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  • Name: Levofloxacin Hydrochloride Capsules
  • Add time: 2015-05-15
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Please read the instructions carefully and use under the guidance of the physician
Prohibited for use in food and feed processing
In all age groups, fluoroquinolones, including levofloxacin can lead to the risk of tendinitis and tendon rupture is

increased. In a typical 60-year-old or older patients, patients receiving glucocorticoid therapy and receive a kidney

transplant, a patient's heart transplant or lung transplant, the risk is further increased.
Fluoroquinolones, including levofloxacin can worsen muscle weakness in patients with myasthenia gravis. Should be avoided

in patients with a known history of myasthenia gravis use levofloxacin.
[Drug Name]
Generic Name:盐酸左氧氟沙星胶囊
English name:Levofloxacin Hydrochloride Capsules
Pinyin:Yansuan Zuoyangfushaxing Jiaonang
Chemical name: (-) - (S) - 3- methyl-9-fluoro-2,3-dihydro-10- (4-methyl-1-piperazinyl) -7-oxo-pyridin -7H- and [1,2,3-de] -

[1,4] benzoxazine-6-carboxylic acid hydrochloride monohydrate.
The chemical structural formula:
This product is hard capsules, the contents of white or off-white powder.
It applies to goods caused by:
1. Urogenital infections, including simple and complicated urinary tract infections, bacterial prostatitis, urethritis or

cervicitis Neisseria gonorrhoeae (including those caused by strains enzyme production).
2. Respiratory tract infections, including gram-negative bacilli sensitive due to bronchial infection and acute lung

3. Gastrointestinal infection, caused by Shigella, Salmonella, enterotoxigenic E. coli, hydrophilic Aeromonas, Vibrio

4. Typhoid fever.
5. Bone and joint infections.
6. Skin and soft tissue infections.
7. Sepsis and other systemic infections.
0.1g (at C18H20FN3O4 dollars)
Oral. The usual dose for adults:
1. Bronchial infections, lung infections: a 0.2g, 2 times a day or once 0.1g, 3 times a day for 7 to 14 days.
2. Acute uncomplicated urinary tract infections: a 0.1g, 2 times a day, 5 to 7 days of treatment; a sense of the complexity

of the urinary tract
Dye: a 0.2g, 2 times a day, or once 0.1g, three times a day, treatment for 10 to 14 days.
3. Bacterial prostatitis: a 0.2g, 2 times a day, treatment for six weeks.
The usual dose of adult day 0.3 ~ 0.4g, 2 to 3 times daily, such as severe infection or infection by a pathogen less

sensitive, such as Pseudomonas aeruginosa Pseudomonas dose bacterial infections can also be day increased to 0.6g, 3 times

Adverse reactions
This product Levofloxacin, the active ingredient is levofloxacin, reported in the literature related to the case of

levofloxacin as follows:
1. serious adverse reactions and other important
The following serious adverse reactions and other important in [Note] in detail: tendinitis and tendon rupture, worsening

of myasthenia gravis, hypersensitivity, other serious and sometimes fatal reactions, liver toxicity, CNS effects, difficult

Resolution Clostridium-associated diarrhea, peripheral neuropathy, QT prolongation, pediatric patients with musculoskeletal

disorders, blood disorders, photosensitivity / phototoxicity and resistant bacteria.
According to the report, the use of quinolones (including levofloxacin) may lead to the crystallization of urine and

urinary tube. Thus, for the treatment of patients receiving levofloxacin, adequate hydration should be maintained to

prevent the formation of a highly concentrated urine.
2. Clinical Trials Experience
As the clinical trials carried out under different conditions, adverse reaction rates observed in the clinical trials of a

drug can not be directly adverse reaction rates and other drugs in clinical trials compared and are not necessarily

reflected in the practical application of adverse reactions rate.
Data described below reflect 29 Ⅲ clinical trials of 7537 patients levofloxacin combined exposures. The average age of the

study population was 50 years (about 74% of the population <65 years), of which 50% were male, 71% were white, 17 percent

were black people. Because patients with a wide range of infectious diseases and receiving levofloxacin (see indications).

