DOXYCYCLINE HYCLATE tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alembic Pharmaceuticals Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 . - 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 tablets 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, cul

Product summary:

How Supplied    Doxycycline hyclate tablets USP, 75 mg are round, convex, light-teal, film-coated, tablets with “L22” debossed on one side of the tablet and plain on the other side (each tablet contains 75 mg doxycycline as 86.599 mg doxycycline hyclate). NDC 62332-387-60                Bottle of 60 tablets NDC 62332-387-91                Bottle of 1,000 tablets Doxycycline hyclate tablets USP, 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 debossed individually with “L, 2 & 3” respectively on one side of the tablet and no debossing on the other side (each tablet contains 150 mg doxycycline as 173.117 mg doxycycline hyclate). NDC 62332-388-60                Bottle of 60 tablets NDC 62332-388-91                Bottle of 1,000 tablets   Storage   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 and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE HYCLATE - DOXYCYCLINE HYCLATE TABLET, FILM COATED
ALEMBIC PHARMACEUTICALS 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: (1)
· Rickettsial infections (1.1) (1)
· Sexually transmitted infections (1.2) (1)
· Respiratory tract infections (1.3) (1)
· Specific bacterial infections (1.4) (1)
· Ophthalmic infections (1.5) (1)
· Anthrax, including inhalational anthrax (post-exposure) (1.6) (1)
· Alternative treatment for selected infections when penicillin is
contraindicated (1.7) (1)
· Adjunctive therapy for acute intestinal amebiasis and severe acne
(1.8) (1)
· Prophylaxis of malaria (1.9) (1)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of doxycycline
hyclate tablets and other antibacterial 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) (1)
DOSAGE AND ADMINISTRATION
· Important Administration Instructions for Doxycycline Hyclate
Tablets: (2)
o 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) (2)
· Dosage in Adults for Doxycycline Hyclate Tablets: (2)
o 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) (2)
o In the management of more severe infections (particularly chronic
infections of the urinary tract), 100
mg every 12 hours is recommended. (2.1) (2)
· Dosage in Pediatric Patients for Doxycycline Hyclate Tablets: (2)
o For all pediatric patients weighing less than 45 kg with severe or
life-threatening infections