DOXYCYCLINE HYCLATE- doxycycline hyclate tablet, delayed release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

זמין מ:

Mylan Pharmaceuticals Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycycline hyclate delayed-release tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is a tetracycline-class antibacterial indicated in the following conditions or diseases: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae . Uncomplicated urethral, endocervical or rectal infections caused by Chlamydia trachomatis . Nongonococcal urethritis caused by Ureaplasma urealyticum . Lymphogranuloma venereum caused by Chlamydia t

leaflet_short:

Doxycycline Hyclate Delayed-Release Tablets, USP are available containing delayed-release beads of doxycycline hyclate, USP equivalent to 150 mg of doxycycline. The 150 mg tablets are white, capsule shaped, trisected tablets containing yellow beads debossed with M in the center trisect on one side of the tablet and D | 3 | 3 on the other side. They are available as follows: NDC 0378-3030-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXYCYCLINE HYCLATE DELAYED-
RELEASE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR DOXYCYCLINE HYCLATE
DELAYED-RELEASE TABLETS.
DOXYCYCLINE HYCLATE DELAYED-RELEASE TABLETS, FOR ORAL USE.
INITIAL U.S. APPROVAL: 1967
INDICATIONS AND USAGE
Doxycycline hyclate delayed-release tablets are a tetracycline-class
drug indicated for:
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To reduce the development of drug-resistant bacteria and maintain the
effectiveness of doxycycline hyclate and other
antibacterial drugs, doxycycline hyclate delayed-release tablets
should be used only to treat or prevent infections that are
proven or strongly suspected to be caused by bacteria. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Doxycycline Hyclate Delayed-Release Tablets: 150 mg (3)
CONTRAINDICATIONS
Doxycycline is contraindicated in persons who have shown
hypersensitivity to any of the tetracyclines. (4)
WARNINGS AND PRECAUTIONS
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Rickettsial infections (1.1)
Sexually transmitted infections (1.2)
Respiratory tract infections (1.3)
Specific bacterial infections (1.4)
Ophthalmic infections (1.5)
Anthrax, including inhalational anthrax (post-exposure) (1.6)
Alternative treatment for selected infections when penicillin is
contraindicated (1.7)
Adjunctive therapy in acute intestinal amebiasis and severe acne (1.8)
Prophylaxis of malaria (1.9)
Adults:
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The usual dosage is 200 mg on the first day of treatment (administered
100 mg every 12 hours) followed by a
maintenance dose of 100 mg daily. (2.1)
In the management of more severe infections (particularly chronic
infections of the urinary tract), 100 mg every
12 hours is recommended. (2.1)
Pediatric Patients:
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For all pediatric patients weighing less than 45 kg with severe or
life-threatening infections (e.g., anthrax, Rocky
Moun