Approval Date:
Date of revision:
Azithromycin Capsules InstructionsPlease read the instructions carefully and use under Use under the guidance of a physician
[Drug Name]
Generic Name: Azithromycin Capsules
Trade Name: Weihong
English Name:Azithromycin Capsules
Hanyu Pinyin:Aqimeisu Jiaonang
[Cheng
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The main ingredient of this product is Azithromycin dihydrate.
Chemical name: (2R, 3S, 4R,5R,8R,10R span>,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3- em>O-methyl-α-L-nuclear-hexopyranosyl)oxy]-2-ethyl-3,4,,10-trihydroxy-3, 5, 6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-beta-D- /span>xylopyranosyl-hexopyranosyl]oxygen]-1- span>oxa-6-azacyclopentadecane-15-one dihydrate.
Chemical structure formula:
Molecular Formula:C38H72N2O12-2H2O
molecular weight:785.03
[Properties]
The content of this product is white or off-white crystalline powder and, or lumps.
[Indications]
(1)Acute pharyngitis and acute tonsillitis caused by Streptococcus pyogenes.
(2)Acute attacks of sinusitis, otitis media, acute bronchitis, chronic bronchitis caused by sensitive bacteria.
(3)Pneumonia due to Streptococcus pneumoniae, Haemophilus influenzae, and Mycoplasma pneumoniae.
(4)Urethritis and cervicitis due to Chlamydia trachomatis and non-multiple drug-resistant Neisseria gonorrhoeae.
(5)Soft tissue skin infections caused by sensitive bacteria.
[Specifications]
0.25g
[dosage]
Azithromycin should be administered orally once daily, swallowed whole, at least one hour before or at least two hours after a meal. The regimen and usage of azithromycin capsules for the treatment of various infectious diseases are as follows:
For sexually transmitted diseases caused by Chlamydia trachomatis, Haemophilus ducreyi or sensitive gonococci, only a single oral dose of this product1000mg is required .
For other infections: total dose1500mg, once daily dose of this product500mg for three days. Or the same total dose with 500mg on the first day and the product is given orally once daily on the second to fifth days250mg.
Patients with renal insufficiency
Mild to moderate renal insufficiency (glomerular filtration rate of 10-80 ml/min) do not require dose adjustment. Use with caution in severe renal insufficiency (glomerular filtration rate<10ml/min) (see [Precautions] and [ Pharmacokinetics]).
Patients with hepatic insufficiency
In patients with mild to moderate hepatic insufficiency, the dosage and administration of this product is the same as for those with normal hepatic function (see [Precautions] and [Pharmacokinetics]).
[Adverse Reactions]
(1)Adverse Reactions in Clinical Trials
Clinical trials are conducted under a variety of different conditions; therefore, the incidence of adverse reactions observed in clinical trials of different drugs is not directly comparable and may not reflect the incidence of adverse reactions observed during actual drug administration.
The majority of adverse reactions reported in clinical trials were mild to moderate in severity and were reversible after discontinuation of the drug. Cases of potentially severe angioedema and cholestatic jaundice have been reported. 5day multi-dose clinical trials with approximately0.7% of patients (both adult and pediatric patients) discontinued azithromycin therapy due to treatment-related adverse reactions. At doses of 500 mg/day and continuous dosing3days in adult patients, approximately0.6% of patients discontinued the drug due to treatment-related adverse effects. At a single dose of 30 mg/kgor3day total dose of 30mg/kgin pediatric patients in clinical trials, approximately1% of patients discontinued due to treatment-related adverse reactions. The majority of adverse reactions leading to discontinuation were gastrointestinal related, such as nausea, vomiting, diarrhea, or abdominal pain.
Adult patients
Multi-dose dosing regimens: Overall, the most common treatment-related adverse reactions in adult patients on multi-dose dosing regimens were related to the gastrointestinal system, with the most commonly reported adverse reactions being Diarrhea/Dilute stools (4%-5%4%-5%), nausea (3%) and abdominal pain (2%-3%).
