Moxifloxacin Kabi 400mg Dosage

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Dosage of Moxifloxacin Kabi 400mg in details

infoThe dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Dosage in Adult Patients

The dose of Moxifloxacin Kabi 400mg 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 Kabi 400mg Injection may be switched to Moxifloxacin Kabi 400mg Tablets when clinically indicated at the discretion of the physician.

Important Administration Instructions

Moxifloxacin Kabi 400mg Tablets

With Multivalent Cations

Administer Moxifloxacin Kabi 400mg 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 Kabi 400mg Tablets can be taken with or without food, drink fluids liberally.

Moxifloxacin Kabi 400mg 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 Kabi 400mg intravenous injection with other intravenous substances, additives or other medications should not be added to Moxifloxacin Kabi 400mg 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 Kabi 400mg Injection with an infusion solution compatible with Moxifloxacin Kabi 400mg Injection as well as with other drug(s) administered via this common line.

Compatible

Intravenous Solutions: Moxifloxacin Kabi 400mg 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 Kabi 400mg Injection

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

To prepare Moxifloxacin Kabi 400mg 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.

What other drugs will affect Moxifloxacin Kabi 400mg?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Moxifloxacin Kabi 400mg, especially:

  • erythromycin;

  • a diuretic or "water pill";

  • insulin or oral diabetes medicine;

  • a blood thinner--warfarin, Coumadin, Jantoven;

  • heart rhythm medication--amiodarone, disopyramide, dofetilide, dronedarone, procainamide, quinidine, sotalol, and others;

  • medicine to treat depression or mental illness--amitriptylline, clomipramine, desipramine, iloperidone, imipramine, nortriptyline, and others;

  • NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

  • steroid medicine--prednisone, dexamethasone, methylprednisolone, and others.

This list is not complete. Other drugs may interact with Moxifloxacin Kabi 400mg, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Moxifloxacin Kabi 400mg interactions

infoInteractions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Moxifloxacin Kabi 400mg, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Tablet: For the following substances, absence of a clinically relevant interaction with Moxifloxacin Kabi 400mg 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 Kabi 400mg with antacids, minerals and multivitamins may result in impaired absorption of Moxifloxacin Kabi 400mg 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 Kabi 400mg dose.

Ranitidine: The concomitant administration with ranitidine did not change the absorption characteristics of Moxifloxacin Kabi 400mg. Absorption parameters (Cmax, tmax, AUC) were comparable, indicating absence of an influence of gastric pH on Moxifloxacin Kabi 400mg 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 Kabi 400mg is considered as clinically not relevant.

Theophylline: In accordance with in vitro data, no influence of Moxifloxacin Kabi 400mg on theophylline pharmacokinetics (and vice versa) at steady state was detected in humans, indicating that Moxifloxacin Kabi 400mg 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 Kabi 400mg. The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between Moxifloxacin Kabi 400mg 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 Kabi 400mg with oral contraceptives.

Antidiabetics: No clinically relevant interaction was seen between glibenclamide and Moxifloxacin Kabi 400mg.

Itraconazole: Exposure (AUC) to itraconazole was only marginally altered under concomitant Moxifloxacin Kabi 400mg treatment. Pharmacokinetics of Moxifloxacin Kabi 400mg were not significantly altered by itraconazole. No dose adjustment is necessary for itraconazole when given with Moxifloxacin Kabi 400mg and vice versa.

Digoxin: The pharmacokinetics of digoxin are not significantly influenced by Moxifloxacin Kabi 400mg (and vice versa). After repeated dosing in healthy volunteers, Moxifloxacin Kabi 400mg increased Cmax of digoxin by approximately 30% at steady state without affecting AUC or trough levels.

Morphine:

Parenteral administration of morphine with Moxifloxacin Kabi 400mg did not reduce the oral bioavailability of Moxifloxacin Kabi 400mg and only slighlty decreased Cmax (17 %).

Atenolol: The pharmacokinetics of atenolol are not significantly altered by Moxifloxacin Kabi 400mg. 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 Kabi 400mg was found in a clinical study investigating the impact of probenecid on renal excretion.

Charcoal: Concomitant dosing of charcoal and oral Moxifloxacin Kabi 400mg 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 Kabi 400mg was not altered by food intake (including dairy products). Moxifloxacin Kabi 400mg can be taken independent from food intake.

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


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References

  1. FDA/SPL Indexing Data. "U188XYD42P: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
  2. MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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