Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
INJECTION
**Dosage and Administration:** IM dose of 75mg once daily. In severe condition, 75mg twice daily. In renal colic, a dose of 75mg repeated once after 30 minutes if necessary. **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.
INTRAMUSCULAR
Medical Information
**Indications:** Relief of pain and inflammation in condition such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, renal colic, acute gout.
**Contraindications:** Diclofenac Sodium is contraindicated in patients with history of Hypersensitivity, active peptic ulcer or Gastrointestinal bleeding, and those who are known to develop asthma, urticaria or other allergic reactions with aspirin or other NSAID's. Acute porphyria is a contraindication for Diclofenac. 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.
M01AB05
diclofenac
Manufacturer Information
NAINA MOHAMED & SONS PRIVATE LIMITED
BROWN & BURK PHARMACEUTICAL LTD
Active Ingredients
Documents
Package Inserts
Neodol Injection PI.pdf
Approved: September 29, 2022