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Tavanic (Levaquin) 500 Mg 1 Vial

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FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING:

1 INDICATIONS AND USAGE

1.1 Nosocomial Pneumonia

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

1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen

1.4 Acute Bacterial Sinusitis: 5-day and 10–14 day Treatment Regimens

1.5 Acute Bacterial Exacerbation of Chronic Bronchitis

1.6 Complicated Skin and Skin Structure Infections

1.7 Uncomplicated Skin and Skin Structure Infections

1.8 Chronic Bacterial Prostatitis

1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen

1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen

1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen

1.12 Uncomplicated Urinary Tract Infections

1.13 Inhalational Anthrax (Post-Exposure)

1.14 Plague

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adult Patients with Normal Renal Function

2.2 Dosage in Pediatric Patients

2.3 Dosage Adjustment in Adults with Renal Impairment

2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

2.5 Administration Instructions

2.6 Preparation of Intravenous Product

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Tendinopathy and Tendon Rupture

5.2 Exacerbation of Myasthenia Gravis

5.3 Hypersensitivity Reactions

5.4 Other Serious and Sometimes Fatal Reactions

5.5 Hepatotoxicity

5.6 Central Nervous System Effects

5.7 Clostridium difficile-Associated Diarrhea

5.8 Peripheral Neuropathy

5.9 Prolongation of the QT Interval

5.10 Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals

5.11 Blood Glucose Disturbances

5.12 Photosensitivity/Phototoxicity

5.13 Development of Drug Resistant Bacteria

6 ADVERSE REACTIONS

6.1 Serious and Otherwise Important Adverse Reactions

6.2 Clinical Trial Experience

6.3 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

7.2 Warfarin

7.3 Antidiabetic Agents

7.4 Non-Steroidal Anti-Inflammatory Drugs

7.5 Theophylline

7.6 Cyclosporine

7.7 Digoxin

7.8 Probenecid and Cimetidine

7.9 Interactions with Laboratory or Diagnostic Testing

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Nosocomial Pneumonia

14.2 Community-Acquired Pneumonia: 7–14 day Treatment Regimen

14.3 Community-Acquired Pneumonia: 5-day Treatment Regimen

14.4 Acute Bacterial Sinusitis: 5-day and 10–14 day Treatment Regimens

14.5 Complicated Skin and Skin Structure Infections

14.6 Chronic Bacterial Prostatitis

14.7 Complicated Urinary Tract Infections and Acute Pyelonephritis: 5-day Treatment Regimen

14.8 Complicated Urinary Tract Infections and Acute Pyelonephritis: 10-day Treatment Regimen

14.9 Inhalational Anthrax (Post-Exposure)

14.10 Plague

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 TAVANIC (Generic LEVAQUIN)® Tablets

16.2 TAVANIC (Generic LEVAQUIN)® Oral Solution

16.3 TAVANIC (Generic LEVAQUIN)® Injection Pre-Mixed Solution, Single-Use in Flexible Container

17 PATIENT COUNSELING INFORMATION

17.1 Antibacterial Resistance

17.2 Administration with Food, Fluids, and Concomitant Medications

17.3 Serious and Potentially Serious Adverse Reactions

17.4 Drug Interactions with Insulin, Oral Hypoglycemic Agents, and Warfarin

17.5 Plague and Anthrax Studies

* Sections or subsections omitted from the full prescribing information are not listed.

 

FULL PRESCRIBING INFORMATION

WARNING:

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

1 INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of TAVANIC (Generic LEVAQUIN)® and other antibacterial drugs, TAVANIC (Generic LEVAQUIN)® 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.

TAVANIC (Generic LEVAQUIN)® Tablets/Injection and Oral Solution are 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. TAVANIC (Generic LEVAQUIN)® Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).

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 TAVANIC (Generic LEVAQUIN)® 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 TAVANIC (Generic LEVAQUIN)®. 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.

1.1 Nosocomial Pneumonia

TAVANIC (Generic LEVAQUIN)® is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureusPseudomonas aeruginosaSerratia marcescensEscherichia coliKlebsiella pneumoniaeHaemophilus 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 β-lactam is recommended[see Clinical Studies (14.1)].

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

TAVANIC (Generic LEVAQUIN)® is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureusStreptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]),Haemophilus influenzaeHaemophilus parainfluenzaeKlebsiella pneumoniaeMoraxella catarrhalisChlamydophila pneumoniaeLegionella 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

TAVANIC (Generic LEVAQUIN)® is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzaeHaemophilus parainfluenzaeMycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.3)].

