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Avelox

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Avelox

Avelox

INDICATIONS

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

AVELOX® Tablets and IV are indicated for the treatment of adults (≥ 18 years of age) with infections caused by susceptible isolates of the designated microorganisms in the conditions listed below [see DOSAGE AND ADMINISTRATION and Use In Specific Populations].

Culture and Susceptibility Testing

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to moxifloxacin [see CLINICAL PHARMACOLOGY]. Therapy with AVELOX may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

Acute Bacterial Sinusitis

AVELOX is indicated for the treatment of Acute Bacterial Sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies].

Acute Bacterial Exacerbation of Chronic Bronchitis

AVELOX is indicated for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis [see Clinical Studies].

Community Acquired Pneumonia

AVELOX is indicated for the treatment of Community Acquired Pneumonia caused by Streptococcus pneumoniae (including multi-drug resistant isolates*), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae.

* MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates previously known as PRSP (Penicillinresistant S. pneumoniae), and are isolates resistant to two or more of the following antibiotics: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole [see Clinical Studies].

Uncomplicated Skin and Skin Structure Infections

AVELOX is indicated for the treatment of Uncomplicated Skin and Skin Structure Infections caused by methicillinsusceptible Staphylococcus aureus or Streptococcus pyogenes [see Clinical Studies].

Complicated Skin and Skin Structure Infections

AVELOX is indicated for the treatment of Complicated Skin and Skin Structure Infections caused by methicillinsusceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae [see Clinical Studies].

Complicated Intra-Abdominal Infections

AVELOX is indicated for the treatment of Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species [see Clinical Studies ].

DOSAGE AND ADMINISTRATION

Dosage in Adult Patients

The dose of AVELOX is 400 mg (orally or as an intravenous infusion) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.

Table 1: Dosage and Duration of Therapy in Adult Patients

Type of Infectiona Dose Every 24 hours Durationb (days)
Acute Bacterial Sinusitis (1.1) 400 mg 10
Acute Bacterial Exacerbation of Chronic Bronchitis (1.2) 400 mg 5
Community Acquired Pneumonia 400 mg 7-14
Uncomplicated Skin and Skin Structure Infections (SSSI ) (1.4) 400 mg 7
Complicated SSSI (1.5) 400 mg 7-21
Complicated Intra-Abdominal Infections (1.6) 400 mg 5-14
aDue to the designated pathogens [see INDICATIONS AND USAGE, for IV use, see Use In Specific Populations].
b Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician

Intravenous formulation is indicated when it offers a route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form). When switching from intravenous to oral formulation, no dosage adjustment is necessary. Patients whose therapy is started with AVELOX IV may be switched to AVELOX Tablets when clinically indicated at the discretion of the physician.

Drug interactions with Multivalent Cations

Oral doses of AVELOX should be administered at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and VIDEX® (didanosine) chewable/buffered tablets or the pediatric powder for oral solution [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Administration Instructions

AVELOX Film-Coated Tablets

AVELOX Tablets can be taken with or without food, drink fluids liberally.

AVELOX IV Solution for Infusion

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

AVELOX IV should be administered by INTRAVENOUS infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

AVELOX IV should be administered by intravenous infusion over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place. Caution: rapid or bolus intravenous infusion must be avoided.

Because only limited data are available on the compatibility of AVELOX intravenous injection with other intravenous substances, additives or other medications should not be added to AVELOX IV or infused simultaneously through the same intravenous line. If the same intravenous line or a Y-type line is used for sequential infusion of other drugs, or if the “piggyback” method of administration is used, the line should be flushed before and after infusion of AVELOX IV with an infusion solution compatible with AVELOX IV as well as with other drug(s) administered via this common line.

AVELOX IV is compatible with the following intravenous solutions at ratios from 1:10 to 10:1

0.9% Sodium Chloride Injection, USP Sterile Water for Injection, USP
1M Sodium Chloride Injection 10% Dextrose for Injection, USP
5% Dextrose Injection, USP Lactated Ringer’s for Injection

Preparation for Administration of AVELOX IV

To prepare AVELOX IV injection premix in flexible containers:

  1. Close flow control clamp of administration set.
  2. Remove cover from port at bottom of container.
  3. Insert piercing pin from an appropriate transfer set (for example, one that does not require excessive force, such as ISO compatible administration set) into port with a gentle twisting motion until pin is firmly seated.

NOTE: Refer to complete directions that have been provided with the administration set.

HOW SUPPLIED

Dosage Forms And Strengths

AVELOX Tablets
  • Containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin)
  • Oblong, dull red film-coated tablets
  • Imprinted with BAYER on one side and M400 on the other
AVELOX IV
  • Containing 400 mg moxifloxacin in 0.8% saline (moxifloxacin hydrochloride in sodium chloride injection) with pH ranging from 4.1 to 4.6.
  • Ready-to-use 250 mL latex-free flexibags. No further dilution is necessary  
  • Sterile, preservative free, 0.8% sodium chloride aqueous solution of moxifloxacin hydrochloride

Storage And Handling

AVELOX Tablets

AVELOX (moxifloxacin) hydrochloride tablets are available as oblong, dull red film-coated tablets containing 400 mg moxifloxacin.

The tablet is coded with the word “BAYER” on one side and “M400” on the reverse side.

Package NDC Code
Bottles of 30: 0085-1733-01
Unit Dose Pack of 50: 0085-1733-02
ABC Pack of 5: 0085-1733-03

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

AVELOX Intravenous Solution – Premix Bags

AVELOX IV (moxifloxacin) hydrochloride in sodium chloride injection is available in ready-to-use 250 mL latex-free flexible bags containing 400 mg of moxifloxacin in 0.8% saline. NO FURTHER DILUTION OF THIS PREPARATION IS NECESSARY.

Package NDC Code
250 mL flexible container 0085-1737-01

Parenteral drug products should be inspected visually for particulate matter prior to administration. Samples containing visible particulates should not be used.

Because the premix flexible containers are for single-use only, any unused portion should be discarded.

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

DO NOT REFRIGERATE – PRODUCT PRECIPITATES UPON REFRIGERATION.

Revised 07 2013. Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470, AVELOX Tablets manufactured in Germany AVELOX IV manufactured in Germany or AVELOX IV manufactured in Norway by Fresenius Kabi Norge AS NO-1753 Halden, Norway. Distributed by: Merck Sharp & Dohme Corp., a subsidiary of Whitehouse Station, NJ 08889, USA AVELOX® is a registered trademark of Bayer Aktiengesellschaft and is used under license by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Last reviewed on RxList: 8/29/2013
This monograph has been modified to include the generic and brand name in many instances.

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