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:

Physicians Total Care, Inc.

INN (International Name):

Doxycycline Hyclate

Composition:

Doxycycline Anhydrous 20 mg

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. This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

Product summary:

Doxycycline hyclate tablets USP equivalent to 20 mg of doxycycline, round, white, unscored, film coated tablet, debossed MP 573 on one side and blank on the other side. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature] DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE HYCLATE - DOXYCYCLINE HYCLATE TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
----------
DOXYCYCLINE HYCLATE
TABLETS USP
RX ONLY
DESCRIPTION
Doxycycline hyclate is available as a 20 mg tablet formulation of
doxycycline for oral administration.
The structural formula of doxycycline hyclate is:
with an emperical 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,
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 to light-yellow crystalline powder
which is soluble in water.
Each tablet for oral administration contains 23 mg doxycycline hyclate
equivalent to 20 mg of
doxycycline. In addition, each tablet contains the following inactive
ingredients: anhydrous lactose,
carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate,
microcrystalline cellulose,
polydextrose, polyethylene glycol, titanium dioxide, and triacetin.
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
22
24
2
8
2
2
6
2
1
2,3
microorganisms commonly associated with adult periodontitis. Clinical
studies with this product
demonstrated no effect on total anaerobic and facu