Label: ACTICLATE CAP- doxycycline hyclate capsule
- NDC Code(s): 16110-601-01
- Packager: Aqua Pharmaceuticals
- 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 INFORMATIONThese 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 ...
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Table of ContentsTable of Contents
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1 INDICATIONS AND USAGE1.1 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 ...
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2 DOSAGE AND ADMINISTRATION2.1 Important Administration Instructions - The usual dosage and frequency of administration of ACTICLATE and ACTICLATE CAP differs from that of the other tetracyclines. Exceeding the ...
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3 DOSAGE FORMS AND STRENGTHSACTICLATE 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 ...
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4 CONTRAINDICATIONSACTICLATE and ACTICLATE CAP are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
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5 WARNINGS AND PRECAUTIONS5.1 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 ...
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6 ADVERSE REACTIONSThe following adverse reactions have been identified during clinical trials or post-approval use of tetracycline-class drugs, including doxycycline. Because these reactions are reported ...
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7 DRUG INTERACTIONS7.1 Anticoagulant Drugs - Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their ...
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8 USE IN SPECIFIC POPULATIONS8.1 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 ...
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10 OVERDOSAGEIn 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 ...
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11 DESCRIPTIONACTICLATE (doxycycline hyclate) Tablets and ACTICLATE CAP (doxycycline hyclate) Capsules contain doxycycline hyclate, a tetracycline class drug synthetically derived from oxytetracycline, in an ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Doxycycline is a tetracycline-class antimicrobial drug [see Microbiology (12.4)]. 12.3 Pharmacokinetics - Absorption - ACTICLATE (doxycycline hyclate) Tablets ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term studies in animals to evaluate carcinogenic potential of ACTICLATE (doxycycline hyclate) and ACTICLATE CAP (doxycycline ...
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15 REFERENCESFriedman 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 ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGHow 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 ...
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17 PATIENT COUNSELING INFORMATIONAdvise 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 ...
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PATIENT PACKAGE INSERTFDA-Approved Patient Labeling - Instructions for Use - ACTICLATE® (‘aktəˌklāt) (doxycycline hyclate) tablets - for oral use - Read this Instructions for Use ...
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PRINCIPAL DISPLAY PANEL - NDC: 16110-601-01 - 75 mg Capsule 60-count Bottle Label
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INGREDIENTS AND APPEARANCEProduct Information