No incidence >1% in adult patients on a multi-dose dosing regimenof other adverse reactions. Adverse reactions with an incidence ≤1% include:
Cardiovascular: palpitations, chest pain.
Gastrointestinal system: dyspepsia, flatulence, vomiting, black stools, cholestatic jaundice.
Genitourinary system: Candida infection, vaginitis, nephritis.
Nervous system: Dizziness, headache, vertigo, drowsiness.
Systemic: Fatigue
Allergic: rash, pruritus, photosensitivity dermatitis, and angioedema.
1gSingle-dose dosing regimen:
Overall, in using 1gThe most common adverse reactions in patients on single-dose regimens were related to the gastrointestinal system and were reported more frequently than in patients on multi-dose dosing regimens.
In patients on a 1gsingle Adverse reactions with an incidence of ≥1% in patients on dosing regimens include diarrhea/thin stools (7%), nausea (5%), abdominal pain (5%), vomiting (2%), dyspepsia (1%) and vaginitis (1%).
2gSingle-dose dosing regimen:
Overall, in using 2gThe most common adverse reactions in patients on a single-dose dosing regimen were related to the gastrointestinal system. In this study, adverse reactions with an incidence of ≥1% included nausea (18%), diarrhea/dilute stools (14%), vomiting (7%), abdominal pain (7%), vaginitis (2%), indigestion (1%), dizziness (1%), the majority of which were mild in severity.
Pediatric patients:
Single- and multiple-dose dosing regimens: The types of adverse reactions observed in pediatric patients were similar to those observed in adult patients, but the incidence of adverse reactions varied among the recommended dosing regimens in pediatric patients.
Acute otitis media: For patients treated with the recommended total dose dosing regimen (30 mg/ kg) in patients treated with the recommended total dose regimen (1%) of adverse reactions due to treatment were diarrhea, abdominal pain, vomiting, nausea, and rash.
The following table shows the incidence of adverse reactions by dosing regimen:
Dosing day protocolDiarrhea%Abdominal pain%vomiting%Nauseous%Rash%1day 4.3%1.4%4.9%1.0%1.0%3day2.6%1.7%2.3%0.4%0.6%5day1.8%1.2%1.1%0.5%0.4%Community-acquired pneumonia: Using the recommended dosing regimen (day1Day10mg/kg, Day2-5days5mg/kg), the most common adverse reactions due to treatment are diarrhea/dilute stools, abdominal pain, vomiting, nausea, and rash.
The following table shows the incidence of each adverse reaction:
Dosing regimenDiarrhea/Dilute stools %abdominal pain%Vomiting%Nauseous%Rash%5day 5.8%1.9%1.9%1.9%1.6%Pharyngitis/Tonsillitis: for the use of the recommended dosing regimen (pp1-5days12 mg/kg), the most common adverse reactions due to treatment were diarrhea, vomiting, abdominal pain, nausea, and headache.
The following table shows the incidence of each adverse reaction:
Dosing regimendiarrhea%Abdominal pain%Vomiting%Nauseous% Rash%Headache5day5.4%3.4%5.6%1.8%0.7%1.1%No incidence > in treated pediatric patients, regardless of treatment regimen >1% of other adverse reactions. Adverse reactions with an incidence of ≤1% include:
Cardiovascular: chest pain.
Gastrointestinal system: indigestion, constipation, anorexia, enteritis, flatulence, gastritis, jaundice, loose stools, oral candidiasis.
Blood and lymphatic system: anemia, leukopenia.
Nervous system: Headache (otitis media dose), hypermobility, dizziness, agitation, nervousness and insomnia.
Systemic: fever, facial edema, fatigue, fungal infections, discomfort and pain.
Allergy: rash, allergic reactions.
Respiratory: cough, pharyngitis, pleural effusion and rhinitis.
