Goodsense Irritation Relief Eye Drops
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Questions & Answers
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Legal Issues
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
TIVICAY® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.
Limitations of Use:
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- Use of TIVICAY in integrase strand transfer inhibitor (INSTI)-experienced patients should be guided by the number and type of baseline INSTI substitutions. The efficacy of TIVICAY 50 mg twice daily is reduced in patients with an INSTI-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions, including T66A, L74I/M, E138A/K/T, G140S/A/C, Y143R/C/H, E157Q, G163S/E/K/Q, or G193E/R [see Microbiology (12.4)].
History
There is currently no drug history available for this drug.
Other Information
TIVICAY contains dolutegravir, as dolutegravir sodium, an HIV INSTI. The chemical name of dolutegravir sodium is sodium (4R,12aS)-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2H-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazin-7-olate. The empirical formula is C20H18F2N3NaO5 and the molecular weight is 441.36 g per mol. It has the following structural formula:
Dolutegravir sodium is a white to light yellow powder and is slightly soluble in water.
Each film-coated tablet of TIVICAY for oral administration contains 52.6 mg of dolutegravir sodium, which is equivalent to 50 mg dolutegravir free acid, and the following inactive ingredients: D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate. The tablet film‑coating contains the inactive ingredients iron oxide yellow, macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.
Sources
Goodsense Irritation Relief Eye Drops Manufacturers
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Hanlim Pharm. Co., Ltd.
![Goodsense Irritation Relief Eye Drops (Tetrahydrozoline Hydrochloride Zinc Sulfate) Solution [Hanlim Pharm. Co., Ltd.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Goodsense Irritation Relief Eye Drops | Viiv Healthcare Company
TIVICAY tablets may be taken with or without food.
2.1 Adults Table 1. Dosing Recommendations for TIVICAY in Adult PatientsPopulation
Recommended DoseTreatment-naïve or treatment-experienced INSTI-naïve
50 mg once dailyTreatment-naïve or treatment-experienced INSTI-naïve when coadministered with the following potent UGT1A/CYP3A inducers: efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin
50 mg twice dailyINSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistancea [see Microbiology (12.4)]
50 mg twice dailya Alternative combinations that do not include metabolic inducers should be considered where possible [see Drug Interactions (7)].
The safety and efficacy of doses above 50 mg twice daily have not been evaluated.
2.2 Pediatric PatientsTreatment-naïve or Treatment-experienced INSTI-naïve
The recommended dose of TIVICAY in pediatric patients aged 12 years and older and weighing at least 40 kg is 50 mg administered orally once daily.
If efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin are coadministered, the recommended dose of TIVICAY is 50 mg twice daily.
Safety and efficacy of TIVICAY have not been established in pediatric patients younger than 12 years or weighing less than 40 kg, or in pediatric patients who are INSTI-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir).
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