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Avelox ABC Pack
Overview
What is Avelox ABC Pack?
AVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum
antibacterial agent and is available as AVELOX Tablets for oral administration
and as AVELOX I.V. for intravenous administration. Moxifloxacin, a
fluoroquinolone, is available as the monohydrochloride salt of
1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3
quinoline carboxylic acid. It is a slightly yellow to yellow crystalline
substance with a molecular weight of 437.9. Its empirical formula is CHFNO*HCl and its chemical structure is as follows:
AVELOX Tablets are available as film-coated tablets containing moxifloxacin
hydrochloride (equivalent to 400 mg moxifloxacin). The inactive ingredients are
microcrystalline cellulose, lactose monohydrate, croscarmellose sodium,
magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and
ferric oxide.
AVELOX I.V. is available in ready-to-use 250 mL latex-free flexibags as a
sterile, preservative free, 0.8% sodium chloride aqueous solution of
moxifloxacin hydrochloride (containing 400 mg moxifloxacin) with pH ranging from
4.1 to 4.6. The appearance of the intravenous solution is yellow. The color does
not affect, nor is it indicative of, product stability. The inactive ingredients
are sodium chloride, USP, Water for Injection, USP, and may include hydrochloric
acid and/or sodium hydroxide for pH adjustment. AVELOX I.V. contains
approximately 34.2 mEq (787 mg) of sodium in 250 mL.
What does Avelox ABC Pack look like?
What are the available doses of Avelox ABC Pack?
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What should I talk to my health care provider before I take Avelox ABC Pack?
Following oral administration of 400 mg moxifloxacin 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 pharmacokinetics.
In 16 healthy male volunteers (8 young; 8 elderly) given a single 200 mg dose of
oral moxifloxacin, the extent of systemic exposure (AUC and C) 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 moxifloxacin in pediatric subjects have
not been studied.
Following oral administration of 400 mg moxifloxacin daily for 10
days to 23 healthy males (19-75 years) and 24 healthy females (19-70 years), the
mean AUC and C were 8% and 16% higher, respectively,
in females compared to males. There are no significant differences in
moxifloxacin 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 pharmacokinetics in this study (9 young females and 9
young males) showed no differences in AUC or C due to
gender. Dosage adjustments based on gender are not necessary.
Steady-state moxifloxacin pharmacokinetics in male Japanese
subjects were similar to those determined in Caucasians, with a mean C of 4.1 µg/mL, an AUC of 47
µg•h/mL, and an elimination half-life of 14 hours, following 400 mg p.o.
daily.
The pharmacokinetic parameters of moxifloxacin 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 (C) of moxifloxacin were reduced by 21% and 28% in the
patients with moderate (CL≥ 30 and ≤ 60 mL/min) and
severe (CLless 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 C 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 were
studied in patients with CLless 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 in these HD and
CAPD patients did not vary significantly from the AUC generally found in healthy
volunteers. C values of moxifloxacin 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 C
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 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 for 7 days to patients on HD or
CAPD produced mean systemic exposure (AUC) to
moxifloxacin similar to that generally seen in healthy volunteers. Steady-state
C 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 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, moxifloxacin should be used with caution in these patients. (See
and .)
In 400 mg single oral dose studies in 6 patients with mild (Child-Pugh Class
A) and 10 patients with moderate (Child-Pugh Class B) hepatic insufficiency,
moxifloxacin mean systemic exposure (AUC) was 78% and 102%, respectively, of 18
healthy controls and mean peak concentration (C) was
79% and 84% of controls.
The mean AUC of the sulfate conjugate of moxifloxacin (M1) increased by
3.9-fold (ranging up to 5.9-fold) and 5.7-fold (ranging up to 8-fold) in the
mild and moderate groups, respectively. The mean Cof
M1 increased by approximately 3-fold in both groups (ranging up to 4.7- and
3.9-fold). The mean AUC of the glucuronide conjugate of moxifloxacin (M2)
increased by 1.5-fold (ranging up to 2.5-fold) in both groups. The mean Cof M2 increased by 1.6- and 1.3-fold (ranging up to 2.7-
and 2.1-fold), respectively. The clinical significance of increased exposure to
the sulfate and glucuronide conjugates has not been studied. In a subset of
patients participating in a clinical trial, the plasma concentrations of
moxifloxacin and metabolites determined approximately at the moxifloxacin T following the first intravenous or oral moxifloxacin dose
in the Child-Pugh Class C patients (n=10) were similar to those in the
Child-Pugh Class A/B patients (n=5), and also similar to those observed in
healthy volunteer studies.