Skin and adnexa: eczema, fungal dermatitis, pruritus, sweating, urticaria, blistering rash.
Special sensory system: Conjunctivitis.
(2) post-market application experience
The following adverse reactions have been identified after the approval of azithromycin for marketing. Because these reactions are derived from spontaneous reports in populations of indeterminate size, it may often not be possible to reliably estimate their incidence or to determine their relationship to drug exposure.
Azithromycin is available in adults and/ or pediatric patients reported during administration, adverse reactions for which a causal relationship with the drug may not be established include:
Allergy: arthralgia, edema, urticaria, and angioedema.
Cardiovascular: arrhythmias, including ventricular tachycardia and hypotension. Cases of prolonged QTintervals and tip-twisting ventricular tachycardia have been reported.
Gastrointestinal system: anorexia, constipation, dyspepsia, flatulence, vomiting/ diarrhea, pseudomembranous enteritis, pancreatitis, oral candidiasis, pyloric stenosis, tongue discoloration.
Systemic: malaise, abnormal sensation, fatigue, malaise, anaphylaxis.
Genitourinary system: interstitial nephritis, acute renal failure, vaginitis.
Hematopoietic system: thrombocytopenia.
Hepatic/Biliary: abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, liver failure[see Cautions].
Neurological: Convulsions, dizziness/Vertigo, headache, drowsiness, hyperfunction, nervousness, agitation, syncope.
Psychiatric: Aggressive reactions, anxiety.
Skin and adnexa: pruritus, severe skin reactions (including erythema multiforme, acute generalized eruptive pustulosis, Stevens-Johnson syndrome, toxic epidermolysis bullosa and eosinophilia and systemic symptoms of drug reactions).
Specialized sensory systems: Hearing impairment (including hearing loss, deafness and/or tinnitus) and have reported taste/sense of smell abnormalities and/or loss of cases.
(3) Abnormal laboratory tests:
Adult patients:
Clinically significant abnormalities reported in clinical trials (regardless of their correlation with drugs) include:
Incidence >1%. Decreased hemoglobin, decreased erythrocyte pressure volume, decreased lymphocytes, decreased neutrophils, decreased blood glucose, increased serum creatine phosphokinase, increased potassium,ALT,GGT,AST, BUN, elevation, creatinine elevation, glucose elevation, increased platelet count, lymphocytosis, neutrophilia, and eosinophilia.
Incidence 1%. Leukopenia, neutropenia, decreased sodium ion, decreased potassium ion, decreased platelet count, increased monocytes, increased basophils, increased bicarbonate, increased serum alkaline phosphatase, increased bilirubin,LDHand elevated phosphate.
The vast majority of patients with elevated serum creatinine also have abnormal baseline values. The change in laboratory values is reversible after follow-up is performed.
In a multi-dose clinical trial involving5000 In a multi-dose clinical trial with multiple patients, 4 patients discontinued treatment due to treatment-related liver enzyme abnormalities, and another1 patient discontinued treatment because of treatment-related renal function abnormalities.
Patients with children:
1day,day,3day and5day andday dosing regimen
In using two 3day regimen (30 mg/kg oror 60 mg/kg in3day dosing) or two5day regimens (30 mg/kgor60 mg/kg, administered over5 days) in a controlled clinical trial in which laboratory test data were collected. The data from the azithromycin regimen were found to be similar to the combined data from all controls, with the incidence of most clinically meaningful laboratory test abnormalities being 1~5%. Data were collected in a single-center trial in patients with a single dose of30 mg/kg azithromycin. In this trial,64 patients were given a single dose of30 mg/kg of azithromycin,62patients3days were given a total of “font-family:Times New Roman”>30 mg/kg of azithromycin, and63control patients. In these three groups of patients, there were 10, 9name and8 patients presented with absolute neutrophil values of 500-1500pcs/mm3. No patient with absolute neutrophil values less than500pc/mm3.
