VISINE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VISINE (VISINE).
Tetrahydrozoline is a sympathomimetic amine that acts as an alpha-1 adrenergic receptor agonist, causing vasoconstriction of conjunctival blood vessels, thereby reducing redness and edema.
| Metabolism | Not systemically absorbed; no significant metabolism occurs in the eye. |
| Excretion | Primarily renal as unchanged drug and metabolites; minor biliary/fecal elimination (<10%) |
| Half-life | Approximately 1-2 hours for ocular absorption; systemic half-life not clinically relevant due to low systemic absorption |
| Protein binding | Approximately 80% bound to plasma proteins, primarily albumin |
| Volume of Distribution | Not clinically significant for topical ophthalmic use; systemic Vd estimated at 0.5-1 L/kg based on IV data |
| Bioavailability | Ocular: negligible systemic bioavailability (<1% from topical dose); oral not applicable |
| Onset of Action | Ocular: within minutes after topical administration |
| Duration of Action | Ocular: 4-8 hours depending on formulation and individual response |
1-2 drops in affected eye(s) every 6-8 hours as needed, not to exceed 4 times daily.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No dose adjustment required; systemic absorption is minimal. |
| Liver impairment | No dose adjustment required; systemic absorption is minimal. |
| Pediatric use | Children 6 years and older: 1 drop in affected eye(s) every 6-8 hours as needed, not to exceed 4 times daily. Safety and efficacy in children under 6 years not established. |
| Geriatric use | No specific dose adjustment, but use with caution due to increased risk of systemic effects (e.g., hypertension, cardiac arrhythmias) and potential for angle-closure glaucoma. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VISINE (VISINE).
| Breastfeeding | Negligible systemic absorption with topical ocular use; M/P ratio not determined. Excretion into breast milk unlikely. Considered compatible with breastfeeding; use caution with excessive or prolonged use. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies. In humans, limited data; topical ocular use results in negligible systemic absorption. First trimester: theoretical risk minimal. Second and third trimesters: no specific risks identified. However, avoid prolonged use due to potential vasoconstrictive effects. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to tetrahydrozoline or any component; narrow-angle glaucoma; concurrent use with MAO inhibitors
| Precautions | Do not use in patients with narrow-angle glaucoma; overuse may cause rebound hyperemia; avoid in children under 6 years; discontinue if eye pain or vision changes occur. |
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| Fetal Monitoring |
| No specific monitoring required for routine use. In cases of chronic use or ocular conditions, monitor intraocular pressure and maternal blood pressure. Fetal monitoring not indicated. |
| Fertility Effects | No known effects on fertility. Systemic absorption is minimal; reproductive impact is unlikely with topical ocular use. |