Moxifloxacine Mylan Uses

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What is Moxifloxacine Mylan?

Moxifloxacine Mylan injection is used to treat bacterial infections in many different parts of the body.

Moxifloxacine Mylan belongs to the class of medicines known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, Moxifloxacine Mylan will not work for colds, flu, or other virus infections.

Moxifloxacine Mylan is to be given only by or under the direct supervision of your doctor.

Moxifloxacine Mylan indications

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Community Acquired Pneumonia

Moxifloxacine Mylan is indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumonia .

MDRSP isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.

Uncomplicated Skin And Skin Structure Infections

Moxifloxacine Mylan is indicated in adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes.

Complicated Skin And Skin Structure Infections

Moxifloxacine Mylan is indicated in adult patients for the treatment of Complicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae.

Complicated Intra-Abdominal Infections

Moxifloxacine Mylan is indicated in adult patients for the treatment of Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by susceptible isolates of Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species.

Plague

Moxifloxacine Mylan is indicated in adult patients for the treatment of plague, including pneumonic and septicemic plague, due to susceptible isolates of Yersinia pestis and prophylaxis of plague in adult patients. Efficacy studies of Moxifloxacine Mylan could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only.

Acute Bacterial Sinusitis

Moxifloxacine Mylan is indicated in adult patients (18 years of age and older) for the treatment of acute bacterial sinusitis (ABS) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.

Because fluoroquinolones, including Moxifloxacine Mylan, have been associated with serious adverse reactions and for some patients ABS is self-limiting, reserve Moxifloxacine Mylan for treatment of ABS in patients who have no alternative treatment options.

Acute Bacterial Exacerbation Of Chronic Bronchitis

Moxifloxacine Mylan is indicated in adult patients for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis.

Because fluoroquinolones, including Moxifloxacine Mylan, have been associated with serious adverse reactions and for some patients ABECB is self-limiting, reserve Moxifloxacine Mylan for treatment of ABECB in patients who have no alternative treatment options.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Moxifloxacine Mylan and other antibacterial drugs, Moxifloxacine Mylan 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.

How should I use Moxifloxacine Mylan?

Use Moxifloxacine Mylan tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Ask your health care provider any questions you may have about how to use Moxifloxacine Mylan tablets.

Uses of Moxifloxacine Mylan in details

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Use: Labeled Indications

Treatment of mild to moderate community-acquired pneumonia, including multidrug-resistant Streptococcus pneumoniae (MDRSP); acute bacterial exacerbation of chronic bronchitis; acute bacterial rhinosinusitis; complicated and uncomplicated skin and skin structure infections; complicated intra-abdominal infections; prophylaxis and treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis.

Limitations of use: Because fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions (eg, tendinitis and tendon rupture, peripheral neuropathy, CNS effects), reserve Moxifloxacine Mylan for use in patients who have no alternative treatment options for acute exacerbation of chronic bronchitis or acute sinusitis.

Off Label Uses

Anthrax

Based on the Centers for Disease Control and Prevention (CDC) Expert Panel Meetings on Prevention and Treatment of Anthrax in Adults, Moxifloxacine Mylan is as an effective and recommended agent for the treatment of cutaneous anthrax and an alternative agent for postexposure prophylaxis and treatment of systemic anthrax (with or without possible/confirmed meningitis).

Bite wounds (animal/human)

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), Moxifloxacine Mylan is an effective and recommended alternative option for treatment of bite wounds, particularly in patients with a human bite wound who are hypersensitive to beta-lactams.

Diabetic foot infections

Based on the Infectious Diseases Society of America (IDSA) guidelines for diagnosis and treatment of diabetic foot infections, Moxifloxacine Mylan is an effective and recommended treatment option for moderate to severe diabetic foot infections.

Meningitis, bacterial

Based on the Infectious Diseases Society of America (IDSA) guidelines for the management of bacterial meningitis and health care-associated ventriculitis and meningitis, Moxifloxacine Mylan is an effective and recommended alternative agent for the treatment of meningitis caused by penicillin- and cephalosporin-resistant Streptococcus pneumoniae.

Mycoplasma genitalium

Noncontrolled trials support the use of Moxifloxacine Mylan as alternative treatment in patients with persistent detection of Mycoplasma genitalium who have not responded to or are intolerant of azithromycin. Additional data may be necessary to further define the role of Moxifloxacine Mylan in this condition.

Pelvic inflammatory disease

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, Moxifloxacine Mylan may be considered as alternative treatment in patients allergic to cephalosporins with pelvic inflammatory disease. The CDC recommends use as an alternative therapy only if standard parenteral cephalosporin therapy is not feasible and community prevalence of quinolone-resistant gonococcal organisms is low. Culture sensitivity must be confirmed.

