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Rx Item-Levofloxacin 500Mg Tab 50 By Sandoz Pharma

NDC 00781-5791-50 UPC/GTIN No.3-07815-79150-6 Mfg.Part No.579150BRAND: LEVOFLOXACIN NDC: 00781-5791-50,781579150 UPC: 3-07815-79150-6,307815791506 Sandoz/RxOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Levofloxacin 500Mg Tab 50 By Sandoz Pharma

$964.40$1102.17

Item No.:RX130468 NDC No.781579150 UPC No.:307815791506 NDC No. 00781-5791-50 UPC/GTIN No. 3-07815-79150-6 MPN 579150 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No. Rx130468 Levofloxacin 500mg Tab 50 by Sandoz Pharma Item No. 3130468 NDC No. 00781579150 UPC No. 307815791506 Other Name Levaquin

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LEVOFLOXACIN - levofloxacin injection, solution
AuroMedics Pharma LLC

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

Fluoroquinolones, including levofloxacin, have been associated with disabling ?and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1)], including:
Tendinitis ?and tendon rupture [see Warnings and Precautions (5.2)]
Peripheral ?neuropathy[see Warnings and Precautions (5.3)]
Central nervous ?system effects [see Warnings and Precautions (5.4)]


Discontinue levofloxacin immediately and avoid the use ?of fluoroquinolones, including levofloxacin, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1)]

Fluoroquinolones, including levofloxacin, may exacerbate muscle weakness ?in patients with myasthenia gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis [see Warnings and Precautions (5.5)].
Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.14)] , reserve levofloxacin for use ?in patients who have no alternative treatment options for the following indications:
Uncomplicated urinary ?tract infection [see Indications and Usage (1.12)]
Acute bacterial exacerbation ?of chronic bronchitis [see Indications and Usage (1.13)]
Acute ?bacterial sinusitis [see Indications and Usage (1.14)].
1 INDICATIONS AND USAGE

Levofloxacin injection is indicated for the treatment of adults (?18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).

1.1 Nosocomial Pneumonia

Levofloxacin injection is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal ?-lactam is recommended [see Clinical Studies (14.1)].

1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen

Levofloxacin injection is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)].
MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ?2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen
Levofloxacin injection is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.3)].

1.4 Complicated Skin and Skin Structure Infections
Levofloxacin injection is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)].

1.5 Uncomplicated Skin and Skin Structure Infections
Levofloxacin injection is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus , or Streptococcus pyogenes.

1.6 Chronic Bacterial Prostatitis
Levofloxacin injection is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)].

1.7 Inhalational Anthrax (Post-Exposure)
Levofloxacin injection is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin injection is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin injection has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)].

1.8 Plague
Levofloxacin injection is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of levofloxacin could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.10)].

1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen

Levofloxacin injection is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)].

1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen

Levofloxacin injection is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis , Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)].

1.11 Acute Pyelonephritis : 5 or 10-day Treatment Regimen
Levofloxacin injection is indicated for the treatment of acute pyelonephritis caused by Escherichia coli , including cases with concurrent bacteremia [see Clinical Studies (14.7, 14.8)].

1.12 Uncomplicated Urinary Tract Infections
Levofloxacin injection is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.

Because fluoroquinolones, including levofloxacin injection, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.14)] and for some patients uncomplicated urinary tract infection ?is self-limiting, reserve levofloxacin injection for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options.

1.13 Acute Bacterial Exacerbation of Chronic Bronchitis
Levofloxacin injection is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus , Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

Because fluoroquinolones, including levofloxacin injection, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.14)] and for some patients ABECB is self-limiting, reserve levofloxacin injection for treatment ?of ABECB in patients who have no alternative treatment options.

1.14 Acute Bacterial Sinusitis :5-day and 10 to 14 day Treatment Regimen
Levofloxacin injection is indicated for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae , Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)].
Because fluoroquinolones, including levofloxacin injection, have been associated with serious adverse reactions [see Warnings and Precautions (5.1-5.14)] and for some patients ABS is self-limiting, reserve levofloxacin injection for treatment of ABS ?in patients who have no alternative treatment options.

1.15 Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin injection and other antibacterial drugs, levofloxacin injection 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.

Culture and susceptibility testing

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4)]. Therapy with levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.

NDC 00781-5791-50 UPC/GTIN No.3-07815-79150-6 Mfg.Part No.579150
RX ITEM-Levofloxacin 500Mg Tab 50 By San
NDC 00781-5791-50 UPC/GTIN No.3-07815-79150-6 Mfg.Part No.579150

BRAND: LEVOFLOXACIN NDC: 00781-5791-50,781579150 UPC: 3-07815-79150-6,307815791506 Sandoz/Rx
Levofloxacin 500Mg Tab 50 By Sandoz Phar
BRAND: LEVOFLOXACIN NDC: 00781-5791-50,781579150 UPC: 3-07815-79150-6,307815791506 Sandoz/Rx

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
LEVOFLOXACIN ORAL TABLET
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.