A study of the skin response to ultraviolet (UVA and UVB) and
visible radiation conducted in 32 healthy volunteers (8 per group) demonstrated
that moxifloxacin does not show phototoxicity in comparison to placebo. The
minimum erythematous dose (MED) was measured before and after treatment with
moxifloxacin (200 mg or 400 mg once daily), lomefloxacin (400 mg once daily), or
placebo. In this study, the MED measured for both doses of moxifloxacin were not
significantly different from placebo, while lomefloxacin significantly lowered
the MED. (See .)
It is difficult to ascribe relative photosensitivity/phototoxicity among
various fluoroquinolones during actual patient use because other factors play a
role in determining a subject’s susceptibility to this adverse event such as: a
patient’s skin pigmentation, frequency and duration of sun and artificial
ultraviolet light (UV) exposure, wearing of sunscreen and protective clothing,
the use of other concomitant drugs and the dosage and duration of
fluoroquinolone therapy (See and .
The potential for pharmacokinetic drug interactions between
moxifloxacin and itraconazole, theophylline, warfarin, digoxin, atenolol,
probenecid, morphine, oral contraceptives, ranitidine, glyburide, calcium, iron,
and antacids has been evaluated. There was no clinically significant effect of
moxifloxacin on itraconazole, theophylline, warfarin, digoxin, atenolol, oral
contraceptives, or glyburide kinetics. Itraconazole, theophylline, warfarin,
digoxin, probenecid, morphine, ranitidine, and calcium did not significantly
affect the pharmacokinetics of moxifloxacin. These results and the data from
studies suggest that moxifloxacin is
unlikely to significantly alter the metabolic clearance of drugs metabolized by
CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2 enzymes.
As with all other quinolones, iron and antacids significantly reduced
bioavailability of moxifloxacin.
In a study involving 11 healthy volunteers, there was no
significant effect of itraconazole (200 mg once daily for 9 days), a potent
inhibitor of cytochrome P4503A4, on the pharmacokinetics of moxifloxacin (a
single 400 mg dose given on the 7 day of itraconazole
dosing). In addition, moxifloxacin was shown not to affect the pharmacokinetics
of itraconazole.
No significant effect of moxifloxacin (200 mg every twelve hours
for 3 days) on the pharmacokinetics of theophylline (400 mg every twelve hours
for 3 days) was detected in a study involving 12 healthy volunteers. In
addition, theophylline was not shown to affect the pharmacokinetics of
moxifloxacin. The effect of co-administration of a 400 mg dose of moxifloxacin
with theophylline has not been studied, but it is not expected to be clinically
significant based on metabolic data showing
that moxifloxacin does not inhibit the CYP1A2 isoenzyme.
No significant effect of moxifloxacin (400 mg once daily for
eight days) on the pharmacokinetics of R- and S-warfarin (25 mg single dose of
warfarin sodium on the fifth day) was detected in a study involving 24 healthy
volunteers. No significant change in prothrombin time was observed. (See .)
No significant effect of moxifloxacin (400 mg once daily for two
days) on digoxin (0.6 mg as a single dose) AUC was detected in a study involving
12 healthy volunteers. The mean digoxin C increased by
about 50% during the distribution phase of digoxin. This transient increase in
digoxin C is not viewed to be clinically significant.
Moxifloxacin pharmacokinetics were similar in the presence or absence of
digoxin. No dosage adjustment for moxifloxacin or digoxin is required when these
drugs are administered concomitantly.
In a crossover study involving 24 healthy volunteers (12 male;
12 female), the mean atenolol AUC following a single oral dose of 50 mg atenolol
with placebo was similar to that observed when atenolol was given concomitantly
with a single 400 mg oral dose of moxifloxacin. The mean C of single dose atenolol decreased by about 10% following
co-administration with a single dose of moxifloxacin.
No significant effect of morphine sulfate (a single 10 mg
intramuscular dose) on the mean AUC and C of
moxifloxacin (400 mg single dose) was observed in a study of 20 healthy male and
female volunteers.
A placebo-controlled study in 29 healthy female subjects showed
that moxifloxacin 400 mg daily for 7 days did not interfere with the hormonal
suppression of oral contraception with 0.15 mg levonorgestrel/0.03 mg
ethinylestradiol (as measured by serum progesterone, FSH, estradiol, and LH), or
with the pharmacokinetics of the administered contraceptive agents.
Probenecid (500 mg twice daily for two days) did not alter the
renal clearance and total amount of moxifloxacin (400 mg single dose) excreted
renally in a study of 12 healthy volunteers.
No significant effect of ranitidine (150 mg twice daily for
three days as pretreatment) on the pharmacokinetics of moxifloxacin (400 mg
single dose) was detected in a study involving 10 healthy volunteers.
In diabetics, glyburide (2.5 mg once daily for two weeks
pretreatment and for five days concurrently) mean AUC and C were 12% and 21% lower, respectively, when taken with
moxifloxacin (400 mg once daily for five days) in comparison to placebo.
Nonetheless, blood glucose levels were decreased slightly in patients taking
glyburide and moxifloxacin in comparison to those taking glyburide alone,
suggesting no interference by moxifloxacin on the activity of glyburide. These
interaction results are not viewed as clinically significant.
Twelve healthy volunteers were administered concomitant
moxifloxacin (single 400 mg dose) and calcium (single dose of 500 mg Cadietary supplement) followed by an additional two doses of
calcium 12 and 24 hours after moxifloxacin administration. Calcium had no
significant effect on the mean AUC of moxifloxacin. The mean C was slightly reduced and the time to maximum plasma
concentration was prolonged when moxifloxacin was given with calcium compared to
when moxifloxacin was given alone (2.5 hours versus 0.9 hours). These
differences are not considered to be clinically significant.
When moxifloxacin (single 400 mg tablet dose) was administered
two hours before, concomitantly, or 4 hours after an
aluminum/magnesium-containing antacid (900 mg aluminum hydroxide and 600 mg
magnesium hydroxide as a single oral dose) to 12 healthy volunteers there was a
26%, 60% and 23% reduction in the mean AUC of moxifloxacin, respectively.
Moxifloxacin should be taken at least 4 hours before or 8 hours after antacids
containing magnesium or aluminum, as well as sucralfate, metal cations such as
iron, and multivitamin preparations with zinc, or VIDEX
(didanosine) chewable/ buffered tablets or the pediatric powder for oral
solution. (See and .)
Iron:
Prolongation of the QT interval in the ECG has been observed in
some patients receiving moxifloxacin. Following oral dosing with 400 mg of
moxifloxacin the mean (± SD) change in QTc from the pre-dose value at the time
of maximum drug concentration was 6 msec (± 26) (n = 787). Following a course of
daily intravenous dosing (400 mg; 1 hour infusion each day) the mean change in
QTc from the Day 1 pre-dose value was 9 msec (± 24) on Day 1 (n = 69) and 3 msec
(± 29) on Day 3 (n = 290). (See .)
There is limited information available on the potential for a pharmacodynamic
interaction in humans between moxifloxacin and other drugs that prolong the QTc
interval of the electrocardiogram. Sotalol, a Class III antiarrhythmic, has been
shown to further increase the QTc interval when combined with high doses of
intravenous (I.V.) moxifloxacin in dogs. Therefore, moxifloxacin should be
avoided with Class IA and Class III antiarrhythmics. (See , , and .)
How should I use Avelox ABC Pack?
AVELOX Tablets and I.V. are indicated for the treatment of adults
(≥ 18 years of age) with infections caused by susceptible strains of the
designated microorganisms in the conditions listed below. (See for specific
recommendations. In addition, for I.V. use, see .)
Acute Bacterial Sinusitis
Streptococcus pneumoniae, Haemophilus influenzae
Moraxella catarrhalis
Acute Bacterial Exacerbation of Chronic Bronchitis
Streptococcus pneumoniae, Haemophilus influenzae,
Haemophilus parainfluenzae,
Klebsiella
pneumoniae,
Staphylococcus
aureus,
Moraxella catarrhalis.
