omidria
Omidria is a combination medicine containing Ketorolac Tromethamine and Phenylephrine Hydrochloride.
Ketorolac Tromethamine and Phenylephrine Hydrochloride · by Rayner Surgical
Key facts
- Active ingredient
- Ketorolac Tromethamine and Phenylephrine Hydrochloride
- Form
- Injectable
- Strength
- Ketorolac Tromethamine EQ 0.3% Base; Phenylephrine Hydrochloride EQ 1% Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Rayner Surgical
- Half-life
- about 5 to 6 hours (how long it stays in your system)
- FDA application
- NDA205388
What is Omidria?
From the FDA label:Omidria is a sterile aqueous solution, containing the α 1 -adrenergic receptor agonist phenylephrine HCl and the nonsteroidal anti-inflammatory ketorolac tromethamine, for addition to ocular irrigating solution. The descriptions and structural formulae are: Phenylephrine Hydrochloride Drug Substance: Common Name: phenylephrine hydrochloride Chemical Name: (-)- m -Hydroxy-α-[(methylamino)methyl]benzyl alcohol hydrochloride Molecular Formula: C 9 H 13 NO 2 · HCl Molecular Weight: 203.67 g/mole Figure 1: Chemical Structure for Phenylephrine HCl Ketorolac Tromethamine Drug Substance: Common Name: ketorolac tromethamine Chemical Name: (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid : 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) Molecular Formula: C 15 H 13 NO 3 · C 4 H 11 NO 3 Molecular Weight: 376.40 g/mole Figure 2: Chemical Structure for Ketorolac Tromethamine Omidria is a clear, colorless to slightly yellow, sterile solution concentrate with a pH of approximately 6.3. Each vial of Omidria contains: Actives: phenylephrine hydrochloride 12.4 mg/mL equivalent to 10.16 mg/mL of phenylephrine and ketorolac tromethamine 4.24 mg/mL equivalent to 2.88 mg/mL of ketorolac. Inactives: citric acid monohydrate; sodium citrate dihydrate; water for injection; may include sodium hydroxide and/or hydrochloric acid for pH adjustment. Figure 1 Figure 2
How to use
Omidria must be diluted prior to intraocular use. For administration to patients undergoing cataract surgery or intraocular lens replacement, 4 mL of Omidria is diluted in 500 mL of ocular irrigating solution. Irrigation solution is to be used as needed for the surgical procedure for a single patient. The storage period for the diluted product is not more than 4 hours at room temperature or 24 hours under refrigerated conditions. Do not use if the solution is cloudy or if it contains particulate matter. Each vial of OMIDRIA must be diluted prior to use for administration to a single patient undergoing cataract surgery or intraocular lens replacement. Dilute 4 mL of OMIDRIA in 500 mL of ocular irrigating solution. Irrigation solution is to be used as needed for the surgical procedure. ( 2 )
Side effects
The most common reported adverse reactions (≥2%) are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Omeros Corporation at 1-844-OMEROS1 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice. Table 1 shows frequently reported ocular adverse reactions with an incidence of ≥ 2% of adult patients as seen in the combined clinical trial results from three randomized, placebo-controlled studies [see Clinical Studies ( 14 )] . Table 1: Ocular Adverse Reactions Reported by ≥ 2% of Adult Patients MedDRA Preferred Term Placebo (N=462) Omidria (N=459) n (%) n (%) Ocular Events Anterior Chamber Inflammation 102 (22%) 111 (24%) Intraocular Pressure Increased 15 (3%) 20 (4%) Posterior Capsule Opacification 16 (4%) 18 (4%) Eye Irritation 6 (1%) 9 (2%) Foreign Body Sensation in Eyes 11 (2%) 8 (2%) In a safety study that enrolled 72 pediatric patients up to 3 years old, no overall difference in safety was observed between pediatric and adult patients.
Warnings
Important safety information
Systemic exposure to phenylephrine may cause elevations in blood pressure. ( 5.1 ) 5.1 Elevated Blood Pressure Systemic exposure to phenylephrine can cause elevations in blood pressure. 5.2 Cross-Sensitivity or Hypersensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory drugs (NSAIDs). There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac in patients who either have a known hypersensitivity to aspirin/NSAIDs or a past medical history of asthma. Therefore, use Omidria with caution in individuals who have previously exhibited sensitivities to these drugs.
Who should not take Omidria
Omidria is contraindicated in patients with a known hypersensitivity to any of its ingredients. Hypersensitivity to any component of this product ( 4 )
Overdose — what happens if you take too much
Systemic overdosage of phenylephrine may cause a rise in blood pressure. It may also cause headache, anxiety, nausea, vomiting, and ventricular arrhythmias. Supportive care is recommended.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
How long does Ketorolac Tromethamine and Phenylephrine Hydrochloride stay in your body?
The elimination half-life of ketorolac tromethamine and phenylephrine hydrochloride is about 5 to 6 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. FDA label mean terminal elimination half-life is 5.6 hours (range 4.0-7.9) in healthy young adults (24-35 yrs). It lengthens with age (about 7 hours in the elderly, 65-78 yrs) and, most importantly, with reduced kidney function: in renally impaired patients the mean half-life ranges from 6 to 19 hours depending on severity, since ketorolac is largely eliminated renally. Ketorolac has no long-lasting active metabolite and is not a prodrug. Half-life is not the same as a drug-test detection window — how long it stays measurable can exceed the time the drug is clinically active.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: KETOROLAC TROMETHAMINE tablet — FDA label (DailyMed).
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- Is there a coupon or discount for Omidria?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Omidria. 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 Omidria?
- Omidria is marketed by Rayner Surgical. You can see Rayner Surgical's full profile, rating, and other products on pharmaranks.
- Is Omidria a brand-name or generic drug?
- Omidria is a brand-name product with the active ingredient Ketorolac Tromethamine and Phenylephrine Hydrochloride.
- Is Omidria available over the counter?
- No. Omidria 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 Omidria come in?
- Omidria is currently marketed as injectable, per the FDA's National Drug Code Directory.
- Is Omidria FDA-registered?
- Omidria is on record with the U.S. FDA under application number NDA205388. You can verify this on its official FDA label.
- Is Omidria safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Omidria. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Omidria?
- Omidria's side effects are taken directly from its FDA label. From the label: The most common reported adverse reactions (≥2%) are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS,… 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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