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Azithromycin dispersible tablets

Product description
Date of approval: June 18, 2006
 
Date of revision: October 1, 2010
 
October 16, 2013
 
Azithromycin dispersible tablet
 
Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
 
Generic Name: Azithromycin Dispersible Tablets
English name: Azithromycin Dispersible Tablets
Chinese Pinyin: Aqimeisu Fensanpian
 
[Ingredients] The main component of this product is azithromycin, and its chemical name is: (2R, 3S, 4R, 5R, 8R, 10R, 11R, 12S, 13S, 14R)-13-[(2,6-dideoxy-3- C-methyl-3-O-methyl-α-L-nuclear-hexyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10 ,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xy-hexyranosyl]oxy]-1-oxa- 6-Azacyclopentadecane-15-one.
                          
    Molecular formula: C38H72N2O12
    Molecular weight: 749.00
 
【Properties】 This product is white or off-white.
[indications]
    1. Acute pharyngitis and acute tonsillitis caused by Streptococcus pyogenes.
 
2. Acute sinusitis caused by sensitive bacteria, acute otitis media, acute bronchitis, acute exacerbation of chronic bronchitis.
 
3. Pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Mycoplasma pneumoniae.
 
4. Chlamydia trachomatis and non-multiple drug-resistant urethritis and cervicitis caused by Neisseria gonorrhoeae.
 
5. Skin and soft tissue infections caused by sensitive bacteria.
 
[Specification] 0.25g
【Dosage】
    This product is a dispersible tablet, which can be directly taken or swallowed, or put into the 100ml water in an appropriate amount. After shaking and dispersing, take it 1 hour before meals or 2 hours after meals.
 
Adult dosage: 1, sexually transmitted diseases caused by Chlamydia trachomatis or Neisseria gonorrhoeae, only need a single oral dose of 1.0g (4 tablets).
 
2, the treatment of other infections: the first day, 0.5g (2 tablets), the second to the 5th, 0.25g (1 tablet) a day; or 0.5g (2 tablets) a day, Even served for 3 days.
 
Pediatric dosage: 1, treatment of otitis media, pneumonia, the first day, according to the weight of 10mg / kg of the service [maximum amount of no more than 0.5g (2 tablets)], 2nd to 5th, daily weight of 5mg / kg Service [maximum amount of one day does not exceed 0.25g (1 piece)].
 
2, treatment of pediatric pharyngitis, tonsillitis, one day according to the weight of 12mg / kg ton [maximum amount of no more than 0.5g (2 tablets)], for 5 days.
 
Or follow the doctor's advice.
 
【Adverse reactions】
 
(1) Clinical trial experience
 
Since clinical trials are performed under different conditions, the adverse reaction rate of one drug observed in clinical trials cannot be directly compared with the adverse reaction rates of other drugs in clinical trials, and may not reflect adverse reactions in practical applications. rate.
 
In the clinical trial of azithromycin intravenous preparation for community-acquired pneumonia, 2 to 5 doses were administered intravenously, and most of the reported adverse reactions were mild to moderate, and recovered after stopping the drug. Most patients in these clinical trials have more than one comorbidity and need to apply other drugs. About 1.2% of patients who received intravenous injections of this product discontinued medication, and 2.4% of patients treated with intravenous or oral azithromycin discontinued medication due to adverse reaction symptoms or abnormal laboratory tests.
 
In clinical trials in patients with pelvic inflammatory disease, 2% of patients who received azithromycin monotherapy received intravenous drug administration, 2% of patients discontinued due to clinical adverse reactions, and patients with azithromycin and metronidazole 4% of patients discontinued treatment due to adverse reactions.
 
In the above studies, the most common adverse reactions leading to discontinuation of the drug were gastrointestinal reactions (abdominal pain, nausea, vomiting, diarrhea, etc.) and rashes, leading to abnormal laboratory tests for discontinuation of aminotransferase and/or alkaline phosphatase. high.
 
In the community-acquired pneumonia study, the most common adverse reaction in adult patients receiving intravenous/oral preparations was gastrointestinal reactions, including diarrhea or loose stools (4.3%), nausea (3.9%), and abdominal pain (2.7). %), vomiting (1.4%). About 12% of patients had adverse reactions related to intravenous injection, the most common being injection site pain (6.5%) and local inflammatory response (3.1%).
 
In clinical trials of patients with pelvic inflammatory disease, adult female patients receive intravenous/oral preparations of this product. The most common adverse reactions associated with treatment are gastrointestinal reactions, among which diarrhea (8.5%) and nausea (6.6) are common. %), followed by vaginitis (2.8%), abdominal pain (1.9%), anorexia (1.9%), rash and itching (1.9%). In these studies, a combination of azithromycin and metronidazole occurred in a higher proportion of female patients with nausea (10.3%), abdominal pain (3.7%), vomiting (2.8%), site of administration, stomatitis, dizziness, and difficulty breathing. 1.9%).
 
