- Approval Id
- 6778343979224600
- Drug Name
- NEODOL-K TABLET 50 MG
- Product Name
- NEODOL-K TABLET 50 MG
- Approval Number
- SIN10619P
- Approval Date
- 1999-01-07
- Registrant
- NAINA MOHAMED & SONS PRIVATE LIMITED
- Licence Holder
- NAINA MOHAMED & SONS PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, SUGAR COATED
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION:</strong><br>
<u>Osteoarthritis:</u> The recommended dosage is 100–150mg/day in divided doses.<br>
<u>Rheumatoid Arthritis:</u> the dosage is 150–200mg/day in divided doses, 50 mg t.i.d, or q.i.d. Diclofenac Potassium.<br>
<u>Ankylosing Spondylitis:</u> The recommended dosage is 100–125 mg/day administered as 25 mg q.i.d. with an extra 25 mg dose at bed time if necessary.<br>
After satisfactory response has been obtained, dosage should be reduced to the minimum dose that provides continuing control of symptoms, usually 75 to 100 mg a day in three divided doses.<br>
<u>Analgesia and Primary Dysmenorrhea:</u> Initial dose of 50 mg of Diclofenac Potassium, followed by 50 mg doses every 8 hours as needed.</p>
<p><strong>Special populations</strong><br>
<strong>Established cardiovascular disease or significant cardiovascular risk factors</strong><br>
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 if the treatment is 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.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>INDICATIONS AND USES:</strong> Diclofenac Potassium is indicated for acute and chronic treatment of signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. Diclofenac Potassium is indicated for the management of pain and primary dysmenorrhea.</p>
- Contraindications
- <p><strong>CONTRAINDICATIONS:</strong> Diclofenac Potassium is contraindicated in patients with hypersensitivity to Diclofenac. Diclofenac Potassium should not be given to patients who have experienced asthma, urticarial, or other allergic-type reactions after taking aspirin or other Non Steroidal Anti-inflammatory Drugs. Severe, rarely fatal, anaphylactic-like reactions to Diclofenac have been reported in such patients.</p>
<p>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.</p>
- Atc Code
- M01AB05
- Atc Item Name
- diclofenac
- Pharma Manufacturer Name
- NAINA MOHAMED & SONS PRIVATE LIMITED
