Moxifloxacin Hydrochloride

Moxifloxacin Hydrochloride Manufacturers

• Remedyrepack Inc.
  

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  Moxifloxacin Hydrochloride | Remedyrepack Inc.

  

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  Type of Infection

  Dose 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 Patients

  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 (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.

   

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• Teva Pharmaceuticals Usa Inc
  

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  Moxifloxacin Hydrochloride | Walgreens

  

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  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 syringe

  ​Children under 12 years of age: consult a doctor.

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• Aurobindo Pharma Limited
  

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  Moxifloxacin Hydrochloride | Rugby Laboratories

  

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  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

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• American Health Packaging
  

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  Moxifloxacin Hydrochloride | American Health Packaging

  

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  2.1 Dosage in Adult Patients

  The 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 Cations

  Oral 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 Instructions

  Moxifloxacin hydrochloride tablets can be taken with or without food, drink fluids liberally.

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• Torrent Pharmaceuticals Limited
  

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  Moxifloxacin Hydrochloride | Torrent Pharmaceuticals Limited

  

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  2.1 Dosage in Adult Patients

  The 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

  a)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 Cations

  Oral 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 Instructions

  Moxifloxacin Hydrochloride Film-Coated Tablets

  Moxifloxacin hydrochloride tablets can be taken with or without food, drink fluids liberally.

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• Alvogen, Inc.
  

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  Moxifloxacin Hydrochloride | Mylan Pharmaceuticals Inc.

  

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  2.1 Major Depressive Disorder Initial Treatment Adult

  Initiate 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 Patients

  As 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 Adult

  Initiate 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 Treatment

  Administer 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 Treatment

  Initiate 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 Disorder

  When using fluoxetine and olanzapine in combination, also refer to the Clinical Studies section of the package insert for Symbyax®.

  Adult

  Administer 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 Women

  When 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)].

  Geriatric

  Consider a lower or less frequent dosage for the elderly [see Use in Specific Populations (8.5)].

  Hepatic Impairment

  As 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 Illness

  Patients 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 Combination

  Use 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 Treatment

  Symptoms 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 Disorders

  At 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 Blue

  Do 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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