Avelox

AVELOX — moxifloxacin hydrochloride tablet, film coated
REMEDYREPACK INC.

Boxed Warning section

Fluoroquinolones , including AVELOX® , are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. [ see Warnings and Precautions (5.1)].

Fluoroquinolones , including AVELOX, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid AVELOX in patients with known history of myasthenia gravis [see Warnings and Precautions (5.2)].

MICROBIOLOGY

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.

INDICATIONS & 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.

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 (2) and Use In Specific Populations (8.5)].

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 (12.4)]. Therapy with AVELOX may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.

AVELOX is indicated for the treatment of Acute Bacterial Sinusitis caused by Streptococcus pneumoniae , Haemophilus influenzae , or Moraxella catarrhalis [see Clinical Studies (14.4)].

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 (14.1)].

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 (Penicillin-resistant 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 (14.2)].

AVELOX is indicated for the treatment of Uncomplicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes [see Clinical Studies (14.5)].

AVELOX is indicated for the treatment of Complicated Skin and Skin Structure Infections caused by methicillin-susceptible Staphylococcus aureus , Escherichia coli, Klebsiella pneumoniae , or Enterobacter cloacae [ see Clinical Studies (14.6)].

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 (14.7)].

DOSAGE & ADMINISTRATION

Type of Infection

Dose Every 24 hours

Duration (days)

Acute Bacterial Sinusitis (1.1)

400 mg

10

Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)

400 mg

5

Community Acquired Pneumonia (1.3)

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

•No dosage adjustment in patients with renal or hepatic impairment. (8.6, 8.7)

•AVELOX Tablets: Administer 4 hours before or 8 hours after antacids, sucralfate, multivitamins and other products with multivalent cations. (2.2)

•AVELOX IV: Slow IV infusion over 60 minutes. Avoid rapid or bolus IV. (2.3)

•Do not mix with other medications in IV bag or in IV line (2.3)

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 Infection *

DoseEvery 24 hours

Duration (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

1

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.

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 (7.1) and Clinical Pharmacology (12.3)].

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

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

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.

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