September 2, 2015
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Avelox

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Avelox




Indications
Dosage
How Supplied

INDICATIONS

Acute Bacterial Sinusitis

AVELOX is indicated in adult patients (18 years of age and older) for the treatment of Acute Bacterial Sinusitis caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies].

Acute Bacterial Exacerbation Of Chronic Bronchitis

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

Community Acquired Pneumonia

AVELOX is indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Clinical Studies].

MDRSP isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.

Uncomplicated Skin And Skin Structure Infections

AVELOX is indicated in adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible solates of methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes [see Clinical Studies].

Complicated Skin And Skin Structure Infections

AVELOX is indicated in adult patients for the treatment of Complicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae [see Clinical Studies].

Complicated Intra-Abdominal Infections

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

Plague

AVELOX is indicated in adult patients for the treatment of plague, including pneumonic and septicemic plague, due to susceptible isolates of Yersinia pestis and prophylaxis of plague in adult patients. Efficacy studies of moxifloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see Clinical Studies].

Usage

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.

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 400 mg 10
Acute Bacterial Exacerbation of Chronic Bronchitis 400 mg 5
Community Acquired Pneumonia 400 mg 7-14
Uncomplicated Skin and Skin Structure Infections (SSSI ) 400 mg 7
Complicated SSSI 400 mg 7-21
Complicated Intra-Abdominal Infections 400 mg 5-14
Plaguec 400 mg 10-14
a Due to the designated pathogens [see INDICATIONS AND USAGE].
b Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician
c Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

Conversion of Intravenous to Oral Dosing in Adults

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 Injection may be switched to AVELOX Tablets when clinically indicated at the discretion of the physician.

Important Administration Instructions

AVELOX Tablets

With Multivalent Cations

Administer AVELOX Tablets at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

With Food

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

AVELOX Injection

Administer by Intravenous infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

Administer 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. Avoid rapid or bolus intravenous infusion.

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

Discard any unused portion because the premix flexible containers are for single-use only.

Drug And Diluent Compatibilities

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 Injection 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 Injection with an infusion solution compatible with AVELOX Injection as well as with other drug(s) administered via this common line.

Compatible Intravenous Solutions

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

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

Preparation For Administration Of AVELOX Injection

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

To prepare AVELOX 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.

HOW SUPPLIED

Dosage Forms And Strengths

AVELOX Tablets

Oblong, dull red, film-coated tablets imprinted with “BAYER” on one side and “M400” on the other containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin).

AVELOX Injection

Ready-to-use 250 mL flexibags containing moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin) in 0.8% sodium chloride aqueous solution. The appearance of the intravenous solution is yellow.

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 Injection – Premix Bags

AVELOX (moxifloxacin) hydrochloride in sodium chloride injection is available in ready-to-use 250 mL flexible bags containing 400 mg of moxifloxacin in 0.8% saline. The flexibag is not made with natural rubber latex. No further dilution of this preparation is necessary.

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

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.

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany NJ, NJ 07981.AVELOX Tablets manufactured in Germany AVELOX Injection manufactured in Germany or AVELOX Injection 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. Revised May 2015.

Last reviewed on RxList: 9/2/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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