Tarivid Otic Solution

TARIVID^®
Ofloxacin
Otic Solution

Composition
Each mL of solution contains:
Ofloxacin ................................................. 3.0 mg

Pharmacology
Ofloxacin which is considered to specifically affect DNA gyrase and inhibit DNA synthesis in microorganism is bactericidal and causes bacteriolysis at MIC₈₀.
Ofloxacin has a wide range of antibacterial spectrum against various gram-positive and gram-negative bacteria. MIC₈₀ of ofloxacin against clinical isolates including Staphylococcus sp., Streptococcus sp., Proteus sp., Pseudomonas aeruginosa, and Haemophilus influenzae in otitis media and otitis externa was one fourth of cefmenoxime and one sixtyfourth of fosfomycin, thus indicating an excellent antibacterial effects. Especially, MIC₈₀ of ofloxacin against Staphylococcus aureus and Pseudomonas aeruginosa, major causal bacteria, in otitis media and otitis externa were one fourth and one eight of cefmenoxime, and one sixtyfourth and one thirtysecond of fosfomycin, respectively.
When 0.3% ofloxacin solution was instilled into the middle ear at 10 drops per administration and allowed to maintain twice a day for 7 days (totally 14 times) in adult patients, the serum concentration in 30 minutes after administration ranged from 0.009 to 0.012 μg/mL, showing a low value. Furthermore, when a single administration of ofloxacin solution at 5 drops per administration was instilled into the cavity of the middle ear and allowed to maintain in children, the serum concentration in 120 minutes after administration was 0.013 μg/mL of lower, similarly showing a low value.
When 0.3% ofloxacin solution was instilled into the middle ear at 10 drops per administration and allowed to maintain twice a day for 10 days (totally 19 times) in adult patients, the concentration in the mucosa of the middle ear in 90 minutes after administration was 20 μg/g, and a single administration of 0.1 % ofloxacin solution at 10 drops was instilled, the concentration in the otorrhea in 30 minutes after administration ranged from 107 to 610 μg/mL, showing a high value.

Indication
- Chronic Suppurative otitis media
- Otitis externa

Contraindications
Patients with hypersensitivity to ofloxacin

Dosage and administration
For adults, 6 to 10 drops of TARIVID^® otic solution is usually applied into the ear twice a day. The eardrop should be aliowed to maintain in the ear lor 10 minutes. Dosage should be adjusted according to the severlty of syrnptorns.
For children, dosage should be decreased.

Warnings and precautions
1. TARIVID^® otic solution should not be administered for more than 4 weeks.
2. Use only for instillation.
3. Topical therapy by the instillation of this agents is generally applicable when inflammation is localized in the mucosa of the middle ear in patients with tympanitis. When inflammation is extended into the region around the tympanum, systemic therapy with oral agents should be considered in combination with topical therapy.
4. If the solution is cold, dizziness may occur. Thus, use the drug at a temperature as similar to that of the body temperature as possible.
5. For children, oral administration of ofloxacin is a contraindication, since oral ofloxacin can produce arthropathy in immature animals and the safety in children has not been established. However, when this agent was topically instilled and allow to maintain in the ear, the peak blood concentration was 1/100 compared to that of oral administration. Safety has been confirmed in the clinical trials in children, and it s possible to use this agent for children.

Adverse reactions
In the general clinical trials and double-blind comparative study on otitis media or otitis externa, adverse reactions were observed in 2 cases (0.5%), such as earaches (0.5%, 2 cases) and itching (0.2%, 1 case) in the 424 patients Iincluding 110 children (15 years old or younger). No adverse reactions were observed in the children. Laboratory examinations were performed in 52 patients, revealing no abnormal changes. In addition, audiometry was also performed in 100 patients and no cases of hearing reduction were observed.

Presentation
Box of 1 plastic bottle @ 5 mL
Reg. No. DKL0911639548A1

Store below 30°C.

ON MEDICAL PRESCRIPTION ONLY.
HARUS DENGAN RESEP DOKTER.

Manufactured by:
Santen Pharmaceutical Co. Ltd., Ishikawa - Japan
For: DAIICHI SANKYO CO. , LTD., Tokyo - Japan

Imported and repacked by:
PT KALBE FARMA Tbk., Bekasi - Indonesia

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