Community Acquired Pneumonia
Streptococcus pneumoniae
Haemophilus influenzae, Moraxella
catarrhalis,
Staphylococcus
aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae,
Chlamydia pneumoniae
* MDRSP, Multi-drug resistant includes isolates previously known as PRSP
(Penicillin-resistant ), and are strains
resistant to two or more of the following antibiotics: penicillin (MIC ≥ 2
µg/mL), 2 generation cephalosporins (e.g., cefuroxime),
macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
Uncomplicated Skin and Skin Structure Infections
Staphylococcus
aureus
Streptococcus pyogenes
Complicated Intra-Abdominal Infections
Escherichia coli, Bacteroides fragilis, Streptococcus anginosus,
Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis,
Clostridium perfringens, Bacteroides thetaiotaomicron,
Peptostreptococcus species
Complicated Skin and Skin Structure Infections
Staphylococcus aureus,
Escherichia coli, Klebsiella pneumoniae,
Enterobacter cloacae
Appropriate culture and susceptibility tests should be performed before
treatment in order to isolate and identify organisms causing infection and to
determine their susceptibility to moxifloxacin. Therapy with AVELOX may be
initiated before results of these tests are known; once results become
available, appropriate therapy should be continued.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of AVELOX and other antibacterial drugs, AVELOX should be used
only to treat or prevent infections that are proven or strongly suspected to be
caused by susceptible bacteria. When culture and susceptibility information are
available, they should be considered in selecting or modifying antibacterial
therapy. In the absence of such data, local epidemiology and susceptibility
patterns may contribute to the empiric selection of therapy.
The dose of AVELOX 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 below.
For Complicated Intra-Abdominal Infections, therapy should usually be
initiated with the intravenous formulation.
When switching from intravenous to oral dosage administration, no dosage
adjustment is necessary. Patients whose therapy is started with AVELOX I.V. may
be switched to AVELOX Tablets when clinically indicated at the discretion of the
physician.
Oral doses of moxifloxacin should be administered at least 4 hours before or
8 hours after antacids containing magnesium or aluminum, as well as sucralfate,
metal cations such as iron, and multivitamin preparations with zinc, or
VIDEX (didanosine) chewable/buffered tablets or the
pediatric powder for oral solution. (See and
.)
No dosage adjustment is required in renally impaired patients,
including those on either hemodialysis or continuous ambulatory peritoneal
dialysis.
No dosage adjustment is recommended for mild, moderate, or severe
hepatic insufficiency (Child-Pugh Classes A, B, or C). (See .)
AVELOX I.V. should be administered by INTRAVENOUS infusion only. It is not
intended for intra-arterial, intramuscular, intrathecal, intraperitoneal, or
subcutaneous administration.
AVELOX I.V. should be administered 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. CAUTION: RAPID OR BOLUS INTRAVENOUS INFUSION MUST BE
AVOIDED.
Since only limited data are available on the compatibility of moxifloxacin
intravenous injection with other intravenous substances, additives or other
medications should not be added to AVELOX I.V. 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
AVELOX I.V. with an infusion solution compatible with AVELOX I.V. as well as
with other drug(s) administered via this common line.
NOTE
What interacts with Avelox ABC Pack?
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What are the warnings of Avelox ABC Pack?
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What are the precautions of Avelox ABC Pack?
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What are the side effects of Avelox ABC Pack?
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What should I look out for while using Avelox ABC Pack?
Moxifloxacin is contraindicated in persons with a history of
hypersensitivity to moxifloxacin or any member of the quinolone class of
antimicrobial agents.
Tendinopathy and Tendon Rupture:
QT prolongation:
Pharmacokinetic studies between moxifloxacin and other drugs that prolong the
QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic
antidepressants have not been performed. An additive effect of moxifloxacin and
these drugs cannot be excluded; therefore caution should be exercised when
moxifloxacin is given concurrently with these drugs. In premarketing clinical
trials, the rate of cardiovascular adverse events was similar in 798
moxifloxacin and 702 comparator treated patients who received concomitant
therapy with drugs known to prolong the QTc interval.
Moxifloxacin should be used with caution in patients with ongoing
proarrhythmic conditions, such as clinically significant bradycardia, acute
myocardial ischemia. The magnitude of QT prolongation may increase with
increasing concentrations of the drug or increasing rates of infusion of the
intravenous formulation. Therefore the recommended dose or infusion rate should
not be exceeded. QT prolongation may lead to an increased risk for ventricular
arrhythmias including torsade de pointes. No cardiovascular morbidity or
mortality attributable to QTc prolongation occurred with moxifloxacin treatment
in over 9,200 patients in controlled clinical studies, including 223 patients
who were hypokalemic at the start of treatment, and there was no increase in
mortality in over 18,000 moxifloxacin tablet treated patients in a
post-marketing observational study in which ECGs were not performed. (See . For I.V. use, see and ) In addition,
moxifloxacin should be used with caution in patients with mild, moderate, or
severe liver cirrhosis. (See , .)
The oral administration of moxifloxacin caused lameness in immature dogs.
Histopathological examination of the weight-bearing joints of these dogs
revealed permanent lesions of the cartilage. Related quinolone-class drugs also
produce erosions of cartilage of weight-bearing joints and other signs of
arthropathy in immature animals of various species. (See .)
Convulsions have been reported in patients receiving quinolones. Quinolones
may also cause central nervous system (CNS) events including: dizziness,
confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts
or acts. These reactions may occur following the first dose. If these reactions
occur in patients receiving moxifloxacin, the drug should be discontinued and
appropriate measures instituted. As with all quinolones, moxifloxacin should be
used with caution in patients with known or suspected CNS disorders (e.g. severe
cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors
that may predispose to seizures or lower the seizure threshold. (See , , and .)
Hypersensitivity reactions:
Other serious and sometimes fatal events, some due to hypersensitivity, and
some due to uncertain etiology, have been reported rarely in patients receiving
therapy with quinolones, including AVELOX. These events may be severe and
generally occur following the administration of multiple doses. Clinical
manifestations may include one or more of the following:
The drug should be discontinued immediately at the first appearance of a skin
rash, jaundice, or any other sign of hypersensitivity and supportive measures
instituted (See and ).
Clostridium difficile
C. difficile
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed
against may need to be discontinued.
Appropriate fluid and electrolyte management, protein supplementation,
antibiotic treatment of , and surgical
evaluation should be instituted as clinically indicated.
Peripheral neuropathy:
What might happen if I take too much Avelox ABC Pack?
Single oral overdoses up to 2.8 g were not associated with any
serious adverse events. In the event of acute overdose, the stomach should be
emptied and adequate hydration maintained. ECG monitoring is recommended due to
the possibility of QT interval prolongation. The patient should be carefully
observed and given supportive treatment. The administration of activated
charcoal as soon as possible after oral overdose may prevent excessive increase
of systemic moxifloxacin exposure. About 3% and 9% of the dose of moxifloxacin,
as well as about 2% and 4.5% of its glucuronide metabolite are removed by
continuous ambulatory peritoneal dialysis and hemodialysis, respectively.
Single oral moxifloxacin doses of 2000, 500, and 1500 mg/kg were lethal to
rats, mice, and cynomolgus monkeys, respectively. The minimum lethal intravenous
dose in mice and rats was 100 mg/kg. Toxic signs after administration of a
single high dose of moxifloxacin to these animals included CNS and
gastrointestinal effects such as decreased activity, somnolence, tremor,
convulsions, vomiting and diarrhea.
How should I store and handle Avelox ABC Pack?
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.A Schedule CIII Narcotic.AVELOX (moxifloxacin hydrochloride) Tablets are available as oblong, dull red film-coated tablets containing 400 mg moxifloxacin.The tablet is coded with the word “BAYER” on one side and “M400” on the reverse side. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid high humidity.AVELOX I.V. (moxifloxacin hydrochloride in sodium chloride injection) is available in ready-to-use 250 mL latex-free flexible bags containing 400 mg of moxifloxacin in 0.8% saline. NO FURTHER DILUTION OF THIS PREPARATION IS NECESSARY.Parenteral drug products should be inspected visually for particulate matter prior to administration. Samples containing visible particulates should not be used.Since the premix flexible containers are for single-use only, any unused portion should be discarded.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE – PRODUCT PRECIPITATES UPON REFRIGERATION.AVELOX (moxifloxacin hydrochloride) Tablets are available as oblong, dull red film-coated tablets containing 400 mg moxifloxacin.The tablet is coded with the word “BAYER” on one side and “M400” on the reverse side. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid high humidity.AVELOX I.V. (moxifloxacin hydrochloride in sodium chloride injection) is available in ready-to-use 250 mL latex-free flexible bags containing 400 mg of moxifloxacin in 0.8% saline. NO FURTHER DILUTION OF THIS PREPARATION IS NECESSARY.Parenteral drug products should be inspected visually for particulate matter prior to administration. Samples containing visible particulates should not be used.Since the premix flexible containers are for single-use only, any unused portion should be discarded.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE – PRODUCT PRECIPITATES UPON REFRIGERATION.AVELOX (moxifloxacin hydrochloride) Tablets are available as oblong, dull red film-coated tablets containing 400 mg moxifloxacin.The tablet is coded with the word “BAYER” on one side and “M400” on the reverse side. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid high humidity.AVELOX I.V. (moxifloxacin hydrochloride in sodium chloride injection) is available in ready-to-use 250 mL latex-free flexible bags containing 400 mg of moxifloxacin in 0.8% saline. NO FURTHER DILUTION OF THIS PREPARATION IS NECESSARY.Parenteral drug products should be inspected visually for particulate matter prior to administration. Samples containing visible particulates should not be used.Since the premix flexible containers are for single-use only, any unused portion should be discarded.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE – PRODUCT PRECIPITATES UPON REFRIGERATION.AVELOX (moxifloxacin hydrochloride) Tablets are available as oblong, dull red film-coated tablets containing 400 mg moxifloxacin.The tablet is coded with the word “BAYER” on one side and “M400” on the reverse side. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid high humidity.AVELOX I.V. (moxifloxacin hydrochloride in sodium chloride injection) is available in ready-to-use 250 mL latex-free flexible bags containing 400 mg of moxifloxacin in 0.8% saline. NO FURTHER DILUTION OF THIS PREPARATION IS NECESSARY.Parenteral drug products should be inspected visually for particulate matter prior to administration. Samples containing visible particulates should not be used.Since the premix flexible containers are for single-use only, any unused portion should be discarded.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE – PRODUCT PRECIPITATES UPON REFRIGERATION.AVELOX (moxifloxacin hydrochloride) Tablets are available as oblong, dull red film-coated tablets containing 400 mg moxifloxacin.The tablet is coded with the word “BAYER” on one side and “M400” on the reverse side. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid high humidity.AVELOX I.V. (moxifloxacin hydrochloride in sodium chloride injection) is available in ready-to-use 250 mL latex-free flexible bags containing 400 mg of moxifloxacin in 0.8% saline. NO FURTHER DILUTION OF THIS PREPARATION IS NECESSARY.Parenteral drug products should be inspected visually for particulate matter prior to administration. Samples containing visible particulates should not be used.Since the premix flexible containers are for single-use only, any unused portion should be discarded.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE – PRODUCT PRECIPITATES UPON REFRIGERATION.AVELOX (moxifloxacin hydrochloride) Tablets are available as oblong, dull red film-coated tablets containing 400 mg moxifloxacin.The tablet is coded with the word “BAYER” on one side and “M400” on the reverse side. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid high humidity.AVELOX I.V. (moxifloxacin hydrochloride in sodium chloride injection) is available in ready-to-use 250 mL latex-free flexible bags containing 400 mg of moxifloxacin in 0.8% saline. NO FURTHER DILUTION OF THIS PREPARATION IS NECESSARY.Parenteral drug products should be inspected visually for particulate matter prior to administration. Samples containing visible particulates should not be used.Since the premix flexible containers are for single-use only, any unused portion should be discarded.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE – PRODUCT PRECIPITATES UPON REFRIGERATION.AVELOX (moxifloxacin hydrochloride) Tablets are available as oblong, dull red film-coated tablets containing 400 mg moxifloxacin.The tablet is coded with the word “BAYER” on one side and “M400” on the reverse side. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid high humidity.AVELOX I.V. (moxifloxacin hydrochloride in sodium chloride injection) is available in ready-to-use 250 mL latex-free flexible bags containing 400 mg of moxifloxacin in 0.8% saline. NO FURTHER DILUTION OF THIS PREPARATION IS NECESSARY.Parenteral drug products should be inspected visually for particulate matter prior to administration. Samples containing visible particulates should not be used.Since the premix flexible containers are for single-use only, any unused portion should be discarded.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE – PRODUCT PRECIPITATES UPON REFRIGERATION.AVELOX (moxifloxacin hydrochloride) Tablets are available as oblong, dull red film-coated tablets containing 400 mg moxifloxacin.The tablet is coded with the word “BAYER” on one side and “M400” on the reverse side. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid high humidity.AVELOX I.V. (moxifloxacin hydrochloride in sodium chloride injection) is available in ready-to-use 250 mL latex-free flexible bags containing 400 mg of moxifloxacin in 0.8% saline. NO FURTHER DILUTION OF THIS PREPARATION IS NECESSARY.Parenteral drug products should be inspected visually for particulate matter prior to administration. Samples containing visible particulates should not be used.Since the premix flexible containers are for single-use only, any unused portion should be discarded.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. DO NOT REFRIGERATE – PRODUCT PRECIPITATES UPON REFRIGERATION.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Moxifloxacin, given as an oral tablet, is well absorbed from the
gastrointestinal tract. The absolute bioavailability of moxifloxacin is
approximately 90 percent. Co-administration with a high fat meal (i.e., 500
calories from fat) does not affect the absorption of moxifloxacin.
