Tropicamide-Cyclopent-Pe-Ktrlc (cyclopentolate/tropicamide/phenylephrine/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.

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.

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.

There are no severe interactions for this drug.

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.

There is no enhanced messaging for this drug.

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
• Rheumatoid arthritis

There is no enhanced messaging for this drug.

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
• Corneal erosion
• Corneal ulcer
• Dizziness
• Drowsy
• Drug-induced psychosis
• Drug-induced psychosis
• Dyskinesia
• Fatigue
• Flushing
• Hallucinations
• Hallucinations
• Hyperhidrosis
• Hypertension
• Impaired wound healing
• Ocular hemorrhage
• Ocular hypertension
• 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
• Eye tearing
• Headache disorder
• Headache disorder
• Infiltrate of cornea
• Ocular hypertension
• Ocular irritation
• 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
• Photophobia
• Photophobia
• Skin rash

Rare or Very Rare

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

No enhanced messaging available.

No enhanced messaging available.

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 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 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.

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