Label: ACTICLATE CAP- doxycycline hyclate capsule

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

Drug Label Information

Updated November 28, 2017

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ACTICLATE® and ACTICLATE® CAP safely and effectively. See full prescribing information for ACTICLATE® and ACTICLATE ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Rickettsial Infections - ACTICLATE® and ACTICLATE® CAP are indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox, and tick ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Important Administration Instructions - The usual dosage and frequency of administration of ACTICLATE and ACTICLATE CAP differs from that of the other tetracyclines. Exceeding the ...
  • 3 DOSAGE FORMS AND STRENGTHS
    ACTICLATE Tablets: ACTICLATE (doxycycline hyclate) Tablets, 75 mg are round, convex, light-teal, film-coated, tablets with “75” debossed on one side of the tablet and “AQ101” debossed on the ...
  • 4 CONTRAINDICATIONS
    ACTICLATE and ACTICLATE CAP are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Tooth Development - 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 ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions have been identified during clinical trials or post-approval use of tetracycline-class drugs, including doxycycline. Because these reactions are reported ...
  • 7 DRUG INTERACTIONS
    7.1 Anticoagulant Drugs - Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Teratogenic Effects. Pregnancy Category D: [see Warnings and Precautions (5.7)] There are no adequate and well-controlled studies on the use of doxycycline in ...
  • 10 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 ...
  • 11 DESCRIPTION
    ACTICLATE (doxycycline hyclate) Tablets and ACTICLATE CAP (doxycycline hyclate) Capsules contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in an ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Doxycycline is a tetracycline-class antimicrobial drug [see Microbiology (12.4)]. 12.3 Pharmacokinetics - Absorption - ACTICLATE (doxycycline hyclate) Tablets ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals to evaluate carcinogenic potential of ACTICLATE (doxycycline hyclate) and ACTICLATE CAP (doxycycline ...
  • 15 REFERENCES
    Friedman JM, Polifka JE. Teratogenic Effects of Drugs. A Resource for Clinicians (TERIS). Baltimore, MD: The Johns Hopkins University Press: 2000: 149-195. The TERIS (Teratogen Information ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - ACTICLATE (doxycycline hyclate) Tablets, 75 mg are round, convex, light-teal, film-coated, tablets with “75” debossed on one side of the tablet and “AQ101” debossed on the other ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Instructions for Use). Advise patients taking ACTICLATE and ACTICLATE CAP for malaria prophylaxis: that no present-day ...
  • PATIENT PACKAGE INSERT
    FDA-Approved Patient Labeling - Instructions for Use - ACTICLATE® (‘aktəˌklāt) (doxycycline hyclate) tablets - for oral use - Read this Instructions for Use ...
  • PRINCIPAL DISPLAY PANEL - NDC: 16110-601-01 - 75 mg Capsule 60-count Bottle Label
    75 mg Capsule 60-count Bottle Label
  • INGREDIENTS AND APPEARANCE
    Product Information