Label: DOXYCYCLINE HYCLATE tablet

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

Drug Label Information

Updated October 7, 2024

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION
    To reduce the development of drug-resistant   bacteria and maintain   the effectiveness of Doxycycline and other antibacterial drugs, Doxycycline should be used only to treat or prevent infections ...
  • DESCRIPTION
    Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline. The chemical designation for doxycyclin is ...
  • CLINICAL PHARMACOLOGY
    Tetracyclines are readily absorbed and are bound to plasma proteins in varying degree. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations and ...
  • INDICATIONS AND USAGE
    To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to ...
  • CONTRAINDICATIONS
    This drug is contraindicated in persons who have shown hypersensitivity to any of the 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 - As with other antibacterial drugs, use of Doxycycline may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, Doxycycline should be discontinued ...
  • INFORMATION FOR PATIENTS
    Patients taking doxycycline for malaria prophylaxis should be advised: - that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria. - to avoid being ...
  • DRUG INTERACTIONS
    Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since ...
  • ADVERSE REACTIONS
    Due to oral doxycycline's virtually   complete absorption, side effects of the lower bowel, particularly diarrhea, have been infrequent.  The following adverse reactions   have been observed in ...
  • 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 usual dosage and frequency of administration of doxycycline differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side ...
  • HOW SUPPLIED
    Each film-coated tablet for oral administration contains doxycycline hyclate equivalent to 100 mg of doxycycline (anhydrous). Doxycycline hyclate tablets USP, equivalent to 100 mg doxycycline ...
  • 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 PO 4 and methacycline; in ...
  • REFERENCES
    Friedman JM and Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press, 2000: 149–195. Cziezel AE and Rockenbauer M ...
  • SPL UNCLASSIFIED SECTION
    Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 - Rev.: 10/22
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    Product Information