Carbachol And Brimonidine Tartrate

Prescription

Tên thương mại: YUVEZZI

Dạng bào chế

Drops

Đường dùng

OPHTHALMIC

Nhà sản xuất

Visus Therapeutics, Inc.

About This Medication

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. The chemical name for carbachol is 2-carbamoyloxyethyl(trimethyl)azanium chloride. The molecular weight is 182.648 g/mol and the molecular formula is C 6 H 15 ClN 2 O 2 . Its structural formula is: The chemical name for brimonidine tartrate is 5-bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-6-quinoxalinamine L-tartrate. The molecular weight is 442.226 g/mol and the molecular formula is C 15 H 16 BrN 5 O 6 . Its structural formula is: Each mL of YUVEZZI contains carbachol 2.75% (27.5 mg/mL) and brimonidine tartrate 0.1% (1 mg/mL) as the active ingredients. Inactive ingredients are: hydroxypropyl methylcellulose (HPMC), sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, water for injection, and may also include hydrochloric acid and/or sodium hydroxide to adjust pH, if necessary. Chemical Structure Chemical Structure

Hoạt chất

Thành phần	Hàm lượng
Brimonidine Tartrate	-
Carbachol	-

Chỉ định & Cách dùng

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 )

Cơ chế hoạt động

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.

Liều dùng & Cách dùng

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.

Side Effects Overview

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 . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. YUVEZZI was evaluated in 536 patients with presbyopia in two randomized, double-masked, controlled studies. BRIO™ I (NCT05270863) was a single-dose crossover study in which 178 patients received YUVEZZI. BRIO II (NCT05135286) included 358 patients who received YUVEZZI in the long-term safety portion of the study (up to 12 months duration, including a 6-month open-label extension). Adverse reactions reported in > 5% to 7% of participants were eye pain upon instillation and visual impairment. Adverse reactions reported in > 10% to 16% of participants were eye irritation upon instillation and headache. The majority of adverse events were mild, transient, and self-resolving.

Cảnh báo & Thận trọng

5 WARNINGS AND PRECAUTIONS Blurred Vision : Advise patients not to drive or operate machinery if vision is not clear (e.g., blurred vision). Exercise caution in night driving and other hazardous activities in poor illumination. ( 5.1 ) Risk of Retinal Detachment : Rare cases of retinal tear and detachment have been reported with miotics. Individuals with preexisting retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to initiation of therapy. Patients should be advised to seek immediate medical care with sudden onset of flashes of lights, floaters, or vision loss. ( 5.2 ) Iritis : Caution is advised in patients with iritis. ( 5.3 ) Potentiation of Vascular Insufficiency : Use with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans. ( 5.4 ) 5.1 Blurred Vision Miotics may cause accommodative spasm. Advise patients to not drive or operate machinery if vision is not clear (e.g., blurred vision). In addition, patients may experience temporary dim or dark vision with miotics. Advise patients to exercise caution in night driving and other hazardous activities in poor illumination. 5.2 Risk of Retinal Detachment Rare cases of retinal tear and detachment have been reported with miotics. Individuals with pre-existing retinal disease are at increased risk. Examination of the retina is advised in all patients prior to the initiation of therapy. Advise patients to seek immediate medical care with sudden onset of flashes of lights, floaters, or vision loss. 5.3 Iritis Sequelae of ocular inflammation, i.e., adhesions (synechiae) between the iris and the lens, may be exacerbated with miotic use, therefore, YUVEZZI is not recommended to be used when iritis is present. 5.4 Potentiation of Vascular Insufficiency YUVEZZI may potentiate syndromes associated with vascular insufficiency. YUVEZZI should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans. 5.5 Potential for Eye Injury or Contamination To prevent eye injury or contamination, avoid touching the single-dose vial to the eye, eyelids, or to any other surface.

Chống chỉ định

4 CONTRAINDICATIONS YUVEZZI is contraindicated in patients with known hypersensitivity to the active ingredients or to any of the excipients. Hypersensitivity. ( 4 )

Dược động học

12.3 Pharmacokinetics Absorption Systemic exposures to brimonidine tartrate and carbachol were evaluated in participants with presbyopia who were administered 1 drop of YUVEZZI to each eye. Brimonidine tartrate plasma concentrations were quantifiable in 5 of 14 subjects, with C max and T max up to 0.066 ng/mL and 0.52 hours respectively. Carbachol plasma concentrations were quantifiable in 6 of 14 subjects, with C max and T max up to 1.02 ng/mL and 4.42 hours respectively. Distribution Brimonidine is approximately 29% bound to plasma proteins in healthy subjects. The protein binding of carbachol has not been studied. Elimination Metabolism In humans, brimonidine is extensively metabolized by the liver. Metabolism of carbachol has not been studied. Excretion Urinary excretion is the major route of elimination of brimonidine and its metabolites. Approximately 87% of an orally administered radioactive dose of brimonidine was eliminated within 120 hours, with 74% found in the urine. Excretion of carbachol has not been studied.

Frequently Asked Questions

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 )

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 …

5 WARNINGS AND PRECAUTIONS Blurred Vision : Advise patients not to drive or operate machinery if vision is not clear (e.g., blurred vision). Exercise caution in night driving and other hazardous activities in poor illumination. ( 5.1 ) Risk of Retinal Detachment : Rare cases of retinal tear and detachment have been reported with miotics. Individuals with preexisting retinal disease are at increased risk. Therefore, examination of the retina is advised in all patients prior to initiation of therapy. Patients …

4 CONTRAINDICATIONS YUVEZZI is contraindicated in patients with known hypersensitivity to the active ingredients or to any of the excipients. Hypersensitivity. ( 4 )

Carbachol And Brimonidine Tartrate is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Carbachol And Brimonidine Tartrate drug label (National Library of Medicine)
• openFDA — Carbachol And Brimonidine Tartrate label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 2736933 (NLM Normalized Drug Names)
• NDC Directory — Carbachol And Brimonidine Tartrate (FDA National Drug Code)

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Nguồn dữ liệu: DailyMed (NLM), openFDA, MFDS