Adant Dispo

Adant Dispo

sodium hyaluronate

Manufacturer:

Meiji
Full Prescribing Info
Contents
Sodium hyaluronate.
Description
Sodium hyaluronate is [->3)-2-acetamido-2-deoxy-β-D-glucopyranosil-(1->4)-β-D-glucopyranosyluronic acid-(1->]n. It is a white powder, slightly soluble in water and almost insoluble in ethanol, acetone or in ether. Molecular Formula: (C14H20NNaO11)n. Molecular Weight: Average 600,000-1,200,000. Optical Rotation: [α]20D= -70 to -81.
Adant Dispo has a pH of 6.8-7.8 and a specific osmotic pressure of 1-1.2.
Action
Pharmacology: Sodium hyaluronate has a covering and protective action to the cartilage surface of the joint, a suppressive action to the degenerative change in the cartilage tissue and an ameliorative action to the mobility range in articular contracture. It relieves pain in general arthrosis deformans, improves mobility range of the joints and normalizes synovial fluid.
Action to the Cartilage of the Joint: Sodium hyaluronate was recognized to have entered into the surface layer of the cartilage by administration into the cavity of the knee joint of a normal rabbit. Moreover, in the cartilage of man with arthrosis deformans in the knee (in vitro), distribution of sodium hyaluronate extends widely from the surface layer into the entire layer of the cartilage with the progress of time. This distribution within the cartilage was in agreement with the parts deprived of proteoglycan. Separation of proteoglycan in the cells of articular cartilage of a cow is suppressed by sodium hyaluronate. Administration of sodium hyaluronate in the joint cavity of the knee using a rabbit as the model of arthrosis deformans of the knee and the model of fixed articular contracture of the knee, proved to have suppressed degeneration of cartilage.
Improvement of Mobility Range of the Joints: In the model of fixed articular contracture using the rabbit, mobility range of the joint was improved by administration of sodium hyaluronate into articular cavity.
Toxicology: Nonclinical Tests: Acute Toxicity: LD50 value obtained when single administration was given intra-abdominally in male and female rats were 2014 and 1761 mg/kg, respectively.
Subacute Toxicity: When repeated intra-abdominal administrations were given in rats during 28 days at a dose level of 30, 60, 120 and 240 mg/kg, the indifferent dose recognized was 30 mg/kg. Doses of >60 mg/kg caused a decrease of red blood cells (RBC) and total protein, which was recognized to be dose-dependent. This was considered to have relation with the change of blood picture by the use of sodium hyaluronate, however a tendency of recovery was shown after discontinuation of the drug.
Antigenicity: Sodium hyaluronate was allowed to exhibit its action by IM and intra-articular administration in guinea pigs, and the tests for mobile anaphylaxis, corneal and PCA reactions was carried out. The result showed that there was no antigenicity observed in any of the tests.
Mutagenicity: In the Ames test using bacteria, occurrence of mutagenicity was not recognized.
Local Irritability: Sodium hyaluronate 0.1 mL was dropped into the rabbit eyes and it showed no influence on the cornea, iris and conjunctiva. Irritation to the mucous membrane of the eyes was also negative.
Indications/Uses
Treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics (eg, acetaminophen).
Dosage/Direction for Use
Adults: Usually 2 mL once a week for 5 consecutive weeks, administered by injection in the cavity of the knee joint. Frequency of injection may be adjusted according to condition of the disease.
As Adant Dispo is injected into the joint, injection should be performed according to a strict aseptic procedure.
Administration: How to Use: After Adant Dispo is restored to room temperature, take out the syringe from the blister pack.
Cut and sever by hand the tips of finger-wing at the central part of the syringe and expand it until it is fixed and firm.
Turn the stopper and pull it away.
Syringe needle (22-23 G size) is fixed by screwing it in.
Push the plunger rod and start administration. Before administration, the site of injection should be cleaned and disinfected. After administration, separate the components of Adant Dispo kit and discard.
Contraindications
Patients with history of hypersensitivity to any of the ingredients of Adant Dispo.
Infection or skin disease at the injection site.
Special Precautions
