SYNOVALYTE IN PLASTIC CONTAINER
Clinical safety rating
cautionComprehensive 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. |
| Molecular Weight | 1.0e6 to 4.0e6 Da (average ~2.0e6 Da) |
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 | No adequate studies in pregnant women. Use only if potential benefit justifies potential risk to fetus. |
| 2nd trimester | No adequate studies in pregnant women. Use only if potential benefit justifies potential risk to fetus. |
| 3rd trimester | No adequate studies in pregnant women. Use only if potential benefit justifies potential risk to fetus. |
Clinical note
Comprehensive clinical and safety monograph for SYNOVALYTE IN PLASTIC CONTAINER (SYNOVALYTE IN PLASTIC CONTAINER).
| Placental transfer | Unknown; molecular weight suggests minimal transfer but no human data available. |
| Breastfeeding | It is not known whether sodium hyaluronate is excreted in human milk. Caution should be exercised when administered to a nursing woman. |
| Lactation Rating | L3 (Moderately Safe) |
| 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 | No specific monitoring required beyond routine obstetric care. |
| Fertility Effects | No known effects on fertility based on available data. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to sodium hyaluronate or any component of the formulationActive infection in the knee joint
| 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. |
| Food/Dietary | No known food interactions. Maintain normal diet unless instructed otherwise by physician. |
| Clinical Pearls | Synovalyte in plastic container is a sterile, non-pyrogenic irrigating solution for intraoperative joint irrigation. Use only if solution is clear and container undamaged. Discard any unused portion; no preservatives. Monitor for fluid overload in patients with renal impairment or heart failure. Do not administer intravenously. |
| Patient Advice | This solution is used during surgery to wash the joint area. · You may experience temporary swelling or discomfort after irrigation. · Report any signs of infection like increased pain, redness, or fever. · Follow your surgeon's post-operative instructions carefully. |
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