Other adverse reactions caused by azithromycin intravenous/oral multi-dose regimen did not exceed 1%.
 
Adverse reactions with an incidence of no more than 1% are:
 
Gastrointestinal reactions: indigestion, bloating, mucositis, oral candidiasis and gastritis.
 
Nervous system: headache, lethargy.
 
Allergic reaction: bronchospasm.
 
Special feeling: the taste is wrong.
 
(II) Experience after application after listing
 
Oral azithromycin preparations are used in adult and/or child patients after marketing, and there are reports of the following adverse events, but it is not certain whether it is caused by azithromycin:
 
Allergies: joint pain, edema, urticaria, angioedema.
 
Cardiovascular: Arrhythmias include ventricular tachycardia, hypotension, rare QT interval prolongation, and torsades de point ventricular tachycardia.
 
Gastrointestinal tract: anorexia, constipation, indigestion, bloating, vomiting/diarrhea but rarely causes dehydration, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis and rare tongue discoloration.
 
Systemic reactions: fatigue, paresthesia, fatigue, discomfort, and anaphylactic shock response.
 
Genitourinary system: interstitial nephritis, acute renal failure, vaginitis.
 
Hematopoietic system: thrombocytopenia.
 
Liver/biliary: The adverse effects associated with liver dysfunction have been reported in the experience of azithromycin after marketing.
 
Nervous system: convulsions, dizziness/vertigo, headache, lethargy, hyperactivity, nervousness, agitation, and syncope.
 
Abnormal ears and lost: deafness, tinnitus, hearing loss, dizziness.
 
Spirit: Aggressive reactions and anxiety.
 
Skin and Accessories: Itching, a rare and severe skin reaction including erythema multiforme, Stevens Johnson syndrome, and toxic epidermal necrosis.
 
Special Sense: Hearing impairment includes hearing loss, deafness and/or tinnitus, as well as reports of taste/olfactory abnormalities and/or loss.
 
Laboratory check abnormalities:
 
Significant laboratory tests (whether or not related to drugs) seen in clinical trials are:
 
The incidence rate is 4% to 6%: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine.
 
The incidence rate is 1% to 3%: lactate dehydrogenase (LDH) and bilirubin are elevated.
 
The incidence is less than 1%: leukopenia, neutropenia, decreased platelet count, and elevated serum alkaline phosphatase.
 
Follow-up found that the above laboratory abnormalities were reversible.
 
In a clinical trial of multiple doses of azithromycin (intravenous/oral) in more than 750 patients, no more than 2% of patients discontinued azithromycin due to treatment-related liver enzyme abnormalities.
 
[taboo]
It is known to be banned in patients who are allergic to azithromycin, erythromycin, other macrolides or ketolides. Previously used
 
Patients with a history of cholestatic jaundice/liver dysfunction after azithromycin were banned.
 
caveat
 
Allergic reaction
 
Reports of severe allergic reactions, including angioedema, anaphylactic shock, and skin reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis, are rare in the treatment with azithromycin. Although rare, there are reports of death. In some patients, allergic symptoms are initially given symptomatic treatment. If the treatment is stopped prematurely, even if azithromycin is not used, the allergic symptoms can recur quickly. It is necessary to extend the time for symptomatic treatment and observation for such patients. It is not known whether the occurrence of these events is related to the long half-life of azithromycin in the tissue and the longer exposure of the body to the antigen.
 
In the event of an allergic reaction, the drug should be discontinued immediately and given appropriate treatment. The doctor should know that allergic symptoms may reappear after stopping symptomatic treatment.
 
Hepatotoxicity
 
There have been reports of abnormal liver function, hepatitis, cholestasis of jaundice, liver necrosis, and liver failure, some of which may be fatal. If symptoms and signs of hepatitis appear, stop using this product immediately.
 
Clostridium difficile-associated diarrhea
 
Almost all antibacterial drugs have reports of Clostridium difficile-associated diarrhea (CDAD), including this product, which can range from mild diarrhea to fatal colitis. Antimicrobial treatment can cause changes in the normal flora in the colon, leading to excessive reproduction of Clostridium difficile.
 
Toxin A and toxin B produced by Clostridium difficile are associated with the pathogenesis of CDAD. Highly toxic C. difficile causes increased morbidity and mortality, and these infections may be difficult to treat with antibiotics and may require colectomy. For all patients with diarrhea after using antibiotics, the possibility of CDAD must be considered. Since there have been reports of CDAD after more than 2 months of antibiotic treatment, it is necessary to carefully ask about the medical history.
 
If the CDAD is suspected or diagnosed, it may be necessary to discontinue the antibiotic that is not being used for Clostridium difficile. Must root
 
Appropriately supplement water, electrolytes and protein according to clinical needs, and give antibiotics effective against Clostridium difficile, if necessary
 
Assessment.
 
