ACTICLATE- doxycycline hyclate tablet, coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Almirall, LLC

DCI (Denominação Comum Internacional):

DOXYCYCLINE HYCLATE

Composição:

DOXYCYCLINE ANHYDROUS 75 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

ACTICLATE® and ACTICLATE® CAP 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 . ACTICLATE and ACTICLATE CAP 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 . ACTICLATE and ACTICLATE CAP 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 have been shown to be resistant to doxycycline, c

Resumo do produto:

How Supplied ACTICLATE (doxycycline hyclate) Tablets, 75 mg are round, convex, light-teal, film-coated, tablets with “75” debossed on one side of the tablet and “AQ101” debossed on the other. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Bottles of 60 tablets:        NDC 16110-501-01 ACTICLATE (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 “A” 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. Bottles of 60 tablets:        NDC 16110-502-01 ACTICLATE CAP (doxycycline hyclate) Capsules, 75 mg, have a navy blue opaque body and cap with the inscription “AQUA 101C75” in black. Each 75 mg capsule contains 86.6 mg of doxycycline hyclate equivalent to 75 mg of doxycycline. Bottles of 60 capsules:     NDC 16110-601-01 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.

Status de autorização:

New Drug Application

Características técnicas

ACTICLATE- DOXYCYCLINE HYCLATE TABLET, COATED
ALMIRALL, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACTICLATE AND
ACTICLATE CAP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR ACTICLATE AND
ACTICLATE CAP.
ACTICLATE (DOXYCYCLINE HYCLATE) TABLETS, FOR ORAL USE
ACTICLATE CAP (DOXYCYCLINE HYCLATE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1967
INDICATIONS AND USAGE
ACTICLATE and ACTICLATE CAP 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 ACTICLATE and
ACTICLATE CAP and other antibacterial drugs, ACTICLATE and ACTICLATE
CAP 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 ACTICLATE and ACTICLATE CAP
ACTICLATE Tablets (150 mg) can be broken into two-thirds or one-third
to provide a 50 mg and 100
mg strength, respectively. (2.1)
Swallow ACTICLATE CAP Capsule whole. Do not break, open, crush,
dissolve or chew the capsule.
(2.1)
Dosage in Adults for ACTICLATE or ACTICLATE CAP:
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 ACTICLATE or ACTICLATE CAP:
For all pediatric patients weighing less than 45 kg with severe or
life-threaten