Trade Name: Moxifloxacin

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Fresenius Kabi Norge AS

Presentation: INJECTION, SOLUTION, HUMAN PRESCRIPTION DRUG

Strength: 400 mg/250mL

Storage and handling

MOXIFLOXACIN HYDROCHLORIDE Quinolone Antimicrobial [EPC],Quinolones [CS]

Disclaimer:
  1. These products are NOT FOR SALE in US territories. We offer them for Exports outside of US Territories to Trade Professionals or patients with a valid prescription.
  2. Trademark shown are property of their respective owners and GNH India does not lay any claim on them.
  3. Read more
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  • Boxed Warningu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a05/2016
  • Indications and Usageu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a05/2016
  • Dosage and Administrationu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 5/2016
  • Warnings and Precautionsu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 5/2016
  • Discontinue moxifloxacin immediately and avoid the use of fluoroquinolones, including moxifloxacin, in patients who experience any of these serious adverse reactions n n n .n n n
  • Array
  • WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVISn n n n n
  • Discontinue moxifloxacin injection immediately and avoid the use of fluoroquinolones, including moxifloxacin, in patients who experience any of these serious adverse reactions.
  • Moxifloxacin injection is a fluoroquinolone antibacterial drug indicated for treating infections in adults u2265 18 years of age caused by designated, susceptible bacteria. (n n n , n n n )n nn
  • Community Acquired Pneumonia (n n n )n n n
  • Skin and Skin Structure Infections: Uncomplicated (n n n ) and Complicated (n n n )n n n
  • Complicated Intra-Abdominal Infections (n n n )n n n
  • Acute Bacterial Sinusitis (n n n )n n n
  • Acute Bacterial Exacerbation of Chronic Bronchitis (n n n )n n n
  • No data
  • No dosage adjustment in patients with renal or hepatic impairment. (n n n , n n n )n n n
  • Moxifloxacin injection: Slow Intravenous infusion over 60 minutes.u00a0 Avoid rapid or bolus Intravenous infusion. (n n n )n n n
  • Do not mix with other medications in intravenous bag or in intravenous line. (n n n )n n n
  • Arrayn- Moxifloxacin Injection
  • Each bag contains 400 mg of moxifloxacin in 250 mL, each mL contains 1.6 mg of moxifloxacin.
  • Injection:u00a0 400 mg moxifloxacinu00a0in 250 mL. (n n n )n nn
  • Moxifloxacin is contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.u00a0
  • Known hypersensitivity to moxifloxacin or other quinolones. (n n n , n n n )n nn
  • No data
  • Prolongation of the QT interval and isolated cases of torsades de pointes has been reported. u00a0Avoid use in patients with known prolongation, hypokalemia, and with drugs that prolong the QT interval. (n n n , n n n , n n n ). u00a0Use caution in patients with proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischemia. (n n n )n n n
  • Serious and sometimes fatal hypersensitivity reactions, including anaphylactic reactions, may occur after first or subsequent doses. u00a0Discontinue moxifloxacinu00a0at theu00a0first sign of skin rash, jaundice or any other sign of hypersensitivity. (n n n , n n n )n n n
  • Arrayn- Clostridium difficile
  • High sodium load: each unit dose contains 52.5 mEq (1,207 mg) of sodium.u00a0 Avoid in patients with sodium restriction.u00a0 (n n n )n n n
  • Most common reactions (u2265 3%) were nausea, diarrhea, headache, and dizziness. (n n n )n nn
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  • Pregnancy:n n n n
  • Geriatrics:
  • Single oral overdoses up to 2.8 g were not associated with any serious adverse events.u00a0 In the event of acute overdose, the stomach should be emptied and adequate hydration maintained.u00a0 ECG monitoring is recommended due to the possibility of QT interval prolongation.u00a0 The patient should be carefully observed and given supportive treatment.u00a0 The administration of activated charcoal as soon as possible after oral overdose may prevent excessive increase of systemic moxifloxacin exposure.u00a0 About 3% and 9% of the dose of moxifloxacin, as well as about 2% and 4.5% of its glucuronide metabolite are removed by continuous ambulatory peritoneal dialysis and hemodialysis, respectively.u00a0u00a0
  • Moxifloxacin is a synthetic broad spectrum antibacterial agent for intravenous administration. u00a0Moxifloxacin, a fluoroquinolone, is available as a buffered salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. u00a0It is a slightly yellow to yellow crystalline substance. u00a0Its chemical structure is as follows:u00a0n n n n n n n n
  • Moxifloxacin injection is sterile solution for infusion in a ready-to-use flexible plastic container.u00a0n n n n n n
  • * 400 mg moxifloxacin equivalent to 437.5 mg of moxifloxacin hydrochloride.
  • **The pH may have been adjusted with sulfuric acid. u00a0The pH is 5.0 to 6.0.
  • Each mL contains 1.6 mg of moxifloxacin.u00a0
  • The appearance of the intravenous solution is clear. u00a0The plastic container is fabricated from a specially designed multilayer plastic (freeflexn n n ). u00a0Solution is in contact with the polypropylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period.u00a0 The leachable compounds were all within acceptable limits based on animal toxicology studies.u00a0u00a0n nn
  • Moxifloxacin injection contains approximately 52.5 mEq (1,207 mg) of sodium in 250 mL.
  • No data
  • No data
  • No data
  • No data
  • Arrayn- How Supplied
  • Moxifloxacin Injection 400 mg/250 mL is a sterile solution available in a single-use, ready-to-use flexible plastic container.
  • No further dilution is necessary.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • Parenteral drug products should be inspected visually for particulate matter prior to administration.u00a0 Samples containing visible particulates should not be used.
  • Because the premix flexible plastic containers are for single-use only, any unused portion should be discarded.
  • Arrayn- Storage and Handling
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [see USP Controlled Room Temperature].
  • Do not refrigerateu00a0- Product precipitates upon refrigeration.
  • Use immediately once removed from the overwrap.u00a0 Product is sensitive to light.
  • The container closure is not made with natural rubber latex.u00a0 Non-PVC, Non-DEHP.u00a0 Sterile.
  • Advise patients to read the FDA approved Medication Guide.n n n n n
  • Advise patients to stop taking moxifloxacin if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug.
  • Inform patients of the following serious adverse reactions that have been associated with moxifloxacin or other fluoroquinolone use:
  • Arrayn- occur together:
  • Arrayn- u2022
  • Arrayn- u2022
  • Arrayn- :
  • Arrayn- u2022
  • Arrayn- u2022
  • Arrayn- u2022
  • Arrayn- u2022
  • Arrayn- u2022
  • Arrayn- u2022
  • Arrayn- Array
  • Antibacterial drugs including moxifloxacin should only be used to treat bacterial infections. u00a0They do not treat viral infections (for example, the common cold). u00a0When moxifloxacin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. u00a0Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by moxifloxacin or other antibacterial drugs in the future.n n n n
  • The brand names mentioned in this document are the trademarks of their respective owners.n n n n n Manufactured for:n nn
  • Lake Zurich, IL 60047n n n n Made in Norwayn n n n www.fresenius-kabi.usn n n n 451325Cn nn
  • Medication Guide
  • Moxifloxacin Injection
  • (mox i FLOX a sin) (in jeku00b4 shu016dn)
  • solution for intravenous use
  • Read the Medication Guide that comes with Moxifloxacin Injectionn n n before you start receiving it and each time you receive it. u00a0There may be new information. u00a0This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. n nn
  • What is the most important information I should know about moxifloxacin injection?
  • Moxifloxacin injection belongs to a class of antibiotics called fluoroquinolones. u00a0Moxifloxacin injection can cause serious side effects that can happen at the same time and could result in death. u00a0If you get any of the following serious side effects, you should stop taking moxifloxacin and get medical help right away. u00a0Talk with your healthcare provider about whether you should continue to receive moxifloxacin injection.
  • 1. Tendon rupture or swelling of the tendon (tendinitis).
  • Tendon problems can happen in people who do not have the above risk factors when they receive moxifloxacin injection.
  • u00a0u00a0u00a0u00a0u00a0 Stop receiving moxifloxacin injection until tendinitis or tendon rupture has been ruled out by your healthcare provider. u00a0Avoid exercise and using the affected area. u00a0The most commonu00a0n n n u00a0u00a0u00a0u00a0u00a0 area of pain and swellingu00a0is in the Achilles tendon at the back of your ankle. u00a0This can also happen with other tendons. n nn
  • u00a0u00a0u00a0u00a0u00a0u00a0You may need a different antibiotic that is not a fluoroquinolone to treat your infection.
  • u00a0u00a0u00a0u00a0u00a0u00a0Tendon ruptures can happen within hours or days after taking moxifloxacin and have happened up to several months after patients have finished receiving their fluoroquinolone.
  • 2. Changes in sensation and possible nerve damage (Peripheral Neuropathy).
  • Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including moxifloxacin.u00a0 Stop taking moxifloxacin immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
