–317.
  4. 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

Distr. by:
West- W ard Pharmaceutical s Corp.
Eatontown, NJ 07724 USA

2INDOXY-ERevised June 2020

DOXYCYCLINE HYCLATE

Label ImageLabel Image
DOXYCYCLINE HYCLATE doxycycline hyclate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-5825(NDC:0143-9802)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOXYCYCLINE HYCLATE (DOXYCYCLINE ANHYDROUS) DOXYCYCLINE ANHYDROUS 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
FERROSOFERRIC OXIDE
BUTYL ALCOHOL
PROPYLENE GLYCOL
ALCOHOL
FD&C BLUE NO. 2
FD&C RED NO. 40
FD&C BLUE NO. 1
D&C YELLOW NO. 10
Product Characteristics
Color BLUE (Blue/White Opaque) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code Westward;3141
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-5825-4 30 CAPSULE in 1 BOTTLE None
2 NDC:50090-5825-0 14 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062396 05/07/1984
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-5825), REPACK (50090-5825)

Revised: 11/2021 A-S Medication Solutions

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