DOXYCYCLINE HYCLATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

TYA Pharmaceuticals

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 .

Product summary:

NDC:64725-5440-1 in a BOTTLE of 50 CAPSULES Store below 30°C (86°F). Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO , and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO , and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline. 4 4 Minocycline, tetracycline PO , 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. 4 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 CAPSULE
TYA PHARMACEUTICALS
----------
DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE CAPSULES USP
DOXYCYCLINE HYCLATE TABLETS USP
Revised: June 2012
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 a broad-spectrum antibiotic 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, silicon dioxide,
sodium lauryl sulfate and
titanium dioxide.
Doxycycline Hyclate Tablets USP 100 mg contain the following inactive
ingredients: croscarmellose
2224282262
sodium, FD&C Red No. 40, FD&C Yellow No. 6, hypromellose, magnesium
stearate, microcrystalline
cellulose, polyethylene glyco