DOXYCYCLINE HYCLATE DELAYED RELEASE- doxycycline hyclate tablet, delayed release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Designació comuna internacional (DCI):

DOXYCYCLINE HYCLATE

Composición:

DOXYCYCLINE ANHYDROUS 75 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Doxycycline hyclate delayed-release tablets are indicated for treatment of Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. Doxycycline hyclate delayed-release 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 delayed-release tablets are indicated for treatment of the following respiratory infections: • Respiratory tract infections caused by Mycoplasma pneumoniae . Psittacosis (ornithosis) caused by Chlamydophila psittaci . • Because many strains of the following groups of microorganisms have bee

Resumen del producto:

Doxycycline hyclate delayed-release tablets, USP 75 mg are white to off white capsule shaped biconvex coated tablets embedded with yellowish pellets, with breakline on both sides and debossed with "I'' and "15" on either side of the breakline on one side. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 75 mg of doxycycline. Bottles of 60 tablets: NDC 23155-141-06 Bottles of 100 tablets: NDC 23155-141-01 Bottles of 500 tablets: NDC 23155-141-05 Doxycycline hyclate delayed-release tablets, USP 100 mg are white to off white capsule shaped biconvex coated tablets embedded with yellowish pellets, with breakline on both sides and debossed with "I'' and "16" on either side of the breakline on one side. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline. Bottles of 100 tablets: NDC 23155-142-01 Bottles of 500 tablets: NDC 23155-142-05 Doxycycline hyclate delayed-release tablets, USP 150 mg are White to off white, rectangular coated dual-scored tablets embedded with yellowish pellets and debossed with "I|1|7" on one side and dual-scored on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 150 mg of doxycycline. Bottles of 60 tablets: NDC 23155-143-06 Bottles of 100 tablets: NDC 23155-143-01 Bottles of 250 tablets: NDC 23155-143-04 Doxycycline hyclate delayed-release tablets, USP 200 mg are white to off-white, oval biconvex coated tablets embedded with yellowish pellets, with breakline on both sides and debossed with "I1" and "18" on either side of the breakline on one side. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 200 mg of doxycycline. Bottles of 60 tablets: NDC 23155-611-06 Bottles of 250 tablets: NDC 23155-611-04 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container (USP).

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

DOXYCYCLINE HYCLATE DELAYED RELEASE- DOXYCYCLINE HYCLATE TABLET,
DELAYED RELEASE
HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.
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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 HYCLATE DELAYED-RELEASE TABLETS.
DOXYCYCLINE HYCLATE DELAYED-RELEASE TABLETS, FOR 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)
Usage
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. (1.10)
DOSAGE AND ADMINISTRATION
• Dosage in Adult Patients:
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 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.
(