DOXYCYCLINE HYCLATE tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

DOXYCYCLINE HYCLATE

Composition:

DOXYCYCLINE ANHYDROUS 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Doxycycline Hyclate Delayed-Release Tablets, USP are available containing delayed-release beads of doxycycline hyclate, USP equivalent to 50 mg of doxycycline. The 50 mg tablets are white, round, unscored tablets containing yellow beads debossed with M on one side of the tablet and D36 on the other side. They are available as follows: NDC 0378-4535-78 bottles of 120 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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: 50 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:
o
o
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:
o
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For all pediatric patients weighing less than 45 kg with severe or
life-threatening infections (e.g., anthrax, Rocky
Mountain spot