In a study involving approximately 4700No patient discontinued treatment due to treatment-related laboratory abnormalities in a multi-dose clinical trial in pediatric patients.
[Contraindicated]
Allergic reactions
Prohibited in patients with hypersensitivity to azithromycin, erythromycin, other macrolides or ketolactones.
Hepatic dysfunction
Contraindicated in cholestatic jaundice following azithromycin/Patients with a history of hepatic insufficiency.
[Caution]
General Patient Information
Because food reduces the absorption of azithromycin capsules, patients should take them at least one hour before or at least two hours after a meal.
Patients should be aware that azithromycin and antacids containing aluminum and magnesium should not be taken together.
At the first sign of any allergic reaction after taking azithromycin, patients should stop taking the medication immediately with guidance and contact their physician.
Physicians should inform patients that antibacterial drugs, including azithromycin, should only be used to treat bacterial infections and should not be used for viral infections (e.g., the common cold). When prescribing azithromycin to patients for bacterial infections, physicians should inform patients that they should take the medication as prescribed, even though most patients will feel relief from symptoms at the beginning of treatment. Not taking the medication on time or stopping it in the middle of treatment may: (1) reduce the effectiveness of timely treatment, () style=”font-family:Times New Roman”>2) increases the likelihood that bacteria will develop resistance, which in turn leads to the development of bacteria that cannot be destroyed later with azithromycin or other antibacterial drugs.
Diarrhea is a common adverse effect of antibacterial drugs, and this symptom usually resolves when the drug is stopped. Patients may sometimes develop watery and bloody stools (with/without stomach cramps and high fever) after starting antibacterial medications for treatment, and these symptoms may occur up to 2months or more after the patient’s last dose of antibacterial medication. If these symptoms occur, patients should contact their physician as soon as possible.
Allergic reactions
Severe drug allergic reactions have been reported in patients taking azithromycin for treatment, including angioedema, anaphylaxis, and skin reactions (including acute generalized eruptive pustulosis,Stevens-Johnson syndrome, and toxic epidermal necrolysis relaxation). [See [Contraindications]]
Fatal cases of azithromycin hypersensitivity have been reported. Cases of drug reactions with eosinophilia and systemic symptoms (DRESS) have also been reported. Although symptomatic treatment of allergic symptoms was initially more successful, allergic symptoms reappeared soon after treatment was discontinued in some patients, even after they stopped taking azithromycin. These patients require an extended period of observation and treatment of allergic symptoms. The relationship between the longer semi-retention period of azithromycin in human tissues and the prolonged presence of the antigen thereafter has not yet been established.
In the event of an allergic reaction, the medication should be stopped immediately and treated appropriately. Physicians should be aware that allergic reactions may reappear after allopathic treatment has been discontinued.
Hepatotoxicity
Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and liver failure have been reported, some of which are lethal. Azithromycin should be discontinued as soon as signs and symptoms of hepatitis appear.
Infantile hypertrophic pyloric stenosis
After azithromycin application in neonates (after birth42) =”font-family:equine”>treatment within days), the occurrence of infantile hypertrophic pyloric stenosis has been reported. Parents and their caregivers should contact their physician directly if vomiting and irritation occur during feeding.
Prolonged QT interval
Prolonged cardiac repolarization process during treatment with macrolides such as azithromycin and Prolonged cardiac repolarization process and Prolonged cardiac repolarization process during treatment with macrolides such as azithromycin and prolonged QTinterval, which may lead to tachycardia and tip-twisting ventricular tachycardia. Cases of tip-twisting ventricular tachycardia have been spontaneously reported in patients taking azithromycin during postmarketing surveillance. When weighing the possible risks and benefits of azithromycin, healthcare professionals should consider that the following high-risk groups may be at risk for fatalQT Risk of extended intervals:
known withQTinterval prolongation, a history of tip-twist ventricular tachycardia, suffering from congenital longQTinterval syndrome, slow arrhythmias or non-compensated heart failure.
are taking medications known to causePatients who are taking medications known to cause interval prolongation.
