Actions of Moxifloxacin Apotex 400mg in details
Microbiology: Moxifloxacin Apotex 400mg is a fluoroquinolone antibacterial with a broad spectrum of activity and bactericidal action. Moxifloxacin Apotex 400mg has in vitro activity against a wide range of gram-positive and gram-negative organisms, anaerobes, acid-fast bacteria and atypicals, eg Mycoplasma, Chlamydia and Legionella spp.
Moxifloxacin Apotex 400mg is effective against β-lactam- and macrolide-resistant bacteria. Studies in animal models of infection have demonstrated the high in vitro activity.
Moxifloxacin Apotex 400mg has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections.
Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-sensitive strains); Streptococcus pneumoniae (including penicillin- and macrolide-resistant strains); Streptococcus pyogenes (group A).
Gram-Negative Microorganisms: Haemophilus influenzae (including β-lactamase-negative and -positive strains); Haemophilus parainfluenzae; Klebsiella pneumoniae; Moraxella catarrhalis (including β-lactamase-negative and -positive strains; Escherichia coli; Enterobacter cloacae.
Atypicals: Chlamydia pneumoniae; Mycoplasma pneumoniae.
According to in vitro studies, the following organisms are sensitive to Moxifloxacin Apotex 400mg, however, the safety and effectiveness of Moxifloxacin Apotex 400mg in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.
Gram-Positive Microorganisms: Streptococcus milleri, Streptococcus mitior, Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus cohnii, Staphylococcus epidermidis (including methicillin-sensitive strains), Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus simulans, Corynebacterium diphtheriae.
Gram-Negative Microorganisms: Bordetella pertussis, Klebsiella oxytoca, Enterobacter aerogenes, Enterobacter agglomerens, Enterobacter intermedius, Enterobacter sakazaki, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Providencia stuartii.
Anaerobes: Bacteroides distasonis, Bacteroides eggerthii, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides uniformis, Fusobacterium and Porphyromonas spp, Porphyromonas anaerobius, Porphyromonas asaccharolyticus, Porphyromonas magnus, Prevotella and Propionibacterium spp, Clostridium perfringens, Clostridium ramosum.
Atypicals: Legionella pneumophila, Caxiella burnetii.
The bactericidal action results from the interference with topoisomerase II and IV. Topoisomerases are essential enzymes which control DNA topology and assist in DNA replication, repair and transcription.
Moxifloxacin Apotex 400mg exhibits concentration-dependent bactericidal killing. Minimum bactericidal concentrations are generally similar to minimum inhibitory concentrations.
Resistance mechanisms which inactivate penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not interfere with the antibacterial activity of Moxifloxacin Apotex 400mg. There is no cross-resistance between Moxifloxacin Apotex 400mg and these agents. Plasmid-mediated resistance has not been observed to date. A very low overall frequency of resistance was demonstrated (10-7 to 10-10). In vitro studies have demonstrated that resistance to Moxifloxacin Apotex 400mg develops slowly by multiple-step mutations.
Serial exposure of organisms to sub-MIC concentrations of Moxifloxacin Apotex 400mg showed only a small increase in MIC values. Cross-resistance among quinolones has been observed. However, some gram-positive and anaerobic organisms resistant to other quinolones are susceptible to Moxifloxacin Apotex 400mg.
How should I take Moxifloxacin Apotex 400mg?
Take Moxifloxacin Apotex 400mg only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
Moxifloxacin Apotex 400mg comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Swallow the tablet whole with a glass of water. Do not split, crush or chew it. Moxifloxacin Apotex 400mg may be taken with or without food.
Take Moxifloxacin Apotex 400mg at the same time each day.
Drink plenty of fluids with Moxifloxacin Apotex 400mg to help prevent some unwanted effects.
If you are taking aluminum or magnesium-containing antacids, iron supplements, multivitamins, didanosine (Videx®), sucralfate (Carafate®), or zinc, do not take them at the same time that you take Moxifloxacin Apotex 400mg. It is best to take these medicines at least 4 hours before or 8 hours after taking Moxifloxacin Apotex 400mg. These medicines may keep Moxifloxacin Apotex 400mg from working properly.
Keep using Moxifloxacin Apotex 400mg for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
Dosing
The dose of Moxifloxacin Apotex 400mg will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Moxifloxacin Apotex 400mg. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For infections:
- Adults—400 milligrams (mg) once every 24 hours.
- Children—Use and dose must be determined by your doctor.
