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Uses
Moxifloxacin Hydrochloride is a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below:
•Acute Bacterial Sinusitis (
1.1
)•Acute Bacterial Exacerbation of Chronic Bronchitis (
1.2
)•Community Acquired Pneumonia (
1.3
)•Skin and Skin Structure Infections: Uncomplicated (
1.4
) and Complicated (
1.5
)•Complicated Intra-Abdominal Infections (
1.6)
•Plague (
1.7
) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Moxifloxacin Hydrochloride and other antibacterial drugs. Moxifloxacin Hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. (
1.8
)
Moxifloxacin Hydrochloride is indicated in adult patients (18 years of age and older) for the treatment of Acute Bacterial Sinusitis caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.1)].
Moxifloxacin Hydrochloride is indicated in adult patients for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, or Moraxella catarrhalis [see Clinical Studies (14.2)].
Moxifloxacin Hydrochloride is indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Clinical Studies (14.3)].
MDRSP isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
Moxifloxacin Hydrochloride is indicated in adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus or Streptococcus pyogenes [see Clinical Studies (14.4)].
Moxifloxacin Hydrochloride is indicated in adult patients for the treatment of Complicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae, or Enterobacter cloacae [see Clinical Studies (14.5)].
Moxifloxacin Hydrochloride is indicated in adult patients for the treatment of Complicated Intra-Abdominal Infections including polymicrobial infections such as abscess caused by susceptible isolates of Escherichia coli, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, Enterococcus faecalis, Proteus mirabilis, Clostridium perfringens, Bacteroides thetaiotaomicron, or Peptostreptococcus species [see Clinical Studies (14.6)].
Moxifloxacin Hydrochloride is indicated in adult patients for the treatment of plague, including pneumonic and septicemic plague, due to susceptible isolates of Yersinia pestis and prophylaxis of plague in adult patients. Efficacy studies of moxifloxacin could not be conducted in humans with plague for feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only [see Clinical Studies (14.7)].
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Moxifloxacin Hydrochloride and other antibacterial drugs, Moxifloxacin Hydrochloride 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.
History
There is currently no drug history available for this drug.
Other Information
Moxifloxacin Hydrochloride (moxifloxacin) hydrochloride is a synthetic antibacterial agent for oral and 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 C21H24FN3O4*HCl and its chemical structure is as follows:
•Moxifloxacin Hydrochloride 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.
Sources
Moxifloxacin Hydrochloride Manufacturers
-
Remedyrepack Inc.
Moxifloxacin Hydrochloride | Remedyrepack Inc.
Type of InfectionDose Every 24 hours
Duration
(days)
Acute Bacterial Sinusitis (1.1)
400 mg
10
Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)
400 mg
5
Community Acquired Pneumonia (1.3)
400 mg
7–14
Uncomplicated Skin and Skin Structure Infections (SSSI) (1.4)
400 mg
7
Complicated SSSI (1.5)
400 mg
7–21
Complicated Intra-Abdominal Infections (1.6)
400 mg
5–14
Plague (1.7)
400 mg
10–14
•No dosage adjustment in patients with renal or hepatic impairment. (
8.6
,
8.7
)
The dose of Moxifloxacin Hydrochloride 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.
Table 1: Dosage and Duration of Therapy in Adult PatientsType of Infectiona
Dose
Every 24 hoursDurationb
(days)Acute Bacterial Sinusitis (1.1)
400 mg
10
Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)
400 mg
5
Community Acquired Pneumonia (1.3)
400 mg
7–14
Uncomplicated Skin and Skin Structure Infections (SSSI) (1.4)
400 mg
7
Complicated SSSI (1.5)
400 mg
7–21
Complicated Intra-Abdominal Infections (1.6)
400 mg
5–14
Plague (1.7)C
400 mg
10–14
a)Due to the designated pathogens
[see Indications and Usage (1)].
b)Sequential therapy (intravenous to oral) may be instituted at the discretion of the physicianc)
Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis
.
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 Hydrochloride Injection may be switched to Moxifloxacin Hydrochloride Tablets when clinically indicated at the discretion of the physician.
Administer Moxifloxacin Hydrochloride 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 [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
Moxifloxacin Hydrochloride Tablets can be taken with or without food, drink fluids liberally.
