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Tequin

Clinical Pharmacology
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CLINICAL PHARMACOLOGY

Tequin

Gatifloxacin is administered as a racemate, with the disposition and antibacterial activity of the R- and S-enantiomers virtually identical.

Absorption

Gatifloxacin is well absorbed from the gastrointestinal tract after oral administration and can be given without regard to food. The absolute bioavailability of gatifloxacin is 96%. Peak plasma concentrations of gatifloxacin usually occur 1-2 hours after oral dosing.

The oral and intravenous routes of administration for TEQUIN can be considered interchangeable, since the pharmacokinetics of gatifloxacin after 1-hour intravenous administration are similar to those observed for orally administered gatifloxacin when equal doses are administered (Figure 1) (see DOSAGE AND ADMINISTRATION).

Figure 1: Mean Plasma Concentration-Time Profiles of Gatifloxacin Following Intravenous (IV) and Oral (PO) Administration of a Single 400-mg Dose to Healthy Subjects.

Pharmacokinetics

The mean (SD) pharmacokinetic parameters of gatifloxacin following oral administration to healthy subjects with bacterial infections and subjects with renal insufficiency are listed in Table 1. The mean (SD) pharmacokinetic parameters of gatifloxacin following intravenous administration to healthy subjects are listed in Table 2.

Table 1: Gatifloxacin Pharmacokinetic Parameters- Oral Administration

Cmax (mg/mL)

Tmaxa (h)

AUCb (mg.h/mL)

T ½ (h)

Cl/F (mL/min)

C1R (mL/min)

UR (%)

200 mg - Healthy Volunteers

Single dose (n=12)

2.0 ±0.4

1.00 (0.50, 2.50)

14.2 ± 0.4

-

241 ±40

-

73.8 ± 10.9

400 mg - Healthy Volunteers

Single dose (n=202)c

3.8 ±1.0

1.00 (0.50, 6.00)

33.0 ± 6.2

7.8±1.3

210 ±44

151 ±46

72.4 ± 18.1

Multiple dose (n=18)

4.2 ±1.3

1.50 (0.50, 4.00)

34.4 ± 5.7

7.1±0.6

199 ±31

159 ±34

80.2 ±12.1

400 mg - Patients with Infection

Multiple dose (n=140)d

4.2 ±1.9

-

51.3±20.4

-

147 ±48

-

-

400 mg - Single Dose Subjects with Renal Insufficiency

Clcr50 - 89 mL/min (n=8)

4.4 ±1.1

1.13 (0.75-2.00)

48.0 ± 12.7

11.2±2.8

148 ±41

124 ± 38

83.7±7.8

Clcr 30 - 49 mL/min (n=8)

5.1 ±1.8

0.75 (0.50, 6.00)

74.9 ± 12.6

17.2±8.5

92 ±17

67 ±24

71.1 ±17.4

Clcr <30 mL/min (n=8)

4.5 ±1.2

1.50 (0.50, 6.00)

149.3±35.6

30.7±8.4

48 ±16

23 ±13

44.7 ±13.0

Hemodialysis (n=8)

4.7 ±1.0

1.50 (1.00,3.00)

180.3±34.4

35.7±7.0

38 ±8

-

-

CAPD(n=8)

4.7 ±1.3

1.75 (0.50, 3.00)

227.0±60.0

40.3±8.3

31±8

-

-

Brand Name: Tequin
Generic Name: Gatifloxacin (Removed from US Market - May 2006)

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