In case inflammation of the joint in arthrosis deformans of the knee is conspicuous, and considering that the use of sodium hyaluronate may cause exacerbation of inflammatory symptoms of the affected part, it is desired that treatment be given after such inflammatory symptoms have been eliminated.
Occasionally, local pain occurs after the use of sodium hyaluronate, therefore, necessary measures should be taken eg, instruction of how to rest the affected part after application of sodium hyaluronate.
If the injection should leak outside the articular cavity, it may cause pain, therefore, it should be administered accurately into the cavity of the joint.
Administer with care in patients with history of hypersensitivity to some other drug, with liver impairment or a history of such impairment.
The safety and effectiveness of the use of joints other than the knee have not been established.
Use with caution when injecting into patients who are allergic to avian proteins, feathers and egg products.
Remove joint effusion, if present, before injecting sodium hyaluronate.
Use in pregnancy & lactation: In animal experiment (rabbit), teratogenicity is not observed, however, safety of sodium hyaluronate in pregnant women has not yet been established, therefore, it should be administered carefully in women who are or possibly are pregnant.
In animal experiment (rat), it is recognized that sodium hyaluronate can pass into breast milk.
The safety and effectiveness of sodium hyaluronate have not yet been established in pregnant and lactating women.
Use in children: As safety of sodium hyaluronate in children has not yet been established, administration should be carefully made only if such treatment is unavoidable.
Use in the elderly: Administer with caution in elderly patients because their physiological function is generally declining.
Use In Pregnancy & Lactation
In animal experiment (rabbit), teratogenicity is not observed, however, safety of sodium hyaluronate in pregnant women has not yet been established, therefore, it should be administered carefully in women who are or possibly are pregnant.
In animal experiment (rat), it is recognized that sodium hyaluronate can pass into breast milk.
The safety and effectiveness of sodium hyaluronate have not yet been established in pregnant and lactating women.
Side Effects
Rarely: <0.1%; occasionally: 0.1% to <5%; no limitation: >5% or frequency not clear.
Severe: Shock: Symptoms of shock occur rarely, however, when there are abnormalities recognized after adequate observation, Adant Dispo should be discontinued and the patient given appropriate treatment.
Others: Hypersensitivity: Eruption eg, urticaria, etc and itching occur rarely, however, if such symptoms should occur, Adant Dispo should be discontinued and the patient should be given appropriate treatment.
Joints Under Treatment: Occasionally, pain (mainly transient pain after administration of sodium hyaluronate), swelling, rarely edema, rash, flush, hot sensation and local pain may occur.
Drug Interactions
The safety and effectiveness of the use of sodium hyaluronate concomitantly with other intra-articular injection has not yet been established.
As sodium hyaluronate is precipitated by quaternary amine bactericides or disinfectants eg, benzalkonium chloride and chlorhexidine, etc, adequate attention should be given.
Caution For Usage
During Injection: When sodium hyaluronate is administered into the cavity of the knee joint, it should be performed according to strict aseptic procedure. In case improvement of symptoms is not recognized after treatment, administration should be limited to 5 times before discontinuing. When accumulation of articular fluid occurs, it should be drained out of syringe if the condition necessitates.
Others: Sodium hyaluronate should not be administered into blood vessels, it should not be applied for ophthalmological treatment. Because the drug is viscous, the use of 22-23 G syringe is desired. Since it is kept in a cool place, restore to room temperature before administering. It is intended for 1 application, therefore it should be used as soon as possible after opening. Discard after using.
Storage
Keep in a cool place (2°-8°C). Protect from light. Do not freeze.
ATC Classification
M09AX01 - hyaluronic acid ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Presentation/Packing
Inj 10 mg/mL (syringe, clear, colourless, odourless, viscous, aqueous soln) x 2.5 mL x 1's.
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