Carbachol And Brimonidine Tartrate
Generic Name: carbachol and brimonidine tartrate
Brand Names:
Yuvezzi
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.
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. The chemical name for carbachol is 2-carbamoyloxyethyl(trimethyl)azanium chloride.
Uses
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 )
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.
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 . 6.1 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.
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.
Warnings
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. 4 CONTRAINDICATIONS YUVEZZI is contraindicated in patients with known hypersensitivity to the active ingredients or to any of the excipients. Hypersensitivity. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of YUVEZZI administration in pregnant women to inform a drug-associated risk. Topical ocular administration of YUVEZZI to pregnant rats throughout organogenesis did not produce adverse effects up to 3 times the maximum recommended human ocular dose (MRHOD).
Storage
Storage Store at 36°F to 77°F (2°C to 25°C). Once a pouch is opened, store the single-dose vials in the foil pouch away from light until ready for use. Discard opened single-dose vials and any remaining contents immediately after use.
Frequently Asked Questions
What is Carbachol And Brimonidine Tartrate used for?▼
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 )
What are the side effects of Carbachol And Brimonidine Tartrate?▼
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.
Can I take Carbachol And Brimonidine Tartrate during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of YUVEZZI administration in pregnant women to inform a drug-associated risk. Topical ocular administration of YUVEZZI to pregnant rats throughout organogenesis did not produce adverse effects up to 3 times the maximum recommended human ocular dose (MRHOD).
What are the important warnings for Carbachol And Brimonidine Tartrate?▼
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. 4 CONTRAINDICATIONS YUVEZZI is contraindicated in patients with known hypersensitivity to the active ingredients or to any of the excipients. Hypersensitivity. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.