iheezo
Pharmaranks rates Iheezo 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Iheezo (Chloroprocaine Hydrochloride) is an ester local anesthetic used to treat Pain.
Chloroprocaine Hydrochloride · by Harrow Eye
Available as a generic: Chloroprocaine Hydrochloride
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Chloroprocaine Hydrochloride
- Drug class
- Ester Local Anesthetic
- Form
- Topical
- Strength
- Chloroprocaine Hydrochloride 3%
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- pain
- Manufacturer
- Harrow Eye
- FDA application
- NDA216227
What is Iheezo?
From the FDA label: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
How to use
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 )
Side effects
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…
Warnings
Important safety information
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.
Who should not take Iheezo
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 )
Drug class
May treat (source: NIH RxClass)
See how Iheezo ranks — best-rated ester local anesthetic for:
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Frequently asked questions
- What does Iheezo treat?
- Iheezo (Chloroprocaine Hydrochloride) may be used to treat pain, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Iheezo rated?
- pharmaranks gives Iheezo a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Iheezo?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Iheezo. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Iheezo?
- Iheezo is marketed by Harrow Eye. You can see Harrow Eye's full profile, rating, and other products on pharmaranks.
- Is Iheezo a brand-name or generic drug?
- Iheezo is a brand-name product with the active ingredient Chloroprocaine Hydrochloride. Lower-cost generic equivalents containing Chloroprocaine Hydrochloride are available — ask your pharmacist.
- Is Iheezo available over the counter?
- No. Iheezo is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Iheezo come in?
- Iheezo is currently marketed as topical, per the FDA's National Drug Code Directory.
- What class of drug is Iheezo?
- Iheezo is classified as ester local anesthetic, per the FDA's Established Pharmacologic Class.
- Is Iheezo FDA-registered?
- Iheezo is on record with the U.S. FDA under application number NDA216227. You can verify this on its official FDA label.
- Has Iheezo been recalled by the FDA?
- Iheezo has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Iheezo safe?
- There's no single safe-or-not verdict. pharmaranks gives Iheezo a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Iheezo?
- Iheezo's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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iheezo
70/100