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Trovan (Trovafloxacin Mesylate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

TROVAN is indicated for the treatment of patients initiating therapy in in-patient health care facilities (i.e., hospitals and long term nursing care facilities) with serious, life- or limb-threatening infections caused by susceptible strains of the designated microorganisms in the conditions listed below. (See DOSAGE AND ADMINISTRATION.)

Nosocomial pneumonia caused by Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, or Staphylococcus aureus. As with other antimicrobials, where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with either an aminoglycoside or aztreonam may be clinically indicated.

Community acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Mycoplasma pneumoniae, Moraxella catarrhalis, Legionella pneumophila, or Chlamydia pneumoniae.

Complicated intra-abdominal infections, including post-surgical infections caused by Escherichia coli, Bacteroides fragilis, viridans group streptococci, Pseudomonas aeruginosa, Klebsiella pneumoniae, Peptostreptococcus species, or Prevotella species.

Gynecologic and pelvic infections including endomyometritis, parametritis, septic abortion and post-partum infections caused by Escherichia coli, Bacteroides fragilis, viridans group streptococci, Enterococcus faecalis, Streptococcus agalactiae, Peptostreptococcus species, Prevotella species, or Gardnerella vaginalis.

Complicated skin and skin structure infections, including diabetic foot infections, caused by Staphylococcus aureus, Streptococcus agalactiae, Pseudomonas aeruginosa, Enterococcus faecalis, Escherichia coli, or Proteus mirabilis. NOTE: TROVAN has not been studied in the treatment of osteomyelitis. (See WARNINGS.)

DOSAGE AND ADMINISTRATION

The recommended dosage for TROVAN for the treatment of serious, life- or limb-threatening infections is described in the table below. Doses of TROVAN are administered once every 24 hours. TROVAN should not usually be administered for more than 2 weeks. It should only be administered for longer than 2 weeks if the treating physician believes the benefits to the individual patients clearly outweigh the risks of such longer-term treatment. (See boxed WARNING.)

Oral doses should be administered at least 2 hours before or 2 hours after antacids containing magnesium or aluminum, as well as sucralfate, citric acid buffered with sodium citrate (e.g., Bicitra®), metal cations (e.g., ferrous sulfate) and Videx®, (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution.

Intravenous morphine should be administered at least 2 hours after oral TROVAN dosing in the fasted state and at least 4 hours after oral TROVAN is taken with food.

Patients whose therapy is started with TROVAN I.V. may be switched to TROVAN Tablets to complete the course of therapy, if deemed appropriate by the treating physician. In certain patients with serious and life- or limb-threatening infections as described in the INDICATIONS AND USAGE Section, TROVAN Tablets may be considered appropriate initial therapy, when the treating physician believes that the benefit of the product for the patient outweighs the potential risk.

TROVAN I.V. (alatrofloxacin mesylate injection) should only be administered by INTRAVENOUS infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

Single-use vials require dilution prior to administration. (See PREPARATION OF ALATROFLOXACIN MESYLATE INJECTION FOR ADMINISTRATION.)

DOSAGE GUIDELINES
INFECTIONdue to the designated pathogens (See INDICATIONS AND USAGE.)/LOCATION
AND TYPE
DAILY UNIT DOSE
AND ROUTE OF
ADMINISTRATION
TOTAL DURATION
(See WARNINGS.)
Nosocomial Pneumonia (See NOTE 1 below.)300 mg I.V. 1 followed by 200 mg oral10–14 days
Community Acquired Pneumonia200 mg oral or 200 mg I.V. followed by 200 mg oral7–14 days
Complicated Intra-Abdominal Infections, including post-surgical infections 300 mg I.V. followed by 200 mg oral7–14 days
Gynecologic and Pelvic Infections 300 mg I.V. followed by 200 mg oral7–14 days
Skin and Skin Structure Infections, Complicated, including diabetic foot infections200 mg oral or 200 mg I.V. followed by 200 mg oral10–14 days

1 Where the 300 mg TROVAN I.V. dose is indicated, therapy should be decreased to the 200 mg dose as soon as clinically indicated.

NOTE: As with other antimicrobials, where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with either an aminoglycoside or aztreonam may be clinically indicated.

IMPAIRED RENAL FUNCTION: No adjustment in the dosage of TROVAN is necessary in patients with impaired renal function. Trovafloxacin is eliminated primarily by biliary excretion. Trovafloxacin is not efficiently removed from the body by hemodialysis.

CHRONIC HEPATIC DISEASE (cirrhosis): The following table provides dosing guidelines for patients with mild or moderate cirrhosis (Child-Pugh Class A and B). There are no data in patients with severe cirrhosis (Child-Pugh Class C).

INDICATED DOSE (Normal hepatic function)CHRONIC HEPATIC DISEASE DOSE
300 mg I.V.200 mg I.V.
200 mg I.V. or oral100 mg I.V. or oral

INTRAVENOUS ADMINISTRATION

AFTER DILUTION WITH AN APPROPRIATE DILUENT, TROVAN I.V. SHOULD BE ADMINISTERED BY INTRAVENOUS INFUSION OVER A PERIOD OF 60 MINUTES. CAUTION: RAPID OR BOLUS INTRAVENOUS INFUSION SHOULD BE AVOIDED. (See PRECAUTIONS.)

