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Sinuva
Overview
What is Sinuva?
The SINUVA Sinus Implant is a self-expanding, bioabsorbable, drug eluting implant provided with a crimper and a single-use delivery system. SINUVA Sinus Implant is comprised of poly(L-lactide-co-glycolide) and poly(L-lactide-co-ε-caprolactone) coated with mometasone furoate embedded in a bioabsorbable polymer matrix containing poly(DL-lactide-co-glycolide) and polyethylene glycol (inactive ingredients) which provides for gradual release of the drug. The SINUVA Sinus Implant is packaged in a tray, which is then sealed in a foil pouch and placed in the product carton. The SINUVA Sinus Implant is provided sterile.
Mometasone furoate, the active component of the SINUVA Sinus Implant, is a corticosteroid with the chemical name 9,21-dichloro-11(β),17-dihydroxy-16(α)-methylpregna-1,4-diene-3,20-dione 17 (2-furoate). Mometasone furoate is a white powder with an empirical formula of CHClO, and molecular weight of 521.44 Daltons.
The chemical structure of mometasone furoate is shown below:
The inactive ingredients are poly-(DL-lactide-co-glycolide) and polyethylene glycol. Poly-(DL-lactide-co-glycolide) is an amorphous biodegradable polymer.
What does Sinuva look like?
What are the available doses of Sinuva?
One SINUVA Sinus Implant system contains 1350 mcg of mometasone furoate and a sterile Delivery System. ()
What should I talk to my health care provider before I take Sinuva?
How should I use Sinuva?
SINUVA™ Sinus Implant is a corticosteroid-eluting (mometasone furoate) implant indicated for the treatment of nasal polyps in patients ≥ 18 years of age who have had ethmoid sinus surgery.
One SINUVA Sinus Implant containing 1350 mcg of mometasone furoate.
What interacts with Sinuva?
Sorry No Records found
What are the warnings of Sinuva?
Sorry No Records found
What are the precautions of Sinuva?
Sorry No Records found
What are the side effects of Sinuva?
Sorry No records found
What should I look out for while using Sinuva?
Patients with known hypersensitivity to mometasone furoate, or to any of the copolymers of the SINUVA Sinus Implant [].
What might happen if I take too much Sinuva?
There are no data available on the effects of acute or chronic overdosage with SINUVA Sinus Implant. Chronic overdosage may result in signs/symptoms of hypercorticism [].
Because the SINUVA Sinus Implant is designed for placement in the ethmoid sinus by a physician under endoscopic visualization, overdose is unlikely to occur. Low systemic bioavailability and an absence of acute drug-related systemic findings in clinical studies, indicate that acute overdose is unlikely to require any treatment other than observation. Single inhalation daily doses of a mometasone furoate dry powder inhalation formulation as high as 1200 mcg per day for 28 days were well tolerated and did not cause a significant reduction in plasma cortisol AUC (94% of placebo AUC). Single oral doses up to 8000 mcg have been studied on human volunteers with no adverse reactions reported.
How should I store and handle Sinuva?
Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. Reconstituted ZYPREXA IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP] for up to 1 hour if necessary. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Protect ZYPREXA tablets and ZYPREXA ZYDIS from light and moisture. Protect ZYPREXA IntraMuscular from light, do not freeze. Store ZYPREXA tablets, ZYPREXA ZYDIS, and ZYPREXA IntraMuscular vials (before reconstitution) at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP]. Reconstituted ZYPREXA IntraMuscular may be stored at controlled room temperature, 20° to 25°C (68° to 77°F) [ USP] for up to 1 hour if necessary. The USP defines controlled room temperature as a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°C (68° to 77°F); that results in a mean kinetic temperature calculated to be not more than 25°C; and that allows for excursions between 15° and 30°C (59° and 86°F) that are experienced in pharmacies, hospitals, and warehouses. Protect ZYPREXA tablets and ZYPREXA ZYDIS from light and moisture. Protect ZYPREXA IntraMuscular from light, do not freeze. One SINUVA Sinus Implant kit consists of an individual Implant inside of a Crimper and one disposable Delivery System packaged in a foil pouch. The SINUVA Sinus Implant is 20 mm in length and 34 mm in expanded diameter (Figure 1) and contains 1350 mcg of mometasone furoate.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mometasone furoate is a corticosteroid demonstrating potent anti-inflammatory activity. The precise mechanism of corticosteroid action on inflammation is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.
Non-Clinical Toxicology
Patients with known hypersensitivity to mometasone furoate, or to any of the copolymers of the SINUVA Sinus Implant [].Monitor nasal mucosa adjacent to the SINUVA Sinus Implant for any signs of bleeding (epistaxis), irritation, infection, or perforation. Avoid use in patients with nasal ulcers or trauma.
The following adverse reactions are discussed in more detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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