- For infections:
Missed Dose
If you miss a dose of Moxifloxacin Apotex 400mg, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Moxifloxacin Apotex 400mg administration
Use Moxifloxacin Apotex 400mg ophthalmic eye drops exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.
Wash your hands before using the eye drops.
If you wear contact lenses, remove them before applying Moxifloxacin Apotex 400mg ophthalmic. Ask your doctor if contact lenses can be reinserted after application of the medication.
To apply the eye drops:
- Shake the drops gently to be sure the medicine is well mixed. Tilt the head back slightly and pull down on the lower eyelid. Position the dropper above the eye. Look up and away from the dropper. Squeeze out a drop and close the eye. Apply gentle pressure to the inside corner of the eye (near the nose) for about 1 minute to prevent the liquid from draining down the tear duct..
Do not touch the dropper to any surface, including the eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in the eye.
Do not use any eye drop that is discolored or has particles in it.
Store Moxifloxacin Apotex 400mg ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped.
Moxifloxacin Apotex 400mg pharmacology
Absorption
Moxifloxacin Apotex 400mg, given as an oral tablet, is well absorbed from the gastrointestinal tract. The absolute bioavailability of Moxifloxacin Apotex 400mg is approximately 90 percent. Co-administration with a high fat meal (i.e., 500 calories from fat) does not affect the absorption of Moxifloxacin Apotex 400mg.
Consumption of 1 cup of yogurt with Moxifloxacin Apotex 400mg does not significantly affect the extent or rate of systemic absorption (AUC).
Mean Steady-State Plasma Concentrations of Moxifloxacin Apotex 400mg Obtained With Once Daily Dosing of 400 mg Either
Orally (n=10) or by I.V. Infusion (n=12)
Distribution
Moxifloxacin Apotex 400mg is approximately 30-50% bound to serum proteins, independent of drug concentration. The volume of distribution of Moxifloxacin Apotex 400mg ranges from 1.7 to 2.7 L/kg. Moxifloxacin Apotex 400mg is widely distributed throughout the body, with tissue concentrations often exceeding plasma concentrations. Moxifloxacin Apotex 400mg has been detected in the saliva, nasal and bronchial secretions, mucosa of the sinuses, skin blister fluid, subcutaneous tissue, skeletal muscle, and abdominal tissues and fluids following oral or intravenous administration of 400 mg. Moxifloxacin Apotex 400mg concentrations measured post-dose in various tissues and fluids following a 400 mg oral or I.V. dose are summarized in the following table. The rates of elimination of Moxifloxacin Apotex 400mg from tissues generally parallel the elimination from plasma.
Metabolism
Approximately 52% of an oral or intravenous dose of Moxifloxacin Apotex 400mg is metabolized via glucuronide and sulfate conjugation. The cytochrome P450 system is not involved in Moxifloxacin Apotex 400mg metabolism, and is not affected by Moxifloxacin Apotex 400mg. The sulfate conjugate (M1) accounts for approximately 38% of the dose, and is eliminated primarily in the feces. Approximately 14% of an oral or intravenous dose is converted to a glucuronide conjugate (M2), which is excreted exclusively in the urine. Peak plasma concentrations of M2 are approximately 40% those of the parent drug, while plasma concentrations of M1 are generally less than 10% those of Moxifloxacin Apotex 400mg.
In vitro studies with cytochrome (CYP) P450 enzymes indicate that Moxifloxacin Apotex 400mg does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2, suggesting that Moxifloxacin Apotex 400mg is unlikely to alter the pharmacokinetics of drugs metabolized by these enzymes.
Excretion
Approximately 45% of an oral or intravenous dose of Moxifloxacin Apotex 400mg is excreted as unchanged drug (~20% in urine and ~25% in feces). A total of 96% ± 4% of an oral dose is excreted as either unchanged drug or known metabolites. The mean (± SD) apparent total body clearance and renal clearance are 12 ± 2 L/hr and 2.6 ± 0.5 L/hr, respectively.
Special Populations
Geriatric
Following oral administration of 400 mg Moxifloxacin Apotex 400mg for 10 days in 16 elderly (8 male; 8 female) and 17 young (8 male; 9 female) healthy volunteers, there were no age-related changes in Moxifloxacin Apotex 400mg pharmacokinetics. In 16 healthy male volunteers (8 young; 8 elderly) given a single 200 mg dose of oral Moxifloxacin Apotex 400mg, the extent of systemic exposure (AUC and Cmax) was not statistically different between young and elderly males and elimination half-life was unchanged. No dosage adjustment is necessary based on age. In large phase III studies, the concentrations around the time of the end of the infusion in elderly patients following intravenous infusion of 400 mg were similar to those observed in young patients.
