Label: DOXYCYCLINE HYCLATE tablet
- NDC Code(s): 0615-8529-14
- Packager: NCS HealthCare of KY, LLC dba Vangard Labs
- This is a repackaged label.
- Source NDC Code(s): 72578-001
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated October 7, 2024
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SPL UNCLASSIFIED SECTIONTo 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 ...
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DESCRIPTIONDoxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline. The chemical designation for doxycyclin is ...
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CLINICAL PHARMACOLOGYTetracyclines 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 ...
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INDICATIONS AND USAGETo 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 ...
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CONTRAINDICATIONSThis drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
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WARNINGSThe 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 ...
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PRECAUTIONSGeneral - As with other antibacterial drugs, use of Doxycycline may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, Doxycycline should be discontinued ...
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INFORMATION FOR PATIENTSPatients taking doxycycline for malaria prophylaxis should be advised: - that no present-day antimalarial agent, including doxycycline, guarantees protection against malaria. - to avoid being ...
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DRUG INTERACTIONSBecause tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since ...
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ADVERSE REACTIONSDue 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 ...
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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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DOSAGE AND ADMINISTRATIONThe 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 ...
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HOW SUPPLIEDEach 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 ...
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ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGYHyperpigmentation 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 ...
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REFERENCESFriedman 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 ...
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SPL UNCLASSIFIED SECTIONManufactured by: Zydus Lifesciences Ltd. Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc. Cranford, NJ 07016 - Rev.: 10/22
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCEProduct Information