DOXYCYCLINE HYCLATE tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Zydus Pharmaceuticals USA Inc.

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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

Огляд продуктів:

Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 75 mg of doxycycline. Doxycycline Hyclate Delayed-Release Tablets USP, 75 mg are white to off-white, oval-shaped, uncoated single-score tablets with yellow speckles debossed with "70│8" on one face and plain on the other and are supplied as follows: NDC 68382-708-14 in bottle of 60 tablets NDC 68382-708-01 in bottle of 100 tablets NDC 68382-708-05 in bottle of 500 tablets NDC 68382-708-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline. Doxycycline Hyclate Delayed-Release Tablets USP, 100 mg are white to off-white, oval-shaped, uncoated single-score tablets with yellow speckles debossed with "70│9" on one face and plain on the other and are supplied as follows: NDC 68382-709-14 in bottle of 60 tablets NDC 68382-709-01 in bottle of 100 tablets NDC 68382-709-05 in bottle of 500 tablets NDC 68382-709-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 150 mg of doxycycline. Doxycycline Hyclate Delayed-Release Tablets USP,  150 mg are white to off-white, capsule-shaped, uncoated dual-score tablets with yellow speckles debossed with "7│1│0" on one face and dual-score on the other and are supplied as follows: NDC 68382-710-14 in bottle of 60 tablets NDC 68382-710-01 in bottle of 100 tablets NDC 68382-710-05 in bottle of 500 tablets NDC 68382-710-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Store at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

DOXYCYCLINE HYCLATE - DOXYCYCLINE HYCLATE TABLET
ZYDUS PHARMACEUTICALS USA 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 DOXYCYCLINE HYCLATE DELAYED-RELEASE TABLETS.
DOXYCYCLINE HYCLATE DELAYED-RELEASE TABLETS ORAL USE.
INITIAL U.S. APPROVAL: 1967
INDICATIONS AND USAGE
Doxycycline hyclate delayed-release tablets are a tetracycline-class
drug 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 in 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 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
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, Rocky Mountain spotted fever), the recommended dose is 2.2 mg
per kg of body weight
administered every 12 hours. Pediatric patients weighing 45 kg or more
should receive the adult
dose. (2.1)
For pediatric patients with less severe disease (greater than 8 years
of age and weighing less than
45 kg), the recommended dose is 4.4