Tropic-Cyclopent-Pe-Ktrlc-Prop (cyclopent/tropicamide/proparacaine/phenyl/ketorolac in water)

To produce mydriasis for funduscopic examination of the eye, 1 or 2 drops of a 0.5% solution of tropicamide may be instilled onto the eye(s) 15-20 minutes before examination. In patients with heavily pigmented irides, higher solution concentrations may be required. To produce cycloplegia for refraction, a 1% solution should be used; 1 or 2 drops of this solution may be instilled onto the eye(s) and repeated in 5 minutes. The examination must be performed within 30 minutes after the second instillation. If the patient is not examined within 20-30 minutes, an additional drop of the 1% solution should be instilled.

When a combination preparation containing tropicamide and hydroxyamphetamine hydrobromide is used to produce mydriasis, 1 or 2 drops of the solution may be instilled onto the eye(s). Patients with lighter irides may experience slightly greater mydriasis than patients with darker irides.

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.

To produce mydriasis and cycloplegia for refraction in adults, 1 or 2 drops of a 0.5, 1, or 2% cyclopentolate hydrochloride solution may be instilled onto the eye(s) approximately 40-50 minutes before the procedure; if necessary, a second dose may be instilled in 5-10 minutes. In adults with darkly pigmented irides, more doses or use of the 2% solution may be needed. Although recovery from mydriasis and cycloplegia usually occurs within 24 hours, 1 or 2 drops of a 1 or 2% pilocarpine solution instilled onto the eye(s) may reduce recovery time to 3-6 hours in most patients.

For cycloplegic refraction in children, 1 drop of a 0.5, 1, or 2% solution may be instilled onto the eye(s); if necessary, this dose may be followed by a second drop of a 0.5 or 1% solution 5-10 minutes later. The concentration of cyclopentolate hydrochloride used in pediatric patients should be selected based on the patient's weight, iris coloration, and dilation history. In small infants, 1 drop of the 0.5% solution may be instilled into the eye(s). Following instillation, infants should be observed closely for at least 30 minutes. (See Cautions: Pediatric Precautions.)

To produce mydriasis for funduscopic examination with the combination preparation (Cyclomydril(R)), 1 drop of the solution containing 0.2% cyclopentolate hydrochloride and 1% phenylephrine hydrochloride instilled onto each eye will generally provide rapid mydriasis and permit ready visual access to the fundus. The dose may be repeated every 5-10 minutes if necessary. When used in infants to produce mydriasis for screening for retinopathy of prematurity, instillation 30 minutes before the examination is recommended.

Phenylephrine hydrochloride ophthalmic solutions are applied topically to the conjunctiva or cornea. A local anesthetic other than butacaine (See Chemistry and Stability: Stability) may be instilled prior to phenylephrine to prevent stinging and lacrimation.

Tropicamide is applied topically to the eye. To avoid excessive systemic absorption, finger pressure should be applied on the lacrimal sac for 1-2 minutes following topical instillation of the solution. Care should be taken to avoid contamination of the solution container.

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.

Cyclopentolate hydrochloride is applied topically to the eye in the form of a solution. To avoid excessive systemic absorption, finger pressure should be applied on the lacrimal sac during and for 2-3 minutes following topical instillation of the solution, particularly if the 2% solution is used and especially in children.

Ketorolac tromethamine is applied topically to the eye as an ophthalmic solution. To prevent contamination of the solution, patients should be instructed to avoid allowing the tip of the dispensing container to contact any surface, the eyelids, or surrounding structures. Contact lenses should be removed prior to administration of ketorolac tromethamine ophthalmic solution. The preservative-free solution is for single use only in one or both eyes; the preservative-free solution should be used immediately after opening and any unused portion should be discarded immediately after administration.

No dosing information is available for this tab.

No dosing information is available for this tab.

Concomitant administration of phenylephrine with cycloplegic antimuscarinic drugs such as atropine sulfate, cyclopentolate hydrochloride, homatropine hydrobromide, or scopolamine hydrobromide produces increased dilation of the pupil which is of clinical value.

