Azithromycin dispersible tablets
Indications: This product is suitable for the following infections caused by sensitive bacteria: otitis media, sinusitis, pharyngitis, tonsillitis and other upper respiratory tract infections: bronchitis, pneumonia and other lower respiratory tract infections. Skin and soft tissue infections. Simple genital infection caused by Chlamydia trachomatis. Simple genital infection not caused by multidrug-resistant gonococci (co-infection with Treponema pallidum needs to be excluded).
Main ingredients
Azithromycin.
Functional indications
This product is suitable for the following infections caused by sensitive bacteria: otitis media, sinusitis, pharyngitis, tonsillitis and other upper respiratory tract infections; bronchitis, pneumonia and other lower respiratory tract infections. Skin and soft tissue infections. Simple genital infection caused by Chlamydia trachomatis. Simple genital infection not caused by multidrug-resistant gonococci (co-infection with Treponema pallidum needs to be excluded).
Dosage
Azithromycin dispersible tablets are used to treat infectious diseases. The course of treatment and usage are as follows: Disperse with water and take orally or swallow directly to treat sexually transmitted diseases caused by Chlamydia trachomatis or sensitive gonococci. Only 1.0g of this product is taken orally in a single dose. For other infections Treatment: The total dose is 1.5g, taken in three divided doses; 0.5g of this product is taken once a day. Or the total dose is the same, which is still 1.5g. Take 0.5g on the first day, and then take 0.25g of this product orally once a day on the second to fifth days. In case of overdose (not yet reported), gastric lavage or oral administration can be performed. General supportive care.
drug interactions
Drug Interactions: When nelfinavir is at steady state, combined with a single oral dose of azithromycin, the serum concentration of azithromycin may increase. Although no dose adjustment of azithromycin is required when administered with nelfinavir, close monitoring is necessary for known side effects of azithromycin such as liver enzyme abnormalities and hearing impairment. aSpontaneous postmarketing reports suggest that concomitant use of azithromycin may potentiate the effects of oral anticoagulants. When patients take azithromycin and oral anticoagulants concomitantly, their prothrombin time should be closely monitored. When used at therapeutic doses, azithromycin is effective against atorvatajan, carbamazepine, cetirizine, and didanosine: efavirenz, fluconazole, indinavir, midazole, fabutin, and cetirizine Nafil: The pharmacokinetics of theophylline (intravenous and oral administration), triazolam, trimethoprim/sulfamethoxazole, or zidovudine are not affected. When used together, efavirenz or fluconazole have little effect on the pharmacokinetics of azithromycin. When azithromycin is used with any of the above drugs, no dose adjustment of either drug is necessary. Azithromycin has not been reported to interact with the following drugs in clinical trials. However, no specific studies have been conducted to date to evaluate potential interactions between azithromycin and these drugs. However, these situations have occurred with other macrolides. Therefore, in the absence of new research data, patients should be closely observed when azithromycin is combined with the following drugs: Digoxin – The blood concentration of digoxin is increased. Ergotamine or dihydroergotamine – Acute ergot poisoning, manifested by severe peripheral vasospasm and dysesthesia. Effects of elevated concentrations of terfenadine, cyclosporine, hysobia and phenytoin on laboratory tests: No effects on laboratory test results have been reported.
Medication for special populations
Pregnant and lactating women: Animal reproductive toxicity studies have shown that azithromycin crosses the placenta, but has no signs of damage to the fetus. There is no data on the secretion of this product in breast milk. The safety of use in human pregnancy and lactation has not been confirmed so far, so this product should be used only when pregnant or lactating women have no appropriate choice. Use in children: Not known. Medication for the elderly: Please refer to the [Precautions] section.