【Precautions】
General: Because azithromycin is mainly cleared by the liver, patients with impaired liver function should use azithromycin with caution. GFR
 
 Subjects <10 mL/min have limited data, and azithromycin should be used with caution in such patients. Have had abnormal liver function, hepatitis,
 
Reports of cholestatic jaundice, liver necrosis, and liver failure, some of which may be fatal. If there are signs of hepatitis and
 
Symptoms, azithromycin should be discontinued immediately.
 
This product should be dissolved and diluted according to the instructions. The time of intravenous drip should not be less than 60 minutes.
 
It has been reported that intravenous injection of azithromycin may cause adverse reactions when injected locally. Azithromycin 500 mg was administered to a concentration of 2 mg/ml, and a 250 ml solution was dispensed or formulated into 1 mg/ml in 1 hour, and a 500 ml solution was dripped in 3 hours. The incidence and severity of local adverse reactions were similar. All volunteers who received azithromycin concentration greater than 2.0 mg/ml had a local injection, so the concentration of the solution at the time of intravenous infusion should not be too high.
 
QT interval extension
 
It has been reported that the use of other macrolide antibiotics, including azithromycin, can cause ventricular repolarization and prolongation of the QT interval, leading to the risk of arrhythmia and torsade ventricular tachycardia. In the post-marketing surveillance of patients taking azithromycin, there was a spontaneous report of a case of torsades de pointes ventricular tachycardia. When weighing the risks and benefits of using azithromycin in high-risk populations, health care providers should consider the risk of potentially fatal QT interval prolongation, including:
 
• Patients with prolonged QT interval, torsade de pointive ventricular tachycardia, congenital QT prolongation syndrome, bradyarrhythmia or decompensated heart failure are known.
 
· Patients who are known to prolong their QT interval medications, such as antipsychotics, antidepressants, and fluoroquinolones.
 
· Patients with arrhythmia, such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and receiving type IA (quinidine, procainamide) and type III (Dofetilide, amiodarone, sotalol) patients with antiarrhythmic drugs.
 
Older patients: Older patients may be more sensitive to drug-related QT interval effects.
 
Azithromycin-treated patients have reported aggravation of myasthenia gravis or a new myasthenia gravis syndrome.
 
In the absence of a diagnosis or a high degree of suspected bacterial infection, or no indication of prevention, the use of this product may not be beneficial to the patient, and will increase the risk of drug-resistant bacteria.
 
Patients need to know:
 
Azithromycin should be discontinued immediately when any signs of allergic reactions occur and contact your doctor.
 
Patients should be advised that antibiotics including this product (azithromycin) can only be used to treat bacterial infections and cannot be used to treat viral infections (eg the common cold). When using this product (azimycin) to treat bacterial infections, patients must be informed that although they usually feel better at the beginning of treatment, they should follow the doctor's instructions for accurate medication. Missing or not completing the entire course of treatment may: (1) reduce the efficacy of current treatments; (2) increase the possibility of bacterial resistance, which will lead to the inability of azithromycin or other antibiotics to treat these resistant bacteria in the future.
 
Antibiotic treatment often causes diarrhea, which usually recovers after stopping the antibiotic. Sometimes after giving antibiotics, patients
 
Even after 2 months or more after the last use of antibiotics, watery stools or bloody stools (with or without stomach cramps and fever) appear. If this happens, the patient should contact the doctor as soon as possible.
 
Patients with mild renal insufficiency (creatinine clearance > 40 ml / min) do not need to be adjusted for dose, but azithromycin is not adequate for the use of patients with severe renal insufficiency. Care should be taken when using azithromycin in these patients.
 
As with other antibiotics, attention should be paid to the observation of the symptoms of double infection caused by non-sensitive bacteria including fungi.
 
If you have any adverse events and/or adverse reactions during the use of this product, please consult your doctor.
 
Please let your doctor know if you are using other medicines at the same time.
 
Please keep out of reach of children.
 
[Pregnant women and lactating women]
    There are currently no adequate and strictly controlled clinical trials in pregnant women. Since the results of animal reproduction studies do not always predict human conditions, the application of maternity must be fully weighed against the pros and cons.
 
It is not known whether this product is secreted in human milk. Since many drugs are secreted by human milk, breast-feeding women must be carefully considered when using them.
 
[Children's medication]
 
Regardless of the infection, the total dose of azithromycin in children is recommended to be no more than 1500 mg.
 
This product is used in adults with a weight of more than 45kg.
 
The efficacy and safety of otitis media, community-acquired pneumonia, and pharyngitis or tonsillitis in children less than 2 years old have not been determined.
 
[Geriatric medication] is not clear.
 
【medicine interactions】
 
Drug interactions: Oral administration of a single dose of azithromycin in the steady state of nelfinavir can increase the serum concentration of azithromycin. Although it does not need to be adjusted when used with nelfinavir
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