Administration of a 10% solution of phenylephrine hydrochloride to patients pretreated with 2% pilocarpine hydrochloride produces mydriasis but to a lesser degree than occurs in patients who are not receiving the miotic. Pilocarpine may prevent or reduce visual disturbances and the risk of increased intraocular pressure associated with mydriasis in some patients and may be used to hasten recovery from mydriasis after ophthalmologic examination. Phenylephrine may reduce ciliary and conjunctival congestion and accommodative myopia often encountered when miotics are used alone in the treatment of glaucoma, without compromising the effectiveness of glaucoma therapy.

Phenylephrine must be administered under careful supervision and in reduced dosage if used within 21 days after the patient has received a monoamine oxidase inhibitor because potentiation of the pressor effects of phenylephrine may result. The pressor response to phenylephrine may also be potentiated if a tricyclic antidepressant is administered concomitantly.

If phenylephrine is administered to a patient undergoing chronic oral therapy with guanethidine, the pupillary response to phenylephrine is greatly increased and the pressor response may also be potentiated. Phenylephrine should be administered cautiously to patients receiving guanethidine.

The mydriatic response to phenylephrine is decreased in patients receiving levodopa.

The manufacturer states that ketorolac tromethamine ophthalmic solution has been used safely in conjunction with other ophthalmic agents, including antibiotics, beta-adrenergic blocking agents, carbonic anhydrase inhibitors, cycloplegics, and/or mydriatics. The ophthalmic solution also has been used in conjunction with injectable sedatives (e.g., diazepam, hydroxyzine, lorazepam, promethazine hydrochloride), hyaluronidase, and/or local anesthetics (bupivacaine hydrochloride, lidocaine hydrochloride, tetracaine hydrochloride).

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)

Moderate Interaction: Assess the risk to the patient and take action as needed.

Sympathomimetics/Rauwolfia Alkaloids

SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed.

MECHANISM OF ACTION: Reserpine depletes catecholamine stores within the peripheral vascular adrenergic nerve endings, thus indirect acting sympathomimetics are unable to trigger the release of catecholamines. The reserpine-induced catecholamine release increases sensitivity to the effects of direct acting sympathomimetics.

CLINICAL EFFECTS: Increased effects of direct acting sympathomimetics. Decreased effects of indirect acting sympathomimetics. Mixed acting sympathomimetics will show effects based on the predominance of either direct or indirect activity.

PREDISPOSING FACTORS: None determined.

PATIENT MANAGEMENT: If these agents are administered concurrently, monitor blood pressure. The dose of the sympathomimetic may need to be adjusted.

DISCUSSION: This interaction has been well documented in animal studies and human case reports have confirmed the interaction. Reserpine has been shown to decrease the response to epinephrine administered for hypotension. Reserpine has also been shown to decrease the effectiveness of ophthalmic epinephrine, a direct acting sympathomimetic. Ophthalmic phenylephrine has been shown to decrease the hypotensive effects of reserpine.

Known hypersensitivity to any of the ingredients of this preparation.

There are no contraindication contraindications for this drug.

• Angle-closure glaucoma
• Ocular hypertension
• Predisposition to glaucoma

• Atherosclerotic cardiovascular disease
• Benign prostatic hyperplasia
• Cardiac arrhythmia
• Corneal degeneration
• Corneal erosion
• Coronary artery disease
• Diabetes mellitus
• Down's syndrome
• Dry eye
• Hemophilia
• Hypertension
• Hyperthyroidism
• Increased risk of bleeding due to coagulation disorder
• Ocular infection
• Ocular inflammation
• Rheumatoid arthritis

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.