Consumption of 1 cup of yogurt with moxifloxacin does not significantly
affect the extent or rate of systemic absorption (AUC).
Mean Steady-State Plasma Concentrations of
Moxifloxacin Obtained With Once Daily Dosing of 400 mg Either Orally (n=10) or
by I.V. Infusion (n=12)
Moxifloxacin is approximately 30-50% bound to serum proteins,
independent of drug concentration. The volume of distribution of moxifloxacin
ranges from 1.7 to 2.7 L/kg. Moxifloxacin is widely distributed throughout the
body, with tissue concentrations often exceeding plasma concentrations.
Moxifloxacin 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 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 from tissues generally parallel
the elimination from plasma.
Approximately 52% of an oral or intravenous dose of moxifloxacin
is metabolized via glucuronide and sulfate conjugation. The cytochrome P450
system is not involved in moxifloxacin metabolism, and is not affected by
moxifloxacin. 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.
In vitro
Approximately 45% of an oral or intravenous dose of moxifloxacin
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.
Non-Clinical Toxicology
Moxifloxacin is contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antimicrobial agents.Tendinopathy and Tendon Rupture:
QT prolongation:
Pharmacokinetic studies between moxifloxacin and other drugs that prolong the QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants have not been performed. An additive effect of moxifloxacin and these drugs cannot be excluded; therefore caution should be exercised when moxifloxacin is given concurrently with these drugs. In premarketing clinical trials, the rate of cardiovascular adverse events was similar in 798 moxifloxacin and 702 comparator treated patients who received concomitant therapy with drugs known to prolong the QTc interval.
Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia. The magnitude of QT prolongation may increase with increasing concentrations of the drug or increasing rates of infusion of the intravenous formulation. Therefore the recommended dose or infusion rate should not be exceeded. QT prolongation may lead to an increased risk for ventricular arrhythmias including torsade de pointes. No cardiovascular morbidity or mortality attributable to QTc prolongation occurred with moxifloxacin treatment in over 9,200 patients in controlled clinical studies, including 223 patients who were hypokalemic at the start of treatment, and there was no increase in mortality in over 18,000 moxifloxacin tablet treated patients in a post-marketing observational study in which ECGs were not performed. (See . For I.V. use, see and ) In addition, moxifloxacin should be used with caution in patients with mild, moderate, or severe liver cirrhosis. (See , .)
The oral administration of moxifloxacin caused lameness in immature dogs. Histopathological examination of the weight-bearing joints of these dogs revealed permanent lesions of the cartilage. Related quinolone-class drugs also produce erosions of cartilage of weight-bearing joints and other signs of arthropathy in immature animals of various species. (See .)
Convulsions have been reported in patients receiving quinolones. Quinolones may also cause central nervous system (CNS) events including: dizziness, confusion, tremors, hallucinations, depression, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose. If these reactions occur in patients receiving moxifloxacin, the drug should be discontinued and appropriate measures instituted. As with all quinolones, moxifloxacin should be used with caution in patients with known or suspected CNS disorders (e.g. severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold. (See , , and .)
Hypersensitivity reactions:
Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with quinolones, including AVELOX. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:
The drug should be discontinued immediately at the first appearance of a skin rash, jaundice, or any other sign of hypersensitivity and supportive measures instituted (See and ).
Clostridium difficile
C. difficile
C. difficile
C. difficile
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , and surgical evaluation should be instituted as clinically indicated.
Peripheral neuropathy:
Quinolones may cause central nervous system (CNS) events, including: nervousness, agitation, insomnia, anxiety, nightmares or paranoia. (See and .)
Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolone antibiotics after sun or UV light exposure. Therefore, excessive exposure to these sources of light should be avoided. Drug therapy should be discontinued if phototoxicity occurs (See and ).
Prescribing AVELOX in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Clinical efficacy trials enrolled over 9,200 moxifloxacin orally and intravenously treated patients, of whom over 8,600 patients received the 400 mg dose. Most adverse events reported in moxifloxacin trials were described as mild to moderate in severity and required no treatment. Moxifloxacin was discontinued due to adverse reactions thought to be drug-related in 2.9% of orally treated patients and 6.3 % of sequentially (intravenous followed by oral) treated patients. The latter studies were conducted in community acquired pneumonia and complicated skin and skin structure infections and complicated intra-abdominal infections with, in general, a sicker patient population compared to the tablet studies.
