Instructions

【Ingredients】The main ingredient of this product is Roxithromycin.
Chemical name: 9-[O-[(2-methoxyethoxy)-methyl] oxime] Erythromycin
Chemical structure:

【Description】The contents of this product are white or off-white powder and granules. 
【Indications】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; Urethritis and cervicitis caused by Chlamydia trachomatis; skin and soft tissue infections caused by sensitive bacteria. 
【Strength】150mg 
【Usage and Dosage】Oral administration, the general course of treatment is 5~12 days. Adult: 0.15g once, 2 times a bit; or 0.3g once, once a day. Children: once by weight 2.5~5mg/kg, 2 times a day. Or follow the doctor's advice. 
【Adverse Reaction】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. 
【Contraindications】It is forbidden to be allergic to any component of this product, erythromycin or other macrolides. 
【Precautions】
1.Patients with liver dysfunction should be used with caution. The blood elimination half-life (t1/28) of patients with severe cirrhosis is extended to more than twice the normal level. If it is really needed, 0.15 g is administered once a day, once a day. 
2.Patients with mild renal insufficiency do not need dose adjustment, and the time of administration of severe renal insufficiency is doubled (0.15g 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.Regularly check liver function during medication. 
6.If any adverse events and/or adverse reactions occur during the use of this product, please consult your doctor. 
7.Please let your doctor know if you are using other medicines at the same time. 
8.Please keep out of reach of children. 
【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 there is no significant change in the pharmacokinetics of the elderly, no dose adjustment is needed. Or follow the doctor's advice.
【Drug 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】It 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. 
【Pharmacokinetics】Oral absorption is good, blood peak concentration (Cmax) is high, a single dose of oral roxithromycin 150mg after about 2 hours to reach peak plasma concentration (Cmax) 6.6～7.9mg / L, eating can make organisms Utilization is reduced by about half. Widely distributed, the concentration of drugs in the tonsils, sinuses, middle ears, lungs, sputum, prostate and other genitourinary tissues can reach effective therapeutic levels. The 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 (t12) is 8.4～15.5 hours. 
【Storage】Preserve in tightly closed containers, stored in a dry place.
【Package】Aluminum plastic packaging, 150mgX12 capsules. 
【The shelf life】36 months. 
【Executive Standard】Chinese Pharmacopoeia（2015）Volume 2.
【Approval No.】GYZZ H20083006
【Manufacturer】Fujian Pacific Pharmaceutical Co., Ltd.