Moxifloxacin Hydrochloride Tablets, 400 Mg
Generic Name: moxifloxacin hydrochloride tablets, 400 mg
Brand Names:
Moxifloxacin Hydrochloride Tablets, 400 Mg
11 DESCRIPTION Moxifloxacin hydrochloride, USP is a synthetic antibacterial agent for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals, slightly hygroscopic substance with a molecular weight of 437.9.
Overview
11 DESCRIPTION Moxifloxacin hydrochloride, USP is a synthetic antibacterial agent for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals, slightly hygroscopic substance with a molecular weight of 437.9.
Uses
1 INDICATIONS AND USAGE Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: Community Acquired Pneumonia ( 1.1 ) Skin and Skin Structure Infections: Uncomplicated ( 1.2 ) and Complicated ( 1.3 ) Complicated Intra-Abdominal Infections ( 1.4 ) Plague ( 1.5 ) Acute Bacterial Sinusitis ( 1.6 ) Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.7 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride and other antibacterial drugs. Moxifloxacin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
Dosage
2 DOSAGE AND ADMINISTRATION Type of Infection Dose Every 24 hours Duration (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 ) 400 mg 10 to 14 Acute Bacterial Sinusitis ( 1.6 ) 400 mg 10 Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.7 ) 400 mg 5 No dosage adjustment in patients with renal or hepatic impairment. ( 8.6 , 8.7 ) 2.1 Dosage in Adult Patients The dose of moxifloxacin tablets is 400 mg (orally) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1.
Side Effects
6 ADVERSE REACTIONS The following serious and otherwise important adverse reactions are discussed in greater detail in the warnings and precautions section of the label: • Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects [see Warnings and Precautions (5.1) ] • 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) ] • Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.5) ] • QT Prolongation [see Warnings and Precautions (5.6)] • Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions (5.7) ] •...
Interactions
7 DRUG INTERACTIONS Interacting Drug Interaction Multivalent cation-containing products including : antacids, sucralfate, multivitamins Decreased Moxifloxacin hydrochloride absorption. Take moxifloxacin tablet at least 4 hours before or 8 hours after these products. ( 2.2 , 7.1 , 12.3 ) Warfarin Anticoagulant effect enhanced. Monitor prothrombin time/INR, and bleeding. (6, 7.2 , 12.3 ) Class IA and Class III antiarrhythmics: Proarrhythmic effect may be enhanced. Avoid concomitant use. ( 5.6 , 7.5 ) Antidiabetic agents Carefully monitor blood glucose. ( 5.11 , 7.3 ) 7.1 Antacids, Sucralfate, Multivitamins and Other Products Containing Multivalent Cations Fluoroquinolones, including moxifloxacin hydrochloride, form chelates with alkaline earth and transition metal cations.
Warnings
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 [See warnings and Precautions (5.1) ], including: Tendinitis and tendon rupture [See warnings and Precautions (5.2)] Peripheral Neuropathy [See warnings and Pre... 5 WARNINGS AND PRECAUTIONS Prolongation of the QT interval and isolated cases of torsade de pointes has been reported. Avoid use in patients with known prolongation, proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischemia, hypokalemia, hypomagnesemia, and with drugs that prolong the QT interval. ( 5.6 , 7.5 , 8.5 ) Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions, including anaphylactic reactions, may occur after first or subsequent doses of moxifloxacin hydrochloride. Discontinue moxifloxacin hydrochloride at first sign of skin rash, jaundice or any other sign of hypersensitivity. ( 5.7 , 5.8 ) Clostridium difficile -Associated diarrhea: Evaluate if diarrhea occurs. 4 CONTRAINDICATIONS Moxifloxacin hydrochloride is 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) ]. Known hypersensitivity to Moxifloxacin hydrochloride or other quinolones ( 4 , 5.8 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available human data establishing a drug associated risk with the use of moxifloxacin. Based on animal studies with moxifloxacin, moxifloxacin may cause fetal harm. Moxifloxacin was not teratogenic when administered to pregnant rats (IV and oral), rabbits (IV), and monkeys (oral) at exposures that were 0.25–2.5 times of those at the human clinical dose (400 mg/day moxifloxacin).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 Moxifloxacin Tablets, USP Moxifloxacin Tablets, USP are available as dull red colored, caplet shaped, film coated tablets containing 400 mg moxifloxacin. The tablet is debossed with "M" on one side and "400" on other side.
Frequently Asked Questions
What is Moxifloxacin Hydrochloride Tablets, 400 Mg used for?▼
1 INDICATIONS AND USAGE Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: Community Acquired Pneumonia ( 1.1 ) Skin and Skin Structure Infections: Uncomplicated ( 1.2 ) and Complicated ( 1.3 ) Complicated Intra-Abdominal Infections ( 1.4 ) Plague ( 1.5 ) Acute Bacterial Sinusitis ( 1.6 ) Acute Bacterial Exacerbation of Chronic Bronchitis ( 1.7 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of moxifloxacin hydrochloride and other antibacterial drugs. Moxifloxacin hydrochloride should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
What are the side effects of Moxifloxacin Hydrochloride Tablets, 400 Mg?▼
6 ADVERSE REACTIONS The following serious and otherwise important adverse reactions are discussed in greater detail in the warnings and precautions section of the label: • Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects [see Warnings and Precautions (5.1) ] • 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) ] • Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.5) ] • QT Prolongation [see Warnings and Precautions (5.6)] • Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions (5.7) ] •...
Can I take Moxifloxacin Hydrochloride Tablets, 400 Mg during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available human data establishing a drug associated risk with the use of moxifloxacin. Based on animal studies with moxifloxacin, moxifloxacin may cause fetal harm. Moxifloxacin was not teratogenic when administered to pregnant rats (IV and oral), rabbits (IV), and monkeys (oral) at exposures that were 0.25–2.5 times of those at the human clinical dose (400 mg/day moxifloxacin).
What are the important warnings for Moxifloxacin Hydrochloride Tablets, 400 Mg?▼
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 [See warnings and Precautions (5.1) ], including: Tendinitis and tendon rupture [See warnings and Precautions (5.2)] Peripheral Neuropathy [See warnings and Pre... 5 WARNINGS AND PRECAUTIONS Prolongation of the QT interval and isolated cases of torsade de pointes has been reported. Avoid use in patients with known prolongation, proarrhythmic conditions such as clinically significant bradycardia or acute myocardial ischemia, hypokalemia, hypomagnesemia, and with drugs that prolong the QT interval. ( 5.6 , 7.5 , 8.5 ) Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions, including anaphylactic reactions, may occur after first or subsequent doses of moxifloxacin hydrochloride. Discontinue moxifloxacin hydrochloride at first sign of skin rash, jaundice or any other sign of hypersensitivity. ( 5.7 , 5.8 ) Clostridium difficile -Associated diarrhea: Evaluate if diarrhea occurs. 4 CONTRAINDICATIONS Moxifloxacin hydrochloride is 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) ]. Known hypersensitivity to Moxifloxacin hydrochloride or other quinolones ( 4 , 5.8 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.