Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
MOXIFLOXACIN HYDROCHLORIDE (UNII: C53598599T) (MOXIFLOXACIN - UNII:U188XYD42P)
RedPharm Drug, Inc.
ORAL
PRESCRIPTION DRUG
Moxifloxacin hydrochloride 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 Chlamydophila pneumoniae [see Clinical Studies ( 14.3) ]. MDRSP isolates are isolates resistant to two or more of the following antibacterial drugs: penicillin (minimum inhibitory concentrations [MIC] ≥ 2 mcg/mL), 2nd generation cephalosporins (for example, cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole. Moxifloxacin hydrochloride tablets are indicated in adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible
Moxifloxacin hydrochloride tablets 400 mg are available as Beige colored, capsule shaped, biconvex tablets debossed ‘112’ on one side and plain on other side. They are supplied in bottles of 30, 100, 500, and unit dose package of 50’s (5 x 10’s). Bottles of 30 NDC 55111-112-30 Bottles of 100 NDC 55111-112-01 Bottles of 500 NDC 55111-112-05 Unit dose package of 50 (5 x 10’s) NDC 55111-112-66 Store at 20-25°C (68-77°F); [see USP Controlled Room Temperature]. Avoid high humidity.
Abbreviated New Drug Application
MOXIFLOXACIN- MOXIFLOXACIN TABLET, FILM COATED RedPharm Drug, Inc. ---------- FDA-Approved Medication Guide MEDICATION GUIDE Moxifloxacin Hydrochloride Tablets (mox'' i flox' a sin hye'' droe klor' ide) Read the Medication Guide that comes with moxifloxacin hydrochloride tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment. What is the most important information I should know about moxifloxacin hydrochloride tablets? Moxifloxacin hydrochloride tablet belongs to a class of antibiotics called fluoroquinolones. Moxifloxacin hydrochloride tablets can cause serious side effects that can happen at the same time and could result in death. If you get any of the following serious side effects, you should stop taking moxifloxacin tablets and get medical help right away. Talk with your healthcare provider about whether you should continue to take moxifloxacin hydrochloride tablets. 1. Tendon rupture or swelling of the tendon (tendinitis). • Tendon problems can happen in people of all ages who take moxifloxacin hydrochloride tablets. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include: • Pain, swelling, tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites. • The risk of getting tendon problems while you take moxifloxacin hydrochloridetablets is higher if you: • Are over 60 years of age • Are taking steroids (corticosteroids) • Have had a kidney, heart or lung transplant Tendon problems can happen in people who do not have the above risk factors when they take moxifloxacin hydrochloride tablets. • Other reasons that can increase your risk of tendon problems can include: • Physical activity or exercise • Kidney failure • Tendon problems in the past, such as in people with rheumatoid arthritis (RA). • Call your healthca Belgenin tamamını okuyun
MOXIFLOXACIN- MOXIFLOXACIN TABLET, FILM COATED REDPHARM DRUG, INC. ---------- MOXIFLOXACIN 400MG BOXED WARNING SECTION WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAI NERVOUS SYTEM EFFECTS and EXACERBATION OF MYASTHENIA GRAVIS • Fluoroquinolones, including moxifloxacin, 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 Precautions (5.3)] • Central nervous system effects [see Warnings and Precautions (5.4)] Discontinue moxifloxacin, immediately and avoid the use of fluoroquinolones, including moxifloxacin, in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1)]. • Fluoroquinolones, including moxifloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid moxifloxacin, in patients with known history of myasthenia gravis [see Warnings and Precautions (5.5)]. • Because fluoroquinolones, including moxifloxacin, have been associated with serious adverse reactions [see Warnings and Precautions(5.1-5.13)], reserve moxifloxacin, for use in patients who have no alternative treatment options for the following indications: • Acute bacterial sinusitis [see Indications and Usage (1.6)] • Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage (1.7)] 1 INDICATIONS AND USAGE 1.1 COMMUNITY ACQUIRED PNEUMONIA Moxifloxacin hydrochloride 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 Chlamydophila_ _pneumoniae_ [see CLINICAL STUDIES Belgenin tamamını okuyun