Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)
Mayne Pharma Commercial LLC
Doxycycline Hyclate
Doxycycline Anhydrous 75 mg
ORAL
PRESCRIPTION DRUG
Doxycycline hyclate tablets are indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsial pox, and tick fevers caused by Rickettsiae . Doxycycline hyclate tablets are indicated for treatment of the following sexually transmitted infections: - Uncomplicated urethral, endocervical or rectal infections caused by Chlamydia trachomatis . - Nongonococcal urethritis caused by Ureaplasma urealyticum . - Lymphogranuloma venereum caused by Chlamydia trachomatis . - Granuloma inguinale caused by Klebsiella granulomatis . - Uncomplicated gonorrhea caused by Neisseria gonorrhoeae . - Chancroid caused by Haemophilus ducreyi . Doxycycline hyclate tablets are indicated for treatment of the following respiratory tract infections: - Respiratory tract infections caused by Mycoplasma pneumoniae . - Psittacosis (ornithosis) caused by Chlamydophila psittaci . - Because many strains of the following groups of microorganisms ha
How Supplied Doxycycline hyclate tablets, 75 mg are round, convex, blue colored, film-coated, tablets debossed with "75" on one side of the tablet and plain on the other. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Doxycycline hyclate tablets, 150 mg are oval-shaped, convex, mossy-green, film-coated tablets. Each side of the functionally scored tablet has two parallel score lines for splitting into 3 equal portions with "m" debossed on each portion of one side of the tablet, and no debossing on the other. Each 150 mg tablet contains 173.2 mg of doxycycline hyclate equivalent to 150 mg of doxycycline. Storage Store at 20° to 25°C (68° to 77°F) excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
Abbreviated New Drug Application
DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED MAYNE PHARMA COMMERCIAL LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE DOXYCYCLINE HYCLATE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DOXYCYCLINE HYCLATE TABLETS. DOXYCYCLINE HYCLATE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1967 INDICATIONS AND USAGE Doxycycline hyclate tablets are tetracycline class drugs indicated for: 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 for acute intestinal amebiasis and severe acne ( 1.8) Prophylaxis of malaria ( 1.9) To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.10) DOSAGE AND ADMINISTRATION Important Administration Instructions for Doxycycline Hyclate Tablets Doxycycline hyclate tablets (150 mg) can be broken into two-thirds or one-third to provide a 50 mg and 100 mg strength, respectively. ( 2.1) Dosage in Adults for Doxycycline Hyclate Tablets: 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) Dosage in Pediatric Patients for Doxycycline Hyclate Tablets: For all pediatric patients weighing less than 45 kg with severe or life-threatening infections (e.g., anthrax, Rocky Mountain spotted fever), the recommended dose is 2.2 mg per kg of body weight ad Izlasiet visu dokumentu