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Moxifloxacin HEXAL Dosage |
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Generic name: Moxifloxacin HEXAL 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.
The dose of Moxifloxacin HEXAL 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 | 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 |
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 HEXAL Injection may be switched to Moxifloxacin HEXAL Tablets when clinically indicated at the discretion of the physician.
Administer Moxifloxacin HEXAL 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 HEXAL Tablets can be taken with or without food, drink fluids liberally.
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.
Because only limited data are available on the compatibility of Moxifloxacin HEXAL intravenous injection with other intravenous substances, additives or other medications should not be added to Moxifloxacin HEXAL 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 HEXAL Injection with an infusion solution compatible with Moxifloxacin HEXAL Injection as well as with other drug(s) administered via this common line.
Compatible
Intravenous Solutions: Moxifloxacin HEXAL 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
Refer to complete directions that have been provided with the administration set.
To prepare Moxifloxacin HEXAL Injection premix in flexible containers:
Some medicines can make Moxifloxacin HEXAL much less effective when taken at the same time. If you take any of the following medicines, take your Moxifloxacin HEXAL dose 4 hours before or 8 hours after you take the other medicine:
the ulcer medicine sucralfate, or antacids that contain calcium, magnesium, or aluminum (such as Maalox, Milk of Magnesia, Mylanta, Pepcid Complete, Rolaids, Tums, and others);
didanosine (Videx) powder or chewable tablets;
lanthanum carbonate or sevelamer; or
vitamin or mineral supplements that contain aluminum, iron, magnesium, or zinc.
Tell your doctor about all your other medicines, especially:
erythromycin;
a blood thinner (warfarin, Coumadin, Jantoven);
a diuretic or "water pill";
heart rhythm medication;
insulin or oral diabetes medicine (check your blood sugar regularly);
medicine to treat depression or mental illness;
steroid medicine (such as prednisone); or
NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.
This list is not complete. Other drugs may affect Moxifloxacin HEXAL, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Moxifloxacin HEXAL drug interactions (in more detail)
Tablet: For the following substances, absence of a clinically relevant interaction with Moxifloxacin HEXAL 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 HEXAL with antacids, minerals and multivitamins may result in impaired absorption of Moxifloxacin HEXAL 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 HEXAL dose.
Ranitidine: The concomitant administration with ranitidine did not change the absorption characteristics of Moxifloxacin HEXAL. Absorption parameters (Cmax, tmax, AUC) were comparable, indicating absence of an influence of gastric pH on Moxifloxacin HEXAL 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 HEXAL is considered as clinically not relevant.
Theophylline: In accordance with in vitro data, no influence of Moxifloxacin HEXAL on theophylline pharmacokinetics (and vice versa) at steady state was detected in humans, indicating that Moxifloxacin HEXAL 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 HEXAL. The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between Moxifloxacin HEXAL 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.
Antidiabetics: No clinically relevant interaction was seen between glibenclamide and Moxifloxacin HEXAL.
Itraconazole: Exposure (AUC) to itraconazole was only marginally altered under concomitant Moxifloxacin HEXAL treatment. Pharmacokinetics of Moxifloxacin HEXAL were not significantly altered by itraconazole. No dose adjustment is necessary for itraconazole when given with Moxifloxacin HEXAL and vice versa.
Digoxin: The pharmacokinetics of digoxin are not significantly influenced by Moxifloxacin HEXAL (and vice versa). After repeated dosing in healthy volunteers, Moxifloxacin HEXAL increased Cmax of digoxin by approximately 30% at steady state without affecting AUC or trough levels.
Morphine:
Parenteral administration of morphine with Moxifloxacin HEXAL did not reduce the oral bioavailability of Moxifloxacin HEXAL and only slighlty decreased Cmax (17 %).
Atenolol: The pharmacokinetics of atenolol are not significantly altered by Moxifloxacin HEXAL. 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 HEXAL was found in a clinical study investigating the impact of probenecid on renal excretion.
Charcoal: Concomitant dosing of charcoal and oral Moxifloxacin HEXAL 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 HEXAL was not altered by food intake (including dairy products). Moxifloxacin HEXAL 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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Information checked by Dr. Sachin Kumar, MD Pharmacology
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