The presence of a condition that causes persistent arrhythmias (e.g. uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and receiving IAclass antiarrhythmic drugs ( quinidine, procainamide) or IIIclass antiarrhythmic drugs (dofetilide, amiodarone, sotalol) therapy) in patients.
Older patients are more likely to suffer from drug effects onQTinterval.
Clostridium difficile-associated diarrhea
Almost all antimicrobial agents, including azithromycin, have been reported to cause C. difficile-associated diarrhea during administration, which can range in severity from mild diarrhea to fatal colitis. Treatment with antimicrobial agents can cause alterations in the normal colonic flora, leading to C. difficile overgrowth.
Clostridium difficile producesA,Btwo toxins that cause patients to develop diarrhea associated with C. difficile. Highly virulent C. difficile production leads to increased morbidity and mortality in patients, and these infections are ineffective with antimicrobial therapy and may require colonic resection. The possibility of C. difficile-associated diarrhea must be considered in all patients who develop diarrhea after taking antibiotics. Cases of C. difficile-associated diarrhea have been reported after more than two months of antimicrobial agents, so a careful history needs to be taken.
If C. difficile-associated diarrhea is suspected or confirmed in a patient, antibiotics that do not directly act on C. difficile may need to be discontinued. Appropriate hydration, electrolytes, and protein must be administered as clinically indicated, and antibiotics effective against C. difficile must be given and surgically evaluated if necessary.
Worsening myasthenia gravis
Patients treated with azithromycin have reported cases of worsening myasthenia gravis and new onset myasthenia gravis syndrome.
for sexually transmitted infections
Recommended doses of azithromycin do not treat syphilis. Antimicrobial agents used to treat non-gonococcal urethritis may mask the symptoms of latent syphilis or delay the onset of these symptoms. At the time of diagnosis, a syphilis serologic test and an appropriate gonorrhea test should be performed on all patients with sexually transmitted urethritis or cervicitis. If infection is confirmed, appropriate antimicrobial therapy and follow-up should be instituted.
Production of drug-resistant bacteria
In cases of undiagnosed or not highly suspected bacterial infection, or where prophylaxis is not indicated, the use of this product may not be beneficial to the patient but may increase the risk of drug-resistant bacterial production.
Restrictions on use
Azithromycin should not be used in patients with pneumonia who are not candidates for oral therapy because of the presence of the following moderate to severe disease or risk factors:
Patients with cystic fibrosis disease,
patient with hospital-acquired infection,
Patient is diagnosed or suspected to have bacteremia,
Patient requires hospitalization,
The patient is older or more frail,
Patients with underlying health problems (including immunodeficiency or absence of spleen syndrome) that may impair their ability to respond to disease.
[For Pregnant and Lactating Women]
Pregnant women
Teratogenic effects:Bclasses of gestational drugs: reproductive toxicity tests in both rats and mice have shown that when doses are administered at dose levels that produce moderate maternal toxicity (i.e.200 mg/kg/ “font-family:equilinear”>day, which is approximately 500mg/kg/day of the human dose based on body surface area. span>2to4fold), no teratogenic effect was found. However, rigorous and adequate studies have not been performed on pregnant women. Because it is not always possible to predict the appropriate response in humans from animal reproduction studies, azithromycin should be given to pregnant women only when clearly needed.
Lactating women
Small amounts of azithromycin have been reported to be secreted in breast milk; therefore, azithromycin should be used with caution in breastfeeding women.
[Pediatric use]
Regardless of the infection, the maximum recommended total dose of azithromycin in children is1500 mg /span>.
Azithromycin capsules are only indicated for patients weighing >45kg. family:equinox”>Children, use and dosage as in adults.
Children’s pharmacokinetic profile suggests children20 mg/kgis comparable to the adult1200mgdose, but itsCmaxvalues were higher.
