Moxifloxacin Hydrochloride: Uses,Dosage,Side Effects

Generic Name

Moxifloxacin Hydrochloride

Therapeutic Class: Anti Bacterial (4-Quinolone preparations)

Indications:
Moxifloxacin is indicated for the treatment of 

• acute bacterial sinusitis, 
• acute exacerbation of chronic bronchitis, 
• community-acquired pneumonia, 
• uncomplicated & complicated skin and skin structure infections, 
• complicated intra-abdominal infections, and 
• pelvic inflammatory disease.

Presentation:
Moxifloxacin 400: Each film-coated tablet contains Moxifloxacin Hydrochloride USP equivalent to Moxifloxacin 400 mg.
Moxifloxacin 400 mg IV infusion: Each bottle contains a 250 ml solution containing Moxifloxacin Hydrochloride BP equivalent to Moxifloxacin 400 mg.

Description:
Moxifloxacin is a 4th generation synthetic broad-spectrum, fluoroquinolone class of antibacterial drug. It has activity against a wide range of gram-positive, gram-negative, anaerobic, and atypical bacteria including Mycoplasma pneumoniae. It acts by inhibiting topoisomerase II (DNA gyrase) and topoisomerase IV which are necessary for bacterial DNA replication, transcription & repair.

Dosage & Administration:

• Acute bacterial sinusitis: 400 mg once daily 7-10 days.
• Acute bacterial exacerbation of chronic bronchitis: 400 mg once daily 5-10 days.
• Community-acquired pneumonia: 400 mg once daily 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 7-21 days.
• Complicated intra-abdominal infections: 400 mg once daily 5-14 days.
• Pelvic inflammatory disease: 400 mg once daily 14 days.

Moxifloxacin 400 mg IV infusion can be administered intravenously for the entire treatment duration. Alternatively, therapy may be initial intravenous administration, followed by oral administration when clinically indicated. The recommended duration of treatment for the indication being treated should not be exceeded. The solution for infusion should be infused intravenously over 60 minutes.

Elderly:
No adjustment of dosage is required in the elderly.
Children:
Efficacy and safety of Moxquin IV infusion in children and adolescents have not been established.

Administration
Moxifloxacin injection should be administered by intravenous infusion over a period of 60 minutes. Avoid bolus or rapid infusion.

• Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible bags in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of the bag.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend bag from the hanger.
• Squeeze and release drip chamber to establish proper fluid level in the chamber during infusion of Moxifloxacin 400 mg intravenous infusion.
• Open flow control clamp to expel air from set. Close clamp.
• Regulate the rate of administration with a flow control clamp.

Interaction:

There are no data concerning an interaction of intravenous fluoroquinolones with oral antacids, sucralfate, multivitamins, didanosine, or metal cations. However, no fluoroquinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Quinolones, including Moxifloxacin, have been reported to enhance the anticoagulant effects of warfarin or its derivatives in the patient population. Although not observed with Moxifloxacin in predinical and clinical trials, the concomitant administration of a nonsteroidal anti-inflammatory drug with a quinolone may increase the risks of CNS stimulation and convulsions. There is limited information available on the potential for a pharmacodynamic interaction in humans between Moxifloxacin and other drugs that prolong the QTc interval of the electrocardiogram. Sotalol, a Class III antiarrhythmic, has been shown to further increase the QTc interval when combined with high doses of intravenous (IV) Moxifloxacin in dogs. Therefore, Moxifloxacin should be avoided with Class IA and Class III antiarrhythmics.

Contraindications:
It is contraindicated in patients with a history of hypersensitivity to Moxifloxacin or other quinolones.

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.

Precautions:
Moxifloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Moxifloxacin should be discontinued if the patient experiences pain, swelling, inflammation, or rupture of a tendon.

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 the use of nearly all antibacterial agents, including Moxifloxacin, and may range in severity from mild diarrhea to fatal colitis.

Use in Special Populations:

• Pediatric patients: Safety and effectiveness in pediatric patients and adolescents less than 18 years of age have not been established.
• Geriatric patients: These patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Moxifloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy

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