Adverse reactions
(1) Clinical trial experience: Since clinical trials are completed under different conditions, the adverse reaction rate of a drug observed in clinical trials cannot be directly compared with the adverse reaction rates of other drugs in clinical trials, and may not necessarily reflect Adverse reaction rates in practical applications. In clinical trials of azithromycin intravenous preparations for the treatment of community-acquired pneumonia, 2 to 5 doses were administered intravenously. Most of the reported adverse reactions were mild to moderate and could be recovered after discontinuation of the drug. Most patients in these clinical trials had more than one comorbidity and required additional medications. Approximately 1.2% of patients taking intravenous preparations of this product discontinued taking the medication, and 2.4% of patients taking intravenous or oral azithromycin discontinued taking the medication due to adverse reaction symptoms or abnormal laboratory tests. In clinical trials in patients with pelvic inflammatory disease, 2% of female patients who received azithromycin alone discontinued the drug due to clinical adverse reactions after 1 to 2 intravenous doses, and patients who received azithromycin in combination with metronidazole 4% of patients discontinued treatment due to adverse reactions. In the above studies, the most common adverse reactions that led to drug discontinuation were gastrointestinal reactions (abdominal pain, nausea, vomiting, diarrhea, etc.) and rash, and the laboratory test abnormalities that led to drug discontinuation were mainly elevated levels of aminotransferase and/or alkaline phosphatase. high. In studies of community-acquired pneumonia, the most common adverse reactions in adult patients treated with intravenous/oral formulations of this product were gastrointestinal reactions, including diarrhea or loose stools (4.3%), nausea (3.9%), and abdominal pain (2.7%). %), vomiting (1.4%). About 12% of patients experienced intravenous injection-related adverse reactions, the most common being injection site pain (6.5%) and local inflammatory reaction (3.1%). In clinical trials in patients with pelvic inflammatory disease, adult female patients were treated with intravenous/oral formulations of this product. The most common adverse reactions related to treatment were gastrointestinal reactions, the most common of which were diarrhea (8.5%) and nausea (6.6%). %), followed by vaginitis (2.8%), abdominal pain (1.9%), anorexia (1.9%), rash and itching (1.9%). When azithromycin was combined with metronidazole in these studies, a higher proportion of female patients experienced nausea (10.3%), abdominal pain (3.7%), vomiting (2.8%), administration site reactions, stomatitis, dizziness, and dyspnea (total 1.9%). Other adverse reactions caused by the intravenous/oral multi-dose treatment regimen of azithromycin did not exceed 1%. Adverse reactions with an incidence of less than 1% include: gastrointestinal reactions: indigestion, abdominal distension, mucositis, oral candidiasis and gastritis. Nervous system: headache, drowsiness. Allergic reaction: bronchospasm. Special feeling: paranoia. (2) Experience in post-marketing application: Oral azithromycin preparations have been used in adult and/or pediatric patients after being marketed. The following adverse events have been reported, but it is not certain whether they were caused by azithromycin: Allergic reactions: joint pain, edema, urticaria Measles, angioedema. Cardiovascular: Arrhythmias include ventricular tachycardia, hypotension, rare QT prolongation, and torsade de pointes. Gastrointestinal: Anorexia, constipation, dyspepsia, bloating, vomiting/diarrhea but rarely dehydration, pseudomembranous colitis, pancreatitis, oral candidiasis, pyloric stenosis, and rarely tongue discoloration. Systemic reactions: Asthenia, paresthesia, fatigue, malaise and anaphylactic shock reaction. Genitourinary system: interstitial nephritis, acute renal failure, vaginitis. Hematopoietic System: Thrombocytopenia Liver/Biliary: Adverse reactions related to hepatic insufficiency have been reported in post-marketing experience with azithromycin. Nervous System: Convulsions, dizziness/vertigo, headache, drowsiness, hyperactivity, nervousness, agitation, and syncope. Ear and labyrinth abnormalities: deafness, tinnitus, hearing impairment, vertigo. Mental: Aggressive reactions and anxiety. Skin and appendages: Pruritus. Rare severe skin reactions include erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrosis. Special Senses: Hearing impairment including hearing loss, deafness, and/or tinnitus, abnormal taste/smell and/or loss have also been reported. Abnormal laboratory tests: Laboratory tests with significant abnormalities seen in clinical trials (whether related to drugs or not) are: incidence rate 4% to 6%: alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine increased. Incidence rate 1% to 3%: elevated lactate dehydrogenase (LDH) bilirubin. Incidence less than 1%: leukopenia, neutropenia, decreased platelet count, elevated serum alkaline phosphatase. Follow-up revealed that the above laboratory abnormalities were reversible. In multiple-dose azithromycin (intravenous/oral) clinical trials involving more than 750 patients, no more than 2% of patients discontinued azithromycin due to treatment-related liver enzyme abnormalities. rIt is contraindicated in patients allergic to cyclolides or ketolides.
