DOXYCYCLINE HYCLATE tablet, film coated

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Mayne Pharma Commercial LLC

INN (Международно Name):

Doxycycline Hyclate

Композиция:

Doxycycline Anhydrous 75 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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

Каталог на резюме:

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.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
MAYNE PHARMA COMMERCIAL LLC
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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
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