DOXYCYCLINE HYCLATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Liberty Pharmaceuticals, Inc.

INN (International Name):

DOXYCYCLINE HYCLATE

Composition:

DOXYCYCLINE ANHYDROUS 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated for the treatment of the following infections: - Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae. - Respiratory tract infections caused by Mycoplasma pneumoniae . - Lymphogranuloma venereum caused by Chlamydia trachomatis . - Psittacosis (ornithosis) caused by Chlamydophila psittaci . - Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always 

Product summary:

Doxycycline hyclate tablets, USP (equivalent to 100 mg doxycycline) are round, film-coated, light orange tablets imprinted "DAN " and "5553 " supplied in bottles of:   Recommended storage: Store below 30°C (86°F). Dispense in a tight, light-resistant container with child-resistant closure. PACKAGED BY: AIDAREX PHARMACEUTICALS LLC, CORONA CA, 92880 Revised on: 08/2016. Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO4 , and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO4 , and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline. Minocycline, tetracycline PO4 , methacycline, doxycycline, tetracycline base, oxytetracycline HCl, and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet. Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline); in chickens (chlortetracycline); and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET
LIBERTY PHARMACEUTICALS, INC.
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DOXYCYCLINE HYCLATE CAPS AND TABS
DOXYCYCLINE HYCLATE CAPSULES, USP
DOXYCYCLINE HYCLATE TABLETS, USP
Revised: November 2014
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of doxycycline
hyclate and other antibacterial drugs, doxycycline hyclate should be
used only to treat or prevent
infections that are proven or strongly suspected to be caused by
bacteria.
DESCRIPTION
Doxycycline is an antibacterial drug synthetically derived from
oxytetracycline, and is available as
doxycycline hyclate (doxycycline hydrochloride hemiethanolate
hemihydrate) for oral administration.
The structural formula of doxycycline hyclate is
with a molecular formula of (C
H N O •HCl) •C H O•H O and a molecular weight of 1025.89.
The chemical designation for doxycycline hyclate is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-
octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide
monohydrochloride, compound with ethyl alcohol (2:1), monohydrate.
Doxycycline hyclate is a yellow
crystalline powder which is soluble in water.
Doxycycline has a high degree of lipoid solubility and a low affinity
for calcium binding. It is highly
stable in normal human serum. Doxycycline will not degrade into an
epianhydro form.
Each capsule, for oral administration, contains doxycycline hyclate,
equivalent to 50 mg or 100 mg of
doxycycline.
Each tablet, for oral administration, contains doxycycline hyclate,
equivalent to 100 mg of doxycycline.
Doxycycline hyclate capsules, USP 50 mg and 100 mg contain the
following inactive ingredients:
magnesium stearate and microcrystalline cellulose.
The capsule shells contain: FD&C Blue No. 1, gelatin and titanium
dioxide.
Doxycycline hyclate tablets, USP 100 mg contain the following inactive
ingredients: croscarmellose
sodium, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium
stearate, microcrystalline
cellulose, polyethylene glycol, polysorbate 80, sodium