1.4 Acute Bacterial Sinusitis: 5-day and 10–14 day Treatment Regimens

TAVANIC (Generic LEVAQUIN)® is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniaeHaemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)].

1.5 Acute Bacterial Exacerbation of Chronic Bronchitis

TAVANIC (Generic LEVAQUIN)® is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureusStreptococcus pneumoniaeHaemophilus influenzaeHaemophilus parainfluenzae, orMoraxella catarrhalis.

1.6 Complicated Skin and Skin Structure Infections

TAVANIC (Generic LEVAQUIN)® is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureusEnterococcus faecalisStreptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)].

1.7 Uncomplicated Skin and Skin Structure Infections

TAVANIC (Generic LEVAQUIN)® 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.

1.8 Chronic Bacterial Prostatitis

TAVANIC (Generic LEVAQUIN)® is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coliEnterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)].

1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen

TAVANIC (Generic LEVAQUIN)® is indicated for the treatment of complicated urinary tract infections due to Escherichia coliKlebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)].

1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen

TAVANIC (Generic LEVAQUIN)® is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalisEnterobacter cloacaeEscherichia coliKlebsiella pneumoniaeProteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)].

1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen

TAVANIC (Generic LEVAQUIN)® 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

TAVANIC (Generic LEVAQUIN)® is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coliKlebsiella pneumoniae, or Staphylococcus saprophyticus.

1.13 Inhalational Anthrax (Post-Exposure)

TAVANIC (Generic LEVAQUIN)® is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of TAVANIC (Generic LEVAQUIN)® is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. TAVANIC (Generic LEVAQUIN)® has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of TAVANIC (Generic LEVAQUIN)® 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 TAVANIC (Generic LEVAQUIN)® therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1,2.2) and Clinical Studies (14.9)].

1.14 Plague

TAVANIC (Generic LEVAQUIN)® 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 TAVANIC (Generic LEVAQUIN)® 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) andClinical Studies (14.10)].

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adult Patients with Normal Renal Function

The usual dose of TAVANIC (Generic LEVAQUIN)® Tablets or Oral Solution is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1. The usual dose of TAVANIC (Generic LEVAQUIN)® 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.

These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)

Type of Infection*

Dosed Every 24 hours

Duration (days)†

* Due to the designated pathogens [see Indications and Usage (1)].

† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].

§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniaeor Chlamydophila pneumoniae [see Indications and Usage (1.3)].

¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.

# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.

Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].

ß The safety of TAVANIC (Generic LEVAQUIN)® in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10)Use in Specific Populations (8.4)and Clinical Studies (14.9)]. Prolonged TAVANIC (Generic LEVAQUIN)® therapy should only be used when the benefit outweighs the risk.

à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of TAVANIC (Generic LEVAQUIN)® typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.

Nosocomial Pneumonia

750 mg

7–14

Community Acquired Pneumonia‡

500 mg

7–14

Community Acquired Pneumonia§

750 mg

5

Acute Bacterial Sinusitis

750 mg

5

500 mg

10–14

Acute Bacterial Exacerbation of Chronic Bronchitis

500 mg

7

Complicated Skin and Skin Structure Infections (SSSI)

750 mg

7–14

Uncomplicated SSSI

500 mg

7–10

Chronic Bacterial Prostatitis

500 mg

28

Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶

750 mg

5

Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)#

250 mg

10

Uncomplicated Urinary Tract Infection

250 mg

3

Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg Þ,ß

500 mg

60ß

Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß

see Table 2 below (2.2)

60ß

Plague, adult and pediatric patients > 50 kg à

500 mg

10 to 14

Pediatric patients < 50 kg and ≥ 6 months of age

see Table 2 below (2.2)

10 to 14

2.2 Dosage in Pediatric Patients

The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.

Table 2: Dosage in Pediatric Patients ≥ 6 months of age

Type of Infection*

Dose

Freq. Once every

Duration†

* Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]

§ The safety of TAVANIC (Generic LEVAQUIN)® in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged TAVANIC (Generic LEVAQUIN)® therapy should only be used when the benefit outweighs the risk.

¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

Inhalational Anthrax (post-exposure)‡,§

     

Pediatric patients > 50 kg

500 mg

24 hr

60 days§

Pediatric patients < 50 kg and ≥ 6 months of age

8 mg/kg
(not to exceed 250 mg per dose)

12 hr

60 days§

Plague ¶

     

Pediatric patients > 50 kg

500 mg

24 hr

10 to 14 days

Pediatric patients < 50 kg and ≥ 6 months of age

8 mg/kg
(not to exceed 250 mg per dose)

12 hr

10 to 14 days

2.3 Dosage Adjustment in Adults with Renal Impairment

Administer TAVANIC (Generic LEVAQUIN)® with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.