Patients received a dose of 750 mg levofloxacin once daily, 250 mg once daily or 500 mg once or twice daily, treatment is

usually 3 to 14 days, with an average duration of treatment was 10 days.
The overall incidence of adverse reactions, the type and distribution of levofloxacin 750 mg once daily, 250 mg once daily

or 500 mg twice daily or similar patients. A total of 4.3% of patients due to adverse drug reactions and disabled

levofloxacin, receiving 250 mg and 500 mg daily dose in patients, this proportion was 3.8%; receiving 750 mg daily dose in

patients, this ratio was 5.4 %. Receiving 250 mg and 500 mg daily dose in patients with the most common causes of adverse

drug reactions were gastrointestinal reactions discontinuation (1.4%), mainly nausea (0.6%), and vomiting (0.4%), dizziness

(0.3 %) and headache (0.2%). Receiving 750 mg daily dose in patients with the most common causes of adverse drug

discontinuation were gastrointestinal reactions (1.2%), mainly nausea (0.6%), and vomiting (0.5%), dizziness (0.3%) and

headache (0.3%).
In the following table (Table 1 and Table 2) were enumerated in ≥1% of patients receiving levofloxacin in the treatment of

adverse reactions, and occurs in 0.1 to <1% of patients receiving levofloxacin treatment of adverse reactions. The most

common adverse reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation, and dizziness.



Disabled patients of the goods and fluoroquinolone drug allergies.
This product levofloxacin capsules, the active ingredient is levofloxacin, reported in the relevant circumstances of

levofloxacin as follows:
1. tendinitis and tendon rupture
All age groups of patients using fluoroquinolone antibiotics including levofloxacin, including the treatment of patients

with possible increased risk of tendinitis and tendon rupture occurred. The most common adverse reactions include Achilles

tendon, and Achilles tendon requires surgical repair. Tendinitis and has been reported to occur in parts of the Arab Spring

break includes a shoulder, hand, biceps, the thumb and the other parts of the tendon. 60 years of age, or use of

corticosteroids, or receive a kidney, heart, and lung transplant recipients to a further rise of fluoroquinolone associated

tendinitis and tendon rupture risk. In addition to age and use of corticosteroids, can cause an increased risk of tendon

rupture factors include strenuous physical activity, renal failure, and in the past have rheumatoid arthritis and other

tendon impairment. It has been reported in patients without these risk factors using fluoroquinolones caused tendinitis and

tendon rupture. Medication medication may occur during or after the end of tendon, tendon rupture occurred a few months

after the report has been the end of treatment. If the patient is pain, swelling, inflammation, or tendon rupture should be

discontinued levofloxacin, a finding that there is tendinitis or tendon rupture symptoms should immediately advise the

patient to rest and contact their health care provider to consider switching to a non-quinolone treatment.
2. worsening of myasthenia gravis
Including levofloxacin, including fluoroquinolone antibiotics can cause neuromuscular blockade, myasthenia gravis may

worsen muscle weakness. Including listing of death and the need for ventilatory support, including serious adverse events

after, and myasthenia gravis use fluoroquinolones related. Avoid known history of myasthenia gravis patients with

3. hypersensitivity
The use of fluoroquinolone antibiotics including levofloxacin, including the treatment of patients with occasionally severe

and sometimes fatal hypersensitivity and / or allergic reactions, these reactions occurred after the first dose. Some

reactions may be accompanied by cardiovascular collapse, hypotension / shock, seizures, loss of consciousness, tingling,

angioedema (including tongue, larynx, pharynx, or facial edema / swelling), airway obstruction (including bronchospasm ,

shortness of breath and acute respiratory distress), dyspnea, urticaria, itching and other serious skin reactions. In the

first rash or hypersensitivity to any other symptoms should immediately stop using levofloxacin. Severe acute

hypersensitivity reactions require the use of adrenaline to be treated, and the need to take other measures in accordance

with clinical recovery, such as oxygen, intravenous fluids, antihistamines, corticosteroids, boost amines and airway

management medicine.
4. Other serious and sometimes fatal side effects
Including levofloxacin, including the use of fluoroquinolones for treatment of patients in very rare cases, serious and

sometimes fatal side effects, adverse reactions, some of these belong to hypersensitivity, and some of unknown etiology.

These adverse reactions can be very serious, usually it occurs after multiple administration. Clinical manifestations

include one or more of the following conditions:
● fever, rash or severe skin reactions (such as toxic epidermal necrolysis, erythema multiforme).
● vasculitis, arthralgia, myalgia, serum sickness.
● hypersensitivity pneumonitis.
● interstitial nephritis, acute renal failure or renal failure.
● hepatitis, jaundice, acute hepatic necrosis or liver failure.
● anemia, including hemolytic anemia and aplastic anemia, thrombocytopenia, including thrombotic thrombocytopenic purpura,

leukopenia, agranulocytosis, pancytopenia disease and / or other blood diseases.
In the first rash or other hypersensitivity symptoms should immediately stop the medication and take appropriate support

5. hepatotoxicity
After the patients have received levofloxacin therapy severe hepatotoxicity (including acute hepatitis and fatal events)

listing report. In clinical trials of over 7,000 patients, evidence of serious drug-related liver toxicity was observed.

