NAVSTEL SIDE EFFECTS
- Generic Name: balanced salt ophthalmic solution
- Brand Name: Navstel
SIDE EFFECTS
Clinical Studies Experience
Increased intraocular pressure was the most frequently reported adverse reaction which occurred in 12% of the 391 patients exposed to NAVSTEL® (balanced salt ophthalmic solution) Solution and 11% of the 431 patients exposed to BSS PLUS® Solution.
The following table presents the incidence of patients with IOP ≥ 25 mmHg. IOP lowering medication was not administered until after the first IOP assessment at hour 6 (anterior segment studies) or Day 1 (posterior segment study).
Table 1: Anterior Segment Studies
| Treatment | NAVSTEL® N=223 |
BSS PLUS® n=220 |
| IOP ≥ 25 mmHg | % | % |
| Hour 6 | 38 | 35 |
| Day1 | 17 | 15 |
| Day3 | 6 | 4 |
| Day7 | 0.5 | 0 |
| Posterior Segment Study | ||
| Treatment | NAVSTEL® N=168 |
BSS PLUS® n=176 |
| IOP ≥ 25 mmHg | % | % |
| Day1 | 7 | 5 |
| Day7 | 8 | 8 |
| Day14 | 10 | 4 |
| Day 30 | 4 | 4 |
Table 2 presents the most common adverse reactions reported with NAVSTEL® (balanced salt ophthalmic solution) and BSS PLUS.
Table 2
| Treatment | NAVSTEL® N=391 |
BSS PLUS® n=431 |
| Coded Adverse Reactions | % | % |
| Nervous system disorders | ||
| Headache | 3 | 3 |
| Eye disorders | ||
| Ocular Discomfort | 5 | 3 |
| Macular Edema | 4 | 4 |
| Conjunctival Hyperemia | 4 | 3 |
| Dry Eye | 3 | 5 |
| Iritis | 3 | 1 |
| Retinal Hemorrhage | 3 | 1 |
| Vision Blurred | 2 | 1 |
| Posterior Capsule Opacification | 2 | 3 |
In the posterior segment surgical study, cataract was reported in 11% of patients exposed to NAVSTEL® (balanced salt ophthalmic solution) , compared to 7% of patients exposed to BSS PLUS® .
SRC: NLM .