Surgical prophylaxis

Based on the American Society of Health-System Pharmacists (ASHP), the Infectious Diseases Society of America (IDSA), the Surgical Infection Society (SIS), and the Society of Healthcare Epidemiology of America (SHEA) guidelines for antimicrobial prophylaxis in surgery, Moxifloxacine Mylan (systemic) may be administered (in combination with either clindamycin or vancomycin) as an alternative regimen in patients with beta-lactam allergy.

Tuberculosis (second-line therapy)

Based on the American Thoracic Society, Centers for Disease Control and Prevention (CDC), and Infectious Diseases Society of America (IDSA) Treatment of Tuberculosis guidelines, Moxifloxacine Mylan (systemic) given for second-line therapy of tuberculosis is effective and recommended in the management of this condition.

Moxifloxacine Mylan description

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Each tablet contains Moxifloxacin HCl 436.8 mg equivalent to Moxifloxacine Mylan 400 mg. It also contains croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, hypromellose, macrogol 4000, titanium dioxide (E171) and ferric oxide (E172) as inactive constituents.

Each 250 mL solution for infusion contain Moxifloxacine Mylan HCl 436.8 mg equivalent to Moxifloxacine Mylan 400 mg. It also contains sodium chloride, 1N hydrochloric acid, 2N sodium hydroxide and water for injection. The solution for infusion (250 mL) contains sodium 34 mmol.

Moxifloxacine Mylan dosage

Moxifloxacine Mylan Dosage

Generic name: Moxifloxacine Mylan HYDROCHLORIDE 5mg in 1mL

Dosage form: ophthalmic solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Instill one drop in the affected eye 3 times a day for 7 days.

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Moxifloxacine Mylan interactions

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What other drugs will affect Moxifloxacine Mylan?

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Tablet: For the following substances, absence of a clinically relevant interaction with Moxifloxacine Mylan was proven: Atenolol, ranitidine, calcium supplements, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid. No dose adjustment is necessary for these drugs.

Antacids, Minerals and Multivitamins: Concomitant ingestion of Moxifloxacine Mylan with antacids, minerals and multivitamins may result in impaired absorption of Moxifloxacine Mylan after oral administration due to formation of chelate complexes with the multivalent cations contained in these preparations. This may lead to plasma concentrations considerably lower than desired. Hence, antacids, antiretroviral drugs (eg, didanosine) and other preparations containing magnesium or aluminium, sucralfate and agents containing iron or zinc should be administered at least 4 hours before or 2 hours after ingestion of an oral Moxifloxacine Mylan dose.

Ranitidine: The concomitant administration with ranitidine did not change the absorption characteristics of Moxifloxacine Mylan. Absorption parameters (Cmax, tmax, AUC) were comparable, indicating absence of an influence of gastric pH on Moxifloxacine Mylan uptake from the gastrointestinal tract.

Calcium Supplements: When given with high dose calcium supplements, only a slightly reduced rate of absorption was observed, while extent of absorption remained unaffected. The effect of high-dose calcium supplements on the absorption of Moxifloxacine Mylan is considered as clinically not relevant.

Theophylline: In accordance with in vitro data, no influence of Moxifloxacine Mylan on theophylline pharmacokinetics (and vice versa) at steady state was detected in humans, indicating that Moxifloxacine Mylan does not interfere with the 1A2 subtypes of the CYP450 enzymes.

Warfarin: No interaction during concomitant treatment with warfarin on pharmacokinetics, prothrombin time and other coagulation parameters has been observed.

Changes in International Normalized Ratio (INR): Cases of increased anticoagulant activity have been reported in patients receiving anticoagulants concurrently with antibiotics, including Moxifloxacine Mylan. The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between Moxifloxacine Mylan and warfarin was not demonstrated in clinical trials, INR monitoring should be performed and, if necessary, the oral anticoagulant dosage should be adjusted as appropriate.

Oral Contraceptives:

No interaction has occured following concomitant oral administration of Moxifloxacine Mylan with oral contraceptives.

Antidiabetics: No clinically relevant interaction was seen between glibenclamide and Moxifloxacine Mylan.

Itraconazole: Exposure (AUC) to itraconazole was only marginally altered under concomitant Moxifloxacine Mylan treatment. Pharmacokinetics of Moxifloxacine Mylan were not significantly altered by itraconazole. No dose adjustment is necessary for itraconazole when given with Moxifloxacine Mylan and vice versa.

Digoxin: The pharmacokinetics of digoxin are not significantly influenced by Moxifloxacine Mylan (and vice versa). After repeated dosing in healthy volunteers, Moxifloxacine Mylan increased Cmax of digoxin by approximately 30% at steady state without affecting AUC or trough levels.

