Abstract | BACKGROUND: OBJECTIVE: METHODS: Patients were recruited from more than 800 medical facilities in Japan, in accordance with Japanese Ministry of Health, Labour and Welfare ordinance guidelines. They were followed during three distinct time periods: April 2000 to December 2001, January 2002 to June 2003, and July 2003 to December 2004. RESULTS: Information from 6760 patients receiving levofloxacin for the treatment of a variety of ocular infections was collected. Levofloxacin was well tolerated: adverse drug reactions (ADRs) were reported in 42 of 6686 patients (0.63%), with no serious ADRs reported. The most commonly reported ADRs were ocular disorders such as blepharitis, eye irritation, and punctate keratitis. The incidence of ADRs did not differ significantly with age, but it was significantly higher in females (0.82%) than in males (0.36%; p = 0.028). A clinical response was observed in 95.5% of patients receiving levofloxacin, with no difference in response between the three time periods. The rate of response to levofloxacin by bacterial disease ranged from 97.4% in keratitis to 88.3% in dacryocystitis. The rate was lower in patients with dacryocystitis, elderly patients, patients with a long duration of illness, and relapsing cases (all p < 0.001). CONCLUSION:
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Authors | Yoshiko Kanda, Tomoko Kayama, Shinji Okamoto, Masako Hashimoto, Chiemi Ishida, Tomoko Yanai, Mitsuru Fukumoto, Eiichi Kunihiro |
Journal | Drugs in R&D
(Drugs R D)
Vol. 12
Issue 4
Pg. 177-85
(Dec 01 2012)
ISSN: 1179-6901 [Electronic] New Zealand |
PMID | 23075336
(Publication Type: Journal Article)
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Chemical References |
- Anti-Bacterial Agents
- Ophthalmic Solutions
- Levofloxacin
- Ofloxacin
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Topics |
- Adolescent
- Adult
- Aged
- Anti-Bacterial Agents
(administration & dosage, adverse effects)
- Child
- Child, Preschool
- Drug-Related Side Effects and Adverse Reactions
- Eye Infections
(drug therapy)
- Eye Infections, Bacterial
(drug therapy)
- Female
- Humans
- Infant
- Infant, Newborn
- Japan
- Levofloxacin
- Male
- Middle Aged
- Ofloxacin
(administration & dosage, adverse effects)
- Ophthalmic Solutions
(administration & dosage, adverse effects)
- Product Surveillance, Postmarketing
- Treatment Outcome
- Young Adult
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