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Actions of Moxifloxacino Actavis in details
Microbiology: Moxifloxacino Actavis is a fluoroquinolone antibacterial with a broad spectrum of activity and bactericidal action. Moxifloxacino Actavis 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.
Moxifloxacino Actavis is effective against β-lactam- and macrolide-resistant bacteria. Studies in animal models of infection have demonstrated the high in vitro activity.
Moxifloxacino Actavis 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 Moxifloxacino Actavis, however, the safety and effectiveness of Moxifloxacino Actavis 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.
Moxifloxacino Actavis 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 Moxifloxacino Actavis. There is no cross-resistance between Moxifloxacino Actavis 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 Moxifloxacino Actavis develops slowly by multiple-step mutations.
Serial exposure of organisms to sub-MIC concentrations of Moxifloxacino Actavis 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 Moxifloxacino Actavis.
How should I take Moxifloxacino Actavis?
Take Moxifloxacino Actavis 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.
Moxifloxacino Actavis 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. Moxifloxacino Actavis may be taken with or without food.
Take Moxifloxacino Actavis at the same time each day.
Drink plenty of fluids with Moxifloxacino Actavis 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 Moxifloxacino Actavis. It is best to take these medicines at least 4 hours before or 8 hours after taking Moxifloxacino Actavis. These medicines may keep Moxifloxacino Actavis from working properly.
Keep using Moxifloxacino Actavis 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.
The dose of Moxifloxacino Actavis 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 Moxifloxacino Actavis. 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:
If you miss a dose of Moxifloxacino Actavis, 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.
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.
Moxifloxacino Actavis administration
Use Moxifloxacino Actavis 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 Moxifloxacino Actavis 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 Moxifloxacino Actavis ophthalmic at room temperature away from moisture and heat. Keep the bottle properly capped.
Moxifloxacino Actavis pharmacology
Moxifloxacino Actavis, given as an oral tablet, is well absorbed from the gastrointestinal tract. The absolute bioavailability of Moxifloxacino Actavis is approximately 90 percent. Co-administration with a high fat meal (i.e., 500 calories from fat) does not affect the absorption of Moxifloxacino Actavis.
Consumption of 1 cup of yogurt with Moxifloxacino Actavis does not significantly affect the extent or rate of systemic absorption (AUC).
Mean Steady-State Plasma Concentrations of Moxifloxacino Actavis Obtained With Once Daily Dosing of 400 mg Either
Orally (n=10) or by I.V. Infusion (n=12)
Moxifloxacino Actavis is approximately 30-50% bound to serum proteins, independent of drug concentration. The volume of distribution of Moxifloxacino Actavis ranges from 1.7 to 2.7 L/kg. Moxifloxacino Actavis is widely distributed throughout the body, with tissue concentrations often exceeding plasma concentrations. Moxifloxacino Actavis 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. Moxifloxacino Actavis 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 Moxifloxacino Actavis from tissues generally parallel the elimination from plasma.
Approximately 52% of an oral or intravenous dose of Moxifloxacino Actavis is metabolized via glucuronide and sulfate conjugation. The cytochrome P450 system is not involved in Moxifloxacino Actavis metabolism, and is not affected by Moxifloxacino Actavis. 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 Moxifloxacino Actavis.
In vitro studies with cytochrome (CYP) P450 enzymes indicate that Moxifloxacino Actavis does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2, suggesting that Moxifloxacino Actavis is unlikely to alter the pharmacokinetics of drugs metabolized by these enzymes.
Approximately 45% of an oral or intravenous dose of Moxifloxacino Actavis 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.
Following oral administration of 400 mg Moxifloxacino Actavis 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 Moxifloxacino Actavis pharmacokinetics. In 16 healthy male volunteers (8 young; 8 elderly) given a single 200 mg dose of oral Moxifloxacino Actavis, 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.
The pharmacokinetics of Moxifloxacino Actavis in pediatric subjects have not been studied.
Following oral administration of 400 mg Moxifloxacino Actavis 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 Moxifloxacino Actavis 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 Moxifloxacino Actavis 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.
Steady-state Moxifloxacino Actavis 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.
The pharmacokinetic parameters of Moxifloxacino Actavis 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 Moxifloxacino Actavis 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 Moxifloxacino Actavis 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 Moxifloxacino Actavis in these HD and CAPD patients did not vary significantly from the AUC generally found in healthy volunteers. Cmax values of Moxifloxacino Actavis 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 Moxifloxacino Actavis 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 Moxifloxacino Actavis for 7 days to patients on HD or CAPD produced mean systemic exposure (AUCss) to Moxifloxacino Actavis 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 Moxifloxacino Actavis 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.
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, Moxifloxacino Actavis should be used with caution in these patients. (See
- 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).
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Information checked by Dr. Sachin Kumar, MD Pharmacology