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Hylan G F 20 Brand Names- Synvisc | Synvisc-One
What is Hylan G F 20
Hylan G-F 20 products are classified by the FDA as medical devices, rather than drug products.
A medical device is a product intended to affect the structure or function of the body, but which does not achieve its primary purposes through the chemical action of a drug — nor is it dependent on being metabolized. These products relieve pain via viscosity and lubrication.
Hylan G-F 20 (Synvisc and Synvisc-One) is used as an intra-articular treatment for the pain of osteoarthritis. Hylan G-F 20 is an elastoviscous fluid containing cross-linked polymers of hyaluronan (hyaluronic acid) known as hylans. Hylan G-F 20 is produced from chicken combs and is used clinically as a viscoelastic agent.
Synvisc is administered as 3 injections, but a single injection option (same material and total treatment volume as Synvisc) is provided by Synvisc-One. Synvisc was approved by the FDA in August 1997 and Synvisc-One was approved in February 2009.
Indications
- osteoarthritis
For the treatment of pain in osteoarthritis of the knee when response to conservative nonpharmacologic therapy and simple analgesics (e.g., acetaminophen) has been inadequate
Side Effects
- angioedema
- arthralgia
- arthropathy
- back pain
- chills
- dizziness
- dyspnea
- fever
- flushing
- headache
- hematoma
- hemorrhoids
- infection
- influenza
- injection site reaction
- malaise
- muscle cramps
- musculoskeletal pain
- nausea
- paresthesias
- peripheral edema
- pharyngitis
- phlebitis
- pruritus
- rash
- thrombocytopenia
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- breast-feeding
- children
- egg hypersensitivity
- hyaluronan (sodium hyaluronate) hypersensitivity
- infants
- infection
- inflammation
- intraarterial administration
- intravenous administration
- neonates
- pregnancy
- skin disease
Interactions
- Benzalkonium Chloride
- Intra-articular Corticosteroids
Benzalkonium Chloride: (Major) Do not use concomitant disinfectants that contain quaternary ammonium salts (e.g., benzalkonium chloride) for skin preparation prior to hylan G-F 20 intra-articular injection, as hyaluronan can precipitate in the presence of these disinfectants.
Intra-articular Corticosteroids: (Major) The safety and efficacy of hylan G-F 20 given concomitantly with other intra-articular injectables have not been established. Other intra-articular injections may include intra-articular steroids (betamethasone, dexamethasone, hydrocortisone, prednisolone, methylprednisolone, and triamcinolone).