Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
Solco Healthcare US LLC
DOXYCYCLINE HYCLATE
DOXYCYCLINE ANHYDROUS 150 mg
ORAL
PRESCRIPTION DRUG
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
Doxycycline hyclate delayed-release tablets, USP, 50 mg are white, oval tablets containing yellow pellets and debossed with “P03” on one face and plain on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 50 mg of doxycycline. Bottles of 120 tablets: NDC 43547-462-12 Doxycycline hyclate delayed-release tablets, USP, 150 mg are white, capsule shaped dual-scored tablets containing yellow pellets and debossed with “P | 0 | 1” on one face and plain on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 150 mg of doxycycline. Bottles of 60 tablets: NDC 43547-324-06 Bottles of 100 tablets: NDC 43547-324-10 Bottles of 500 tablets: NDC 43547-324-50 Doxycycline hyclate delayed-release tablets, USP, 200 mg are white, oval scored tablets containing yellow pellets and debossed with “P0 | 02” on one face and plain on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 200 mg of doxycycline. Bottles of 60 tablets: NDC 43547-325-06 Bottles of 100 tablets: NDC 43547-325-10 Bottles of 500 tablets: NDC 43547-325-50 Store at 20 - 25°C (68 - 77°F); excursions permitted to 15 - 30°C (59 - 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).
Abbreviated New Drug Application
DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE SOLCO HEALTHCARE US LLC ---------- 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: • • • • • • • • • 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 • • DOSAGE FORMS AND STRENGTHS Doxycycline hyclate delayed-release tablets: 50 mg, 150 mg, and 200 mg (3) CONTRAINDICATIONS Doxycycline is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. (4) WARNINGS AND PRECAUTIONS • • • 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 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: • • For all pediatric patients weighing less than 45 kg with severe or life-threatening infections (e.g., anthrax, Przeczytaj cały dokument