Label: DOXYCYCLINE HYCLATE tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 3, 2025

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  • DESCRIPTION
    Doxycycline hyclate tablets, USP are available as a 20 mg formulation of doxycycline for oral administration. The structural formula of doxycycline hyclate is: with a structural formula of ...
  • CLINICAL PHARMACOLOGY
    After oral administration, doxycycline hyclate is rapidly and nearly completely absorbed from the gastrointestinal tract. Doxycycline is eliminated with a half-life of approximately 18 hours by ...
  • INDICATIONS AND USAGE
    Doxycycline hyclate tablets, USP are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult ...
  • CONTRAINDICATIONS
    This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.
  • WARNINGS
    THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH ...
  • PRECAUTIONS
    General - Prescribing doxycycline hyclate tablets in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient ...
  • ADVERSE REACTIONS
    Adverse Reactions in Clinical Trials of a bioequivalent form of doxycycline hyclate capsules: In clinical trials of adult patients with periodontal disease 213 patients received 20 mg BID over a ...
  • OVERDOSAGE
    In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases ...
  • DOSAGE AND ADMINISTRATION
    THE DOSAGE OF DOXYCYCLINE HYCLATE TABLETS DIFFERS FROM THAT OF DOXYCYCLINE USED TO TREAT INFECTIONS. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS INCLUDING ...
  • HOW SUPPLIED
    Doxycycline hyclate tablets USP, 20 mg are round, white unscored tablet, debossed “Є” above “362” on one side and plain on the other side. They are supplied as follows: NDC 71335-2526-1: 20 ...
  • References
    1. Golub L.M., Sorsa T., Lee H-M, Ciancio S., Sorbi D., Ramamurthy N.S., Gruber B., Salo T., Konttinen Y.T.: Doxycycline Inhibits Neutrophil (PMN)-type Matrix Metalloproteinases in Human Adult ...
  • PRINCIPAL DISPLAY PANEL
    Doxycycline Hyclate 20mg Tablet
  • INGREDIENTS AND APPEARANCE
    Product Information