Pediatric
The pharmacokinetics of Moxifloxacin Apotex 400mg in pediatric subjects have not been studied.
Gender
Following oral administration of 400 mg Moxifloxacin Apotex 400mg daily for 10 days to 23 healthy males (19-75 years) and 24 healthy females (19-70 years), the mean AUC and Cmax were 8% and 16% higher, respectively, in females compared to males. There are no significant differences in Moxifloxacin Apotex 400mg pharmacokinetics between male and female subjects when differences in body weight are taken into consideration.
A 400 mg single dose study was conducted in 18 young males and females. The comparison of Moxifloxacin Apotex 400mg pharmacokinetics in this study (9 young females and 9 young males) showed no differences in AUC or Cmax due to gender. Dosage adjustments based on gender are not necessary.
Race
Steady-state Moxifloxacin Apotex 400mg pharmacokinetics in male Japanese subjects were similar to those determined in Caucasians, with a mean Cmax of 4.1 µg/mL, an AUC24 of 47 µg•h/mL, and an elimination half-life of 14 hours, following 400 mg p.o. daily.
Renal Insufficiency
The pharmacokinetic parameters of Moxifloxacin Apotex 400mg are not significantly altered in mild, moderate, severe, or end-stage renal disease. No dosage adjustment is necessary in patients with renal impairment, including those patients requiring hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD).
In a single oral dose study of 24 patients with varying degrees of renal function from normal to severely impaired, the mean peak concentrations (Cmax) of Moxifloxacin Apotex 400mg were reduced by 21% and 28% in the patients with moderate (CLCR≥ 30 and ≤ 60 mL/min) and severe (CLCRless than30 mL/min) renal impairment, respectively. The mean systemic exposure (AUC) in these patients was increased by 13%. In the moderate and severe renally impaired patients, the mean AUC for the sulfate conjugate (M1) increased by 1.7-fold (ranging up to 2.8-fold) and mean AUC and Cmax for the glucuronide conjugate (M2) increased by 2.8-fold (ranging up to 4.8-fold) and 1.4-fold (ranging up to 2.5-fold), respectively.
The pharmacokinetics of single dose and multiple dose Moxifloxacin Apotex 400mg were studied in patients with CLCRless than 20 mL/min on either hemodialysis or continuous ambulatory peritoneal dialysis (8 HD, 8 CAPD). Following a single 400 mg oral dose, the AUC of Moxifloxacin Apotex 400mg in these HD and CAPD patients did not vary significantly from the AUC generally found in healthy volunteers. Cmax values of Moxifloxacin Apotex 400mg were reduced by about 45% and 33% in HD and CAPD patients, respectively, compared to healthy, historical controls. The exposure (AUC) to the sulfate conjugate (M1) increased by 1.4- to 1.5-fold in these patients. The mean AUC of the glucuronide conjugate (M2) increased by a factor of 7.5, whereas the mean Cmax values of the glucuronide conjugate (M2) increased by a factor of 2.5 to 3, compared to healthy subjects. The sulfate and the glucuronide conjugates of Moxifloxacin Apotex 400mg are not microbiologically active, and the clinical implication of increased exposure to these metabolites in patients with renal disease including those undergoing HD and CAPD has not been studied.
Oral administration of 400 mg QD Moxifloxacin Apotex 400mg for 7 days to patients on HD or CAPD produced mean systemic exposure (AUCss) to Moxifloxacin Apotex 400mg similar to that generally seen in healthy volunteers. Steady-state Cmax values were about 22% lower in HD patients but were comparable between CAPD patients and healthy volunteers. Both HD and CAPD removed only small amounts of Moxifloxacin Apotex 400mg from the body (approximately 9% by HD, and 3% by CAPD). HD and CAPD also removed about 4% and 2% of the glucuronide metabolite (M2), respectively.
Hepatic Insufficiency
No dosage adjustment is recommended for mild, moderate, or severe hepatic insufficiency (Child-Pugh Classes A, B, or C). However, due to metabolic disturbances associated with hepatic insufficiency, which may lead to QT prolongation, Moxifloxacin Apotex 400mg should be used with caution in these patients. (See
References
- NCIt. "Moxifloxacin: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
- EPA DSStox. "Moxifloxacin: DSSTox provides a high quality public chemistry resource for supporting improved predictive toxicology.". https://comptox.epa.gov/dashboard/ds... (accessed September 17, 2018).
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology
