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Moxifloxacin hydrochloride tablets (baifule)

Moxifloxacin is indicated for the treatment of adults (≥ 18 years old) with upper and lower respiratory tract infections, such as acute sinusitis, acute attack of chronic bronchitis, community-acquired pneumonia, and skin and soft tissue infections. More role
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Common name:
Moxifloxacin Hydrochloride Tablets
Product No.:
S14202008209
Approval No.:
Gyzz j20150015 (inquired by the State Drug Administration)
Jianke price:
¥130.00
Product specification:
0.4g*3s
Manufacturer:
Bayer medical and health care Co., Ltd
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      Product name Moxifloxacin hydrochloride tablets (baifule)
      Main raw materials Moxifloxacin.
      Main role Moxifloxacin is indicated for the treatment of adults (≥ 18 years old) with upper and lower respiratory tract infections, such as acute sinusitis, acute attack of chronic bronchitis, community-acquired pneumonia, and skin and soft tissue infections.
      Product specification 0.4g*3s
      Usage and dosage Dose range: 0.4g (1 tablet) once a day. 1. Adult taking method: take the tablet with a glass of water, and the taking time is not affected by diet. 2. Treatment time: the treatment time shall be determined according to the severity of symptoms or clinical reactions. The following methods can be used for the treatment of upper and lower respiratory tract infections: acute attack of chronic tracheitis: 5 days, community-acquired pneumonia: 10 days, acute sinusitis: 7 days, and the recommended treatment time for skin and soft tissue infection is 7 days; Moxifloxacin 0.4g tablets have been used for up to 14 days in clinical trials. 3. Note: the elderly do not need to adjust the dosage; Prohibited for children and adolescents; Patients with liver function injury do not need to adjust the dose of moxifloxacin; The dose of moxifloxacin (including creatinine clearance rate & le; 30ml / min / 1.73m2) need not be adjusted in patients with any degree of renal impairment; At present, there is a lack of pharmacokinetic data of dialysis patients; There is no need to adjust the drug dose between different races.
      manufacturing enterprise Bayer medical and health care Co., Ltd
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      [drug name] Moxifloxacin hydrochloride tablets (baifule)

      [common name] Moxifloxacin Hydrochloride Tablets

      [specification and model] 0.4g*3s

      [manufacturer] Bayer medical and health care Co., Ltd

      [drug type] Western medicine

      [approval No.] Gyzz j20150015

      [validity period] 36 months

      [functional indications] Moxifloxacin is indicated for the treatment of adults (≥ 18 years old) with upper and lower respiratory tract infections, such as acute sinusitis, acute attack of chronic bronchitis, community-acquired pneumonia, and skin and soft tissue infections.

      [usage and dosage] Dose range: 0.4g (1 tablet) once a day. 1. Adult taking method: take the tablet with a glass of water, and the taking time is not affected by diet. 2. Treatment time: the treatment time shall be determined according to the severity of symptoms or clinical reactions. The following methods can be used for the treatment of upper and lower respiratory tract infections: acute attack of chronic tracheitis: 5 days, community-acquired pneumonia: 10 days, acute sinusitis: 7 days, and the recommended treatment time for skin and soft tissue infection is 7 days; Moxifloxacin 0.4g tablets have been used for up to 14 days in clinical trials. 3. Note: the elderly do not need to adjust the dosage; Prohibited for children and adolescents; Patients with liver function injury do not need to adjust the dose of moxifloxacin; The dose of moxifloxacin (including creatinine clearance rate & le; 30ml / min / 1.73m2) need not be adjusted in patients with any degree of renal impairment; At present, there is a lack of pharmacokinetic data of dialysis patients; There is no need to adjust the drug dose between different races.

