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Rx Item-Omidria 1% 0.3% Vial 4X4Ml By ASD Healthcare

ASD Specialty Healthcare-Special OrderBRAND: OMIDRIA  NDC: 62225-0600-04,62225060004 UPC: 3-62225-60004-6,362225600046 NDC 62225-0600-04 UPC/GTIN No.3-62225-60004-6 Mfg.Part No.44567Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.Image 5 of Rx Item-Omidria 1% 0.3% Vial 4X4Ml By ASD Healthcare

Rx Item-Omidria 1% 0.3% Vial 4X4Ml By ASD Healthcare

$2232.00$2125.71

item No.:RX388266 NDC No.62225060004 UPC No.:362225600046 NDC No.62225-0600-04 UPC/GTIN No.3-62225-60004-6 MPN 44567 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx388266 Omidria 1%/0.3% Vial 4X4ml by ASD Healthcare Item No.3388266 NDC No.62225060004 UPC No.362225600046 Other Name Omidria Therape

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OMIDRIA- phenylephrine and ketorolac injection, solution, concentrate
Omeros Corporation

1 INDICATIONS AND USAGE

Omidria � is added to an ophthalmic irrigation solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain.

2 DOSAGE AND ADMINISTRATION

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 ophthalmic irrigation solution. Irrigation solution is to be used as needed for the surgical procedure.



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.

3 DOSAGE FORMS AND STRENGTHS

Omidria is a sterile solution concentrate containing 10.16 mg/mL (1% w/v) of phenylephrine and 2.88 mg/mL (0.3% w/v) of ketorolac in a single-patient-use vial.

4 CONTRAINDICATIONS

Omidria is contraindicated in patients with a known hypersensitivity to any of its ingredients.

5 WARNINGS AND PRECAUTIONS

5.1 Elevated Blood Pressure
Systemic exposure of 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-inflammatories (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.

6 ADVERSE REACTIONS

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 subjects as seen in the combined clinical trial results from three randomized, placebo-controlled studies.

Table 1: Ocular Adverse Reactions Reported by ≥ 2% of Subjects
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%)
8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy
Teratogenic Effects: Pregnancy Category C
Animal reproduction studies have not been conducted with Omidria or phenylephrine. It is also not known whether Omidria can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Omidria should be used in pregnant women only if clearly needed.

Ketorolac, administered during organogenesis, was not teratogenic in rabbits or rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. These doses produced systemic exposure that is 1150 times and 4960 times the plasma exposure (based on C max ) at the recommended human ophthalmic dose (RHOD), respectively. When administered to rats after Day 17 of gestation at oral doses up to 1.5 mg/kg/day (740 times the plasma exposure at the RHOD) , ketorolac produced dystocia and increased pup mortality.

Clinical Considerations:
Premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of oral and injectable NSAIDs. Detectable ketorolac plasma concentrations are available following ocular Omidria administration [ see Clinical Pharmacology ( 12.3) ]. The use of Omidria during late pregnancy should be avoided.

8.3 Nursing Mothers
Because many drugs are excreted in human milk, caution should be exercised when Omidria is administered to nursing women.

8.4 Pediatric Use
Safety and effectiveness of Omidria in pediatric patients below the age of 18 years have not been established.

8.5 Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and adult patients.

10 OVERDOSAGE

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.

11 DESCRIPTION

Omidria is a sterile aqueous solution concentrate containing the α 1 -adrenergic receptor agonist phenylephrine HCl and the nonsteroidal anti-inflammatory ketorolac tromethamine.

The descriptions and structural formulae are:

ASD Specialty Healthcare-Special Order
RX ITEM-Omidria 1% 0.3% Vial 4X4Ml By AS
ASD Specialty Healthcare-Special Order

BRAND: OMIDRIA  NDC: 62225-0600-04,62225060004 UPC: 3-62225-60004-6,362225600046 NDC 62225-0600-04 UPC/GTIN No.3-62225-60004-6 Mfg.Part No.44567
Omidria 1% 0.3% Vial 4X4Ml By ASD Health
BRAND: OMIDRIA NDC: 62225-0600-04,62225060004 UPC: 3-62225-60004-6,362225600046 NDC 62225-0600-04 UPC/GTIN No.3-62225-60004-6 Mfg.Part No.44567

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
PHENYLEPHRINE/KETOROLAC I
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Want to do Research on this Med or need a large quantity? Email Details with quantity required to:[email protected]

Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.