Morphine:

Parenteral administration of morphine with Moxifloxacine Mylan did not reduce the oral bioavailability of Moxifloxacine Mylan and only slighlty decreased Cmax (17 %).

Atenolol: The pharmacokinetics of atenolol are not significantly altered by Moxifloxacine Mylan. Following single dose administration in healthy subjects, AUC was marginally increased (by approximately 4%) and peak concentrations were decreased by 10%.

Probenecid: No significant effect on apparent total body clearance and renal clearance of Moxifloxacine Mylan was found in a clinical study investigating the impact of probenecid on renal excretion.

Charcoal: Concomitant dosing of charcoal and oral Moxifloxacine Mylan 400 mg reduced the systemic availability of the drug by >80% by preventing absorption in vivo. The application of activated charcoal in the early absorption phase prevents further increase of systemic exposure in cases of overdose.

After IV drug administration, carbo medicinalis only slightly reduces systemic exposure (approximately 20%).

Food and Dairy Products: Absorption of Moxifloxacine Mylan was not altered by food intake (including dairy products). Moxifloxacine Mylan can be taken independent from food intake.

Infusion: No interaction during concomitant treatment with warfarin, itraconazole, theophylline, digoxin and oral contraceptives.

Moxifloxacine Mylan side effects

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What are the possible side effects of Moxifloxacine Mylan?

Applies to Moxifloxacine Mylan ophthalmic: ophthalmic solution

As well as its needed effects, Moxifloxacine Mylan ophthalmic (the active ingredient contained in Moxifloxacine Mylan) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking Moxifloxacine Mylan ophthalmic, check with your doctor immediately:

Incidence not known:

Minor Side Effects

Some Moxifloxacine Mylan ophthalmic side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:

Less common:

Moxifloxacine Mylan contraindications

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What is the most important information I should know about Moxifloxacine Mylan?

You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to Moxifloxacine Mylan or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), ofloxacin (Floxin), norfloxacin (Noroxin), and others.

Before taking Moxifloxacine Mylan, tell your doctor if you have a heart rhythm disorder, kidney or liver disease, joint problems, a history of seizures, low levels of potassium in your blood (hypokalemia), muscle weakness or trouble breathing, a personal or family history of Long QT syndrome, or if you have ever had an allergic reaction to an antibiotic.

Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 8 hours before or 4 hours after you take Moxifloxacine Mylan. These other medicines can make Moxifloxacine Mylan much less effective when taken at the same time.

Taking Moxifloxacine Mylan can make your skin more sensitive to sunlight. Avoid exposure to sunlight, sun lamps, or tanning beds.

Moxifloxacine Mylan may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking Moxifloxacine Mylan and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

Do not share this medication with another person (especially a child), even if they have the same symptoms you do.



Active ingredient matches for Moxifloxacine Mylan:

Moxifloxacin in Belgium.


List of Moxifloxacine Mylan substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
MOXIFORD EYE DROP 1 packet / 5 ML eye drop each (Leeford Healthcare Ltd)$ 0.80
Moxiford 400mg Tablet (Leeford Healthcare Ltd)$ 0.47
Moxifresh NA Eye Drop (Smart Laboratories Pvt Ltd)$ 0.23
MOXIGEN EYE DROP 1 packet / 5 ML eye drop each (Renova Life sciences Pvt Ltd)$ 0.86
Moxigen 0.5% w/v Eye Drop (Renova Life sciences Pvt Ltd)$ 0.86
MOXIGOOD 400 MG TABLET 1 strip / 5 tablets each (Cadila Pharmaceuticals Ltd)$ 1.33
Moxigood 400mg Tablet (Cadila Pharmaceuticals Ltd)$ 0.27
Moxigood 400mg Injection (Cadila Pharmaceuticals Ltd)$ 0.02
Moxigram 0.5% EYE-DPS / 5ml (Micro Vision)$ 0.88
0.5 % x 5ml (Micro Vision)$ 0.88
MOXIGRAM 400 MG TABLET 1 strip / 5 tablets each (Micro Vision)$ 1.40
MOXIGRAM D EYE DROP 1 packet / 10 ML eye drop each (Micro Vision)$ 1.30
MOXIGRAM EYE DROP 1 packet / 5 ML eye drop each (Micro Vision)$ 1.30
MOXIGRAM EYE OINTMENT 1 tube / 5 GM eye ointment each (Micro Vision)$ 0.59
MOXIGRAM INFUSION 1 bottle / 100 ML infusion each (Micro Vision)$ 1.45
MOXIGRAM eye drops 0.5 % x 5ml (Micro Vision)$ 0.88

References

  1. PubChem. "moxifloxacin". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "moxifloxacin". http://www.drugbank.ca/drugs/DB00218 (accessed September 17, 2018).
  3. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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