Moxifloxacin AL Uses

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What is Moxifloxacin AL?

Moxifloxacin AL injection is used to treat bacterial infections in many different parts of the body.

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

Moxifloxacin AL is to be given only by or under the direct supervision of your doctor.

Moxifloxacin AL indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Community Acquired Pneumonia

Moxifloxacin AL 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

Moxifloxacin AL 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

Moxifloxacin AL 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

Moxifloxacin AL 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

Moxifloxacin AL 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 Moxifloxacin AL 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

Moxifloxacin AL 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 Moxifloxacin AL, have been associated with serious adverse reactions and for some patients ABS is self-limiting, reserve Moxifloxacin AL for treatment of ABS in patients who have no alternative treatment options.

Acute Bacterial Exacerbation Of Chronic Bronchitis

Moxifloxacin AL 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 Moxifloxacin AL, have been associated with serious adverse reactions and for some patients ABECB is self-limiting, reserve Moxifloxacin AL 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 Moxifloxacin AL and other antibacterial drugs, Moxifloxacin AL 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 Moxifloxacin AL?

Use Moxifloxacin AL 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 Moxifloxacin AL tablets.

Uses of Moxifloxacin AL in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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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 Moxifloxacin AL 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, Moxifloxacin AL 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), Moxifloxacin AL 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, Moxifloxacin AL 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, Moxifloxacin AL 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 Moxifloxacin AL 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 Moxifloxacin AL in this condition.

Pelvic inflammatory disease

Based on the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases treatment guidelines, Moxifloxacin AL 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, Moxifloxacin AL (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, Moxifloxacin AL (systemic) given for second-line therapy of tuberculosis is effective and recommended in the management of this condition.

Moxifloxacin AL description

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Each tablet contains Moxifloxacin HCl 436.8 mg equivalent to Moxifloxacin AL 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 Moxifloxacin AL HCl 436.8 mg equivalent to Moxifloxacin AL 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.

Moxifloxacin AL dosage

Moxifloxacin AL Dosage

Generic name: Moxifloxacin AL HYDROCHLORIDE 400mg in 250mL

Dosage form: tablet, film coated; injection, solution

See also:

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

Dosage in Adult Patients

The dose of Moxifloxacin AL is 400 mg (orally or as an intravenous infusion) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.

Table 1: Dosage and Duration of Therapy in Adult Patients

Type of Infectiona

Dose

Every 24 hours

Durationb

(days)

Community Acquired Pneumonia (1.1)

400 mg

7–14

Uncomplicated Skin and Skin Structure Infections (SSSI ) (1.2)

400 mg

7

Complicated SSSI (1.3)

400 mg

7–21

Complicated Intra-Abdominal Infections (1.4)

400 mg

5–14

Plague (1.5)C

400 mg

10–14

Acute Bacterial Sinusitis (ABS) (1.6)

400 mg

10

Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) (1.7)

400 mg

5

a)
Due to the designated pathogens.
b)
Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician
c)
Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

Conversion of

Intravenous to

Oral Dosing in Adults

Intravenous formulation is indicated when it offers a route of administration advantageous to the patient (for example, patient cannot tolerate an oral dosage form). When switching from intravenous to oral formulation, no dosage adjustment is necessary. Patients whose therapy is started with Moxifloxacin AL Injection may be switched to Moxifloxacin AL Tablets when clinically indicated at the discretion of the physician.

Important Administration Instructions

Moxifloxacin AL Tablets

With Multivalent Cations

Administer Moxifloxacin AL Tablets at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and didanosine buffered tablets for oral suspension or the pediatric powder for oral solution.

With Food

Moxifloxacin AL Tablets can be taken with or without food, drink fluids liberally.

Moxifloxacin AL Injection

Administer by

Intravenous infusion only. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.

Administer by intravenous infusion over a period of 60 minutes by direct infusion or through a Y-type intravenous infusion set which may already be in place. Avoid rapid or bolus intravenous infusion.

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

Discard any unused portion because the premix flexible containers are for single-use only.

Drug and Diluent Compatibilities

Because only limited data are available on the compatibility of Moxifloxacin AL intravenous injection with other intravenous substances, additives or other medications should not be added to Moxifloxacin AL Injection or infused simultaneously through the same intravenous line. If the same intravenous line or a Y-type line is used for sequential infusion of other drugs, or if the “piggyback” method of administration is used, the line should be flushed before and after infusion of Moxifloxacin AL Injection with an infusion solution compatible with Moxifloxacin AL Injection as well as with other drug(s) administered via this common line.

Compatible

Intravenous Solutions: Moxifloxacin AL Injection is compatible with the following intravenous solutions at ratios from 1:10 to 10:1:

0.9% Sodium Chloride Injection, USP

1 Molar Sodium Chloride Injection

5% Dextrose Injection, USP

Sterile Water for Injection, USP

10% Dextrose for Injection, USP

Lactated Ringer’s for Injection

Preparation for Administration of Moxifloxacin AL Injection

Refer to complete directions that have been provided with the administration set.

To prepare Moxifloxacin AL Injection premix in flexible containers:

Close flow control clamp of administration set.
Remove cover from port at bottom of container.
Insert piercing pin from an appropriate transfer set (for example, one that does not require excessive force, such as ISO compatible administration set) into port with a gentle twisting motion until pin is firmly seated.

More about Moxifloxacin AL (Moxifloxacin AL)

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Moxifloxacin AL interactions

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What other drugs will affect Moxifloxacin AL?

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Tablet: For the following substances, absence of a clinically relevant interaction with Moxifloxacin AL 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 Moxifloxacin AL with antacids, minerals and multivitamins may result in impaired absorption of Moxifloxacin AL 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 Moxifloxacin AL dose.

