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:

Lannett Company, Inc.

INN (International Name):

DOXYCYCLINE HYCLATE

Composition:

DOXYCYCLINE ANHYDROUS 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Doxycycline hyclate tablets are 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 Tablets, USP and other antibacterial drugs, Doxycycline Hyclate Tablets, USP 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 Tablets, USP (equivalent to 20 mg doxycycline) are white, round, film coated tablets, debossed LCI on one side and 1336 on the other side. The tablets are available in: bottles of 60 (NDC 0527-1336-06), bottles of 100 (NDC 0527-1336-01), and bottles of 1000 (NDC 0527-1336-10). Dispense in a tight light-resistant container with a child-resistant closure. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. REFERENCES 1. Golub L.M., Sorsa T., Lee H-M, Ciancio S., Sorbi D., Ramamurthy N.S., Gruber B., Salo T., Konttinen Y.T.: Doxycycline Inhibits Neutrophil (PMN)-type Matrix Metalloproteinases in Human Adult Periodontitis Gingiva. J. Clin. Periodontol 1995; 22: 100-109. 2. Golub L.M., Ciancio S., Ramamurthy N.S., Leung M., McNamara T.F.: Low-dose Doxycycline Therapy: Effect on Gingival and Crevicular Fluid Collagenase Activity in Humans. J. Periodont Res 1990; 25:321-330. 3. Golub L.M., Lee H.M., Greenwald R.A., Ryan M.E., Salo T., Giannobile W.V.: A Matrix Metalloproteinase Inhibitor Reduces Bone-type Collagen Degradation Fragments and Specific Collegenases in Gingival Crevicular Fluid During Adult Periodontitis. Inflammation Research 1997; 46: 310-319. 4. Saivain S., Houin G.: Clinical Pharmacokinetics of Doxycycline and Minocycline. Clin.Pharmacokinetics 1988; 15; 355-366. 5. Schach von Wittenau M., Twomey T.: The Disposition of Doxycycline by Man and Dog. Chemotherapy 1971; 16: 217-228. 6. Campistron G., Coulais Y., Caillard C., Mosser J., Pontagnier H., Houin G.: Pharmacokinetics and Bioavailability of Doxycycline in Humans. Arzneimittel Forschung 1986; 36: 1705-1707. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB70527D Rev. 07/20

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
LANNETT COMPANY, INC.
----------
DOXYCYCLINE HYCLATE TABLETS, USP
(EQUIVALENT TO 20 MG DOXYCYCLINE)
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Doxycycline
Hyclate Tablets, USP and other antibacterial drugs, Doxycycline
Hyclate Tablets, USP should be used
only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Doxycycline Hyclate Tablets, USP are available as a 20 mg formulation
of doxycycline for oral
administration.
The structural formula of doxycycline hyclate is:
with an empirical 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–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.
Inactive ingredients in the formulation are: anhydrous lactose,
microcrystalline cellulose, colloidal
silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium
dioxide, polyethylene glycol, and talc.
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
22
24
2
8
2
2
6
2
1
2,3
adult periodontitis
. The clinical significance of these findings is not known.
SUSCEPTIBILITY TESTING
For specific information regar