Moxikem

Approved Indications:

• Community-Acquired Pneumonia (CAP)
  Including infections caused by multidrug-resistant Streptococcus pneumoniae.
• Acute Bacterial Sinusitis (ABS)
  Caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis.
• Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
  In patients with chronic obstructive pulmonary disease (COPD).
• Uncomplicated and Complicated Skin and Skin Structure Infections (SSSIs)
  Including abscesses, cellulitis, and wound infections.
• Complicated Intra-abdominal Infections (cIAIs)
  As monotherapy or in combination with metronidazole.
• Plague (including pneumonic and septicemic)
  Treatment and post-exposure prophylaxis.
• Bacterial Conjunctivitis (Ophthalmic Formulation)
  Caused by Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, and others.

Off-label (Clinically Accepted) Uses:

• Tuberculosis (MDR/XDR-TB):
  Used as part of combination therapy for multidrug-resistant tuberculosis.
• Prophylaxis for Anthrax (Post-exposure):
  Alternative to ciprofloxacin in penicillin-allergic patients.

Adults:

• Oral/IV (Systemic Infections):
• 400 mg once daily
• Duration varies by condition:
• CAP: 7–14 days
• ABS: 10 days
• ABECB: 5–10 days
• Skin infections: 7–21 days
• cIAIs: 5–14 days (with or without metronidazole)
• Plague: 10–14 days
• Ophthalmic (0.5% solution):
• 1 drop in affected eye(s) 3 times daily for 7 days

Pediatric Use:

• Systemic use:
  Not recommended due to risk of musculoskeletal adverse effects.
• Ophthalmic use (≥4 months):
  Safe and effective.

Elderly:

• No dosage adjustment required unless renal function is severely impaired.

Renal Impairment:

• Systemic use:
  No adjustment needed in mild-to-moderate renal impairment; use with caution in severe impairment.

Hepatic Impairment:

• Mild-to-Moderate: No dose adjustment needed.
• Severe Hepatic Dysfunction: Use with caution due to altered metabolism.

Route of Administration:

• Oral tablets (400 mg), IV infusion over 60 minutes, ophthalmic drops.

Moxifloxacin Hydrochloride is a broad-spectrum fluoroquinolone antibiotic that inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, essential enzymes for DNA replication, transcription, repair, and recombination. Inhibition of DNA gyrase leads to the prevention of supercoiling of DNA, while inhibition of topoisomerase IV impairs chromosome separation during cell division. This dual action leads to bactericidal activity against a wide range of Gram-positive, Gram-negative, atypical, and anaerobic organisms, including strains resistant to other antibiotics.

• Absorption:
  Rapidly and nearly completely absorbed after oral administration.
  Bioavailability: ~90%.
  Tmax: 1–3 hours (oral), immediate (IV).
• Distribution:
  Widely distributed in tissues, especially lungs and sinuses.
  Volume of distribution: ~1.7–2.7 L/kg.
  Plasma protein binding: ~40–50%.
• Metabolism:
  Primarily hepatic via glucuronidation and sulfation (non-CYP450 enzymes).
  Does not inhibit or induce CYP450 enzymes.
• Elimination:
• 45% excreted unchanged (biliary and renal).
• 52% excreted as metabolites.
• Half-life: ~12 hours.
• Elimination routes: feces (major), urine (minor).

• Pregnancy:
  Formerly FDA Category C. Animal studies showed fetal toxicity at high doses. Avoid use unless benefits outweigh risks. Not recommended during pregnancy, especially in the first trimester.
• Lactation:
  Excreted in small amounts into breast milk. Potential risk of joint/cartilage damage in nursing infants. Avoid or use with caution; consider alternative agents if prolonged use is necessary.
• Note:
  Fluoroquinolones generally avoided in pregnancy and lactation unless no alternatives are available.

• Primary Class: Antibacterial (Fluoroquinolone Antibiotic)
• Subclass: Fourth-generation fluoroquinolone
• Activity: Broad-spectrum (Gram-positive, Gram-negative, anaerobic, atypical)

• Known hypersensitivity to moxifloxacin, other quinolones, or excipients.
• History of QT prolongation or torsades de pointes.
• Uncorrected hypokalemia or hypomagnesemia.
• Use with Class IA or Class III antiarrhythmics (e.g., quinidine, amiodarone).
• Children and adolescents for systemic use (due to cartilage toxicity).

• Tendinitis & Tendon Rupture:
  Especially in elderly, corticosteroid users, or renal impairment.
• QT Interval Prolongation:
  Avoid in patients with cardiac arrhythmias or electrolyte imbalances.
• CNS Effects:
  Risk of seizures, confusion, tremor, and hallucinations.
• Peripheral Neuropathy:
  May be irreversible; discontinue immediately if symptoms occur.
• Hepatotoxicity:
  Monitor liver function in long-term or high-dose therapy.
• Photosensitivity:
  Avoid excessive sunlight; wear protective clothing and sunscreen.
• Clostridioides difficile-associated diarrhea (CDAD):
  May occur during or after antibiotic treatment.
• Myasthenia Gravis:
  May exacerbate muscle weakness; avoid use.

Common:

• GI: Nausea, vomiting, diarrhea, abdominal pain
• CNS: Headache, dizziness, insomnia
• Dermatologic: Rash, pruritus
• Musculoskeletal: Arthralgia

Less Common/Serious:

• QT prolongation, palpitations
• Tendonitis or tendon rupture
• Peripheral neuropathy
• Hepatic enzyme elevations, hepatitis
• CNS disturbances (hallucinations, seizures)

Rare:

• Anaphylaxis, Stevens-Johnson syndrome
• Blood dyscrasias (thrombocytopenia, leukopenia)
• Severe hepatotoxicity, liver failure

Onset:

• Tendinopathy may occur within days or months of starting therapy.
• CNS side effects can appear even after a single dose.

• QT-Prolonging Agents (e.g., amiodarone, sotalol):
  Additive effect; avoid concurrent use.
• Antacids, Sucralfate, Multivitamins with Zinc/Iron:
  Significantly reduce absorption. Administer moxifloxacin at least 4 hours before or 8 hours after such agents.
• Corticosteroids:
  Increased risk of tendon rupture.
• NSAIDs:
  May increase risk of CNS stimulation or seizures.
• No major CYP450 interactions.
  Does not significantly inhibit or induce CYP enzymes.

• QT-Prolonging Agents (e.g., amiodarone, sotalol):
  Additive effect; avoid concurrent use.
• Antacids, Sucralfate, Multivitamins with Zinc/Iron:
  Significantly reduce absorption. Administer moxifloxacin at least 4 hours before or 8 hours after such agents.
• Corticosteroids:
  Increased risk of tendon rupture.
• NSAIDs:
  May increase risk of CNS stimulation or seizures.
• No major CYP450 interactions.
  Does not significantly inhibit or induce CYP enzymes.

• Oral Tablets:
  Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C–30°C.
  Protect from light and moisture. Keep in original container.
• IV Solution:
  Store at 15°C to 30°C (59°F to 86°F).
  Do not refrigerate or freeze.
  Use within 14 days once removed from outer protective packaging.
• Ophthalmic Solution (0.5%):
  Store at 15°C to 25°C.
  Do not freeze. Discard 28 days after opening.
• Handling Precautions:
  Avoid contact with strong acids or bases.
  Keep away from direct sunlight and moisture.