Label: DOXYCYCLINE injection, powder, lyophilized, for solution

  • NDC Code(s): 83634-111-20, 83634-111-41
  • Packager: Avenacy Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 1, 2025

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  • SPL UNCLASSIFIED SECTION
    AVENACY - Rx only - To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline for Injection, USP ...
  • DESCRIPTION
    Doxycycline for injection, USP is an antibacterial drug synthetically derived from oxytetracycline, and is available as Doxycycline Hyclate (doxycycline hydrochloride hemiethanolate hemihydrate) ...
  • 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 ...
  • INDICATIONS AND USAGE
    To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline for Injection, USP and other antibacterial drugs, Doxycycline for Injection, USP should be used ...
  • 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 ...
  • ADVERSE REACTIONS
    Gastrointestinal - Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis and inflammatory lesions (with monilial overgrowth) in the anogenital region, and pancreatitis ...
  • DOSAGE AND ADMINISTRATION
    NOTE: Rapid administration is to be avoided. Parenteral therapy is indicated only when oral therapy is not indicated. Oral therapy should be instituted as soon as possible. If intravenous therapy ...
  • PREPARATION OF SOLUTION
    To prepare a solution containing 10 mg/mL, the contents of the vial should be reconstituted with 10 mL (for the 100 mg/vial container) of Sterile Water for Injection or any of the 10 intravenous ...
  • HOW SUPPLIED
    Doxycycline for Injection, USP is a sterile powder supplied as follows: NDCDoxycycline for Injection, USPPackage Factor - 83634-111-20 - 100 mg Single-Dose Vial - 10 vials per ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Vial Label - NDC 83634-111-41 - Doxycycline for Injection, USP - 100 mg per vial - Rx only - For Intravenous Infusion Only - MUST BE FURTHER DILUTED AFTER ...
  • INGREDIENTS AND APPEARANCE
    Product Information