ANALPAN INJECTION 25 MG/ML [SIN09829P]

Product Info

ANALPAN INJECTION 25 MG/ML

[SIN09829P]

INDICATIONS:

1. Inflammatory & degenerative forms of rheumatism

2. Rheumatoid arthritis

3. Ankylosing spondylitis

4. Osteoarthritis, spondylarthritis

5. Non-articular rheumatism

6. Painful inflammatory conditions of non-rheumatic origin

RECOMMENDED DOSAGE:
Adult: Depending on the severity of the condition, commence therapy with a dosage of 75 to 150 mg daily, given in 2 or 3 divided doses, for I/M injection; 75 mg (3mL) per dose. For maintenance in long term therapy 75 or 100 mg daily in 2 or 3 times divided doses is usually sufficient. Analpan injection is not suitable for children and adolescents because of their dosage strength.
Note: After assessing the risk/ benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used. The higher dose is more often required in patients with rheumatoid arthritis than in patients with osteoarthritis. Diclofenac Sodium Injection should not be given for more than 2 days. If necessary, treatment can be continued with tablets or suppositories. Diclofenac Injection also should not be administered by intravenous injection.
Special populations: Established cardiovascular disease or significant cardiovascular risk factors
The use of high dose diclofenac (150mg/day) for more than 4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If diclofenac treatment is needed, patients with established cardiovascular disease, uncontrolled hypertension or significant cardiovascular risk factors (e.g. hypertension, hyperlipidaemia, diabetes mellitus and smoking) should be treated only after careful consideration and at doses ≤100 mg daily when initial treatment with diclofenac injection continues with diclofenac tablets or suppositories for more than 4 weeks. As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, diclofenac should always be prescribed at the lowest effective daily dose and for the shortest duration possible.

CONTRAINDICATIONS:

1. Known allergy to diclofenac sodium, sodium metabisulphite or any of the excipients.

2. Cross sensitivity has been demonstrated between diclofenac, aspirin and naproxen. Diclofenac should not be given to aspirin sensitive patients. Sensitivity phenomena include asthma, rhinitis and urticaria.

3. Active gastrointestinal bleeding (eg. peptic ulcer perforation) recurrent dyspepsia or other gastrointestinal pathology.

4. Severe hepatic impairment

5. Pregnancy - see “Use in Pregnancy" – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information

The use of high dose diclofenac (150mg/day) for more than 4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension.