Moxifloxacin Hydrochloride Injection is indicated for the treatment of the following infections in adults over 18 years of age caused by susceptible bacteria:

• Acute bacterial sinusitis
• Acute bacterial exacerbation of chronic bronchitis
• Community-acquired pneumonia
• Skin and skin structure infections, both uncomplicated and complicated
• Complicated intra-abdominal infections

The recommended dose of Moxifloxacin is 400 mg once daily. The duration of treatment depends on the type of infection, as outlined below:

• 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

Moxifloxacin Injection should be administered by intravenous infusion over 60 minutes. Bolus injection or rapid infusion should be avoided. Before administration, inspect the infusion bag carefully:

• Squeeze the inner bag firmly to check for small leaks. If any leakage is detected or the seal is broken, discard the solution.
• Do not use the solution if it appears cloudy or if any precipitate is present.
• Do not connect flexible bags in series.
• Instructions for Use:
• Close the flow control clamp of the administration set.
• Remove the cover from the port at the bottom of the bag.
• Insert the piercing pin of the administration set into the port with a twisting motion until it is firmly seated.
• Hang the bag on the infusion stand.
• Squeeze and release the drip chamber to establish the proper fluid level during infusion of Moxifloxacin 400 mg IV infusion.
• Open the flow control clamp to expel air from the administration set, then close the clamp.
• Adjust the rate of administration using the flow control clamp.

There are no available data regarding interactions between intravenous fluoroquinolones and oral antacids, sucralfate, multivitamins, didanosine, or metal cations. However, no fluoroquinolone should be administered through the same intravenous line with any solution containing multivalent cations, such as magnesium. Quinolones, including Moxifloxacin, have been reported to enhance the anticoagulant effects of warfarin and its derivatives in some patients. Although this effect was not observed with Moxifloxacin during preclinical and clinical studies, caution is advised when these drugs are used together. Although not seen with Moxifloxacin in preclinical and clinical trials, the combined use of a quinolone with a nonsteroidal anti-inflammatory drug (NSAID) may increase the risk of central nervous system (CNS) stimulation and convulsions. There is limited information in humans regarding the potential pharmacodynamic interaction between Moxifloxacin and other drugs that prolong the QTc interval on the electrocardiogram. Sotalol, a Class III antiarrhythmic, has been shown in animal studies to further increase the QTc interval when used with high-dose intravenous Moxifloxacin. Therefore, Moxifloxacin should be avoided in combination with Class IA and Class III antiarrhythmic drugs.

Moxifloxacin is contraindicated in patients with known hypersensitivity to Moxifloxacin or to any other quinolone antibacterial agents.

Treatment with Moxifloxacin (oral, intravenous, or sequential therapy) may lead to certain adverse effects. Common side effects (occurring in more than 1% of patients) include headache, nausea, vomiting, diarrhea, constipation, abdominal pain, indigestion, dizziness, fever, and insomnia. Less common side effects (occurring in 0.1% to less than 1% of patients) include neutropenia, palpitations, tachycardia, bradycardia, vertigo, tinnitus, dry mouth, gastritis, edema, fatigue, malaise, increased blood sugar (hyperglycemia), loss of appetite (anorexia), elevated lipid levels (hyperlipidemia), low blood sugar (hypoglycemia), dehydration, back pain, and joint pain (arthralgia).

Pregnancy Category C. Adequate and well-controlled studies in pregnant women have not been conducted. Therefore, Moxifloxacin should be used during pregnancy only if the expected benefit outweighs the potential risk to the fetus. Moxifloxacin is excreted in the milk of rats and may also be excreted in human breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made either to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the medication to the mother.

Fluoroquinolones, including Moxifloxacin, are associated with an increased risk of tendinitis and tendon rupture in patients of all age groups. This risk is further increased in older adults, particularly those over 60 years of age, in patients receiving corticosteroid therapy, and in individuals who have undergone kidney, heart, or lung transplantation. Fluoroquinolones may also have neuromuscular blocking activity and can worsen muscle weakness in patients with myasthenia gravis. Clostridium difficile-associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including Moxifloxacin. The severity may range from mild diarrhea to fatal colitis.

Pediatric patients: The safety and effectiveness of Moxifloxacin have not been established in children and adolescents under 18 years of age.

Geriatric patients: Elderly patients are at increased risk of developing serious tendon disorders, including tendon rupture, during treatment with fluoroquinolones such as Moxifloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy.

4-Quinolone antibacterial preparation

Store below 25°C, protected from light. Do not expose to excessive heat or freezing temperatures. Keep out of the reach of children.