  • The nerve damage may be permanent.
  • 3. Central Nervous System (CNS) effects. u00a0
  • 4.n- Worsening of myasthenia gravis (a disease which causes muscle weakness).
  • Fluoroquinolones like moxifloxacin injection may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. u00a0Tell your healthcare provider if you have a history of myasthenia gravis before you start taking moxifloxacin. u00a0Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
  • See the section n n n for more information about side effects. n nn
  • What is moxifloxacin injection?
  • Moxifloxacin injection is a fluoroquinolone antibiotic medicine used to treat certain types of infections caused by certain germs called bacteria in adults 18 years or older. u00a0It is not known if moxifloxacin injection is safe and works in people under 18 years of age. u00a0Children have a higher chance of getting bone, joint, and tendon (musculoskeletal) problems while taking fluoroquinolone antibiotic medicines.
  • Moxifloxacin should not be used in patients with acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis if there are other treatment options available.
  • Sometimes infections are caused by viruses rather than by bacteria. u00a0Examples include viral infections in the sinuses and lungs, such as the common cold or flu. u00a0Antibiotics, including moxifloxacin injection, do not kill viruses. u00a0Call your healthcare provider if you think your condition is not getting better while you are receiving moxifloxacin injection.
  • Who should not receive moxifloxacin injection?
  • Do not receive moxifloxacin injection if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or if you are allergic to any of the ingredients in moxifloxacin injection. u00a0Ask your healthcare provider if you are not sure. u00a0See the list of ingredients in moxifloxacin injection at the end of this Medication Guide.
  • What should I tell my healthcare provider before receiving moxifloxacin injection?
  • See u201cWhat is the most important information I should know about moxifloxacin injection?u201d
  • Tell your healthcare provider about all your medical conditions, including if you:
  • Tell your healthcare provider about all the medicines you take,
  • Ask your healthcare provider if you are not sure if any of your medicines are listed above.
  • Know the medicines you take. u00a0Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
  • How should I receive moxifloxacin injection?
  • This will help make sure that all of the bacteria are killed and lower the chance that the bacteria will become resistant to moxifloxacin injection. u00a0If this happens, moxifloxacin injection and other antibiotic medicines may not work in the future.
  • What should I avoid while receiving moxifloxacin injection?
  • What are the possible side effects of moxifloxacin injection?
  • Moxifloxacin injection can cause side effects that may be serious or even cause death. n- u201cWhat is the most important information I should know about moxifloxacin injection?u201d
  • Other serious side effects of moxifloxacin injection include:
  • See u201cWhat should I avoid while receiving moxifloxacin injection?u201d
  • The most common side effects of moxifloxacin injection include:
  • These are not all the possible side effects of moxifloxacin injection. u00a0Tell your healthcare provider about any side effect that bothers you or that does not go away. u00a0Call your doctor for medical advice about side effects. u00a0You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store moxifloxacin injection?
  • General Information about the safe and effective use of moxifloxacin injection.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. u00a0Do not use moxifloxacin injection for a condition for which it is not prescribed. u00a0Do not give moxifloxacin injection to other people, even if they have the same symptoms that you have. u00a0It may harm them.
  • This Medication Guide summarizes the most important information about moxifloxacin injection. u00a0If you would like more information about moxifloxacin injection, talk with your healthcare provider. u00a0You can ask your healthcare provider or pharmacist for information about moxifloxacin injection that is written for healthcare professionals. u00a0For more information call 1-800-551-7176.
  • What are the ingredients in moxifloxacin injection?
  • Active ingredient:
  • Inactive ingredients:
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.u00a0 n n n Revised: 7/2016n nn
  • Arrayn- Array
  • NDC
  • 850174
  • Moxifloxacin Injection
  • 400 mg* per 250 mLu00a0 (1.6 mg per mL)u00a0u00a0
  • Use immediately once removed from the overwrap.
  • Infuse over 60 minutes.n n n n n n n n

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