Medically reviewed by Drugs.com. Last updated on Jan 27, 2022.
Generic name: trovafloxacin mesylate
Dosage form: Tablets and Injection
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.)
|DAILY UNIT DOSE
AND ROUTE OF
|Nosocomial Pneumonia (See NOTE 1 below.)||300 mg I.V.†followed by 200 mg oral||10–14 days|
|Community Acquired Pneumonia||200 mg oral or 200 mg I.V. followed by 200 mg oral||7–14 days|
|Complicated Intra-Abdominal Infections, including post-surgical infections||300 mg I.V.† followed by 200 mg oral||7–14 days|
|Gynecologic and Pelvic Infections||300 mg I.V.† followed by 200 mg oral||7–14 days|
|Skin and Skin Structure Infections, Complicated, including diabetic foot infections||200 mg oral or 200 mg I.V. followed by 200 mg oral||10–14 days|
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 oral||100 mg I.V. or oral|
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. (SeeCompatible 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)
|VOLUME TO WITHDRAW
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.
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