Ranitidine: The concomitant administration with ranitidine did not change the absorption characteristics of Moxifloxacin AL. Absorption parameters (Cmax, tmax, AUC) were comparable, indicating absence of an influence of gastric pH on Moxifloxacin AL 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 Moxifloxacin AL is considered as clinically not relevant.

Theophylline: In accordance with in vitro data, no influence of Moxifloxacin AL on theophylline pharmacokinetics (and vice versa) at steady state was detected in humans, indicating that Moxifloxacin AL 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 Moxifloxacin AL. The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between Moxifloxacin AL 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 Moxifloxacin AL with oral contraceptives.

Antidiabetics: No clinically relevant interaction was seen between glibenclamide and Moxifloxacin AL.

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

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

Morphine:

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

Atenolol: The pharmacokinetics of atenolol are not significantly altered by Moxifloxacin AL. 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 Moxifloxacin AL was found in a clinical study investigating the impact of probenecid on renal excretion.

Charcoal: Concomitant dosing of charcoal and oral Moxifloxacin AL 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 Moxifloxacin AL was not altered by food intake (including dairy products). Moxifloxacin AL can be taken independent from food intake.

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

Moxifloxacin AL side effects

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What are the possible side effects of Moxifloxacin AL?

Clinical efficacy trials enrolled over 9,200 Moxifloxacin AL orally and intravenously treated patients, of whom over 8,600 patients received the 400 mg dose. Most adverse events reported in Moxifloxacin AL trials were described as mild to moderate in severity and required no treatment. Moxifloxacin AL was discontinued due to adverse reactions thought to be drug-related in 2.9% of orally treated patients and 6.3 % of sequentially (intravenous followed by oral) treated patients. The latter studies were conducted in community acquired pneumonia and complicated skin and skin structure infections and complicated intra-abdominal infections with, in general, a sicker patient population compared to the tablet studies.

Adverse reactions, judged by investigators to be at least possibly drug-related, occurring in greater than or equal to 2% of Moxifloxacin AL treated patients were: nausea (6%), diarrhea (5%), dizziness (2%).

Additional clinically relevant uncommon events, judged by investigators to be at least possibly drug-related, that occurred in greater than or equal to 0.1% and less than 2% of Moxifloxacin AL treated patients were:

BODY AS A WHOLE: abdominal pain, headache, asthenia, dehydration (secondary to diarrhea or reduced fluid intake), injection site reaction (including phlebitis), malaise, moniliasis, pain, allergic reaction

CARDIOVASCULAR: cardiac arrhythmia (not otherwise specified), tachycardia, palpitation, vasodilation, QT interval prolonged

DIGESTIVE: vomiting, abnormal liver function test (increased transaminases, increased bilirubin), dyspepsia, dry mouth, flatulence, oral moniliasis, constipation, GGTP increased, anorexia, stomatitis, glossitis

HEMIC AND LYMPHATIC: leukopenia, eosinophilia, prothrombin decrease (prothrombin time prolonged/International Normalized Ratio (INR) increased), thrombocythemia

METABOLIC AND NUTRITIONAL: lactic dehydrogenase increased, amylase increased

MUSCULOSKELETAL: arthralgia, myalgia

NERVOUS SYSTEM: insomnia, nervousness, vertigo, somnolence, anxiety, tremor

SKIN/APPENDAGES: rash (maculopapular, purpuric, pustular), pruritus, sweating, urticaria

SPECIAL SENSES: taste perversion

UROGENITAL: vaginal moniliasis, vaginitis

Additional clinically relevant rare events, judged by investigators to be at least possibly drug-related, that occurred in less than 0.1% of Moxifloxacin AL treated patients were:

abnormal dreams, abnormal vision (visual disturbances temporally associated with CNS symptoms), agitation, amblyopia, amnesia, anemia, aphasia, arthritis, asthma, atrial fibrillation, back pain, chest pain, confusion, convulsions of various clinical manifestations (including grand mal convulsions), depersonalization, depression (potentially culminating in self-endangering behavior), dysphagia, dyspnea, ECG abnormal, emotional lability, face edema, gastritis, gastrointestinal disorder, hallucinations, hyperglycemia, hyperlipidemia, hypertension, hypertonia, hyperuricemia, hypesthesia, hypotension, incoordination, jaundice (predominantly cholestatic), kidney function abnormal, lab test abnormal (not specified), leg pain, paraesthesia, parosmia, pelvic pain, peripheral edema, photosensitivity/phototoxicity reactions, pseudomembranous colitis, prothrombin increase (prothrombin time decreased/International Normalized Ratio (INR) decreased), sleep disorders, speech disorders, supraventricular tachycardia, syncope, taste loss, tendon disorder, thinking abnormal, thrombocytopenia, thromboplastin decrease, tinnitus, tongue discoloration, ventricular tachycardia

Post-Marketing Adverse Event Reports:

Additional adverse events have been reported from worldwide post-marketing experience with Moxifloxacin AL. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events, some of them life-threatening, include anaphylactic reaction, anaphylactic shock, angioedema (including laryngeal edema), hepatic failure, including fatal cases, hepatitis (predominantly cholestatic), photosensitivity/phototoxicity reaction (see

Moxifloxacin AL contraindications

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What is the most important information I should know about Moxifloxacin AL?

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

Before taking Moxifloxacin AL, 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 Moxifloxacin AL. These other medicines can make Moxifloxacin AL much less effective when taken at the same time.

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

Moxifloxacin AL 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 Moxifloxacin AL 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 Moxifloxacin AL:

Moxifloxacin in Germany.


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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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