Chloroprocaine Hydrochloride (5 brand names, 3 dosage forms, 3 routes)
Available dosage forms: INJECTABLE, GEL, SOLUTION.
Routes of administration: INJECTION, OPHTHALMIC, INTRATHECAL.
Brand Names
- CHLOROPROCAINE HYDROCHLORIDE
- CLOROTEKAL
- IHEEZO
- NESACAINE
- NESACAINE-MPF
Indications and Usage
IHEEZO TMis indicated for ocular surface anesthesia.
Dosage and Administration
The recommended dose of IHEEZO TMis 3 drops applied topically to the ocular surface in the area of the planned procedure. IHEEZO TMmay be reapplied as needed to maintain anesthetic effect.
Contraindications
IHEEZO TMis contraindicated in patients with a history of hypersensitivity to any component of this preparation.
Warnings and Precautions
IHEEZO TMshould not be injected or intraocularly administered.
Adverse Reactions
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect 201 patients undergoing various surgical ocular procedures in two placebo-controlled trials (Study 1 and Study 2). Patients in Study 1 were randomized to receive a single instillation of 3 drops of IHEEZO TMor placebo. Patients in Study 2 were randomized to receive a single or multiple instillations of 1, 3 or 3+3 drops of IHEEZO TMor placebo. The most common adverse reactions in these studies, (incidence greater than or equal to 5%) following IHEEZO TMadministration were mydriasis, conjunctival hyperemia and eye irritation. Adverse Reactions Reported in Controlled Trials Table 1. Adverse Reactions in 5% or more of IHEEZO TMTreated Patients in Studies 1 and 2 IHEEZO TM Placebo Preferred Term N=151 n (%) N=50 n (%) Mydriasis 39 (26%) 1 (2%) Conjunctival hyperemia 16 (11%) 6 (12%) Eye irritation 9 (6%) 2 (4%)