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Tequin Indications, Dosage, Storage, Stability - Gatifloxacin

INDICATIONS AND USAGE

TEQUIN (gatifloxacin) is indicated for the treatment of infections due to susceptible strains of the designated microorganisms in the conditions listed below (see DOSAGE AND ADMINISTRATION).

Acute bacterial exacerbation of chronic bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Staphylococcus aureus.

Acute sinusitis due to Streptococcus pneumoniae or Haemophilus influenzae.

Community-acquired pneumonia due to Streptococcus pneumoniae (including multidrug-resistant strains [MDRSP])*, Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Legionella pneumophila. (See Clinical Studies.)

Uncomplicated skin and skin structure infections (ie, simple abscesses, furuncles, folliculitis, wound infections, and cellulitis) due to Staphylococcus aureus (methicillin-susceptible strains only) or Streptococcus pyogenes.

NOTE: An insufficient number of patients with the diagnosis of impetiginous lesions were available for evaluation.

Uncomplicated urinary tract infections (cystitis) due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.

Complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.

Pyelonephritis due to Escherichia coli.

Uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae. Acute, uncomplicated rectal infections in women due to Neisseria gonorrhoeae (see WARNINGS).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of TEQUIN and other antibacterial drugs, TEQUIN 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.

*Multidrug-resistant Streptococcus pneumoniae (MDRSP) includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC 2 µg/mL), 2^nd generation cephalosporins (eg, cefuroxime), macrolides, tetracyclines, and trimethoprim/ sulfamethoxazole.

DOSAGE AND ADMINISTRATION

The recommended dosage for TEQUIN 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 ³40 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^â (didanosine) buffered tablets or pediatric powder for oral solution.

TEQUIN can be administered without regard to gender or age (³18 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 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 Urethral Gonorrhea in Men; Endocervical and Rectal Gonorrhea in Women	400 mg	Single dose
^adue to the designated pathogens (see INDICATIONS AND USAGE).
^bfor 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 (gatifloxacin) is:

Table 5: Recommended Dosage of TEQUIN in Adult Patients with Renal Impairment
Creatinine Clearance	Initial Dose	Subsequent Dose^a
³40 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
^aStart subsequent dose on Day 2 of dosing.

Administer TEQUIN 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) x (140 - age)

72 x serum creatinine (mg/dL)

Women: 0.85 x 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^Ò 56 and 5% Dextrose Injection (Multiple Electrolytes and Dextrose Injection, Type 1, USP)

M/6 Sodium Lactate Injection, USP

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.

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 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:

1. Tear outer wrap at the notch and remove solution container.

2. 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.

3. Use only if solution is clear and light yellow to greenish-yellow in color.

4. Use sterile equipment.

5. 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:

1. Close flow control clamp of administration set.

2. Remove cover from port at bottom of container.

3. 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.

4. Suspend container from hanger.

5. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of TEQUIN Injection premix in flexible containers.

6. Open flow control clamp to expel air from set. Close clamp.

7. Regulate rate of administration with flow control clamp.

Stability of TEQUIN Injection as Supplied

When stored under recommended conditions, TEQUIN Injection, as supplied in 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.

HOW SUPPLIED

Tablets

TEQUIN^â (gatifloxacin) Tablets are available as 200-mg and 400-mg white, film-coated tablets. The tablets are almond shaped and biconvex and contain gatifloxacin sesquihydrate equivalent to either 200 mg or 400 mg gatifloxacin.

TEQUIN Tablets are packaged in bottles, unit dose blister strips, and multidose blister packs of 5 tablets (TEQUIN Teq-Paqä) in the following configurations:

200 mg tablets—color: white; shape: biconvex; debossing: "BMS" on one side and "TEQUIN" and "200" on the other.

Bottles of 30 (NDC 0015-1117-50)

Blister pack of 100 (NDC 0015-1117-80)

400 mg tablets—color: white; shape: biconvex; debossing: "BMS" on one side and "TEQUIN" and "400" on the other.

