OZEX 150mg

Generic name: Tosufloxacin Tosilate Hydrate

Manufactured by: FUJIFILM Toyama Chemical

Description

This medicine is new quinolone antimicrobials to inhibit DNA replication of bacteria and shows antibacterial action.

It is usually used in the treatment of wide-range infections such as respiratory infections, urinary tract infections, otological infections, etc.

Target Bacterial Strains:

Tosufloxacin is effective against the following bacterial strains: Staphylococcus spp., Streptococcus spp., Pneumococcus (including penicillin-resistant strains), Enterococcus spp., Neisseria gonorrhoeae, Moraxella (Branhamella) catarrhalis, Bacillus anthracis, Escherichia coli, Shigella spp., Salmonella spp., Salmonella typhi, Salmonella paratyphi, Citrobacter spp., Klebsiella spp., Enterobacter spp., Serratia spp., Proteus spp., Morganella morganii, Providencia spp., Vibrio cholerae, Haemophilus influenzae, Pseudomonas aeruginosa, Burkholderia cepacia, Stenotrophomonas (Xanthomonas) maltophilia, Acinetobacter spp., Peptostreptococcus spp., Bacteroides spp., Prevotella spp., Propionibacterium acnes, and Chlamydia trachomatis (causing trachoma).

Indications:

Superficial skin infections, deep skin infections, lymphangitis, lymphadenitis, chronic pyoderma, acne (with purulent inflammation), secondary infections of wounds, burns, and surgical sites, mastitis, perianal abscess, osteomyelitis, arthritis, pharyngitis, laryngitis, tonsillitis (including peritonsillar abscess), acute bronchitis, pneumonia, secondary infections in chronic respiratory conditions, cystitis, pyelonephritis, prostatitis (acute and chronic), epididymitis, urethritis, cholecystitis, cholangitis, infectious enteritis, typhoid fever, paratyphoid fever, cholera, Bartholin’s gland inflammation, uterine infections, adnexitis, dacryocystitis, hordeolum (stye), meibomian gland inflammation, otitis externa, otitis media, sinusitis, purulent sialadenitis, periodontal infections, pericoronitis, osteomyelitis of the jaw, and anthrax.

Ingredients and dosage form

white tablet, φ: 8.6 mm, thickness: 4.7 mm

Dosing schedule/Directions

Your dosing schedule must prescribed by your doctor or a healthcare professional.

General dosage regimen: For adults, take 2-3 tablets (300-450 mg of the active ingredient) in 2 or 3 divided doses, daily. The dosage should be adjusted according to the disease, age or symptoms. If symptoms are severe or if the dose seems to be insufficient, the dose is increased up to 4 tablets (600 mg) daily. Strictly follow the instructions of your doctor/pharmacist.

For osteomyelitis, arthritis, for adults, take 1 tablet (150 mg of the active ingredient) at a time, 3 times a day. The dosage should be adjusted according to the disease, age or symptoms. If symptoms are severe or if the dose seems to be insufficient, the dose is increased up to 4 tablets (600 mg) daily. Strictly follow the instructions of your doctor/pharmacist.

For typhoid, paratyphoid, for adults, take 1 tablet (150 mg of the active ingredient) at a time, 4 times a day, for 14 days. Strictly follow the instructions of your doctor/pharmacist.

Take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose.

If you took too much of the medicine (more than ordered), check with your doctor/pharmacist.

Do not stop taking the medicine without the instructions of your doctor.

Warnings

Before using this medicine, be sure to tell your doctor and pharmacist

If you ever experienced any allergic reaction (itch, rash etc.) to any medicine.

If you are a patient with convulsive disease such as epilepsy, or have a history of convulsive disease.

If you are a patient with renal dysfunction.

If you are a patient with myasthenia gravis.

If you are pregnant or breastfeeding.

If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

Possible adverse reactions to this medicine

Common side effects are reported as below. If any of them occurs, check with your doctor/pharmacist: rash, discomfort in stomach, abdominal discomfort, diarrhea/loose stool, etc.

The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.

breathing difficulty, swelling around eyes or lips, redness [shock, anaphylactoid symptoms] redness in the skin, blister, bulbar conjunctival congestion [toxic epidermal necrosis, Stevens-Johnson syndrome]

general malaise, loss of appetite, yellowing in the skin or conjunctiva [hepatic dysfunction, jaundice]

abdominal pain, diarrhea, melena [pseudomembranous colitis, hemorrhagic colitis]

muscular pain in limbs, weakness, reddish brown urine [rhabdomyolysis]

The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

For pharyngitis, laryngitis, tonsillitis (including peritonsillar abscess), acute bronchitis, infectious enteritis, otitis media, and sinusitis:

Refer to the Guidelines for the Appropriate Use of Antimicrobial Agents before prescribing. Ensure the necessity of antibacterial therapy and administer the drug only when deemed appropriate.

Storing Conditions

Keep out of the reach of children. Store away from direct sunlight, heat, moisture.

Discard the remainder, do not store.

Product specifications, appearance and package content are subject to change without prior notice.

Description of the medical drugs is not intended for prescribing treatment without the involvement of a physician.