      [adverse reactions] The adverse reactions (ADRs) of this product are based on all clinical studies of 0.4g moxifloxacin (oral and sequential therapy) and classified according to the frequency of ciomsiii (total N = 17951, including sequential therapy n = 4583, time: May 2010) as follows: Except for nausea and diarrhea, the incidence of adverse reactions (ADRs) listed under "common" is less than 3%. Adverse reactions (ADRs) from the post marketing report (time: May 2010) are printed in italics. Within each frequency group, adverse reactions were listed in descending order of severity. Frequency is defined as: Common (≥ 1 / 100 to < 1 / 10), Rare (≥ 1 / 1000 to < 1 / 100), Rare (≥ 1 / 10000 to < 1 / 1000), Extremely rare (< 1 / 10000). In the subgroup of patients receiving oral or intravenous sequential treatment, the following adverse reactions occurred more frequently: Common: γ Increased glutamyl aminotranspeptidase Rare: ventricular tachycardia, hypotension, edema, antibiotic induced colitis (rarely accompanied by fatal complications), seizures of various clinical manifestations (including grand mal seizures), hallucinations, renal injury and renal failure (caused by dehydration, especially in elderly patients with nephropathy).

      [precautions] If some patients have hypersensitivity and allergy after the first administration, they should inform the doctor immediately. Very few patients will have life-threatening shock caused by allergic reaction after the first administration. In these cases In case of shock, the drug should be stopped and treated accordingly (e.g. for shock). Moxifloxacin can prolong the QT interval of ECG in some patients. Compared with men, female patients tend to have longer QTc interval, which may be more sensitive to drugs causing QTc interval extension. Elderly patients are also more susceptible to drugs related to QT interval. Because the extent of QT interval prolongation may increase with the increase of drug concentration. Therefore, the recommended dose and infusion rate should not be exceeded (within 90 minutes 0.4g). However, no significant difference was observed in the pneumonia patients. The prolongation of QT interval could lead to the increased risk of ventricular arrhythmias including the incidence rate of tachycardia. There was no cardiovascular morbidity or mortality due to prolonged QTc interval in the clinical study of 9000 patients treated by the treatment of the treatment of chronic heart failure, but some of the patients had no QTc. Potential conditions can increase the risk of ventricular arrhythmia. [u] Due to the lack of clinical experience in the following patient populations, the use of this drug should be avoided [/ u]: ? patients with known QT interval prolongation; ? patients with uncorrectable hypokalemia; ? patients receiving antiarrhythmic drugs of class IA (e.g. quinidine, procainamide) or class III (e.g. amiodarone, sotalol). [u] Since the cumulative effect of bufloxacin on QT interval cannot be excluded, moxifloxacin should be used with caution in the following cases [/ u]: ? the patient received concomitant treatment with drugs that can prolong QT interval, such as cisapride, erythromycin, antipsychotics and tricyclic antidepressants; ? the patient currently has arrhythmia causing conditions, such as clinically significant bradycardia and acute myocardial ischemia; ? patients with liver cirrhosis cannot rule out previous QT interval prolongation in these patients; ? female and elderly patients who may be more sensitive to drugs that cause QTc interval prolongation. It has been reported that baifule can cause fulminant hepatitis and may lead to liver failure (including death) (see [adverse reactions]). If liver failure related symptoms occur, it is recommended that the patient contact the doctor immediately before continuing treatment. The use of quinolones can induce seizures. For patients with known or suspected central nervous system diseases that can lead to seizures or reduce the seizure threshold, attention should be paid to the use of Baifu le. It has been reported that antibiotic associated enteritis occurs when using broad-spectrum antibiotics, including Baifu le. Therefore, it is important to consider this diagnosis when patients have severe diarrhea during the treatment of Baifu le. In this case, adequate treatment measures need to be taken immediately. In patients with severe diarrhea, it is contraindicated to use drugs that can inhibit gastrointestinal peristalsis Drugs. Patients with myasthenia gravis should be careful with bifidolol, because it can aggravate the symptoms. Tendinitis and tendon rupture may occur in quinolones including moxifloxacin, especially in elderly patients and patients treated with corticosteroids at the same time; there have been reported cases that occur several months after the completion of treatment. Once there are symptoms of pain or inflammation, patients need to stop taking drugs and rest the affected limbs. It has been confirmed that quinolones can cause photosensitive reaction in patients. However, photosensitive reaction of Baifu Le has not been observed in specially designed preclinical and clinical studies. In addition, there is no clinical evidence that Baifu Le causes photosensitive reaction since its listing. Nevertheless, patients should be advised to avoid excessive exposure to ultraviolet and sunlight. For the treatment of patients with complex pelvic infection (such as fallopian tube ovary or pelvic abscess), intravenous administration should be considered, rather than oral 0.4g baifule tablets. Moxifloxacin is not recommended for the treatment of MRSA infection. If MRSA infection is suspected or determined, appropriate antibiotics should be selected for treatment. The in vitro activity of moxifloxacin may interfere with the mycobacterial culture test by inhibiting the growth of mycobacteria. Therefore, the sample results may be false negative for patients who are using Baifu le. It has been reported that multiple neuropathy leading to abnormal sensation, hypoesthesia, numbness or weakness of sensation or sensory movement has occurred in patients receiving waronone drugs, including baifule. If patients have neurological symptoms such as pain, burning, tingling, numbness or weakness when receiving baifule, it is recommended to continue to use baifule Inform the doctor before (see [adverse reactions]). Psychiatric reactions, including moxifloxacin, may occur even after the first use of fluoroquinolones. In rare cases, depressive or psychiatric reactions that develop suicidal ideation and self injurious behavior, such as attempted suicide (see [adverse reactions]) . if the patient has the above reaction, he should stop using Baifu le and carry out appropriate disease treatment. Caution is recommended when using Baifu le in patients with mental illness or patients with a history of mental illness. Because Neisseria gonorrhoeae resistant to fluoroquinolone is widely spread and has a high prevalence, patients with pelvic infectious diseases should avoid the use of moxifloxacin monotherapy unless they can be excluded from Neisseria gonorrhoeae resistant to fluoroquinolone. If we can not exclude Neisseria gonorrhoeae resistant to fluoroquinolone, we should consider the experience in Moxifloxacin treatment. Add an antibiotic against Neisseria gonorrhoeae (e.g. a cephalosporin). Due to central nervous system (CNS) reaction and abnormal vision, fluzanolone drugs including moxifloxacin may damage the patient's ability to drive or operate machinery (see [adverse reactions]). Please read the instructions carefully and use them as directed by the doctor.

