IHEEZO- chloroprocaine hydrochloride ophthalmic gel gel

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

CHLOROPROCAINE HYDROCHLORIDE (UNII: LT7Z1YW11H) (CHLOROPROCAINE - UNII:5YVB0POT2H)

Tilgængelig fra:

Harrow Eye, LLC

Indgivelsesvej:

OPHTHALMIC

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

IHEEZO TM is indicated for ocular surface anesthesia. IHEEZO TM is contraindicated in patients with a history of hypersensitivity to any component of this preparation. Risk Summary There are no adequate and well-controlled studies of IHEEZO TM use in pregnant women to inform a drug associated risk. There are no animal reproduction studies for chloroprocaine. Risk Summary There are no data on the presence of chloroprocaine in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for IHEEZO TM and any potential adverse effects on the breastfed infant from IHEEZO TM . The safety and effectiveness of IHEEZO TM have not been established in pediatric patients. No overall differences in safety or effectiveness of IHEEZO TM have been observed between elderly and younger patients.

Produkt oversigt:

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.

Autorisation status:

New Drug Application

Produktets egenskaber

IHEEZO- CHLOROPROCAINE HYDROCHLORIDE OPHTHALMIC GEL GEL
HARROW EYE, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
IHEEZO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR IHEEZO
.
IHEEZO (CHLOROPROCAINE HYDROCHLORIDE OPHTHALMIC GEL) 3%, FOR TOPICAL
OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1955
INDICATIONS AND USAGE
IHEEZO
is an ester anesthetic indicated for ocular surface anesthesia. ( 1)
DOSAGE AND ADMINISTRATION
The recommended dose of IHEEZO
is 3 drops applied topically to the ocular surface in the area of
the planned procedure. ( 2)
IHEEZO
may be reapplied as needed to maintain anesthetic effect. ( 2)
DOSAGE FORMS AND STRENGTHS
IHEEZO
(chloroprocaine hydrochloride ophthalmic gel) 3% contains 24 mg of
chloroprocaine
hydrochloride per vial (800 mg). Clear, colorless to light yellow gel
in single‑patient‑use vial. ( 3)
CONTRAINDICATIONS
IHEEZO
is contraindicated in patients with a history of hypersensitivity to
any component of this
preparation. ( 4)
WARNINGS AND 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
is not intended for patient self-administration (
5.5).
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.
REVISED: 10/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Not for Injection or Intraocular Administration
5.2 Corneal Injury Due to Insensitivity
5.3 Corneal Opacification
5.4 Risk of Contamination
5.5 For Administration by Healthcare Provider
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8 USE IN SPECIFIC POPULATIONS
TM
TM
TM
TM
TM
TM
TM
TM
TM
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use