DOSAGE AND ADMINISTRATION
The recommended dosage for TEQUIN (gatifloxacin) Tablets or TEQUIN Injection is described in Table 4. Doses of TEQUIN are administered once every 24 hours. These recommendations apply to all patients with a creatinine clearance >/=40 mL/min. For patients with a creatinine clearance <40 mL/min, see the Impaired Renal Function subsection.
TEQUIN can be administered without regard to food, including milk and dietary supplements containing calcium.
Oral doses of TEQUIN should be administered at least 4 hours before the administration of ferrous sulfate, dietary supplements containing zinc, magnesium, or iron (such as multivitamins), aluminum/magnesium-containing antacids, or VIDEX® (didanosine) buffered tablets or pediatric powder for oral solution.
TEQUIN can be administered without regard to gender or age (>/=18 years). Consideration should be given to the possibility that the elderly may have impaired renal function (see PRECAUTIONS: Geriatric Use).
When switching from intravenous to oral dosage administration, no dosage adjustment is necessary. Patients whose therapy is started with TEQUIN Injection may be switched to TEQUIN Tablets when clinically indicated at the discretion of the physician.
TEQUIN (gatifloxacin) Injection should be administered by INTRAVENOUS infusion only. It is not intended for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Single-use vials require dilution prior to administration. (See Preparation of Gatifloxacin for Intravenous Administration.)
TEQUIN Injection should be administered by intravenous infusion over a period of 60 minutes. CAUTION: RAPID OR BOLUS INTRAVENOUS INFUSION SHOULD BE AVOIDED.
Table 4: Gatifloxacin -- Dosage Guidelines
| INFECTION a |
DAILY DOSE b |
DURATION |
|
Acute Bacterial Exacerbation of Chronic Bronchitis
|
400 mg
|
5 days
|
|
Acute Sinusitis
|
400 mg
|
10 days
|
|
Community-acquired Pneumonia
|
400 mg
|
7-14 days
|
|
Uncomplicated Skin and Skin Structure Infections
|
400 mg
|
7-10 days
|
|
Uncomplicated Urinary Tract Infections (cystitis)
|
400 mg or 200 mg
|
Single dose 3 days
|
|
Complicated Urinary Tract Infections
|
400 mg
|
7-10 days
|
|
Acute Pyelonephritis
|
400 mg
|
7-10 days
|
|
Uncomplicated Urethal Gonorrhea in Men; Endocervical and Rectal Gonorrhea in Women
|
400 mg
|
Single dose
|
| a Due to the designated pathogens (see INDICATIONS AND USAGE).
|
| b For either the oral or intravenous routes of administration for TEQUIN (see CLINICAL PHARMACOLOGY).
|
|
IMPAIRED RENAL FUNCTION
Since gatifloxacin is eliminated primarily by renal excretion, a dosage modification of TEQUIN is recommended for patients with creatinine clearance <40 mL/min, including patients on hemodialysis and on CAPD. The recommended dosage of TEQUIN is:
Table 5: Recommended Dosage of TEQUIN in Adult Patients with Renal Impairment
| Creatinine Clearance |
Initial Dose |
Subsequent Dose a |
|
>/=40 mL/min
|
400 mg
|
400 mg every day
|
|
<40 mL/min
|
400 mg
|
200 mg every day
|
|
Hemodialysis
|
400 mg
|
200 mg every day
|
Continuous peritoneal
dialysis
|
400 mg
|
200 mg every day
|
| a Start subsequent dose on Day 2 of dosing. |
|
Administer TEQUIN (gatifloxacin) after a dialysis session for patients on hemodialysis.
Single 400 mg dose TEQUIN regimen (for the treatment of uncomplicated urinary tract infections and gonorrhea) and 200 mg once daily for 3 days TEQUIN regimen (for the treatment of uncomplicated urinary tract infections) require no dosage adjustment in patients with impaired renal function.
The following formula may be used to estimate creatinine clearance:
|
Men: Creatinine Clearance (mL/min) =
|
Weight (kg) × (140 - age)
|
|
|
72 × serum creatinine (mg/dL) |
|
Women: 0.85 × the value calculated for men.
|
|
CHRONIC HEPATIC DISEASE
No adjustment in the dosage of TEQUIN is necessary in patients with moderate hepatic impairment (Child-Pugh Class B). There are no data in patients with severe hepatic impairment (Child-Pugh Class C) (see CLINICAL PHARMACOLOGY).