Less Frequent

• Blepharoconjunctivitis
• Conjunctivitis
• Keratitis
• Punctate keratitis

Rare or Very Rare

• Acute cognitive impairment
• Acute cognitive impairment
• Asthma exacerbation
• Ataxia
• Behavioral disorders
• Behavioral disorders
• Bronchospastic pulmonary disease
• Cardiac arrhythmia
• Cardiac arrhythmia
• Cardiac arrhythmia
• Corneal erosion
• Corneal opacity
• Corneal ulcer
• Dizziness
• Drowsy
• Drug-induced psychosis
• Drug-induced psychosis
• Dyskinesia
• Excitement
• Fatigue
• Fatigue
• Flushing
• Hallucinations
• Hallucinations
• Hyperhidrosis
• Hyperhidrosis
• Hypertension
• Impaired wound healing
• Ocular hemorrhage
• Ocular hypertension
• Pallor
• Pallor
• Perforation of cornea
• Polydipsia
• Seizure disorder
• Skin rash
• Slurred speech
• Slurred speech
• Tachycardia
• Tachycardia
• Tremor
• Urinary retention
• Xerostomia

More Frequent

• Blurred vision
• Conjunctival hemorrhage
• Conjunctival hyperemia
• Conjunctival hyperemia
• Epithelial keratopathy
• Eye tearing
• Headache disorder
• Headache disorder
• Headache disorder
• Infiltrate of cornea
• Ocular hypertension
• Ocular irritation
• Ocular irritation
• Ocular pain
• Ocular pain
• Ocular pain
• Photophobia

Less Frequent

• Blurred vision
• Blurred vision
• Contact dermatitis
• Headache disorder
• Ocular irritation
• Ocular irritation
• Ocular itching
• Ocular pain
• Ocular redness
• Ocular redness
• Photophobia
• Photophobia
• Skin rash

Rare or Very Rare

• Allergic conjunctivitis
• Corneal dystrophy
• Corneal edema
• Disorder of the digestive system
• Drowsy
• Dry eye
• Eyelid dermatitis
• Eyelid edema
• Fatigue
• Fever
• General weakness
• Iritis
• Ocular itching
• Skin rash
• Tachycardia
• Vasodilation of blood vessels
• Xerostomia

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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 performed with phenylephrine. It is not known whether topically applied phenylephrine can cause fetal harm when administered to pregnant women. Parenterally administered phenylephrine in late pregnancy or labor may cause fetal anoxia. (See Cautions: Pregnancy and Lactation, in Phenylephrine Hydrochloride 12:12.04.) Topically applied phenylephrine should be used during pregnancy only when clearly needed.

Animal reproduction studies have not been performed with tropicamide. It is not known whether tropicamide can cause fetal harm when administered to pregnant women. Tropicamide should be used during pregnancy only when clearly needed.

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.

Animal reproduction studies have not been performed with cyclopentolate, and it is also not known whether the drug can cause fetal harm when administered to pregnant women. Cyclopentolate should be used during pregnancy only when clearly needed.

Reproduction studies in rabbits and rats receiving oral ketorolac tromethamine dosages up to 109 and 303 times the maximum recommended human topical ophthalmic dosage of ketorolac tromethamine 0.5% (on a mg/kg basis), respectively, have not revealed evidence of harm to the fetus. However, oral dosages exceeding 45 times the maximum recommended human topical ophthalmic dosage of ketorolac tromethamine 0.5% (on a mg/kg basis) in rats produced dystocia and was associated with an increased neonatal death rate. There are no adequate and controlled studies to date using ophthalmic ketorolac tromethamine in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risk to the fetus. Ketorolac tromethamine ophthalmic solution should not be used during late pregnancy, since inhibitors of prostaglandin synthesis may have adverse effects on the fetal cardiovascular system (e.g., premature closure of the ductus arteriosus).

Since it is not known whether phenylephrine is distributed into milk, the drug should be used with caution in nursing women.

It is not known whether tropicamide is distributed into milk. Because many drugs are distributed into milk, tropicamide should be used with caution in nursing women.

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.

It is not known whether cyclopentolate is distributed into milk. Because many drugs are distributed into milk, caution should be exercised when cyclopentolate is used in nursing women.

Because ketorolac is distributed into milk following systemic administration (see Pharmacokinetics: Distribution, in Ketorolac 28:08.04.92), the ophthalmic solution should be used with caution in nursing women.

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