DOXYCYCLINE HYCLATE- doxycycline hyclate tablet, delayed release

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

Mylan Pharmaceuticals Inc.

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 in adults caused by Chlamydia trachomatis . Nongonococcal urethritis caused by Ureaplasma urealyticum . Lymphogranuloma venereum caused by C

Bidhaa muhtasari:

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.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE
MYLAN PHARMACEUTICALS INC.
----------
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
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)
RECENT MAJOR CHANGES
Warnings and Precautions (5.5) 12/2014
INDICATIONS AND USAGE
Doxycycline hyclate delayed-release tablets are a tetracycline-class
antibacterial indicated for:
•
•
•
•
•
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg (4)
CONTRAINDICATIONS
Doxycycline is contraindicated in persons who have shown
hypersensitivity to any of the tetracyclines. (4)
WARNINGS AND PRECAUTIONS
•
•
•
•
ADVERSE REACTIONS
Adverse reactions observed in patients receiving tetracyclines include
anorexia, nausea, vomiting, diarrhea, rash,
photosensitivity, urticaria, and hemolytic anemia. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
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: the usual dose of oral doxycycline is 200 mg on the first day
of treat