Severe liver toxicity usually appear within 14 days after the start of treatment, in most cases, it appears at the

beginning of treatment for 6 days. Most cases of severe liver toxicity has nothing to do with allergies. Most reports of

fatal liver toxicity seen in patients ≥65 years of age, most independent of hypersensitivity. If patients with signs and

symptoms of hepatitis, should immediately stop using levofloxacin.
6. The Central Nervous System
We had patients using fluoroquinolone antibiotics including levofloxacin, including convulsions and toxic psychosis

reported. Quinolone antibiotics can also cause increased intracranial pressure irritation and central nervous system,

causing tremors, restlessness, anxiety, dizziness, confusion, hallucinations, paranoia, depression, nightmares, insomnia,

very few circumstances, cause the patient to produce suicidal thoughts or actions. The above reaction may occur after the

first dose. If the patient appears levofloxacin these reactions should be discontinued immediately and appropriate

treatment. Other quinolone antibiotics same as other risk factors known or suspected in patients suffering from or prone to

epileptic seizure threshold decreased (e.g., severe cerebral arteriosclerosis, epilepsy) in the presence of a CNS disorder

or epilepsy or prone to decrease the seizure threshold patient (for example the use of certain drugs for the treatment of

renal insufficiency) levofloxacin should be used with caution.
7. Clostridium difficile-associated diarrhea
According to the report, almost all antibiotics (including levofloxacin) may be caused by Clostridium difficile associated

diarrhea (CDAD), severity may be mild diarrhea to fatal colitis. Antibiotic treatment can alter the normal flora of the

colon, so Clostridium difficile thrive. Clostridium difficile produces toxins A and toxin B, thus contributing to the

incidence of CDAD. Nonaggressive antimicrobial therapy due to infection onset is difficult and may require colectomy

treatment, ultra-toxin producing strains of Clostridium difficile disease may increase morbidity and mortality. After the

use of antibiotics for all patients with diarrhea should be considered CDAD. According to the report, CDAD occur after the

use of antibiotics for 2 months, it is necessary to careful history.
If you suspect or have been diagnosed with CDAD, you need to stop is not directly antimicrobial treatment for Clostridium

difficile. According to the clinical need for proper management of liquid and dielectric complement proteins,

administration of anti-Clostridium difficile therapy and surgery evaluation.
8. peripheral neuropathy
The use of fluoroquinolone antibiotics including levofloxacin, including the treatment of patients with rare sensory nerves

or sensory axons more neuron disease, the lesions can affect axon small and / or large axons resulting confusion feeling,

sensation, contact was pain and weakness. If the patient is symptomatic neuron disease such as pain, burning, tingling,

numbness and / or weakness, or other sensory disorders such as light touch, pain, temperature sensation, position and

vibration sensations abnormal, should immediately stop using levofloxacin avoid the development of irreversible damage.
9.QT prolongation
Certain antibiotics, including fluoroquinolones, including levofloxacin can make ECG QT interval prolongation, arrhythmias

can occur a few patients. During post-marketing surveillance in patients receiving quinolone antibiotics spontaneous

reports including levofloxacin in patients, including torsades de pointes ventricular tachycardia is rare. Among patients

with known QT prolongation, uncorrected hypokalemia patients and the use of class IA (quinidine, procainamide) and Class Ⅲ

(amiodarone, sotalol) antiarrhythmic agents in patients Levofloxacin should be avoided. Elderly patients are more likely to

cause effects associated with the QT interval of the drug.
10. pediatric patients musculoskeletal diseases and animal arthropathy effect
In pediatric patients (≥6 months), and levofloxacin only for inhalation anthrax (post-exposure) protection. Compared with

the control, receiving levofloxacin in pediatric patients observed in musculoskeletal disorders (arthralgia, arthritis,

tendon disorders and gait abnormalities) increased incidence.
In juvenile rats and dogs, the oral and intravenous administration of levofloxacin resulted in increased osteochondrosis.

For receiving levofloxacin minors dog weight-bearing joints of histopathological examination showed the presence of

sustained cartilage damage. Other quinolones also produce similar erosions weight-bearing joints and other signs of joint

disease in several species of juvenile animals.
11. blood disorder
Same with other fluoroquinolones, it had on blood sugar disorders such as symptoms of hyperglycemia and hypoglycemia

reported that this situation occurred in the same time oral hypoglycemic agents (such as glyburide / glibenclamide) or use

insulin diabetes. So for such patients, it is recommended should closely monitor their blood sugar changes. If hypoglycemia

in patients receiving levofloxacin treatment response, should immediately stop using levofloxacin and appropriate