-
Teva Pharmaceuticals Usa Inc
Moxifloxacin Hydrochloride | Walgreens
Directions For use in the ear only.
Adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear tip of applicator should not enter ear canal keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear use twice daily for up to 4 days if needed, or as directed by a doctor any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringeChildren under 12 years of age: consult a doctor.
-
Aurobindo Pharma Limited
Moxifloxacin Hydrochloride | Rugby Laboratories
shake well before using use only with enclosed dosing cup adults and children 12 years of age and over take 2 teaspoonfuls (10 mL) every 12 hours; do not take more than 4 teaspoonfuls (20 mL) in 24 hours children 2 to under 12 years of age take 1 teaspoonful (5 mL) every 12 hours; do not take more than 2 teaspoonfuls (10 mL) in 24 hours children under 2 years of age ask a doctor adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor -
American Health Packaging
Moxifloxacin Hydrochloride | American Health Packaging
2.1 Dosage in Adult PatientsThe dose of moxifloxacin is 400 mg (orally) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.
Table 1: Dosage and Duration of Therapy in Adult Patients Type of Infectiona Dose Every 24 hours Durationb (days) a) Due to the designated pathogens [see Indications and Usage (1), for IV use, see Use in Specific Populations (8.5)].
b) Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
Acute Bacterial Sinusitis (1.1)
400 mg
10
Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)
400 mg
5
Community Acquired Pneumonia
400 mg
7-14
Uncomplicated Skin and Skin Structure Infections (SSSI ) (1.4)
400 mg
7
Complicated SSSI (1.5)
400 mg
7-21
Complicated Intra-Abdominal Infections (1.6)
400 mg
5-14
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 hydrochloride IV may be switched to moxifloxacin hydrochloride tablets when clinically indicated at the discretion of the physician.
2.2 Drug Interactions with Multivalent CationsOral doses of moxifloxacin should be administered at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and VIDEX® (didanosine) chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
2.3 Administration InstructionsMoxifloxacin hydrochloride tablets can be taken with or without food, drink fluids liberally.
-
Torrent Pharmaceuticals Limited
Moxifloxacin Hydrochloride | Torrent Pharmaceuticals Limited
2.1 Dosage in Adult PatientsThe dose of moxifloxacin is 400 mg (orally) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.
Table 1: Dosage and Duration of Therapy in Adult Patientsa)Due to the designated pathogens [see Indications and Usage (1), for IV use, see Use in Specific Population (8.5)].
b)Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
Type of Infectiona
Dose Every 24 hours
Durationb (days)
Acute Bacterial Sinusitis (1.1)
400 mg
10
Acute Bacterial Exacerbation of Chronic Bronchitis (1.2)
400 mg
5
Community Acquired Pneumonia
400 mg
7-14
Uncomplicated Skin and Skin Structure Infections (SSSI ) (1.4)
400 mg
7
Complicated SSSI (1.5)
400 mg
7-21
Complicated Intra-Abdominal Infections (1.6)
400 mg
5-14
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 hydrochloride IV may be switched to moxifloxicin hydrochloride tablets when clinically indicated at the discretion of the physician.
2.2 Drug interactions with Multivalent CationsOral doses of moxifloxacin hydrochloride tablets should be administered at least 4 hours before or 8 hours after products containing magnesium, aluminum, iron or zinc, including antacids, sucralfate, multivitamins and VIDEX® (didanosine) chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].
2.3 Administration InstructionsMoxifloxacin Hydrochloride Film-Coated Tablets
Moxifloxacin hydrochloride tablets can be taken with or without food, drink fluids liberally.
-
Alvogen, Inc.
Moxifloxacin Hydrochloride | Mylan Pharmaceuticals Inc.
2.1 Major Depressive Disorder Initial Treatment AdultInitiate fluoxetine tablets 20 mg/day orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon).The maximum fluoxetine dose should not exceed 80 mg/day.
In controlled trials used to support the efficacy of fluoxetine, patients were administered morning doses ranging from 20 to 80 mg/day. Studies comparing fluoxetine 20, 40, and 60 mg/day to placebo indicate that 20 mg/day is sufficient to obtain a satisfactory response in Major Depressive Disorder in most cases [see Clinical Studies (14.1)].