      [taboo] Known allergy to any component of moxifloxacin, or other quinolones, or any excipients. Pregnant and lactating women. Due to the lack of clinical data on the use of moxifloxacin in patients with severe liver injury (child Pugh grade C) and patients with transaminase elevation greater than 5 times the upper limit of normal value, the use of moxifloxacin is prohibited in such patients. Patients under 18 years old.

      [listing Permit Holder] Bayer medical and health care Co., Ltd

      [packaging unit] box

      [main ingredients] Moxifloxacin.

      [character] This product is a dark red special-shaped film coating piece, which turns yellow after removing the bag.

      [applicable population] adult

      [medication for pregnant and lactating women] Pregnant women: the safety of human use of moxifloxacin during pregnancy has not been confirmed. Taking quinolones in children can cause reversible joint injury. However, this effect has not been reported in the fetus of pregnant drug users. Animal studies have shown that moxifloxacin has reproductive toxicity, but the potential risk to humans is not clear. Therefore, moxifloxacin is forbidden to women during pregnancy. Lactating women: like other quinolones, moxifloxacin can cause cartilage damage in weight-bearing joints of juvenile experimental animals. Preclinical studies have confirmed that a small amount of moxifloxacin can be distributed in human milk. There is still a lack of data on lactating women. Therefore, moxifloxacin is forbidden to lactating women.

      [medication for children] The efficacy and safety of moxifloxacin in children and adolescents have not been determined.

      [medication for elderly patients] Elderly patients do not need to adjust the dosage.

      [storage] Sealed storage below 25 ℃.

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        Moxifloxacin hydrochloride tablets (baifule)

        ¥130.00

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