INTRAVENOUS ADMINISTRATION
PREPARATION OF GATIFLOXACIN FOR INTRAVENOUS ADMINISTRATION
TEQUIN solution in single-use vials: TEQUIN Injection is supplied in single-use 40 mL vials (10 mg/mL) containing a concentrated solution of gatifloxacin in 5% dextrose (400 mg of gatifloxacin) (see HOW SUPPLIED). THESE TEQUIN INJECTION SINGLE-USE VIALS MUST BE FURTHER DILUTED WITH AN APPROPRIATE SOLUTION PRIOR TO INTRAVENOUS ADMINISTRATION. The concentration of the resulting diluted solution should be 2 mg/mL prior to administration. Compatible intravenous solutions: Because a hypotonic solution results, Water for Injection should not be used as a diluent when preparing a 2 mg/mL solution from the concentrated solution of gatifloxacin (10 mg/mL) (see PRECAUTIONS). Any of the following intravenous solutions may be used to prepare a 2 mg/mL gatifloxacin solution:
5% Dextrose Injection, USP
0.9% Sodium Chloride Injection, USP
5% Dextrose and 0.9% Sodium Chloride Injection, USP
Lactated Ringer's and 5% Dextrose Injection, USP
5% Sodium Bicarbonate Injection, USP
Plasma-Lyte® 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP) M/6 Sodium Lactate Injection, USP
Plasma-Lyte® is a registered trademark of Baxter International, Inc.
Gatifloxacin solutions at 2 mg/mL also have been shown to be compatible with 20 mEq/L Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP.
This intravenous drug product should be inspected visually for particulate matter prior to dilution and administration. Samples containing visible particles should be discarded. Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final intravenous solution. Since the vials are for single-use only, any unused portion remaining in the vial should be discarded.
Since only limited data are available on the compatibility of gatifloxacin intravenous injection with other intravenous substances, additives or other medications should not be added to TEQUIN (gatifloxacin) Injection in single-use vials or infused simultaneously through the same intravenous line.
If the same intravenous line is used for sequential infusion of different drugs, the line should be flushed before and after infusion of TEQUIN Injection with an infusion solution compatible with TEQUIN Injection and with any other drug(s) administered via this common line.
If TEQUIN Injection is to be given concomitantly with another drug, each drug should be given separately in accordance with the recommended dosage and route of administration for each drug.
TEQUIN Injection premix in single-use flexible containers: TEQUIN Injection is also available in ready-to-use 100 and 200 mL flexible bags containing a dilute solution of 200 or 400 mg gatifloxacin in 5% dextrose. NO FURTHER DILUTION OF THIS PREPARATION IS NECESSARY.
This intravenous drug product should be inspected visually for particulate matter prior to administration. Samples containing visible particles should be discarded.
Since the premix flexible bags are for single use only, any unused portion should be discarded.
Since only limited data are available on the compatibility of gatifloxacin intravenous injection with other intravenous substances, additives or other medications should not be added to TEQUIN Injection in flexible containers or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of different drugs, the line should be flushed before and after infusion of TEQUIN (gatifloxacin) Injection with an infusion solution compatible with TEQUIN Injection and with any other drug(s) administered via this common line.
Instructions for the use of TEQUIN (gatifloxacin in 5% dextrose) Injection premix in flexible containers:
To open:
-
Tear outer wrap at the notch and remove solution container.
-
Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution, as the sterility may be compromised.
-
Use only if solution is clear and light yellow to greenish-yellow in color.
-
Use sterile equipment.
- WARNING: Do not use flexible containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.
Preparation for administration:
-
Close flow control clamp of administration set.
-
Remove cover from port at bottom of container.
-
Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton.
-
Suspend container from hanger.
-
Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of TEQUIN Injection premix in flexible containers.
-
Open flow control clamp to expel air from set. Close clamp.
-
Regulate rate of administration with flow control clamp.
Stability of TEQUIN Injection as Supplied
When stored under recommended conditions, TEQUIN Injection, as supplied in 20 mL and 40 mL vials and in 100 mL and 200 mL flexible containers, is stable through the expiration date printed on the label.
Stability of TEQUIN Injection Following Dilution
TEQUIN Injection, when diluted in a compatible intravenous fluid to a concentration of 2 mg/mL, is stable for 14 days when stored between 20°C to 25°C or when stored under refrigeration between 2°C to 8°C.
TEQUIN Injection, when diluted to a concentration of 2 mg/mL in a compatible intravenous fluid EXCEPT FOR 5% SODIUM BICARBONATE INJECTION, USP, may be stored for up to 6 months at -25°C to -10°C (-13°F to 14°F). Frozen solutions may be thawed at controlled room temperature. Solutions that have been thawed are stable for 14 days after removal from the freezer when stored between 20°C to 25°C or when stored under refrigeration between 2°C to 8°C. Solutions should not be refrozen.
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