DOXYCYCLINE HYCLATE- 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:

STI Pharma LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Doxycycline Hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. 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 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. This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

Product summary:

Doxycycline hyclate are white film coated, round, biconvex tablet, debossed LL714 on one side and plain on the other side containing doxycycline hyclate equivalent to 20 mg doxycycline.  Bottle of 60 tablets (NDC 54879-025-26) and Bottle of 100 tablets (NDC 54879-025-01). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers (USP). Manufactured for: STI Pharma LLC Newtown, PA 18940 Rev. 11/16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET
STI PHARMA LLC
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DOXYCYCLINE HYCLATE TABLETS, USP
DESCRIPTION
Doxycycline hyclate is available as a 20 mg tablet formulation of
doxycycline for oral administration.
The structural formula of doxycycline hyclate is:
Figure 1
with a structural formula of (C
H N O •HCl) •C H O•H O and a molecular weight of 1025.89.
The chemical designation for doxycycline is
4-(dimethylamino)-1,4,4(,5,5(,6,11,12(-octahydro-
3,5,10,12,12(-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide
monohydrochloride,
compound with ethyl alcohol (2:1), monohydrate.
Doxycycline hyclate is a yellow to light-yellow crystalline powder
which is soluble in water.
INACTIVE INGREDIENT
Colloidal silicon dioxide, hypromellose, anhydrous lactose, magnesium
stearate, microcrystalline
cellulose, polyethylene glycol, polysorbate 80, sodium starch
glycolate, talc, and titanium oxide. Each
tablet contains 23 mg of doxycycline hyclate equivalent to 20 mg of
doxycycline.
CLINICAL PHARMACOLOGY
After oral administration, doxycycline hyclate is rapidly and nearly
completely absorbed from the
gastrointestinal tract. Doxycycline is eliminated with a half-life of
approximately 18 hours by renal and
fecal excretion of unchanged drug.
MECHANISM OF ACTION
Doxycycline has been shown to inhibit collagenase activity _in vitro_.
Additional studies have shown that
doxycycline reduces the elevated collagenase activity in the gingival
crevicular fluid of patients with
adult periodontitis.
The clinical significance of these findings is not known.
MICROBIOLOGY: Doxycycline is a member of the tetracycline class of
antibiotics. The dosage of
doxycycline achieved with this product during administration is well
below the concentration required
to inhibit microorganism commonly associated with adult periodontitis.
Clinical studies with this
product demonstrated no effect on total anaerobic and facultative
bacteria in plaque samples from
patients administered this dose regimen for 9 to 18 months. This
product should