Intas Synocur Injection 2ml 2 Vial Online – For Osteoarthritis, Lameness & Traumatic joints for Dog

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PENTOSAN POLYSULFATE SODIUM INJECTION 100 mg/ml

COMPOSITION:

Each ml contains:

Pentosan Polysulfate Sodium.................. 100 mg

Benzyl Alcohol IP...................................... 0.01 ml

as (preservative)

Water for Injections IP.............................. q.s.

MECHANISM OF ACTION

Pentosan Polysulfate is a semi-synthetic polysaccharide polymer which possesses anti-inflammatory, anti-arthritic and chondroprotective properties. These beneficial effects arise from:

1) Direct anti-inflammatory activity

2) Inhibition of neutrophil migration into joints

3) Stimulation of hyaluronic acid synthesis by synovial fibroblasts which results in a marked increase in synovial

volume and viscosity

4) Stimulation of chondrocytes and biosynthesis of proteoglycans

5) Strong fibrinolytic activity which improves the circulation of subchondral bone and peri-articular structures.

Pentosan Polysulfate Sodium (PPS) has heparin-like properties that binds to damaged cartilage matrix comprising aggregated proteoglycans and stimulates synthesis of new aggregated glycosaminoglycan molecules and hyaluronic acid. PPS has ability to inhibit a range of proteolytic enzymes may be of particular importance such as metalloproteinase, thereby preserving proteoglycan content and protecting cartilage matrix from degradation. PPS modulates cytokine action, stimulates hyaluronic acid secretion, preserves proteoglycan content and stimulates articular cartilage blood flow, resulting in analgesic and regenerative effects. PPS also inhibits the scavenging free radicals.

PHARMACOKINETICS:

Absorption: In dog, a peak plasma concentration of 7.40 mg-eq. Pentosan Polysulfate sodium/ml is achieved 15 minutes after subcutaneous administration.

Distribution: Pentosan Polysulfate sodium binds many plasma proteins with a variable strength of association and dissociation resulting in a complex equilibrium between bound and unbound drug. Pentosan Polysulfate sodium is concentrated in the liver and kidneys and reticuloendothelial system. Low levels occur in connective tissue and muscle. The volume of distribution in dogs is 0.43 L.

Biotransformation: Desulfation of Pentosan Polysulfate sodium occurs in hepato-reticulo-endothelial system, the liver being main site of activity. Depolymerisation may also occur in the kidney. Elimination: The drug is eliminated with a half-life of approximately 3 hours in dog. Forty eight hours after administered is eliminated via urine.

injection approximately 70% of the dose Pentosan Polysulfate sodium (PPS) has an affinity for cartilage and active drug levels will accumulate for several days after administration. For maximum effect, tissues should be exposed to the drug over an extended period, hence the four injections are recommended in dogs.

INDICATIONS:

• Osteoarthritis (non-infectious arthrosis)
• Osteochondrosis dissecans
• Traumatic joints
• Peri-articular inflammation
• Lameness
• Degenerative joint disease
• Non-infectious inflammatory joint disease

TARGET SPECIES: Dog

CONTRAINDICATIONS

Do not use for the treatment of septic arthritis. In this case, appropriate antimicrobial therapy should be

instigated.

Do not use in dogs with advanced liver or kidney impairment or evidence of infection.

Do not use in dogs with blood disorders, coagulation disorders, bleeding or malignancy (especially haemangiosarcoma). Pentosan Polysulfate has an anticoagulant effect.

Do not use during the peri-operative period. Do not use in the skeletally immature dogs (i.e. dogs whose long bone growth plates have not closed).

When used intra-articularly, there is the possibility of intra-articular bleeding. Appropriate bandaging and rest post injection are recommended.

PRECAUTIONS

Do not exceed the standard dose. Increasing the recommended dose may result in exacerbation of stiffness and discomfort. Because of the fibrinolytic action of Pentosan Polysulfate sodium, the possibility of internal bleeding from a tumour or vascular abnormality should be considered and appropriate therapeutic action taken. Use with caution in dogs with a history of pulmonary lacerations. Caution is also recommended in cases of hepatic impairment. Pentosan Polysulfate sodium has an anticoagulant effect.

It is recommended that the Packed Cell Volume (PVC) and capillary filling time should be monitored, when the product is used. No more than three courses of four injections should be administered in a twelve month period. It is recommended that the animal should be monitored for signs of blood loss and treated appropriately, Interrupt the treatment if signs of increased bleeding occur.

ADVERSE REACTIONS

Rarely, reaction to the injection may occur within 24 hours in an an apparently healthy animal. In these circumstances treatment should be discontinued and symptomatic relief given. A further very rare side effect following administration of Pentosan Polysulfate sodium in dogs is an apparent mild depression and lethargy lasting up to 24 hours. Emesis, diarrhoea, lethargy and anorexia have been reported following the use of Pentosan Polysulfate. These signs may be the result of a hypersensitivity reaction and may require appropriate symptomatic treatment including antihistamine administration. Administration of the product at recommend- ed dose rates results in increases of activated partial thromboplastin time (aPTT) and thrombin time (TT) which may persist for up to 24 hours after administration in healthy dogs. It is recommended that the animal should be monitored for signs of blood loss and treated appropriately.

USE DURING PREGNANCY AND LACTATION

Laboratory studies in rabbits showed embryo toxic effects associated with a primary effect on the parent at repeated daily doses 2.5 times the recommended dose. The safety of the product in the pregnant or lactating animal has not been studied, therefore use is not recommended in pregnant or lactating animals. The product should not be used at the time of parturition due to its anticoagulant effects.

INTERACTION WITH OTHER DRUGS

NSAIDs and in particular aspirin should not be used in combination with Pentosan Polysulfate sodium as they may affect thrombocyte adhesion and potentiate the anticoagulant activity of the product. Corticosteroids have been shown to be antagonistic to a number of actions of Pentosan Polysulfate sodium. Furthermore, use of anti-inflammatory drugs may result in a premature increase in the dog's activity, which may interfere with the analgesic and regenerative effects of the product.

Do not use concurrently with steroids or non-steroidal anti-inflammatory drugs, including aspirin and phenylbutazone or within 24 hours of such administration. Do not use in conjunction with heparin and other anti-clotting agents.

OVERDOSE

At three times the recommended dose a transient increase in bleeding time of about 3 to 4 hours duration has been observed. Repeated daily overdoses of five times the recommended dose or more resulted in anorexia and depression, which were reversible upon wi withdrawal of the drug. At overdose there may be hepatocellular damage and an associated, dose-dependent, elevation in ALT. Signs associated with these defects may include bleeding into the gastro-intestinal tract, body cavities and ecchymoses. At repeated doses greater than ten times that recommended, there may be fatality as a result of gastro-intestinal haemorrhage. If overdose occurs dogs should be hospitalised & observed and supportive therapy provided as deemed necessary by the Veterinarian.

STORAGE

Store at a temperature of 2°C -8°C.

Do not freeze.

Keep away from direct sunlight

Keep out of reach of children.

NOT FOR HUMAN USE

FOR ANIMAL TREATMENT ONLY