Package Insert for Levofloxacin Hydrochloride Tablets

Warning:
Fluoroquinolones, including levofloxacin hydrochloride, are associated with an increased risk of tendonitis and tendon rupture across all age groups. This risk is further elevated in elderly patients aged 60 years and older, in patients receiving glucocorticoid therapy, and in those who have undergone kidney, heart, or lung transplantation. Serious adverse reactions include tendonitis and tendon rupture, peripheral neuropathy, central nervous system effects, and exacerbation of myasthenia gravis.
• Use of fluoroquinolone drugs (including levofloxacin hydrochloride tablets) has been associated with reports of concurrent disabling and potentially irreversible serious adverse reactions (see “Precautions”), including:
o Tendinitis and tendon rupture (see [Precautions])
o Peripheral neuropathy (see [Precautions])
o Effects on the central nervous system (see [Precautions])
When these serious adverse reactions occur (see “Precautions”), levofloxacin hydrochloride should be discontinued immediately.
Use star-shaped tablets and avoid the use of fluoroquinolone drugs.
• Fluoroquinolone drugs may exacerbate myasthenic symptoms in patients with myasthenia gravis. Myasthenia gravis is known to
Patients with a relevant medical history should avoid using levofloxacin hydrochloride tablets (see [Precautions]).
• Serious adverse reactions have been reported with the use of fluoroquinolone drugs, including levofloxacin hydrochloride tablets.
As noted in the [Precautions], for patients with the following indications, treatment should be administered only when no other medicinal products are available.
Levofloxacin Hydrochloride Tablets may be used during treatment:
o Acute bacterial sinusitis (see [Indications] and [Dosage and Administration])
o Acute bacterial exacerbation of chronic bronchitis (see [Indications] and [Dosage and Administration])

o Uncomplicated urinary tract infection (see [Indications] and [Dosage and Administration])

【Drug Name】
Generic Name: Levofloxacin Hydrochloride Tablets
Product Name: Bito
English Name: Levofloxacin Hydrochloride Tablets
Pinyin: Yansuan Zuoyangfushaxing Pian
【Ingredients】
The active ingredient of this product is levofloxacin hydrochloride. Its chemical name is: (–)-(S)-3-methyl-9-fluoro-2,3-dihydro-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid hydrochloride monohydrate.

【Characteristics】This product is a film-coated tablet; after removal of the coating, it appears off-white to pale yellow.
【Indications】
To reduce the emergence of resistant bacteria and ensure the efficacy of levofloxacin hydrochloride and other antimicrobial agents, levofloxacin should be used only for the treatment or prevention of infections that have been proven or are strongly suspected to be caused by susceptible pathogens. When selecting or modifying an antimicrobial therapy regimen, the results of bacterial culture and susceptibility testing should be taken into account. In the absence of such test data, empirical therapy should be guided by local epidemiological information and the susceptibility patterns of the causative organisms.
Prior to initiating treatment, bacterial culture and susceptibility testing should be performed to isolate and identify the causative pathogen and determine its susceptibility to levofloxacin hydrochloride. Treatment with levofloxacin may be initiated pending these results, with subsequent adjustment of the therapeutic regimen based on the final susceptibility findings.
As with other drugs in this class, certain strains of Pseudomonas aeruginosa can rapidly develop resistance when treated with levofloxacin hydrochloride. During therapy, bacterial cultures and susceptibility testing should be performed at regular intervals to determine whether the causative pathogen remains susceptible to the antimicrobial agent and to promptly detect the emergence of resistance.
Levofloxacin hydrochloride oral formulations and injectable preparations are indicated for the treatment of mild, moderate, and severe infections in adults (≥ 18 years of age) caused by susceptible strains of the following bacteria. When intravenous infusion is more advantageous for the patient (e.g., in cases where the patient cannot tolerate oral administration), levofloxacin hydrochloride injection may be used.

【Storage】Store in a light-resistant, sealed container at 10–30°C.
【Packaging】Aluminum-plastic blister packs, available in boxes of 6 tablets; 10 tablets; or 12 tablets.
【Shelf Life】24 months
[Implementation Standard] Volume II of the 2025 Edition of the Chinese Pharmacopoeia
[Approval Number]
(1) National Drug Approval Number H19990053 (calculated as 0.1 g based on C18H20FN3O4)
(2) National Drug Approval Number H20067901 (calculated as 0.2 g based on C18H20FN3O4)
[Marketing Authorization Holder]
Name: Guangdong Bidi Pharmaceutical Co., Ltd.
Registered Address: No. 66, Bidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
【Manufacturing Enterprise】
Company Name: Guangdong Bidi Pharmaceutical Co., Ltd.
Production Address: No. 66, Bidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
Postal code: 529331
Telephone numbers: (0750) 2789348 (product inquiries), 2763089 (quality inquiries).
400-8899-328 (National Service Hotline)
Fax number: (0750)2789285
Website: http://www.pdpharm.com