Fluorescein-Proparacaine (proparacaine HCl/fluorescein sodium)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Usual dosage in adults and pediatric patients: for removal of foreign bodies and sutures and for tonometry, apply 1 to 2 drops (in single instillations) in each eye before operating.

Short corneal and conjunctival procedures in adults and pediatric patients: apply 1 drop in each eye every 5 to 10 minutes for 5 to 7 doses.

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION.

Apply topically to the eye in the form of a 0.5% solution.

Administer under the direct supervision of a healthcare provider; not intended for patient self-administration.

Store bottles under refrigeration at 2degreesC to 8degreesC in unit carton to protect contents from light.

After opening, proparacaine can be used until the expiration date on the bottle.

The ophthalmic solution should be clear to straw-color. If the solution becomes darker, discard the solution.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

Local Anesthetics/Long-Acting Bupivacaine

SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction.

MECHANISM OF ACTION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1)

CLINICAL EFFECTS: Concurrent or use of local anesthetics with 96 hours of use of long-acting bupivacaine may result in neurologic and cardiovascular toxicity. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also result in methemoglobinemia.(1,2) Non-liposomal bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally.(1)

PREDISPOSING FACTORS: Use of additional agents that are associated with methemoglobinemia may further increase the risk of methemoglobinemia.(1) Patients who are at increased risk of developing methemoglobinemia include those with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.(1)

PATIENT MANAGEMENT: Avoid the use of other local anesthetics within 96 hours following the administration of long-acting bupivacaine. In patients for whom use is required, monitor for neurologic and cardiovascular effects. Also monitor for methemoglobinemia with use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine.(1,2) Non-liposomal bupivacaine may be administered in the same syringe as bupivacaine liposomal or injected immediately before bupivacaine liposomal as long as the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1)

DISCUSSION: Concurrent use of other local anesthetics or use of other local anesthetics within 96 hours following long-acting bupivacaine may result in additive neurologic and cardiovascular effects. Use of articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, and tetracaine may also increase the risk of methemoglobinemia.(1,2) Non-liposome bupivacaine may impact the pharmacokinetic and/or physicochemical properties of the liposomal formulation when administered in the same syringe or used simultaneously unless the ratio of mg of non-liposomal bupivacaine to mg of bupivacaine liposomal does not exceed 1:2.(1) Local anesthetics other than bupivacaine may trigger the immediate release of bupivacaine from the liposomal formulation when administered together locally. Lidocaine may be administered 20 minutes or more prior to bupivacaine. It is unknown if other local anesthetics may be used without compromising the release characteristic of bupivacaine liposomal.(1)

There are no moderate interactions for this drug.

Known hypersensitivity to any of the ingredients of this preparation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• Hyperthyroidism
• No disease contraindications
• Ocular infection
• Ocular inflammation

Occasional temporary stinging, burning and conjunctival redness may occur with the use of proparacaine. Corneal edema has been reportedfollowing the use of proparacaine. A rare, severe, immediate-type, apparently hyperallergic corneal reaction characterized by acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and, sometimes, iritis with descemetitis has been reported.

Allergic contact dermatitis with drying and fissuring of the fingertips has also been reported.

Rare or Very Rare

• Anaphylaxis
• Bronchospastic pulmonary disease
• Cardiac arrest
• Cardiac arrhythmia
• Cerebral ischemia
• Corneal opacity
• Excitement
• Extravasation injury
• Fatigue
• Hyperhidrosis
• Injection site sequelae
• Kidney disease with reduction in glomerular filtration rate (GFr)
• Pallor
• Pruritus of skin
• Seizure disorder
• Shock
• Thrombophlebitis
• Urticaria

More Frequent

• Conjunctival hyperemia
• Dyschromia
• Epithelial keratopathy
• Headache disorder
• Ocular irritation
• Ocular pain
• Urine discoloration

Less Frequent

• Dysgeusia
• Ocular redness

Rare or Very Rare

• Allergic conjunctivitis
• Diarrhea
• Eyelid dermatitis
• Gastrointestinal irritation
• Headache disorder
• Hypotension
• Nausea
• Ocular itching
• Syncope
• Vomiting

No enhanced messaging available.

Safety and effectiveness of proparacaine hydrochloride ophthalmic solution in pediatric patients have been established. Use of proparacaine hydrochloride is supported by evidence from adequate and well-controlled studies in adults and children older than 12 years of age, and safety information in neonates and other pediatric patients.

Animal reproduction studies have not been conducted with proparacaine hydrochloride ophthalmic solution. It is also not known whether the drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Proparacaine should be administered to a pregnant woman only if clearly needed.

It is not known whether proparacaine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when proparacaine is administered to a nursing woman.

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.