| Application: | Internal Medicine |
|---|---|
| Usage Mode: | For oral administration |
| Suitable for: | Elderly, Children, Adult |
| State: | Solid |
| Shape: | Capsules |
| Type: | Biological Products |
| Samples: |
|---|
| Customization: |
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Indications:
The treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, acute musculoskeletal disorders and acute gout.
Contra-indications:
Active peptic ulcer or a history of recurrent gastro-intestinal lesions. Sensitivity to aspirin, indometacin or other non-steroidal anti-inflammatory agents.
Pregnancy or lactation.
Patients operating machinery.
Patients with epilepsy, parkinsonism, psychiatric disturbances or porphyria.
Children, since conditions for safe use have not been established.
Severe heart failure.
Adverse Effects:
Most adverse effects are dose related
Gastro-intestinal adverse effects are common and include anorexia, nausea (with or without vomiting) dyspepsia, abdominal pain and diarrhoea. Infrequently, ulceration of the upper GI tract, sometimes with perforation and haemorrhage, has occurred. Acute pancreatitis has been reported. Hepatic involvement is rare, though fatal cases of hepatitis and jaundice have been reported.
CNS effects are also common. Severe frontal headache may occur in 25 - 50% of patients who take the drug chronically. Dizziness, light-headedness, vertigo and mental confusion are also frequent. Depression and psychosis have also been reported but the incidence is less than 1%.
Haemopoietic reactions, including neutropenia, thrombocytopenia and, rarely, aplastic anaemia have been reported.
Hypersensitivity reactions, manifested as rashes, itching, urticaria or rarely acute asthma, may occur.
Oedema, hypertension, and cardiac failure, have been reported in association with NSAID treatment.
| Testing terms | Standards | Results |
| definition | indometacin capsule includes Indometacin | indometacin capsule includes Indometacin |
| Related substance | up to standard | up to standard |
| Dissolution | Q≥80% | up to standard |
| Package differencial | up to standard | up to standard |
| Microbial limit | bacterial count≤1000cfu/g fungal and yeast count≤100cfu/g No Escherichia coli |
up to standard up to standard up to standard |
| Assay | 90.0%-110.0% | 99.2% |
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