Pediatric (Children and Adolescents)Initiate fluoxetine tablets 10 or 20 mg/day. After one week at 10 mg/day, increase the dose to 20 mg/day. However, due to higher plasma levels in lower weight children, the starting and target dose in this group may be 10 mg/day. Consider a dose increase to 20 mg/day after several weeks if insufficient clinical improvement is observed. In the short-term (8 to 9 week) controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Major Depressive Disorder, patients were administered fluoxetine doses of 10 to 20 mg/day [see Clinical Studies (14.1)].
All PatientsAs with other drugs effective in the treatment of Major Depressive Disorder, the full effect may be delayed until 4 weeks of treatment or longer.
Periodically reassess to determine the need for maintenance treatment.
Switching Patients to a Tricyclic Antidepressant (TCA)Dosage of a TCA may need to be reduced, and plasma TCA concentrations may need to be monitored temporarily when fluoxetine is coadministered or has been recently discontinued [see Warnings and Precautions (5.2) and Drug Interactions (7.7)].
2.2 Obsessive Compulsive Disorder Initial Treatment AdultInitiate fluoxetine tablets 20 mg/day, orally in the morning. Consider a dose increase after several weeks if insufficient clinical improvement is observed. The full therapeutic effect may be delayed until 5 weeks of treatment or longer. Administer doses above 20 mg/day once daily in the morning or twice daily (i.e., morning and noon). A dose range of 20 to 60 mg/day is recommended; however, doses of up to 80 mg/day have been well tolerated in open studies of OCD. The maximum fluoxetine dose should not exceed 80 mg/day.
In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fixed daily doses of 20 mg, 40 mg or 60 mg of fluoxetine or placebo [see Clinical Studies (14.2)]. In one of these studies, no dose-response relationship for effectiveness was demonstrated.
Pediatric (Children and Adolescents)In adolescents and higher weight children, initiate treatment with a dose of 10 mg/day. After 2 weeks, increase the dose to 20 mg/day. Consider additional dose increases after several more weeks if insufficient clinical improvement is observed. A dose range of 20 to 60 mg/day is recommended.
In lower weight children, initiate treatment with a dose of 10 mg/day. Consider additional dose increases after several more weeks if insufficient clinical improvement is observed. A dose range of 20 to 30 mg/day is recommended. Experience with daily doses greater than 20 mg is very minimal, and there is no experience with doses greater than 60 mg.
In the controlled clinical trial of fluoxetine supporting its effectiveness in the treatment of OCD, patients were administered fluoxetine doses in the range of 10 to 60 mg/day [see Clinical Studies (14.2)].
Periodically reassess to determine the need for treatment.
2.3 Bulimia Nervosa Initial TreatmentAdminister fluoxetine tablets 60 mg/day in the morning. For some patients it may be advisable to titrate up to this target dose over several days. Fluoxetine doses above 60 mg/day have not been systematically studied in patients with bulimia. In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Bulimia Nervosa, patients were administered fixed daily fluoxetine doses of 20 mg or 60 mg, or placebo [see Clinical Studies (14.3)]. Only the 60 mg dose was statistically significantly superior to placebo in reducing the frequency of binge-eating and vomiting.
Periodically reassess to determine the need for maintenance treatment.
2.4 Panic Disorder Initial TreatmentInitiate treatment with fluoxetine tablets 10 mg/day. After one week, increase the dose to 20 mg/day. Consider a dose increase after several weeks if no clinical improvement is observed. Fluoxetine doses above 60 mg/day have not been systematically evaluated in patients with Panic Disorder. In the controlled clinical trials of fluoxetine supporting its effectiveness in the treatment of Panic Disorder, patients were administered fluoxetine doses in the range of 10 to 60 mg/day [see Clinical Studies (14.4)]. The most frequently administered dose in the two flexible-dose clinical trials was 20 mg/day.
Periodically reassess to determine the need for maintenance treatment.
2.5 Fluoxetine and Olanzapine in Combination: Depressive Episodes Associated with Bipolar I DisorderWhen using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.
