Approved date: January 29, 2007
Date of revision: October 1, 2010
         November 30, 2015
Roxithromycin tablet instructions
 Please read the instructions carefully and use them under the guidance of a physician.
【Drug Name】
    Generic name: Roxithromycin tablets
    English name: Roxithromycin Tablets
    Pinyin: Luohongmeisu Pian
[Ingredients] The main ingredients of this product are: roxithromycin. Its chemical name is: 9-[O-[(2-methoxyethoxy)methyl]anthracene] erythromycin.
    Molecular formula: C41H76N2O15
    Molecular weight: 837.03
    This product is a film-coated tablet that is white or off-white after removal of the coating.
    This product is suitable for pharyngitis and tonsillitis caused by pyogenic streptococcus, sinusitis caused by sensitive bacteria, otitis media, acute bronchitis, acute exacerbation of chronic bronchitis, pneumonia caused by Mycoplasma pneumoniae or Chlamydia pneumoniae; urethra caused by Chlamydia trachomatis Inflammation and cervicitis; skin and soft tissue infections caused by sensitive bacteria.
    Oral on an empty stomach, the general course of treatment is 5 to 12 days. 1 tablet (150mg) once a day, 2 times a day; 2 tablets (300mg) at a time, once a day. The child is weighing 2.5 to 5 mg/kg once a day, twice a day.
【Adverse reactions】
    The main adverse reactions were abdominal pain, diarrhea, nausea, vomiting and other gastrointestinal reactions, but the incidence was significantly lower than erythromycin. Occasionally, rash, itchy skin, dizziness, headache, abnormal liver function (higher ALT and AST), and decreased peripheral blood cells.
    It is forbidden to be allergic to this product, erythromycin or other macrolides.
    1. Patients with liver dysfunction should be used with caution. The blood elimination half-life (t1/2b) of patients with severe cirrhosis is extended to more than twice the normal level. If it is really necessary, one dose is administered once, once a day.
    2. Patients with mild renal insufficiency do not need to adjust the dose, and the time of administration of severe renal insufficiency is doubled (1 tablet once a day, once a day).
    3. This product has cross-resistance with erythromycin.
    4. In order to obtain a higher blood concentration, this product should be taken on an empty stomach (1 hour before a meal or 3 to 4 hours after a meal) with water.
    5. Liver function is regularly measured during medication.
[Pregnant women and lactating women]
    Pregnant women and lactating women should be used with caution. Less than 0.05% of the dose is administered to breast milk. Although it has been reported that the effect on the baby is not significant, it is still necessary to consider whether to terminate the lactation.
[Child medication] is not clear.
[Geriatric Use]
    If the pharmacokinetics of the elderly does not change significantly, no dose adjustment is needed.
【medicine interactions】
    1. Not compatible with ergotamine, dihydroergotamine, bromocriptine, terfenadine, ketoconazole and cisapride.
2. It has little effect on the metabolism of aminophylline, and has no effect on carbamazepine, warfarin, ranitidine and other antacids.
[Drug overdose] is not clear.
【Pharmacology and Toxicology】
This product is a semi-synthetic 14-membered ring macrolide antibiotic. The antibacterial spectrum and antibacterial effect are basically similar to erythromycin. The effect on Gram-positive bacteria is slightly worse than that of erythromycin, and the effect on Legionella pneumophila is stronger than that of erythromycin. The antimicrobial effect against Chlamydia pneumoniae, Mycoplasma pneumoniae, and Ureaplasma urealyticum is similar or slightly stronger than erythromycin.
    This product can reversibly bind to the 50S subunit of bacterial ribosome near the donor ("P" position) through the bacterial cell membrane, blocking the binding of transfer ribonucleic acid (t-RNA) to the "P" position. It also blocks the transfer of the polypeptide chain from the receptor ("A" position) to the "P" position, and thus bacterial protein synthesis is inhibited.
    Oral absorption is good, the peak plasma concentration (Cmax) is high, and the peak plasma concentration (Cmax) is 6.6-7.9 mg/L in about 2 hours after single-dose oral administration of 150 mg of roxithromycin. The bioavailability can be reduced by about half after eating. . Widely distributed, the concentration of drugs in tonsils, sinuses, middle ear, lung, sputum, prostate and other genitourinary tissues can reach effective therapeutic levels. Its protein binding rate was 96% at a blood concentration of 2.5 mg/L. It was excreted from the body in its original form and 5 metabolites, and 7.4% was excreted from the urine. The blood elimination half-life (t1/2b) is 8.4 to 15.5 hours.
[Storage] Sealed and stored in a dry place (10 ~ 30 ° C).
[Packing] Aluminum-plastic packaging, 6 pieces per box; 8 pieces per box; 10 pieces per box; 12 pieces per box.
[Validity Period] 24 months
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
[Approval No.] National Drug Standard H20056872
    Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
    Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
    Postal code: 529331
Phone number: (0750) 2789348 2787017
          400-8899-328 (National Service Phone)
    Fax number: (0750) 2789348


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