DOXYCYCLINE HYCLATE tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Doxycycline Hyclate (UNII: 19XTS3T51U) (Doxycycline Anhydrous - UNII:334895S862)

Available from:

Mayne Pharma Commercial LLC

INN (International Name):

Doxycycline Hyclate

Composition:

Doxycycline Anhydrous 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 been shown t

Product summary:

Doxycycline hyclate delayed-release tablets, USP, 80 mg are white, oval scored tablets containing yellow pellets and debossed with "D|8" on one face and plain on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 80 mg of doxycycline. Bottles of 30 tablets NDC 51862-571-30 Doxycycline hyclate delayed-release tablets, 200 mg are white, oval scored tablets containing yellow pellets and debossed with "D|D" on one face and plain on the other. Each tablet contains specially coated pellets of doxycycline hyclate equivalent to 200 mg of doxycycline. Store at 25°C (77°F); excursions permitted to 15 – 30°C (59 – 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container (USP).

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, DELAYED RELEASE
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
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 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
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. (2.1)
For pediatric patients with less severe disease (greater than 8 ye