AdultAdminister fluoxetine in combination with oral olanzapine once daily in the evening, without regard to meals, generally beginning with 5 mg of oral olanzapine and 20 mg of fluoxetine. Make dosage adjustments, if indicated, according to efficacy and tolerability within dose ranges of fluoxetine 20 mg to 50 mg and oral olanzapine 5 mg to 12.5 mg. Antidepressant efficacy was demonstrated with olanzapine and fluoxetine in combination with a dose range of olanzapine 6 mg to 12 mg and fluoxetine 25 mg to 50 mg. Safety of coadministration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated in clinical studies. Periodically re-examine the need for continued pharmacotherapy.
Safety and efficacy of fluoxetine in combination with olanzapine was determined in clinical trials supporting approval of Symbyax® (fixed-dose combination of olanzapine and fluoxetine). Symbyax® is dosed between 3 mg/25 mg (olanzapine/fluoxetine) per day and 12 mg/50 mg (olanzapine/fluoxetine) per day. The following table demonstrates the appropriate individual component doses of fluoxetine and olanzapine vs. Symbyax®. Adjust dosage, if indicated, with the individual components according to efficacy and tolerability.
Table 1: Approximate Dose Correspondence Between Symbyax®* and the Combination of Fluoxetine and Olanzapine * Symbyax ® (olanzapine/fluoxetine hydrochloride) is a fixed-dose combination of fluoxetine and olanzapine.For Symbyax®
(mg/day)
Use in Combination
Olanzapine
(mg/day)
Fluoxetine
(mg/day)
3 mg olanzapine/25 mg fluoxetine
2.5
20
6 mg olanzapine/25 mg fluoxetine
5
20
12 mg olanzapine/25 mg fluoxetine
10 + 2.5
20
6 mg olanzapine/50 mg fluoxetine
5
40 + 10
12 mg olanzapine/50 mg fluoxetine
10 + 2.5
40 + 10
Fluoxetine tablet monotherapy is not indicated for the treatment of depressive episodes associated with Bipolar I Disorder.
2.7 Dosing in Specific Populations Treatment of Pregnant WomenWhen treating pregnant women with fluoxetine tablets, the physician should carefully consider the potential risks and potential benefits of treatment. Neonates exposed to SSRIs or SNRIs late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding [see Use in Specific Populations (8.1)].
GeriatricConsider a lower or less frequent dosage for the elderly [see Use in Specific Populations (8.5)].
Hepatic ImpairmentAs with many other medications, use a lower or less frequent dosage in patients with hepatic impairment [see Clinical Pharmacology (12.4) and Use in Specific Populations (8.6)].
Concomitant IllnessPatients with concurrent disease or on multiple concomitant medications may require dosage adjustments [see Clinical Pharmacology (12.4) and Warnings and Precautions (5.11)].
Fluoxetine and Olanzapine in CombinationUse a starting dose of oral olanzapine 2.5 mg to 5 mg with fluoxetine 20 mg for patients with a predisposition to hypotensive reactions, patients with hepatic impairment, or patients who exhibit a combination of factors that may slow the metabolism of olanzapine or fluoxetine in combination (female gender, geriatric age, nonsmoking status), or those patients who may be pharmacodynamically sensitive to olanzapine. Titrate slowly and adjust dosage as needed in patients who exhibit a combination of factors that may slow metabolism. Fluoxetine and olanzapine in combination have not been systematically studied in patients over 65 years of age or in patients less than 10 years of age [see Warnings and Precautions (5.16) and Drug Interactions (7.7)].
2.8 Discontinuation of TreatmentSymptoms associated with discontinuation of fluoxetine, SNRIs, and SSRIs, have been reported [see Warnings and Precautions (5.15)].
2.9 Switching a Patient to or from a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric DisordersAt least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with fluoxetine tablets. Conversely, at least 5 weeks should be allowed after stopping fluoxetine tablets before starting an MAOI intended to treat psychiatric disorders [see Contraindications (4.1)].
2.10 Use of Fluoxetine Tablets with Other MAOIs such as Linezolid or Methylene BlueDo not start fluoxetine tablets in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered [see Contraindications (4.1)].
In some cases, a patient already receiving fluoxetine tablet therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, fluoxetine tablets should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 5 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with fluoxetine tablets may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue [see Warnings and Precautions (5.2)].
The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with fluoxetine tablets is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use [see Warnings and Precautions (5.2)].
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