Adverse reactions, judged by investigators to be at least possibly drug-related, occurring in greater than or equal to 2% of moxifloxacin treated patients were: nausea (6%), diarrhea (5%), dizziness (2%).
Additional clinically relevant uncommon events, judged by investigators to be at least possibly drug-related, that occurred in greater than or equal to 0.1% and less than 2% of moxifloxacin treated patients were:
BODY AS A WHOLE: abdominal pain, headache, asthenia, dehydration (secondary to diarrhea or reduced fluid intake), injection site reaction (including phlebitis), malaise, moniliasis, pain, allergic reaction
CARDIOVASCULAR: cardiac arrhythmia (not otherwise specified), tachycardia, palpitation, vasodilation, QT interval prolonged
DIGESTIVE: vomiting, abnormal liver function test (increased transaminases, increased bilirubin), dyspepsia, dry mouth, flatulence, oral moniliasis, constipation, GGTP increased, anorexia, stomatitis, glossitis
HEMIC AND LYMPHATIC: leukopenia, eosinophilia, prothrombin decrease (prothrombin time prolonged/International Normalized Ratio (INR) increased), thrombocythemia
METABOLIC AND NUTRITIONAL: lactic dehydrogenase increased, amylase increased
MUSCULOSKELETAL: arthralgia, myalgia
NERVOUS SYSTEM: insomnia, nervousness, vertigo, somnolence, anxiety, tremor
SKIN/APPENDAGES: rash (maculopapular, purpuric, pustular), pruritus, sweating, urticaria
SPECIAL SENSES: taste perversion
UROGENITAL: vaginal moniliasis, vaginitis
Additional clinically relevant rare events, judged by investigators to be at least possibly drug-related, that occurred in less than 0.1% of moxifloxacin treated patients were:
abnormal dreams, abnormal vision (visual disturbances temporally associated with CNS symptoms), agitation, amblyopia, amnesia, anemia, aphasia, arthritis, asthma, atrial fibrillation, back pain, chest pain, confusion, convulsions of various clinical manifestations (including grand mal convulsions), depersonalization, depression (potentially culminating in self-endangering behavior), dysphagia, dyspnea, ECG abnormal, emotional lability, face edema, gastritis, gastrointestinal disorder, hallucinations, hyperglycemia, hyperlipidemia, hypertension, hypertonia, hyperuricemia, hypesthesia, hypotension, incoordination, jaundice (predominantly cholestatic), kidney function abnormal, lab test abnormal (not specified), leg pain, paraesthesia, parosmia, pelvic pain, peripheral edema, photosensitivity/phototoxicity reactions, pseudomembranous colitis, prothrombin increase (prothrombin time decreased/International Normalized Ratio (INR) decreased), sleep disorders, speech disorders, supraventricular tachycardia, syncope, taste loss, tendon disorder, thinking abnormal, thrombocytopenia, thromboplastin decrease, tinnitus, tongue discoloration, ventricular tachycardia
Additional adverse events have been reported from worldwide post-marketing experience with moxifloxacin. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events, some of them life-threatening, include anaphylactic reaction, anaphylactic shock, angioedema (including laryngeal edema), hepatic failure, including fatal cases, hepatitis (predominantly cholestatic), photosensitivity/phototoxicity reaction (see , psychotic reaction (very rarely culminating in self-endangering behavior), renal dysfunction or renal failure, Stevens-Johnson syndrome, tendon rupture, toxic epidermal necrolysis, and ventricular tachyarrhythmias (including in very rare cases cardiac arrest and torsade de pointes, and usually in patients with concurrent severe underlying proarrhythmic conditions). Cases of altered coordination and abnormal gait as well as exacerbation of myasthenia gravis have also been reported.
Changes in laboratory parameters, without regard to drug relationship, which are not listed above and which occurred in ≥ 2% of patients and at an incidence greater than in controls included: increases in MCH, neutrophils, WBCs, PT ratio, ionized calcium, chloride, albumin, globulin, bilirubin; decreases in hemoglobin, RBCs, neutrophils, eosinophils, basophils, PT ratio, glucose, pO, bilirubin and amylase. It cannot be determined if any of the above laboratory abnormalities were caused by the drug or the underlying condition being treated.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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