Sodium Hyaluronate is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics, e.g., acetaminophen. It may also be used as an adjuvant in orthopaedic surgery.

Sodium Hyaluronate is a viscous solution consisting of a high molecular weight fraction of purified natural sodium hyaluronate in buffered physiological sodium phosphate. It has a pH of 6.8–7.5. Hyaluronic acid is an important component of the body’s extracellular matrix and is present in high concentration in cartilage and synovial fluid. Endogenous hyaluronic acid provides viscosity and elasticity to synovial fluid, which is essential for lubrication and shock-absorbing function. It is also necessary for maintaining the proper structure of proteoglycans in articular cartilage. In osteoarthritis, both the amount and quality of hyaluronic acid in synovial fluid and cartilage are reduced. Intra-articular administration of hyaluronic acid into arthritic joints helps improve joint function and mobility.

Sodium Hyaluronate is administered by intra-articular injection. A treatment cycle consists of five injections given at weekly intervals. Some patients may experience benefit with three injections given at weekly intervals. Inject the full 2 ml in one knee only. If treatment is bilateral, a separate injection should be used for each knee. Treatment may be repeated, usually, at 6 up to 12-month interval.

Pediatrics: The safety and effectiveness of Sodium Hyaluronate have not been demonstrated in children.

Sodium Hyaluronate is for intra-articular injection and is supplied as a single use, ready to use, sterile solution in a 2 ml pre-filled syringe, and must not be diluted. The content of the syringe is sterile and must be used immediately once the syringe has been opened. Intra-articular injection of Sodium Hyaluronate should be made using precise, anatomical localization into the joint cavity of the knee to be treated. The injection site in the knee is determined by that location which is easier to reach. Usually a lateral approach can be followed, but in some cases a medial approach is preferable. Strict aseptic precautions should be observed during the administration. The solution in the prefilled syringe is ready for use and requires only a sterile disposable needle. A 20 gauge needle may be used on the syringe. To ensure sterility, the injection site must be carefully cleansed with antiseptic. Care should be taken to expel any trapped air bubbles from the syringe containing Sodium Hyaluronate prior to administration.

Joint effusion, if present, should be aspirated by arthrocentesis prior to injection of Sodium Hyaluronate. The arthrocentesis should be made using a 20 gauge needle and the joint should be aspirated to almost dryness, but not to a degree that would compromise the accuracy of the subsequent Sodium Hyaluronate injection. The intra articular injection of Sodium Hyaluronate can be given using the same needle as used for the arthrocentesis by simply detaching the aspirating syringe and attaching the syringe containing Sodium Hyaluronate. To make sure the needle is correctly positioned, some synovial fluid should be aspirated prior to the slow injection of Sodium Hyaluronate. If the patient experiences pain during injection, the procedure may need to be stopped.

For the first hours after the injection, the patient should be advised to rest the treated knee, with as little exercise as possible, avoiding any strenuous activities or prolonged weight-bearing activities such as jogging or tennis. Subsequently, they may gradually return to their normal level of activity. Discard any unused Sodium Hyaluronate.

Sodium Hyaluronate should not be administered intra-articularly at the same time or mixed with other products. It should not be used concurrently with disinfectants containing quaternary ammonium salts, as hyaluronic acid may precipitate in their presence.

This drug is contraindicated in patients with known hypersensitivity to hyaluronate preparations. Intra-articular injection is also contraindicated in the presence of current or past infection or skin disease at the injection site to reduce the risk of septic arthritis.

Local reactions such as pain, swelling/effusion, warmth, or redness at the injection site have been reported. These symptoms are usually temporary and resolve spontaneously within a few days with rest of the affected joint and application of ice.

The safety and effectiveness of Sodium Hyaluronate in pregnant women have not been established. It is not known whether Sodium Hyaluronate is excreted in human milk. Its safety in lactating mothers has not been established.

Caution should be taken when injecting Sodium Hyaluronate in patients allergic to avian proteins, feathers, or egg products. Strict aseptic technique must be followed during administration. Joint effusion, if present, should be removed before injection. Patients should avoid strenuous or prolonged weight-bearing activities (e.g., jogging, tennis) for at least 48 hours after intra-articular injection.

Drugs for Osteoarthritis

Store Sodium Hyaluronate injection in a cool (below 25°C), dry place and protect from light. Do not freeze.