Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING IHEEZO TM (chloroprocaine hydrochloride ophthalmic gel) 3% is supplied as a sterile, clear, colorless to light yellow gel in a single-patient‑use vial. Each single‑patient‑use vial contains 24 mg chloroprocaine in 800 mg of gel. Aluminum pouch containing 1 LDPE single-patient‑use vial of IHEEZO TM . The outer surface of the vial is not sterile. NDC 82667-300-01 Package of 1 unit of 1.25 mL single-patient‑use vial (800 mg filled) NDC 82667-300-10 Package of 10 units of 1.25 mL single-patient‑use vials (800 mg filled) NDC 82667-300-00 Sample package of 1 unit of 1.25 mL single-patient-use vial (800 mg filled) Storage Store at 15°C to 25°C (59°F to 77°F). Discard after use.; PRINCIPAL DISPLAY PANEL - Carton NDC 82667-300-01 Sterile Rx Only Iheezo TM (chloroprocaine hydrochloride ophthalmic gel) 3% For topical ophthalmic use Contains no preservatives. 1 Vial 800 mg each HARROW ® carton; PRINCIPAL DISPLAY PANEL - Pouch NDC 82667-300-01 Iheezo TM (chloroprocaine hydrochloride ophthalmic gel) 3% To be administered by physician only. Single-Patient-Use Vial Discard unused portion. For topical ophthalmic use. Contains no preservatives. Sterile (outer surface of the vial not sterile) LOT: 1234 EXP: YYYY-MM Rx Only Vial 800 mg pouch; PRINCIPAL DISPLAY PANEL - Sample Carton NDC 82667-300-00 Professional sample - Not for sale Sterile Rx Only Iheezo TM (chloroprocaine hydrochloride ophthalmic gel) 3% For topical ophthalmic use Contains no preservatives. 1 Vial 800 mg each HARROW ® Sample Carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING IHEEZO TM (chloroprocaine hydrochloride ophthalmic gel) 3% is supplied as a sterile, clear, colorless to light yellow gel in a single-patient‑use vial. Each single‑patient‑use vial contains 24 mg chloroprocaine in 800 mg of gel. Aluminum pouch containing 1 LDPE single-patient‑use vial of IHEEZO TM . The outer surface of the vial is not sterile. NDC 82667-300-01 Package of 1 unit of 1.25 mL single-patient‑use vial (800 mg filled) NDC 82667-300-10 Package of 10 units of 1.25 mL single-patient‑use vials (800 mg filled) NDC 82667-300-00 Sample package of 1 unit of 1.25 mL single-patient-use vial (800 mg filled) Storage Store at 15°C to 25°C (59°F to 77°F). Discard after use.
- PRINCIPAL DISPLAY PANEL - Carton NDC 82667-300-01 Sterile Rx Only Iheezo TM (chloroprocaine hydrochloride ophthalmic gel) 3% For topical ophthalmic use Contains no preservatives. 1 Vial 800 mg each HARROW ® carton
- PRINCIPAL DISPLAY PANEL - Pouch NDC 82667-300-01 Iheezo TM (chloroprocaine hydrochloride ophthalmic gel) 3% To be administered by physician only. Single-Patient-Use Vial Discard unused portion. For topical ophthalmic use. Contains no preservatives. Sterile (outer surface of the vial not sterile) LOT: 1234 EXP: YYYY-MM Rx Only Vial 800 mg pouch
- PRINCIPAL DISPLAY PANEL - Sample Carton NDC 82667-300-00 Professional sample - Not for sale Sterile Rx Only Iheezo TM (chloroprocaine hydrochloride ophthalmic gel) 3% For topical ophthalmic use Contains no preservatives. 1 Vial 800 mg each HARROW ® Sample Carton
Overview
IHEEZO TM is a sterile, single-patient‑use ophthalmic gel preparation for topical ocular anesthesia containing chloroprocaine hydrochloride as the active pharmaceutical ingredient. Chloroprocaine hydrochloride is an ester anesthetic. It is a water-soluble white crystalline powder and its chemical name is 2-(Diethylamino)ethyl 4‑amino-2-chlorobenzoate monohydrochloride. The molecular weight is 307.22 and the molecular formula is C 13 H 19 ClN 2 O 2 ·HCl. It is represented by the following structural formula: IHEEZO TM contains: Active: 30 mg of chloroprocaine hydrochloride (equivalent to 26 mg of chloroprocaine) per gram of gel. Inactive ingredients: Hydroxyethyl Cellulose (HEC), and Water for Injection. The pH may be adjusted to 3.0 to 5.0 with Hydrochloric Acid. This product does not contain an antimicrobial preservative. chemstru
Indications & Usage
IHEEZO TM is indicated for ocular surface anesthesia. IHEEZO TM is an ester anesthetic indicated for ocular surface anesthesia. ( 1 )
Dosage & Administration
The recommended dose of IHEEZO TM is 3 drops applied topically to the ocular surface in the area of the planned procedure. IHEEZO TM may be reapplied as needed to maintain anesthetic effect. The recommended dose of IHEEZO TM is 3 drops applied topically to the ocular surface in the area of the planned procedure. ( 2 ) IHEEZO TM may be reapplied as needed to maintain anesthetic effect. ( 2 )
Warnings & Precautions
Not for Injection or Intraocular Administration ( 5.1 ). Corneal Injury Due to Insensitivity ( 5.2 ). Corneal Opacification ( 5.3 ) For Administration by Healthcare Provider : IHEEZO TM is not intended for patient self-administration ( 5.5 ). 5.1 Not for Injection or Intraocular Administration IHEEZO TM should not be injected or intraocularly administered. 5.2 Corneal Injury Due to Insensitivity Patients should not touch the eye for at least 10 to 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. 5.3 Corneal Opacification Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. 5.4 Risk of Contamination Do not touch the dropper tip to any surface as this may contaminate the gel. 5.5 For Administration by Healthcare Provider IHEEZO TM is indicated for administration under the direct supervision of a healthcare provider. IHEEZO TM is not intended for patient self-administration. 5.1 Not for Injection or Intraocular Administration IHEEZO TM should not be injected or intraocularly administered. 5.2 Corneal Injury Due to Insensitivity Patients should not touch the eye for at least 10 to 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. 5.3 Corneal Opacification Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. 5.4 Risk of Contamination Do not touch the dropper tip to any surface as this may contaminate the gel. 5.5 For Administration by Healthcare Provider IHEEZO TM is indicated for administration under the direct supervision of a healthcare provider. IHEEZO TM is not intended for patient self-administration.
Contraindications
IHEEZO TM is contraindicated in patients with a history of hypersensitivity to any component of this preparation. IHEEZO TM is contraindicated in patients with a history of hypersensitivity to any component of this preparation. ( 4 )
Adverse Reactions
Most common adverse reaction is mydriasis (approximately 25%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 844.446.6979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience 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 TM or placebo. Patients in Study 2 were randomized to receive a single or multiple instillations of 1, 3 or 3+3 drops of IHEEZO TM or placebo. The most common adverse reactions in these studies, (incidence greater than or equal to 5%) following IHEEZO TM administration were mydriasis, conjunctival hyperemia and eye irritation. Adverse Reactions Reported in Controlled Trials Table 1. Adverse Reactions in 5% or more of IHEEZO TM Treated 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%) 6.1 Clinical Trials Experience 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 TM or placebo. Patients in Study 2 were randomized to receive a single or multiple instillations of 1, 3 or 3+3 drops of IHEEZO TM or placebo. The most common adverse reactions in these studies, (incidence greater than or equal to 5%) following IHEEZO TM administration were mydriasis, conjunctival hyperemia and eye irritation. Adverse Reactions Reported in Controlled Trials Table 1. Adverse Reactions in 5% or more of IHEEZO TM Treated 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%)
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