No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.

In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].

Table 3 shows how to adjust dose based on creatinine clearance.

Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance < 50 mL/min)

Dosage in Normal Renal Function Every 24 hours

Creatinine Clearance
20 to 49 mL/min

Creatinine Clearance
10 to 19 mL/min

Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)

750 mg

750 mg every 48 hours

750 mg initial dose, then 500 mg every 48 hours

750 mg initial dose, then 500 mg every 48 hours

500 mg

500 mg initial dose, then 250 mg every 24 hours

500 mg initial dose, then 250 mg every 48 hours

500 mg initial dose, then 250 mg every 48 hours

250 mg

No dosage adjustment required

250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required

No information on dosing adjustment is available

2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

TAVANIC (Generic LEVAQUIN)® Tablets and Oral Solution

TAVANIC (Generic LEVAQUIN)® Tablets and Oral Solution should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].

TAVANIC (Generic LEVAQUIN)® Injection

TAVANIC (Generic LEVAQUIN)® Injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].

2.5 Administration Instructions

Food and TAVANIC (Generic LEVAQUIN)® Tablets and Oral Solution

TAVANIC (Generic LEVAQUIN)® Tablets can be administered without regard to food. It is recommended that TAVANIC (Generic LEVAQUIN)® Oral Solution be taken 1 hour before or 2 hours after eating.

TAVANIC (Generic LEVAQUIN)® Injection

Caution: Rapid or bolus intravenous infusion of TAVANIC (Generic LEVAQUIN)® has been associated with hypotension and must be avoided. TAVANIC (Generic LEVAQUIN)® Injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. TAVANIC (Generic LEVAQUIN)® Injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

Hydration for Patients Receiving TAVANIC (Generic LEVAQUIN)® Tablets, Oral Solution, and Injection

Adequate hydration of patients receiving oral or intravenous TAVANIC (Generic LEVAQUIN)® should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].

2.6 Preparation of Intravenous Product

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

Because only limited data are available on the compatibility of TAVANIC (Generic LEVAQUIN)® Injection with other intravenous substances, additives or other medications should not be added to TAVANIC (Generic LEVAQUIN)® Injection Premix in Single-Use Flexible Containers, 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 TAVANIC (Generic LEVAQUIN)® Injection with an infusion solution compatible with TAVANIC (Generic LEVAQUIN)® Injection and with any other drug(s) administered via this common line.

TAVANIC (Generic LEVAQUIN)® Injection Premix in Single-Use Flexible Containers (5 mg/mL)

TAVANIC (Generic LEVAQUIN)® Injection is supplied in flexible containers within a foil overwrap. These contain a premixed, ready to use levofloxacin solution in 5% dextrose (D5W) for single-use. The 100 mL premixed flexible containers contain either 250 mg/50 mL or 500 mg/100 mL of levofloxacin solution. The 150 mL flexible container contains 750 mg/150 mL of levofloxacin solution. The concentration of each container is 5 mg/mL. No further dilution of these preparations is necessary. Because the premix flexible containers are for single-use only, any unused portion should be discarded.

Instructions for the Use of TAVANIC (Generic LEVAQUIN)® Injection Premix in Flexible Containers:

1.       Tear outer wrap at the notch and remove solution container.

2.       Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution, as the sterility may be compromised.

3.       Do not use if the solution is cloudy or a precipitate is present.

4.       Use sterile equipment.

5.       WARNING: Do not use flexible containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Preparation for Administration:

1.       Close flow control clamp of administration set.

2.       Remove cover from port at bottom of container.

3.       Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton.

4.       Suspend container from hanger.

5.       Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of TAVANIC (Generic LEVAQUIN)® Injection Premix in Flexible Containers.

6.       Open flow control clamp to expel air from set. Close clamp.

7.       Regulate rate of administration with flow control clamp.

3 DOSAGE FORMS AND STRENGTHS

TABLETS, Film-coated, capsule-shaped

·         250 mg terra cotta pink tablets, imprinted with "250" on one side and "TAVANIC (Generic LEVAQUIN)" on the other

·         500 mg peach tablets, imprinted with "500" on one side and "TAVANIC (Generic LEVAQUIN)" on the other

·         750 mg white tablets, imprinted with "750" on one side and

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Tavanic (Levaquin) 500 Mg 1 Vial

  • Brand: Sanofi Aventis
  • Product Code: 8699516091774
  • Availability: In Stock
  • $27.00

Tags: Tavanic (Levaquin) 500 Mg 1 Vial, Sanofi Aventis, All Products, Antibiotics