SYNOVALYTE IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SYNOVALYTE IN PLASTIC CONTAINER (SYNOVALYTE IN PLASTIC CONTAINER).
SYNOVALYTE is a hyaluronan preparation that acts as a viscoelastic supplement, restoring the rheological properties of synovial fluid in osteoarthritic joints. It provides lubrication and shock absorption, and may exert anti-inflammatory and analgesic effects through modulation of synovial fluid viscosity and interaction with hyaluronan receptors.
| Metabolism | Hyaluronan is primarily metabolized in the liver and synovium via hyaluronidases and subsequent breakdown into constituent monosaccharides. |
| Excretion | Renal excretion of sodium, chloride, and lactate; not metabolized; elimination routes not quantified as it is a crystalloid solution. |
| Half-life | Not applicable; components (sodium, chloride, lactate) are endogenous and rapidly redistributed; lactate half-life ~5-10 minutes in normal hepatic function. |
| Protein binding | Not bound; sodium, chloride, and lactate are free in plasma. |
| Volume of Distribution | Sodium and chloride distribute in extracellular fluid (Vd ~0.2 L/kg); lactate distributes in total body water (Vd ~0.6 L/kg). |
| Bioavailability | Intravenous: 100% (by definition); not administered by other routes. |
| Onset of Action | Intravenous: immediate upon infusion; metabolic effect of lactate (buffer) within 5-10 minutes. |
| Duration of Action | Duration depends on infusion rate and patient volume status; electrolyte effects persist as long as infusion continues; bicarbonate generation from lactate lasts 1-2 hours after infusion stops. |
Intra-articular injection: 2 mL per joint once weekly for 3 weeks.
| Dosage form | SOLUTION |
| Renal impairment | No dosage adjustment required in renal impairment. |
| Liver impairment | No dosage adjustment required in hepatic impairment. |
| Pediatric use | Safety and efficacy not established in pediatric patients. |
| Geriatric use | No specific dosage adjustment required; use caution due to potential comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SYNOVALYTE IN PLASTIC CONTAINER (SYNOVALYTE IN PLASTIC CONTAINER).
| Breastfeeding | Not expected to be excreted in breast milk due to high molecular weight. M/P ratio not available; use with caution in nursing mothers. |
| Teratogenic Risk | No teratogenic risk expected as Synovalyte (hyaluronate sodium) is a large molecular weight polysaccharide that does not cross the placenta. No fetal risk identified in animal studies. |
| Fetal Monitoring |
■ FDA Black Box Warning
None.
| Serious Effects |
["Known hypersensitivity to hyaluronate preparations.","Active joint infection or skin infection at the injection site."]
| Precautions | ["Do not use in patients with known hypersensitivity to hyaluronan preparations.","Post-marketing reports of anaphylactoid reactions, including cases of cardiac arrest and death.","Use caution in patients with active joint infections or skin diseases at the injection site.","Effusion may occur post-injection; warn patients to avoid strenuous activities for 48 hours.","Repeated intra-articular injections may increase risk of adverse events."] |
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| No specific monitoring required beyond routine obstetric care. |
| Fertility Effects | No known effects on fertility based on available data. |