Indications

Moxifloxacin Hydrochloride Injection is indicated for treating following infections in adults >18 years of age caused by designated, susceptible bacteria. Acute Bacterial Sinusitis Acute Bacterial Exacerbation of Chronic Bronchitis Community Acquired Pneumonia Skin and Skin Structure Infections: Uncomplicated and Complicated Complicated Intra-Abdominal Infections.

Composition

Pharmacology

Dosage & Administration

The dose of Moxifloxacin is 400 mg once daily. The duration of therapy depends on the type of infection as described in following: Acute Bacterial Sinusitis: 400 mg once daily for 10 days. Acute Bacterial Exacerbation of Chronic Bronchitis: 400 mg once daily for 5 days. Community Acquired Pneumonia: 400 mg once daily for 7-14 days. Uncomplicated Skin and Skin Structure Infections: 400 mg once daily for 7 days. Complicated Skin and Skin Structure Infections: 400 mg once daily for 7-21 days. Complicated Intra-Abdominal Infections: 400 mg once daily for 5-14 days.

Contraindications

Moxifloxacin is contraindicated in persons with known hypersensitivity to Moxifloxacin or other quinolone antibacterials.

Side Effects

Treatment with Moxifloxacin (oral, IV or sequential therapy) may cause some side effects. Common (>1%) side effects include headache, nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, dizziness, pyrexia and insomnia etc. Less common (0.1 to <1%) side effects include neutropenia, palpitations, tachycardia, bradycardia, vertigo, tinnitus, dry mouth, gastritis, edema, fatigue, malaise, hyperglycemia, anorexia, hyperlipidemia, hypoglycemia, dehydration, back pain and arthralgia etc.

Pregnancy & Lactation

Pregnancy Category C. Because no adequate or well controlled studies have been conducted in pregnant women, Moxifloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Moxifloxacin is excreted in the breast milk of rats. Moxifloxacin may also be excreted in human milk. Because of the potential for serious adverse reactions in infants who are nursing from mothers taking Moxifloxacin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Precautions & Warnings

Fluoroquinolones, including Moxifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Moxifloxacin, and may range in severity from mild diarrhea to fatal colitis.

Therapeutic Class

4-Quinolone preparations

Storage Conditions

Store below 25°C and protect from light. Avoid extreme heat and freezing. Keep out of reach of children.