Moxifloxacin Hydrochloride: Package Insert and Label Information

MOXIFLOXACIN HYDROCHLORIDE- moxifloxacin hydrochloride tablet
Torrent Pharmaceuticals Limited

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

  • Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together ( 5.1) including:
  • Tendinitis and tendon rupture [see Warnings and Precautions ( 5.2)]
  • Peripheral neuropathy [see Warnings and Precautions ( 5.3)]
  • Central nervous system effects [see Warnings and Precautions ( 5.4)]

Discontinue moxifloxacin hydrochloride immediately and avoid the use of fluoroquinolones, including moxifloxacin hydrochloride, in patients who experience any of these serious adverse reactions [see Warnings and Precautions ( 5.1)].

  • Fluoroquinolones, including moxifloxacin hydrochloride, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid moxifloxacin hydrochloride in patients with known history of myasthenia gravis [see Warnings and Precautions ( 5.5)].
  • Because fluoroquinolones, including moxifloxacin hydrochloride, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1 to 5.13) ] , reserve moxifloxacin hydrochloride for use in patients who have no alternative treatment options for the following indications:
  • Acute bacterial sinusitis [see Indications and Usage ( 1 .6)]
  • Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage ( 1 .7)]

1 INDICATIONS AND USAGE

1.1 Community Acquired Pneumonia

Moxifloxacin tablets are 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]), Homophiles 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.

1.2 Uncomplicated Skin and Skin Structure Infections

Moxifloxacin tablets are 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)].

1.3 Complicated Skin and Skin Structure Infections

Moxifloxacin tablets are 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)].

1.4 Complicated Intra-Abdominal Infections

Moxifloxacin tablets are indicated in adult patients for the treatment of Complicated Intra-Abdominal Infections (cIAI) 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)] .

1.5 Plague

Moxifloxacin tablets are 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)] .

1.6 Acute Bacterial Sinusitis

Moxifloxacin tablets are indicated in adult patients (18 years of age and older) for the treatment of Acute Bacterial Sinusitis (ABS) caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae , or Moraxella catarrhalis [see Clinical Studies ( 14.1)] .

Because fluoroquinolones, including moxifloxacin hydrochloride, have been associated with serious adverse reactions [ see Warnings and Precautions ( 5.1 to 5.14)] and for some patients ABS is self-limiting, reserve moxifloxacin hydrochloride for treatment of ABS in patients who have no alternative treatment options.

1.7 Acute Bacterial Exacerbation of Chronic Bronchitis

Moxifloxacin tablets are indicated in adult patients for the treatment of Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) 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)].

Because fluoroquinolones, including moxifloxacin hydrochloride, have been associated with serious adverse reactions [ see Warnings and Precautions ( 5.1 to 5.14)] and for some patients ABECB is self-limiting, reserve moxifloxacin hydrochloride for treatment of ABECB in patients who have no alternative treatment options.

1.8 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin tablets and other antibacterial drugs, moxifloxacin tablets 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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adult Patients

The dose of moxifloxacin hydrochloride 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)].

b) Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician

c) Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.

Type of Infection a Dose Every 24 hours Duration b (days)
Community Acquired Pneumonia (1.1) 400 mg 7 to 14
Uncomplicated Skin and Skin Structure Infections (SSSI ) (1.2) 400 mg 7
Complicated SSSI (1.3) 400 mg 7 to 21
Complicated Intra-Abdominal Infections (1.4) 400 mg 5 to 14
Plague (1.5) C 400 mg 10 to 14
Acute Bacterial Sinusitis (ABS) (1.6) 400 mg 10
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) (1.7) 400 mg 5

Conversion of Intravenous to Oral Dosing in Adults

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 moxifloxicin tablets when clinically indicated at the discretion of the physician.

2.2 Important Administration Instructions

Moxifloxacin Tablets

With Multivalent Cations

Administer moxifloxacin 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)].

With Food

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

Missed Doses

If a dose is missed, it should be taken anytime but not later than 8 hours prior to the next scheduled dose. If less than 8 hours remain before the next dose, the missed dose should not be taken and treatment should be continued as prescribed with the next scheduled dose. Double doses should not be taken to compensate for a missed dose.

3 DOSAGE FORMS AND STRENGTHS

3.1 Moxifloxacin Tablets USP

Light pink colored, capsule shaped, biconvex, film-coated tablets debossed with ‘1201’ on one side and ‘400’ on other containing 400 mg moxifloxacin.

4 CONTRAINDICATIONS

Moxifloxacin tablets are contraindicated in persons with a history of hypersensitivity to moxifloxacin or any member of the quinolone class of antibacterials [see Warnings and Precautions ( 5.8)].

5 WARNINGS AND PRECAUTIONS

5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects

Fluoroquinolones, including moxifloxacin hydrochloride, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting moxifloxacin hydrochloride. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions ( 5.2, 5.3, 5.4)] .

Discontinue moxifloxacin hydrochloride immediately at the first signs or symptoms of any serious adverse reaction. In addition, avoid the use of fluoroquinolones, including moxifloxacin hydrochloride, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

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