Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. Breastfeeding

Breast milk is superior in nutrition, It provides resistance against infections and allergies, It is naturally sterile. Despite all the advantages of breastfeeding some mothers choose to pause the breastfeeding in fear of harmful effects of medicines passing in breast milk. Are you wondering about breastfeeding and using Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. ? Know what is Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. and how it can affect your breast milk and whether Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. is safe for your kid or not.

What is Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. used for?


1 INDICATIONS & USAGE Levofloxacin tablets 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. Levofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria ( 1, 12.4). • Pneumonia: Nosocomial ( 1.1) and Community Acquired ( 1.2, 1.3) • Skin and Skin Structure Infections: Complicated ( 1.4) and Uncomplicated ( 1.5) • Chronic bacterial prostatitis ( 1.6) • Inhalational Anthrax, Post-Exposure ( 1.7) • Plague ( 1.8) • Urinary Tract Infections: Complicated ( 1.9, 1.10) and Uncomplicated ( 1.12) • Acute Pyelonephritis ( 1.11) • Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.13) • Acute Bacterial Sinusitis ( 1.14) 1.1 Nosocomial Pneumonia Levofloxacin 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 β-lactam is recommended [see Clinical Studies ( 14.1)] . 1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen Levofloxacin 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), 2 nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. 1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen Levofloxacin 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 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 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 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 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 is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin 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 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 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 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 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 is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to or . Levofloxacin is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [ ] and for some patients uncomplicated urinary tract infection is self-limiting, levofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [ see Warnings and Precautions ( 5.1 to 5.15) ] and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options. 1.13 Acute Bacterial Exacerbation of Chronic Bronchitis Levofloxacin is indicated for the treatment of acute bacterial exacerbation (ABS) of chronic bronchitis due to methicillin-susceptible or . fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [ ] and for some patients ABECB is self-limiting, reserve levofloxacin for of ABECB in patients who have no alternative treatment options. Levofloxacin is indicated for the treatment of acute bacterial exacerbation (ABS) of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [ see Warnings and Precautions ( 5.1to 5.15) ] and for some patients ABECB is self-limiting, reserve levofloxacin 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 Regimens Levofloxacin is indicated for the treatment of acute bacterial sinusitis (ABS) due to , or [see Clinical Studies (14.4)]. fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [ ] and for some patients ABS is self-limiting, reserve levofloxacin for of ABS in patients who have no alternative treatment options. Levofloxacin 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, have been associated with serious adverse reactions [ see Warnings and Precautions ( 5.1to 5.15) ] and for some patients ABS is self-limiting, reserve levofloxacin 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 and other antibacterial drugs, levofloxacin 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.

Is Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. safe to use while breastfeeding? Can it interfere with growth and development of my kid?

Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. low risk for breastfeeding
Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. contains only one active ingredient that is Levofloxacin anhydrous. We have analyzed the usage of Levofloxacin anhydrous in breastfeeding and our analysis suggest that Levofloxacin anhydrous poses Low risk for infant while breastfeeding and hence Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. itself shall be considered Low risk item for breastfeeding.

Statement of Manufacturer/Labeler about breastfeeding usage
8.3 Nursing Mothers Based on data on other fluoroquinolones and very limited data on levofloxacin, it can be presumed that levofloxacin will be excreted in human milk. Because of the potential for serious adverse reactions from levofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. Breastfeeding Analsys


Levofloxacin anhydrous while Breastfeeding

Low Risk

CAS Number: 100986-85-4

Is the S-isomer of ofloxacin. Recently, quinolone-related medication has been used in neonates and infants without apparent side effects. It trespasses in tiny amounts into breast milk. Absorption through the child’s gut may be interfered by the calcium contained in the milk. Should it be necessary to prescribe it to a nursing mother, Norfloxacine, Ofloxacine and Ciprofloxacine have shown a lower level in the milk and thus must be the preferred drugs. Because a case of pseudomembranose colitis has been described possibly related to mother ingestion of Ciporfloxacine in a premature infant previously affected of NEC, a close follow-up for diarrhea is warranted. Be aware of the possibility of false negative results of bacterial cultures when the mother is on antibiotics.


Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. Breastfeeding Analsys - 2


Levofloxacin anhydrous while Breastfeeding

CAS Number: 100986-85-4

Levofloxacin is the -enantiomer of the fluoroquinolone, ofloxacin. No information is available on the clinical use of levofloxacin during breastfeeding. However, amounts in breastmilk appear to be low and would not be expected to cause any adverse effects in breastfed infants. Fluoroquinolones such as levofloxacin have traditionally not been used in infants because of concern about adverse effects on the infants' developing joints. However, recent studies indicate little risk.[1][2] The calcium in milk might prevent absorption of the small amounts of fluoroquinolones in milk,[3] but insufficient data exist to prove or disprove this assertion. Use of levofloxacin is acceptable in nursing mothers with monitoring of the infant for possible effects on the gastrointestinal flora, such as diarrhea or candidiasis (thrush, diaper rash). Avoiding breastfeeding for 4 to 6 hours after a dose should decrease the exposure of the infant to levofloxacin in breastmilk. Maternal use of an eye drop that contains levofloxacin presents negligible risk for the nursing infant.



What if I already have used Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc.?

Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. is in the category of low risk, if you have already used it then its not a big deal if health and behavior of baby is good. However your health care provider shall be aware of the fact that you have used Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. so you should inform him based on your convenience.


My health care provider has asked me to use Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc., what to do?

Though Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. dose not comes in category of safe drugs rather it comes in category of low risk but if your doctor is aware that you are breastfeeding your baby and has still recommended it then its advantages must be outweighing the risks.


If I am using Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc., will my baby need extra monitoring?

Not much monitoring required while using Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc.


Who can I talk to if I have questions about usage of Levofloxacin 20 In 1 Bottle | Nucare Pharmaceuticals, Inc. in breastfeeding?

US
National Womens Health and Breastfeeding Helpline: 800-994-9662 (TDD 888-220-5446) 9 a.m. and 6 p.m. ET, Monday through Friday

UK
National Breastfeeding Helpline: 0300-100-0212 9.30am to 9.30pm, daily
Association of Breastfeeding Mothers: 0300-330-5453
La Leche League: 0345-120-2918
The Breastfeeding Network supporter line in Bengali and Sylheti: 0300-456-2421
National Childbirth Trust (NCT): 0300-330-0700

Australia
National Breastfeeding Helpline: 1800-686-268 24 hours a day, 7 days a week

Canada
Telehealth Ontario for breastfeeding: 1-866-797-0000 24 hours a day, 7 days a week