TROVAN I.V. is supplied in single-use vials containing a concentrated solution of alatrofloxacin mesylate in Water for Injection (equivalent of 200 mg or 300 mg as trovafloxacin). Each mL contains alatrofloxacin mesylate equivalent to 5 mg trovafloxacin. (See HOW SUPPLIED for container sizes.) THESE TROVAN I.V. SINGLE-USE VIALS MUST BE FURTHER DILUTED WITH AN APPROPRIATE SOLUTION PRIOR TO INTRAVENOUS ADMINISTRATION. This parenteral drug product should be inspected visually for discoloration and particulate matter prior to dilution and administration. Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final parenteral solution.

PREPARATION OF ALATROFLOXACIN MESYLATE INJECTION FOR ADMINISTRATION

The intravenous dose should be prepared by aseptically withdrawing the appropriate volume of concentrate from the vials of TROVAN I.V. This should be diluted with a suitable intravenous solution to a final concentration of 1–2 mg/mL. (See Compatible Intravenous Solutions.) The resulting solution should be infused over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place.

Since the vials are for single-use only, any unused portion should be discarded.

Since only limited data are available on the compatibility of alatrofloxacin intravenous injection with other intravenous substances, additives or other medications should not be added to TROVAN I.V. in single-use vials or infused simultaneously through the same intravenous line.

If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of TROVAN I.V. with an infusion solution compatible with TROVAN I.V. and with any other drug(s) administered via this common line.

If TROVAN I.V. 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.

The desired dosage of TROVAN I.V. may be prepared according to the following chart:

DOSAGE STRENGTH (mg)
(trovafloxacin equivalent)
VOLUME TO WITHDRAW
(mL)
DILUENT VOLUME
(mL)
TOTAL VOLUME
(mL
INFUSION CONC
(mg/mL)
100 mg203050 2
100 mg2080100 1
200 mg4060100 2
200 mg40160200 1
300 mg6090150 2
300 mg60240300 1

For example, to prepare a 200 mg dose at an infusion concentration of 2 mg/mL (as trovafloxacin), 40 mL of TROVAN I.V. is withdrawn from a vial and diluted with 60 mL of a compatible intravenous fluid to produce a total infusion solution volume of 100 mL.

Compatible Intravenous Solutions

5% Dextrose Injection, USP
0.45% Sodium Chloride Injection, USP
5% Dextrose and 0.45% Sodium Chloride Injection, USP
5% Dextrose and 0.2% Sodium Chloride Injection, USP
Lactated Ringer's and 5% Dextrose Injection, USP

TROVAN I.V. should not be diluted with 0.9% Sodium Chloride Injection, USP (normal saline), alone or in combination with other diluents. A precipitate may form under these conditions. In addition, TROVAN I.V. should not be diluted with Lactated Ringer's, USP.

Normal saline, 0.9% Sodium Chloride Injection, USP can be used for flushing I.V. lines prior to or after administration of TROVAN I.V.

Stability of TROVAN I.V. as Supplied

When stored under recommended conditions, TROVAN I.V., as supplied in 40 mL or 60 mL vials, is stable through the expiration date printed on the label.

Stability of TROVAN I.V. Following Dilution

TROVAN I.V., when diluted with compatible intravenous solutions to concentrations of 0.5 to 2.0 mg/mL (as trovafloxacin), is physically and chemically stable for up to 7 days when refrigerated or up to 3 days at room temperature stored in glass bottles or plastic (PVC type) intravenous containers.

HOW SUPPLIED

Trovan Tablets and Injection are being distributed only to hospitals and long term nursing care facilities for patients initiating therapy in these facilities

Tablets

TROVAN (trovafloxacin mesylate) Tablets are available as blue, film-coated tablets. The 100 mg tablets are round and contain trovafloxacin mesylate equivalent to 100 mg trovafloxacin. The 200 mg tablets are modified oval-shaped and contain trovafloxacin mesylate equivalent to 200 mg trovafloxacin.

TROVAN Tablets are packaged and in unit dose blister strips in the following configurations:

100-mg tablets: color: blue; shape: round; debossing: "PFIZER" on one side and "378" on the other
  Bottles of 30 (NDC 0049-3780-30)
  Unit Dose/40 tablets (NDC 0049-3780-43)

200-mg tablets: color: blue; shape: modified oval; debossing: "PFIZER" on one side and "379" on the other
  Bottles of 30 (NDC 0049-3790-30)
  Unit Dose/40 tablets (NDC 0049-3790-43)

Storage

TROVAN Tablets should be stored at 15°C to 30°C (59°F to 86°F) in airtight containers (USP).

Injection

TROVAN is also available for intravenous administration as the prodrug, TROVAN I.V. (alatrofloxacin mesylate injection), in the following configurations:

Single-use vials containing a clear, colorless to pale-yellow concentrated solution of alatrofloxacin mesylate equivalent to 5 mg trovafloxacin/mL.

  5 mg/mL, 40 mL, 200 mg
  Unit dose package (NDC 0049-3890-28)

  5 mg/mL, 60 mL, 300 mg
  Unit dose package (NDC 0049-3900-28)

Storage

TROVAN I.V. should be stored at 15°C to 30°C (59°F to 86°F). Protect From Light. Do Not Freeze.

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