Azithromycin dry suspension

Azithromycin is an azalide antibiotic. Its mechanism of action is to interfere with the synthesis of proteins (without affecting the synthesis of nucleic acids) by binding to the subunits of the 50s ribosomes of sensitive microorganisms. In vitro tests and clinical studies have shown that azithromycin is effective against the following pathogens: Gram-positive aerobic microorganisms: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, and hemolytic streptococci. Azithromycin has cross-resistance to erythromycin-resistant Gram-positive bacteria. Most fecal streptococci (enterococci) and methicillin-resistant Staphylococci are resistant to this product. Gram-negative aerobic microorganisms: Haemophilus influenzae, Moraxella catarrhalis, and Chlamydia trachomatis. Anaerobic bacteria: Bacteroides fragilis, Bacteroides spp., Clostridium perfringens, Peptostreptococcus spp., Fusobacterium necroticum, and Propionibacterium acnes. Sexually transmitted disease microorganisms: Treponema pallidum, Neisseria gonorrhoeae, and Haemophilus dukei. Other microorganisms: including Borrelia terrestris (Lyme disease body), Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum, Chlamydia trachomatis, Pneumocystis carinii, Mycobacterium avium, Listeria monocytogenes. In vitro tests and clinical studies suggest that this product can prevent diseases caused by the avian intracellular mycobacterium complex (composed of avian intracellular mycobacterium and intracellular mycobacterium). This product is ineffective against strains that produce beta-lactamase. In vitro research results have been obtained for the following microorganisms, but their clinical significance is still unclear, including Streptococcus (C, F, G), Streptococcus viridans, Bordetella pertussis, Haemophilus dukei, Legionella pneumophila, Bacteroides, Peptostreptococcus, Borrelia terrestris, Mycoplasma pneumoniae, Treponema pallidum, Ureaplasma urealyticum, etc. Toxicological studies Genetic toxicity: The results of human lymphocyte test, mouse bone marrow micronucleus test and mouse in vitro lymphoma cell test showed that azithromycin did not show mutagenic effect. Reproductive toxicity: Reproductive toxicity tests on mice and rats have shown that when the dose of azithromycin (orally administered) reaches the dose level that produces moderate maternal toxicity (i.e. 200 mg/kg/day, which is about 2-4 times the human dose of 500 mg/kg/day calculated based on body surface area), no teratogenic effect is found. No damage to fertility and the fetus has been found. There are currently no adequate and strictly controlled clinical trials in pregnant women. Since the results of animal reproductive studies cannot always predict the situation in humans, pregnant women should only use this product when it is really necessary. It is not known whether this product is secreted in human milk. Since many drugs are secreted in human milk, lactating women should be careful when using it. Carcinogenicity: There is no research data on the carcinogenicity of this product in animals with long-term medication.

Azithromycin

This product is white or off-white suspension granules.

This drug can be used to treat infections caused by sensitive bacteria: 1. Lower respiratory tract infections such as bronchitis and pneumonia; skin and soft tissue infections; otitis media; upper respiratory tract infections such as sinusitis, pharyngitis, tonsillitis. 2. Simple genital infections caused by Chlamydia trachomatis among sexually transmitted diseases in men and women. 3. Azithromycin can also be used for simple genital infections caused by non-multidrug resistant gonococci and chancroid caused by Haemophilus dukei.

Pour this product into a cup, add appropriate amount of cold boiled water, dissolve and shake well, then take orally, 1 hour before or 2 hours after meals. Adult dosage: 1. For sexually transmitted diseases caused by Chlamydia trachomatis or sensitive Neisseria gonorrhoeae, only 1.0g of this product is needed for a single oral administration. 2. For the treatment of other infections: On the first day, take 0.5g at a time, on the 2nd to 5th day, take 0.25g at a time; or take 0.5g at a time for 3 consecutive days. Pediatric dosage: 1. For the treatment of otitis media and pneumonia, on the first day, take 10mg/kg of body weight at a time (maximum daily dose not exceeding 0.5g), on the 2nd to 5th day, take 5mg/kg of body weight at a time (maximum daily dose not exceeding 0.25g).

