MOXIFLOXACIN 5 mg/mL
MOXIFLOXACIN · SOLUTION/ DROPS · Proficient Rx LP
MOXIFLOXACIN is a solution/ drops containing moxifloxacin at 5 mg/mL, taken ophthalmic. Manufactured by Proficient Rx LP.
Key Facts
- Brand Name
- MOXIFLOXACIN
- Generic Name
- MOXIFLOXACIN
- NDC Code (Product)
82804-055- Manufacturer
- Proficient Rx LP
- Strength
- 5 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA206242
- Marketing Start
- 10/04/2017
Recall History
Pharmacy Plus, Inc. dba Vital Care Compounder
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Pine Pharmaceuticals, LLC
Lack of Assurance of Sterility
Direct Rx
cGMP deviation: discontinue of stability support for product.
Imprimis NJOF, LLC
Lack of Assurance of Sterility
Pine Pharmaceuticals, LLC
Lack of Assurance of Sterility
Imprimis NJOF, LLC
Lack of Assurance of Sterility
Denver Solutions, LLC DBA Leiters Health
Presence of Particulate Matter: glass vials from the manufacturer showed signs of glass delamination.
Imprimis NJOF, LLC
Subpotent Drug
Imprimis NJOF, LLC
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 tablets and other antibacterial drugs. Moxifloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.8 ) 1.1 Community Acquired Pneumonia Moxifloxacin tablets are indicated in adult patients for the treatment of Community Acquired Pneumonia caused by susceptible isolates of Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP]) , Haemophilus influenzae, Moraxella catarrhalis, methicillin-susceptible Staphylococcus aureus, Klebsiella pneumoniae, Mycoplasma pneumoniae, or…
Dosage & Administration
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 is 400 mg (orally) once every 24 hours. The duration of therapy depends on the type of infection as described in Table 1. Table 1: Dosage and Duration of Therapy in Adult Patients a) Due to the designated pathogens [see Indications and Usage (1) ] . b) Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician c) Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis . Type of Infection a Dose Every 24 hours Duration b (days) Community Acquired Pneumonia ( 1.1 ) 400 mg 7 to 14 Uncomplicated Skin and Skin Structure Inf…
Contraindications
4 CONTRAINDICATIONS Moxifloxacin tablets are 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 tablets or other quinolones (4, 5.8 )
Drug 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. ( 5.12 , 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. Oral administration of moxifloxacin hydrochloride with antacids containing aluminum or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as didanosine buffered tablets for oral suspension or the pediatric powder for oral solution, may substantially interfere with the absorption of moxifloxa…
Adverse Reactions
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) ] Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions (5.9) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.10) ] Blood Glucose Disturbances [see Warnings and Precautions (5.12) ] Photosensitivity/Phototoxicity [see Warnings and Precautions (5.13) ] Development of Drug Resistant Bacteria [see Warnings…
Frequently Asked Questions
What is MOXIFLOXACIN used for?
MOXIFLOXACIN contains MOXIFLOXACIN. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is MOXIFLOXACIN a controlled substance?
MOXIFLOXACIN is not classified as a controlled substance by the DEA.
What is the generic name for MOXIFLOXACIN?
The generic name for MOXIFLOXACIN is MOXIFLOXACIN. There are 10 other brand versions of MOXIFLOXACIN.
What is the NDC code for MOXIFLOXACIN 5 mg/mL?
The NDC (National Drug Code) for MOXIFLOXACIN 5 mg/mL is 82804-055, listed by Proficient Rx LP.
Other MOXIFLOXACIN Dosages
Other Moxifloxacin Brands
See all →- Moxifloxacin400 mg/172789-233
- Moxifloxacin Ophthalmic Solution5 mg/mL0781-7135
- Moxifloxacin ophthalmic solution5 mg/mL50090-4781
- Moxifloxacin5 mg/mL68180-422
- Moxifloxacin Hydrochloride Tablets, 400 mg400 mg/170518-4312
- Moxifloxacin ophthalmic solution5 mg/mL46708-505
- Moxifloxacin Hydrochloride400 mg/150090-6609
- Moxifloxacin400 mg/163629-8357
- Moxifloxacin Hydrochloride400 mg/171335-2815
- Moxifloxacin Hydrochloride Tablets, 400 mg400 mg/172789-080
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)