Levofloxacin | Apotheca Inc. Breastfeeding

Modern medicine has evolved so much so that sooner or later every breastfeeding mother needs to take it in one form or other. Medication that is present in mothers blood will transfer into her breast milk to some extent. Most drugs do so at low levels and pose no real risk to infants but then there are some exceptions. In This post will discuss whether Levofloxacin | Apotheca Inc. is safe in breast-feeding or not.

What is Levofloxacin | Apotheca Inc. used for?


1 INDICATIONS & USAGE Levofloxacin tablets, USP 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 tablets USP are 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 tablets, USP are indicated for the treatment of nosocomial pneumonia due to methicillinsusceptible 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 antipseudomonal β-lactam is recommended [see Clinical Studies ( 14.1) ]. 1.2 Community-Acquired Pneumonia: 7-14 day Treatment Regimen Levofloxacin tablets, USP are indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multidrug-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 strains 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 tablets, USP are indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [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 tablets, USP are 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 tablets, USP are 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 tablets, USP are 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 tablets, USP are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin tablets, USP are based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablets, USP has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin tablets, USP 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 tablets, USP 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 tablets, USP are 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 tablets, USP 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 tablets, USP are 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 tablets, USP are 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 tablets, USP are 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 tablets, USP are indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to or Levofloxacin tablets, USP are indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. tment options. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1- 5.15)] and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin tablets, USP for treatment of uncomplicated urinary tract infections in patients who have no alternative trea tment options. 1.13 Acute Bacterial Exacerbation of Chronic Bhronchitis Levofloxacin tablets, USP are indicated for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible , , , , or . Levofloxacin tablets, USP are 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. no alternative treatment options. Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1- 5.15)] and for some patients ABECB is self-limiting, reserve levofloxacin tablets, USP for treatment of ABECB in patients who have no alternative treatment options. 1.14 Acute Bacterial Sinusitis: 5-day and 10-14day Treatment Regimens Levofloxacin tablets, USP are indicated for the treatment of acute bacterial sinusitis (ABS) due to , , or . Levofloxacin tablets, USP are indicated for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies ( 14.4)] . tive treatment options. Because fluoroquinolones, including levofloxacin have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1- 5.15)] and for some patients ABS is self-limiting, reserve levofloxacin tablets, USP for treatment of ABS in patients who have no alterna tive 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 tablets, USP 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 tablets, USP. 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

I am breastfeeding mother and I am using Levofloxacin | Apotheca Inc.. Can it have any bad effect on my kid? Shall I search for better alternative?

Levofloxacin | Apotheca Inc. low risk for breastfeeding
Levofloxacin anhydrous is the one and only active ingredient present in Levofloxacin | Apotheca Inc.. Levofloxacin anhydrous in itself is a low risk drug for lactation so it is easy to understand that Levofloxacin | Apotheca Inc. also comes in category of Low Risk item while breastfeeding. Below is the summary of Levofloxacin anhydrous in 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 | Apotheca 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 | Apotheca 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.



I am nursing mother and I have already used Levofloxacin | Apotheca Inc., what should I do?

Levofloxacin | Apotheca 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 | Apotheca Inc. so you should inform him based on your convenience.


I am nursing mother and my doctor has suggested me to use Levofloxacin | Apotheca Inc., is it safe?

Though Levofloxacin | Apotheca 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 | Apotheca Inc., will my baby need extra monitoring?

Not much monitoring required while using Levofloxacin | Apotheca Inc.


Who can I talk to if I have questions about usage of Levofloxacin | Apotheca 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