This product is generally well tolerated, with a low incidence of adverse reactions, mostly mild to moderate reversible reactions. 1. Common adverse reactions include: ⑴ Gastrointestinal reactions: diarrhea, abdominal pain, loose stools, vomiting, etc.; ⑵ Skin reactions: rash, itching, etc.; ⑶ Other reactions: such as anorexia, vaginitis, dizziness or dyspnea, etc.; 2. The following adverse reactions <1% were also observed in clinical practice: ⑴ Digestive system: indigestion, flatulence, mucositis, oral candidiasis, gastritis, etc.; ⑵ Nervous system: headache, drowsiness, etc.; ⑶ Allergic reactions: bronchospasm, etc.; ⑷ Other reactions: no abnormality, etc. 3. The following adverse reactions were also observed in oral preparations after listing, and their relevance to this product is still unclear. ⑴ Allergic reactions: joint pain, angioedema, urticaria, photosensitivity; ⑵ Cardiovascular system.

It is contraindicated in patients who are allergic to azithromycin, erythromycin, or any other macrolide drugs.

Precautions for children: The efficacy and safety of treating otitis media, community-acquired pneumonia in children under 6 months old and pharyngitis or tonsillitis in children under 2 years old have not been determined. Precautions for pregnancy and lactation: Animal experiments show that this product has no effect on the fetus, but there is still a lack of experience in its use in pregnant women, so the pros and cons must be fully weighed before using it in pregnant women. There is no data to show whether this product can be secreted into breast milk, so the use of it in lactating women must be considered with caution. Precautions for the elderly: It is not yet clear.

