Label: ISONIAZID tablet

  • NDC Code(s): 0555-0066-02, 0555-0071-01, 0555-0071-02
  • Packager: Teva Pharmaceuticals USA, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 31, 2021

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  • SPL UNCLASSIFIED SECTION
    Rx only - WARNING - Severe and sometimes fatal hepatitis associated with isoniazid therapy has been reported and may occur or may develop even after many months of treatment. The risk of ...
  • DESCRIPTION
    Isoniazid, USP is an antibacterial available as 100 mg and 300 mg tablets for oral administration. Each tablet also contains as inactive ingredients: colloidal silicon dioxide, crospovidone ...
  • CLINICAL PHARMACOLOGY
    Within 1 to 2 hours after oral administration, isoniazid produces peak blood levels which decline to 50 percent or less within 6 hours. It diffuses readily into all body fluids (cerebrospinal ...
  • INDICATIONS AND USAGE
    Isoniazid tablets, USP are recommended for all forms of tuberculosis in which organisms are susceptible. However, active tuberculosis must be treated with multiple concomitant anti-tuberculosis ...
  • CONTRAINDICATIONS
    Isoniazid is contraindicated in patients who develop severe hypersensitivity reactions, including drug-induced hepatitis; previous isoniazid-associated hepatic injury; severe adverse reactions to ...
  • WARNINGS
    See the boxed warning.
  • PRECAUTIONS
    General - All drugs should be stopped and an evaluation made at the first sign of a hypersensitivity reaction. If isoniazid therapy must be reinstituted, the drug should be given only after ...
  • ADVERSE REACTIONS
    The most frequent reactions are those affecting the nervous system and the liver. Nervous System Reactions - Peripheral neuropathy is the most common toxic effect. It is dose-related, occurs most ...
  • OVERDOSAGE
    Signs and Symptoms - Isoniazid overdosage produces signs and symptoms within 30 minutes to 3 hours after ingestion. Nausea, vomiting, dizziness, slurring of speech, blurring of vision and visual ...
  • DOSAGE AND ADMINISTRATION
    (See also INDICATIONS AND USAGE) NOTE - For preventive therapy of tuberculous infection and treatment of tuberculosis, it is recommended that physicians be familiar with the following ...
  • HOW SUPPLIED
    Isoniazid tablets, USP are available as follows: 100 mg: White to off-white, round, scored, flat-faced, beveled-edge tablet, debossed with stylized b on one side and 066 over 100 on the other ...
  • Package/Label Display Panel
    NDC 0555-0066-02 - Isoniazid Tablets, USP - 100 mg - Rx only - 100 Tablets
  • Package/Label Display Panel
    NDC 0555-0071-02 - Isoniazid Tablets, USP - 300 mg - Rx only - 100 Tablets
  • INGREDIENTS AND APPEARANCE
    Product Information