In a multi-dose clinical trial of oral azithromycin, 9%of patients aged 65years or older (458/4949), 3%of patients aged 75years or older (144/4949). There was no overall difference in the efficacy and safety of azithromycin in these subjects versus younger subjects, and other reported clinical experience has not identified differences in drug response between older and younger patients, but it cannot be ruled out that some older patients may be more sensitive to the drug.
Older patients may be more susceptible to tip-twist ventricular tachyarrhythmias compared to younger patients. [See [Caution]]
[Drug Interactions]
Nelfinavir at steady state in combination with a single oral dose of azithromycin can increase azithromycin serum concentrations. Although no dose adjustment of azithromycin is required when combined with nelfinavir, known adverse effects of azithromycin such as liver enzyme abnormalities and hearing impairment must be monitored closely.
In a study of22 In a study of 5days of azithromycin treatment followed by warfarin did not affect prothrombin time in healthy men, although spontaneous Postmarketing reports suggest that the combined use of azithromycin may potentiate the effects of oral anticoagulants. Patients should be closely monitored for prothrombin time when combining azithromycin and oral anticoagulants.
Studies have been conducted on the interactions between azithromycin and other drugs that may be combined with it. When used at therapeutic doses, the effects of azithromycin on atorvastatin, carbamazepine, cetirizine, desipramine, efavirenz, fluconazole, indinavir, midazolam, rifabutin, sildenafil, theophylline (intravenous and oral administration), triazolam, meperidine /sulfamethoxazole or zidovudine have little effect on pharmacokinetics. When combined, efavirenz or fluconazole have little effect on the pharmacokinetics of azithromycin. No dose adjustment of either drug is required when azithromycin is combined with any of these drugs.
No interactions have been reported in clinical trials between azithromycin and the following drugs. However, no specific studies have been conducted to date to evaluate potential interactions between azithromycin and these drugs. However, these have occurred with the application of other macrolides. Therefore, in the absence of new study data, it is appropriate to monitor patients closely when azithromycin is combined with:
Digoxin: Elevated blood levels of digoxin.
Ergotamine or dihydroergotamine: acute ergot toxicity, manifested by severe peripheral vasospasm and sensory dullness.
Elevated concentrations of terfenadine, cyclosporine, sezobitol, and phenytoin.
Effects on laboratory tests: No effects on laboratory findings have been reported.
[Drug overdose]
Adverse events occurring in the event of drug overdose are the same as those for the recommended dose. Once an overdose is detected, symptomatic and supportive therapy may be given according to the condition.
[Pharmacology and Toxicology]
Pharmacological effects
Azithromycin is an azelaic lactone antibiotic whose mechanism of action is through interaction with sensitive microorganisms50ssubunit of the ribosome, thereby interfering with its protein synthesis (without affecting nucleic acid synthesis).
In vitro tests and clinical studies have shown azithromycin to be effective against a variety of pathogenic bacteria:
Gram-positive aerobic microorganisms: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus haemolyticus.
Azithromycin is cross-resistant to erythromycin-resistant gram-positive bacteria. Most Streptococcus faecalis (enterococci) as well as methicillin-resistant staphylococci are resistant to azithromycin.
Gram-negative aerobic microorganisms: Haemophilus influenzae, Catamorax.
Other microorganisms: Chlamydia trachomatis.
In vitro trials and clinical studies have demonstrated that azithromycin can prevent and treat diseases caused by the Mycobacterium avium complex (composed of Mycobacterium avium and Mycobacterium intracellulare).
Bacterial production of beta- Lactamase does not affect the activity of azithromycin.
In vitro results are available for the following microorganisms, but their clinical significance is unclear, including Streptococcus spp. (C ,F,,G) Streptococcus straw green, Clostridium perfringens, Campylobacter jejuni, Haemophilus ducreyi, Legionella pneumophila, Prevotella bifidum, Clostridium perfringens, Streptococcus pepticus spp. Mycoplasma, Syphilis spirochetes, Mycoplasma solani, etc.