According to the introduction of drug interaction research data conducted abroad, the following information about this product is obtained: Antacids: In the pharmacokinetic study of simultaneous administration of antacids and azithromycin, the peak concentration of azithromycin was reduced by about 25%, and no effect on the total bioavailability was observed. Patients who take azithromycin and need to take antacids should not take these drugs at the same time. Cetirizine: Healthy volunteers took azithromycin and cetirizine (20 mg) orally for 5 days at the same time. There was no pharmacokinetic interaction between the two at steady-state concentrations, and no significant changes in the QT interval were observed. Didanosine (dideoxyinosine nucleoside), compared with placebo, 6 HIV-positive patients who took 1200 mg of azithromycin and 400 mg of didanosine daily did not affect the steady-state pharmacokinetics of didanosine. Digoxin: It has been reported that some macrolide antibiotics affect the intestinal metabolism of digoxin in some patients. Therefore, patients who take azithromycin and digoxin at the same time should be aware of the possibility of increased digoxin blood concentrations. Zidovudine: Single doses of 1000 mg and multiple doses of 1200 mg or 600 mg of azithromycin had little effect on the plasma pharmacokinetics or urinary excretion of zidovudine or its glucuronide metabolite. However, oral azithromycin increased the concentration of phosphorylated zidovudine, the clinically active metabolite, in peripheral blood mononuclear cells. The clinical significance of these findings is unknown, but patients may benefit. Azithromycin has no significant effect on the hepatic cytochrome P450 system. Unlike other macrolide antibiotics such as erythromycin, azithromycin does not affect the pharmacokinetics of other drugs and does not lose activity by inducing hepatic cytochrome P450 or by forming cytochrome metabolic complexes. Ergot: Due to the theoretical possibility of ergotism, the concomitant use of azithromycin and ergot derivatives is not recommended. Pharmacokinetic studies have been conducted between azithromycin and the following drugs that are primarily metabolized by the hepatic cytochrome P450 system. Atorvastatin: Daily administration of atorvastatin 10 mg and azithromycin 500 mg simultaneously had no effect on the blood concentration of atorvastatin (HWG CoA-reductase inhibition assay). Carbamazepine: Pharmacokinetic studies on healthy volunteers showed that the simultaneous use of carbamazepine and azithromycin had no significant effect on the blood concentration of carbamazepine and its active metabolites. Cimetidine: In a pharmacokinetic study of a single dose of cimetidine, no change in the pharmacokinetics of azithromycin was observed when the drug was taken two hours before azithromycin. Coumarin oral anticoagulants: In a pharmacokinetic study conducted on healthy volunteers, azithromycin did not affect the anticoagulant effect of a single oral dose of 15 mg of warfarin. After azithromycin was marketed, it was reported that the simultaneous use of azithromycin and coumarin oral anticoagulants could enhance the anticoagulant effect. Although the causal relationship has not been determined, patients who are taking coumarin oral anticoagulants at the same time should pay attention to frequent monitoring of prothrombin time. Cyclosporine: In a pharmacokinetic study in healthy volunteers, azithromycin 500 mg was taken orally daily, followed by a single dose of cyclosporine 10 mg/kg for 3 consecutive days. The peak concentration of cyclosporine and the area under the 5-hour drug-time curve increased significantly. Therefore, caution must be exercised when the two are used simultaneously. If they must be used simultaneously, the blood concentration of cyclosporine should be monitored so that the dose can be adjusted accordingly. Efavirenz: No clinically significant pharmacokinetic changes were found when azithromycin (single dose 600 mg) and efavirenz (400 mg per day for 7 days) were used simultaneously. Fluconazole: When 800 mg of fluconazole monomer was used simultaneously with a single dose of 1200 mg of azithromycin, no significant changes in the pharmacokinetics of fluconazole were found, and the total exposure and half-life of azithromycin were also unchanged. The peak blood concentration was reduced by 18%, but it was not clinically significant. Indinavir: The simultaneous use of a single dose of azithromycin 1200 mg had no significant effect on the pharmacokinetics of indinavir (800 mg three times a day for 5 consecutive days). Methylprednisolone: In a drug interaction study conducted in healthy volunteers, azithromycin had no significant effect on the pharmacokinetic parameters of methylprednisolone. Midazolam: The simultaneous use of azithromycin (500 mg/day for 3 days) and midazolam (single dose of 15 mg) in healthy volunteers did not significantly change the pharmacokinetics and pharmacodynamics of the latter. Nelfinavir: The simultaneous use of azithromycin 1200 mg and nelfinavir (750 mg, 3 times a day, until the steady-state blood concentration is reached) did not cause clinically significant drug interactions, so no dose adjustment is required. Rifabutin: The combination of this product and rifabutin has no effect on the serum concentrations of either. Neutropenia occurs when azithromycin is used in combination with rifabutin. Although neutropenia is associated with the use of rifabutin, it is unclear whether it is related to the co-administration of azithromycin. Sildenafil: In studies conducted in healthy male volunteers, there was no evidence that azithromycin (500 mg per day for 3 days) had an effect on the peak plasma concentration or area under the concentration-time curve of sildenafil or the major circulating metabolites. Terfenadine: Pharmacokinetic studies have shown that there is no drug interaction between azithromycin and terfenadine. Although rare cases of interaction between the two have been reported and the possibility of such an effect cannot be completely ruled out, there is still no specific evidence that such an interaction has occurred. Theophylline: There is no interaction between azithromycin and theophylline in healthy volunteers. Triazolam: Compared with placebo, 14 healthy volunteers who took azithromycin (500 mg on day 1 and 250 mg on day 2) and triazolam (0.125 mg on day 2) at the same time had no significant effect on the pharmacokinetics of triazolam. TMP/SMZ: TMP/SMZ 160mg/800mg was taken daily for 7 consecutive days, and a single dose of azithromycin 1200mg was taken on the 7th day. The blood concentration, total exposure and urine clearance of TMP/SMZ were not significantly changed. The blood concentration of azithromycin was also similar to that in other studies.

Sealed, store in a dry place.

0.1g

24 months

Jiangxi Gannan Haixin Pharmaceutical Co., Ltd.

• Founded in:

  2001-12-31

• Address:

  No. 209, Lakeside Avenue, Ganzhou Economic and Technological Development Zone, Ganzhou City, Jiangxi Province

• Tax NO.:

  91360700733914344A

• Registered Funds:

  100 million yuan

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