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Dosage of Moxifloxacin Rivopharm 400mg in details
Dosage in Adult Patients
The dose of Moxifloxacin Rivopharm 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.
Type of Infectiona
Every 24 hours
Community Acquired Pneumonia (1.1)
Uncomplicated Skin and Skin Structure Infections (SSSI ) (1.2)
Complicated SSSI (1.3)
Complicated Intra-Abdominal Infections (1.4)
Acute Bacterial Sinusitis (ABS) (1.6)
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) (1.7)
- Due to the designated pathogens.
- Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician
- Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
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 Rivopharm 400mg Injection may be switched to Moxifloxacin Rivopharm 400mg Tablets when clinically indicated at the discretion of the physician.
Important Administration Instructions
Moxifloxacin Rivopharm 400mg Tablets
With Multivalent Cations
Administer Moxifloxacin Rivopharm 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.
Moxifloxacin Rivopharm 400mg Tablets can be taken with or without food, drink fluids liberally.
Moxifloxacin Rivopharm 400mg Injection
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 Rivopharm 400mg intravenous injection with other intravenous substances, additives or other medications should not be added to Moxifloxacin Rivopharm 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 Rivopharm 400mg Injection with an infusion solution compatible with Moxifloxacin Rivopharm 400mg Injection as well as with other drug(s) administered via this common line.
Intravenous Solutions: Moxifloxacin Rivopharm 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 Rivopharm 400mg Injection
Refer to complete directions that have been provided with the administration set.
To prepare Moxifloxacin Rivopharm 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 Rivopharm 400mg?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Moxifloxacin Rivopharm 400mg, especially:
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 Rivopharm 400mg, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Moxifloxacin Rivopharm 400mg interactions
Tablet: For the following substances, absence of a clinically relevant interaction with Moxifloxacin Rivopharm 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 Rivopharm 400mg with antacids, minerals and multivitamins may result in impaired absorption of Moxifloxacin Rivopharm 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 Rivopharm 400mg dose.
Ranitidine: The concomitant administration with ranitidine did not change the absorption characteristics of Moxifloxacin Rivopharm 400mg. Absorption parameters (Cmax, tmax, AUC) were comparable, indicating absence of an influence of gastric pH on Moxifloxacin Rivopharm 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 Rivopharm 400mg is considered as clinically not relevant.
Theophylline: In accordance with in vitro data, no influence of Moxifloxacin Rivopharm 400mg on theophylline pharmacokinetics (and vice versa) at steady state was detected in humans, indicating that Moxifloxacin Rivopharm 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 Rivopharm 400mg. The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between Moxifloxacin Rivopharm 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 Rivopharm 400mg with oral contraceptives.
Antidiabetics: No clinically relevant interaction was seen between glibenclamide and Moxifloxacin Rivopharm 400mg.
Itraconazole: Exposure (AUC) to itraconazole was only marginally altered under concomitant Moxifloxacin Rivopharm 400mg treatment. Pharmacokinetics of Moxifloxacin Rivopharm 400mg were not significantly altered by itraconazole. No dose adjustment is necessary for itraconazole when given with Moxifloxacin Rivopharm 400mg and vice versa.
Digoxin: The pharmacokinetics of digoxin are not significantly influenced by Moxifloxacin Rivopharm 400mg (and vice versa). After repeated dosing in healthy volunteers, Moxifloxacin Rivopharm 400mg increased Cmax of digoxin by approximately 30% at steady state without affecting AUC or trough levels.
Parenteral administration of morphine with Moxifloxacin Rivopharm 400mg did not reduce the oral bioavailability of Moxifloxacin Rivopharm 400mg and only slighlty decreased Cmax (17 %).
Atenolol: The pharmacokinetics of atenolol are not significantly altered by Moxifloxacin Rivopharm 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 Rivopharm 400mg was found in a clinical study investigating the impact of probenecid on renal excretion.
Charcoal: Concomitant dosing of charcoal and oral Moxifloxacin Rivopharm 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 Rivopharm 400mg was not altered by food intake (including dairy products). Moxifloxacin Rivopharm 400mg can be taken independent from food intake.
Infusion: No interaction during concomitant treatment with warfarin, itraconazole, theophylline, digoxin and oral contraceptives.
- 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).
- MeSH. "Anti-Bacterial Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- 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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Information checked by Dr. Sachin Kumar, MD Pharmacology