Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
MOXIFLOXACIN HYDROCHLORIDE (UNII: C53598599T) (MOXIFLOXACIN - UNII:U188XYD42P)
PD-Rx Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Moxifloxacin Hydrochloride is 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 is indicated in adult patients for the treatment of Uncomplicated Skin and Skin Structure Infections caused by susceptible isolates of methicillin-susceptible
Moxifloxacin Hydrochloride (moxifloxacin hydrochloride) tablets are available as oblong, dull red film-coated tablets containing 400 mg moxifloxacin. The tablet is coded with the word “BAYER” on one side and “M400” on the reverse side. Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature] . Avoid high humidity.
New Drug Application Authorized Generic
MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED PD-Rx Pharmaceuticals, Inc. ---------- MEDICATION GUIDE 1. FDA-Approved Medication Guide MEDICATION GUIDE Moxifloxacin Hydrochloride Tablets Read the Medication Guide that comes with Moxifloxacin Hydrochloride ® 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? Moxifloxacin Hydrochloride belongs to a class of antibiotics called fluoroquinolones. Moxifloxacin Hydrochloride 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 Hydrochloride and get medical help right away. Talk with your healthcare provider about whether you should continue to take Moxifloxacin Hydrochloride. 1. Tendon rupture or swelling of the tendon (tendinitis). • Tendon problems can happen in people of all ages who take Moxifloxacin Hydrochloride. 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 Hydrochloride 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. • 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). • Stop taking Moxifloxacin Hydrochloride immediately and Soma hati kamili
MOXIFLOXACIN HYDROCHLORIDE- MOXIFLOXACIN HYDROCHLORIDE TABLET, FILM COATED PD-RX PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE MOXIFLOXACIN HYDROCHLORIDE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MOXIFLOXACIN HYDROCHLORIDE MOXIFLOXACIN HYDROCHLORIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1999 RECENT MAJOR CHANGES Warnings and Precautions ( 5.4, 5.11) INDICATIONS AND USAGE Moxifloxacin Hydrochloride is 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. ( 1.8) DOSAGE AND ADMINISTRATION TYPE OF INFECTION DOSE EVERY 24 HOURS DURATIO N (DAYS) Community Acquired Pneumonia (1.1) 400 mg 7–14 Uncomplicated Skin and Skin Structure Infections (SSSI) (1.2) 400 mg 7 Complicated SSSI (1.3) 400 mg 7–21 Complicated Intra-Abdominal Infections (1.4) 400 mg 5–14 Plague (1.5) 400 mg 10–14 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) Do not mix with other medications in intravenous bag or in an intravenous line. ( 2.3) DOSAGE FORMS AND STRENGTHS Tablets: Moxifloxacin hydrochloride (equivalent to 400 mg moxifloxacin) ( 3.1) CONTRAINDICATIONS Known hypersensitivity to Moxifloxacin Hydrochloride or Soma hati kamili