Bottles of 50 (NDC 0015-1177-60)

Blister pack of 100 (NDC 0015-1177-80)

Carton of 3 TEQUIN Teq-PaqsÔ (5 tablets each) (NDC 0015-1177-21)

Storage

Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].

Intravenous Solution – Single-use Vials

TEQUIN^â (gatifloxacin) Injection is available for intravenous administration in the following configuration:

Single-use vials containing a clear, light yellow to greenish-yellow solution at a concentration of 10 mg/mL gatifloxacin.

10 mg/mL (400 mg), 40-mL vials (NDC 0015-1179-80)

Storage

Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature].

Intravenous Solution – Premix Bags

TEQUIN^â (galifloxacin in 5% dextrose) Injection is available in ready-to-use flexible bags containing a dilute solution of 200 mg or 400 mg of gatifloxacin in 5% dextrose. Premix bags are manufactured by Abbott Laboratories in North Chicago, IL.

2 mg/mL (200 mg), 100-mL flexible container (NDC 0015-1180-80)

Carton of 24 (NDC 0015-1180-79)

2 mg/mL (400 mg), 200-mL flexible container (NDC 0015-1181-80)

Carton of 24 (NDC 0015-1181-79)

Storage

Store at 25° C (77° F); excursions permitted to 15° to 30° C (59° to 86° F) [see USP Controlled Room Temperature]. Do not freeze.

ANIMAL PHARMACOLOGY

In three animal species (rats, beagle dogs, and cynomolgus monkeys) given oral gatifloxacin doses approximately 1.0- to 19-times the approved human dose (based on body surface area) from one to six months, electron microscopy showed vesiculation of rough endoplasmic reticulum and decreased secretory granules in pancreatic b-cells of all three species. These ultrastructural changes correlated with vacuolation of pancreatic b-cells seen by light microscopy in dogs given a dose level for one or six months that was approximately equivalent to the human dose (based upon body surface area and plasma AUC). Following a 4-week recovery period without gatifloxacin, partial recovery from these pancreatic changes was seen in the rat and complete recovery was evident in beagle dogs and cynomolgus monkeys (see WARNINGS and CLINICAL PHARMACOLOGY).

In contrast to some other quinolone antibacterials, there was no evidence of phototoxicity when gatifloxacin was evaluated in the hairless mouse or guinea pig models using simulated sunlight or UVA radiation, respectively.

Unlike some other members of the quinolone class, crystalluria, ocular toxicity, and testicular degeneration were not observed in 6-month repeat dose studies with rats or dogs given gatifloxacin.

While some quinolone antibacterials have proconvulsant activity that is exacerbated with concomitant use of nonsteroidal anti-inflammatory drugs (NSAID), gatifloxacin did not produce an increase in seizure activity when administered intravenously to mice at doses up to 100 mg/kg in combination with the NSAID fenbufen.

Quinolone antibacterials have been shown to cause arthropathy in immature animals. There is no evidence of arthropathy in fully mature rats and dogs given gatifloxacin for 6 months at doses of 240 or 24 mg/kg, respectively (approximately 1.5 times the maximum human dose in both species based on systemic exposure). Arthropathy and chondrodysplasia were observed in immature dogs given 10 mg/kg gatifloxacin orally for 7 days (approximately equal to the maximum human dose based upon systemic exposure) [see WARNINGS]. The relevance of these findings to the clinical use of gatifloxacin is unknown.

Some members of the quinolone class have been shown to cause prolongation of the QT interval in dogs. Intravenous 10-mg/kg bolus doses of gatifloxacin had no effect on QT interval in anesthetized dogs.

CIPRO^â (ciprofloxacin) is a registered trademark of the Bayer Corporation.

LEVAQUIN^â (levofloxacin) is a registered trademark of Ortho-McNeil Pharmaceutical, Inc.

Bristol-Myers Squibb Company Princeton, NJ 08543 USA, Licensed from Kyorin Pharmaceutical Company, Limited, Tokyo, Japan, 117880DIM-XX 51-008627-XX 1099993BX

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