DOXYCYCLINE HYCLATE tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Actavis Pharma, Inc.

INN (International Name):

DOXYCYCLINE HYCLATE

Sammensetning:

DOXYCYCLINE ANHYDROUS 75 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 . Uncomplicated urethral, endocervical or rectal infections caused by Chlamydia trachomatis . - Nongonococcal urethritis caused by Ureaplasma urealyticum . Nongonococcal urethritis caused by Ureaplasma urealyticum . - Lymphogranuloma venereum caused by Chlamydia trachomatis . Lymphogranuloma venereum caused by Chlamydia trachomatis . - Granuloma inguinale caused by Klebsiella granulomatis . Granuloma inguinale caused by Klebsiella granulomatis . - Uncomplicated gonorrhea caused by Neisseria gonorrhoeae . Uncomplicated gonorrhea caused by Neisseria gonorrhoeae . - Chancroid caused by Haemophilus ducreyi . Chancroid ca

Produkt oppsummering:

How Supplied Doxycycline Hyclate Tablets, 75 mg: Doxycycline hyclate tablets, 75 mg are round, convex, light-teal, film-coated, tablets with “75” debossed on one side of the tablet and plain on the other side. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Bottles of 60 tablets:     NDC 0591-6100-60   Doxycycline Hyclate Tablets, 150 mg: 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 “1” debossed on the first portion, “5” debossed on the middle portion and “0” debossed on the last portion and no debossing on the other side. Each 150 mg tablet contains 173.2 mg of doxycycline hyclate equivalent to 150 mg of doxycycline. Bottles of 60 tablets:     NDC 0591-6125-60 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.

Autorisasjon status:

New Drug Application

Preparatomtale

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
ACTAVIS PHARMA, INC.
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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 antimicrobial 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
administered every 12