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Navstel

"A study in mice reveals an elegant circuit within the developing visual system that helps dictate how the eyes connect to the brain. The research, funded by the National Institutes of Health, has implications for treating amblyopia, a vision diso"...

Navstel

Navstel

Navstel Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Navstel (balanced salt ophthalmic solution) is a sterile intraocular irrigating solution for use during ophthalmic surgical procedures, involving perfusion of the eye (e.g. vitrectomy and anterior segment reconstruction). Common side effects include eye discomfort, blurred vision, dry eye, other eye problems, and headache.

Dosing of Navstel is determined by a physician. Navstel may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Navstel should be used only if prescribed. Consult your doctor before breastfeeding.

Our Navstel (balanced salt ophthalmic solution) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Navstel FDA Prescribing Information: Side Effects
(Adverse Reactions)

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® .

Read the entire FDA prescribing information for Navstel (Balanced Salt Ophthalmic Solution) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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