Overview
11 DESCRIPTION YUVEZZI (carbachol and brimonidine tartrate ophthalmic solution) 2.75% / 0.1% is a fixed-dose combination of carbachol, a cholinergic agonist, and brimonidine, an alpha-adrenergic receptor agonist, for topical ophthalmic use. YUVEZZI is formulated as an isotonic, sterile, clear, greenish-yellow ophthalmic solution. YUVEZZI does not contain an anti-microbial preservative.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The proposed mechanism of action of this fixed-dose combination of carbachol and brimonidine in presbyopia is pupillary constriction and the creation of a pinhole effect that improves near visual acuity and depth of focus. Carbachol is a cholinergic agent which produces constriction of the iris sphincter and ciliary body. Brimonidine tartrate, an alpha-adrenergic agonist, blocks contraction of the iris dilator muscle and relaxes tonic contraction of the ciliary muscle, enhancing selectivity for the pupil and increasing bioavailability of carbachol in the aqueous humor. 12.2 Pharmacodynamics Pupil size was assessed using automated digital pupillometry under mesopic conditions.
Indications
- 1 INDICATIONS AND USAGE YUVEZZI™ is indicated for the treatment of presbyopia in adults. YUVEZZI is a combination of carbachol, a cholinergic agonist, and brimonidine, an alpha-adrenergic receptor agonist, indicated for the treatment of presbyopia in adults. ( 1 )
Common Doses
- Refer to label
Dosage
2 DOSAGE AND ADMINISTRATION Instill one drop in each eye once daily. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of YUVEZZI is one drop in each eye once daily. 2.2 Administration Instructions Remove contact lenses prior to instillation of YUVEZZI. Wait 10 minutes after dosing before reinserting contact lenses. If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart. One single-dose vial can be used to dose both eyes. Discard the open single-dose vial and any remaining contents immediately after use.
Contraindications
- 4 CONTRAINDICATIONS YUVEZZI is contraindicated in patients with known hypersensitivity to the active ingredients or to any of the excipients. Hypersensitivity. ( 4 )
Side Effects
- 6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity [see Contraindications (4) ] Most common adverse reactions (incidence >5%) are eye pain upon instillation, visual impairment, eye irritation upon instillation, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Visus Therapeutics, Inc., at 1-888-735-0821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.
Interactions
- 7 DRUG INTERACTIONS Antihypertensives/cardiac glycosides may lower blood pressure. ( 7.1 ) Use with CNS depressants may result in an additive or potentiating effect. ( 7.2 ) Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. ( 7.3 ) Monoamine oxidase inhibitors may result in increased hypotension. ( 7.4 ) 7.1 Antihypertensives/Cardiac Glycosides Because brimonidine tartrate, a component of YUVEZZI, may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with YUVEZZI is advised. 7.