PMS-DOXYCYCLINE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DOXYCYCLINE (DOXYCYCLINE HYCLATE)

Available from:

PHARMASCIENCE INC

ATC code:

A01AB22

INN (International Name):

DOXYCYCLINE

Dosage:

20MG

Pharmaceutical form:

CAPSULE

Composition:

DOXYCYCLINE (DOXYCYCLINE HYCLATE) 20MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

TETRACYCLINES

Product summary:

Active ingredient group (AIG) number: 0105569005; AHFS:

Authorization status:

APPROVED

Authorization date:

2021-07-07

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
PMS-DOXYCYCLINE
Doxycycline Hyclate Capsules, USP
20 mg
COLLAGENASE INHIBITOR FOR PERIODONTAL USE
PHARMASCIENCE INC.
6111 Royalmount Avenue, Suite 100
Montréal, Québec
H4P 2T4 DATE OF REVISION:
July 6, 2021
CONTROL: 251590
_pms-DOXYCYCLINE _
_ Page 2 of 18_
PRODUCT MONOGRAPH
PR
PMS-DOXYCYCLINE
(Doxycycline Hyclate Capsules, USP)
20 mg
THERAPEUTIC CLASSIFICATION
Collagenase Inhibitor for Periodontal Use
ACTIONS AND CLINICAL PHARMACOLOGY
pms-DOXYCYCLINE capsules contain doxycycline hyclate which is a
semi-synthetic tetracycline.
Doxycycline is an inhibitor of collagenase activity. Studies have
shown that doxycycline reduces the
elevated collagenase activity in the gingival crevicular fluid of
patients with chronic adult
periodontitis, in an action unrelated to its antibacterial mode of
action. The clinical significance of
these findings is not known (for details see CLINICAL TRIALS).
PHARMACOKINETICS
The pharmacokinetics of doxycycline following oral administration of
pms-DOXYCYCLINE were
investigated in 3 volunteer studies involving 87 adults.
Pharmacokinetic parameters following
single oral dose and at steady-state in healthy subjects indicated for
a single 20 mg dose, a C
max
of
400 ng/mL and T
1/2
of 18.4 hours, and for the steady-state 20 mg BID, a C
max
of 790 ng/mL and the
T
1/2
has not been determined. These blood levels are considered below the
antimicrobial activity of
doxycycline.
INDICATIONS AND CLINICAL USE
pms-DOXYCYCLINE 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.
pms-DOXYCYCLINE contains an antibacterial ingredient, doxycycline. To
reduce the development
of drug-resistant bacteria and maintain the effectiveness of
doxycycline, pms-DOXYCYCLINE
should only be used for the authorized indication and clinical use.
CONTRAINDICATIONS
This drug is contraindicated in persons who have shown
hypersensitivity to any of the tetracyclines,
and in patients with myasthenia grav