12. The light sensitivity / phototoxicity
The use of fluoroquinolones may cause light sensitivity after exposure to sunlight or ultraviolet light to moderate to

severe / phototoxicity reactions, which may appear to be exposed to the light portion (typically included the face, neck V

region, forearm extensor side, back) of excessive sun exposure reactions (eg sunburn, erythema, exudation, vesicles,

bullae, edema). Therefore, we should avoid excessive exposure to the light source. If the light sensitivity occurs /

phototoxicity should be discontinued.
13. resistant bacteria
In the case has not yet confirmed or highly suspected bacterial infection and prevention indications do not meet the

prescribed levofloxacin open and will not bring benefits to patients, and may increase the risk of resistant bacteria.
Pregnant women and lactating women drug]
Animal experiments did not confirm the quinolones have teratogenic effects, but research conducted on pregnant women use no

clear conclusion. Given the drug can cause minor animals joint disease, so pregnant women, disabled, lactating women should

be the FDA should suspend breast-feeding.
Pediatric Use
This product has not been established in infants and the safety of young people under 18 years of age. But the goods for

the number of young animals, can cause joint disease. It is not appropriate for children and young people under 18 years of

[Geriatric medicine]
Elderly patients often have renal dysfunction, because the product part by renal excretion, required reduction

Drug interactions
1. Urine alkalization agent can reduce the solubility of this product in the urine, resulting in crystallization of urine

and renal toxicity.
2. quinolones and theophylline in combination with cytochrome P450 may be due to competitive inhibition of the binding

site, leading to the liver to eliminate theophylline significantly reduced blood elimination half-life (t1 / 2β) extended

plasma concentration , theophylline poisoning symptoms appear, such as nausea, vomiting, tremor, anxiety, agitation,

seizures, heart palpitations. The product of the metabolism of theophylline, although less affected, but should the

determination of theophylline plasma concentrations and dose adjustment in combination.
3. This product in combination with cyclosporine, can make blood concentration of cyclosporine increased cyclosporine blood

concentration must be monitoring and dose adjustment.
4. This product in combination with anticoagulant warfarin anticoagulant effect of the latter, although the enhancement is

small, but the combination should be closely monitored in patients with prothrombin time.
5. Probenecid can reduce the goods from tubular secretion by about 50%, this may be due to blood concentration and toxicity

when used in combination.
6. It can interfere with the metabolism of caffeine, resulting in the elimination of caffeine reduced blood elimination

half-life (t1 / 2β) extended, and may produce central nervous system toxicity.
7. Containing aluminum, magnesium antacids, iron may reduce oral absorption of the goods, should not be shared.
8. The goods and non-steroidal anti-inflammatory drugs fenbufen combination, occasional convulsions, and therefore should

not be combined with fenbufen.
Not to proceed with the experiment and no reliable references.
Pharmacology and Toxicology
This product has a broad-spectrum antimicrobial effect, antibacterial effect, and the majority of Enterobacteriaceae

bacteria such as Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella and Haemophilus influenzae, addicted

Legionella pneumophila, Neisseria gonorrhoeae Gram-negative bacteria have a strong antibacterial activity. Gram-positive

bacteria and Mycoplasma pneumoniae, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Chlamydia

pneumoniae have antibacterial effect, but the role of anaerobic bacteria and enterococci poor.
This product ofloxacin, its antibacterial activity ofloxacin about two times. Its mechanism of action is through inhibition

of bacterial DNA gyrase activity, prevents bacterial DNA synthesis and replication resulting in bacterial death.
Completely absorbed after oral administration, after a single oral dose of 0.2g, peak plasma concentration (Cmax)

approximately 1.6mg / L, the peak time (Tmax) of approximately one hour. Plasma elimination half-life (t1 / 2β) is about 6

hours. Protein binding rate is about 30% to 40%.
This product is absorbed widely distributed to various tissues, body fluids than in the tonsils, prostate tissue, mucus,

tears, women's reproductive tract tissue, skin and saliva and other tissues and body fluids concentration and plasma

concentration of about 1.1 to 2.1 of Room.
The goods mainly from the phony self renal excretion, metabolism in vivo little. Within 48 hours of oral urine from about

80% to 90% of the administered dose. This product is excreted unchanged since a small amount of feces, within 72 hours

after administration of cumulative discharge less than 4% of the administered dose.
Shading, sealed and stored.
Blister packaging, 10 / plate; carton packaging, a board / box.
24 months
[Executive standard]
"Chinese Pharmacopoeia" 2010 version of the first Supplements
Approval Number
Zhunzi H20010614
Company Name: Shenyang Hongqi Pharmaceutical Co., Ltd.
Production Address: Shenyang Hunnan New District envelope 6th Street
Postal Code: 110179
Telephone: 024-23786260 23786261
Fax: 024-23786263


The above is for reference
If you have questions can contact the manufacturer