Toxicological studies
Genotoxicity: Results from human lymphocyte assay, mouse bone marrow micronucleus assay and mouse in vitro lymphoma cell assay showed that azithromycin did not exhibit mutagenic effects.
Reproductive toxicity:
Reproductive toxicity tests in both rats and mice have shown that azithromycin (administered orally) at doses up to dose levels that produce moderate maternal toxicity (i.e.200 mg/kg/day, both human doses based on body surface area500 mg/kg/) No teratogenic effect was found at 2-4fold of the dailydose.
No impairment of fertility or fetus has been found. There are no adequate and rigorously controlled clinical trials in pregnant women. Because the results of animal reproduction studies are not always predictive of the human condition, this product should be used in pregnant women only when truly necessary. It is not known if this product is secreted in human milk, and since many drugs are secreted through human milk, caution should be taken when using it in nursing women.
Carcinogenicity: No data are available on the carcinogenicity of this drug for long-term use in animals.
[Pharmacokinetics]
Azithromycin, when administered orally, is rapidly distributed from the serum to tissues and various organs by absorption in a single oral dose250 mg in a single oral dose, the bioavailability can reach37%, and the maximum blood concentration is reached 2-3hours after oral administration, up to0.4 mg/l. Azithromycin is rapidly and widely distributed into tissues and can form high concentrations of 1-9 mg/ml in different tissues. After completion of the last dose orally, azithromycin remains in tissues at therapeutic concentrations5-7days.
The most striking feature of azithromycin is that it is taken up by phagocytes and transported to the site of infection by a transport mechanism that allows the concentration of this product to be much higher in infected tissues than in non-infected tissues. In addition to this azithromycin can also form high intracellular concentrations, thus exhibiting high intracellular antibacterial activity.
The primary route of clearance of azithromycin is via the biliary tract in its native form. A small proportion of the oral dose is excreted in the urine, with a clearance half-life of approximately 68hours. The pharmacokinetic properties of azithromycin allow treatment regimens to be shortened and simplified to once-a-day dosing for 3days.
[Storage] at room temperature (15～25℃).
[Packaging]
PVC/PVDCAluminum-plastic packaging (pharmaceutical foil and polyvinyl chloride/Polyvinylidene chloride solid pharmaceutical laminated rigid tablets):66Polyvinylidene chloride solid pharmaceutical laminated rigid tablets span>grain/plate,1board/boxes.
PVC/PVDCAluminum-plastic+pillow pack packaging (pharmaceutical aluminum foil and polyvinyl chloride/polyvinylidene chloride solid pharmaceutical laminate rigid sheet, plus polyester/aluminum span style=”font-family:Times New Roman”>/polyethylene pharmaceutical laminate film): 6granules/board,1board/bag,1bagbag/box.
PVCaluminum-plastic+pillow pack (pharmaceutical aluminum foil and polyvinyl chloride solid pharmaceutical rigid tablets, plus polyester/aluminum/polyethylene pharmaceutical laminate film):6grain/plate,1plate/bag,11bag/box.
[Execution Standard]
[Approval Number] State Drug CertificateH10960195
[Pharmaceutical Marketing Licensee]
Name: Shih Pharma Group Ouyi Pharmaceutical Co.
Registered Address: Yangzi Road, Shijiazhuang Economic and Technological Development Zone88No.
Postal Code:052165
Phone Number:0311-67163660 0311-87886158
Fax Number:0311-87171665
[Manufacturer]
Company Name: Shiyao Group Ouyi Pharmaceutical Co.
Production Address: Yangzi Road, Shijiazhuang Economic and Technological Development Zone88No.
Postal Code:052165
Phone Number:0311-67163660 0311-87886158
Fax Number:0311-87171665