Celofen 100mg Tablets: Each tablet contains 100mg Aceclofenac BP.
Celofen ® is a non-steroidal agent with anti-inflammatory and analgesic properties. Its mechanism of action is largely based on inhibition of prostaglandin synthesis. Celofen ® is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandins.
Adults: The maximum recommended dose is 200mg daily, taken as two separate 100mg doses, one tablet in the morning and one in the evening. Children: There is no clinical data on the use of Aceclofenac in children. Elderly: The pharmacokinetics of Aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose and dose frequency. Renal insufficiency: There is no evidence that the dosage of Aceclofenac needs to be modified in patients with mild renal impairment. Hepatic insufficiency: The dose of Aceclofenac should be reduced in patients with hepatic impairment. An initial daily dose of 100mg should be administered.
Warfarin, heparin, and antiplatelets increase risk of serious gastrointestinal hemorrhage; decreases lithium and methotrexate renal clearance resulting in toxicity; reduces diuretic and antihypertensive efficacy of ACE inhibitors, ARBs, and diuretics; cyclosporine and tacrolimus nephrotoxicity is amplified.
Aceclofenac is contraindicated in patients previously sensitive to Aceclofenac or aspirin or other NSAIDs. It should not be administered to patients with active or suspected peptic ulcer or gastrointestinal bleeding and moderate to severe renal impairment.
Common: Dyspepsia, abdominal pain, nausea, diarrhea, dizziness. Less Common: Pruritus, rash, elevated hepatic enzymes, raised serum creatinine.
Overdose
There is no human data available on the consequences of Aceclofenac overdosage. The symptoms could be: nausea, vomiting, stomach pain, dizziness, somnolence and headache. Treatment: If required, gastric lavage, charcoal in repeated doses. Antacids when necessary and other symptomatic treatment should be given for complications.
Category C (1st/2nd trimesters), Category D (3rd trimester). Avoid during pregnancy; contraindicated in third trimester due to risk of premature closure of ductus arteriosus. Lactation: Excretion in breast milk unknown; avoid during lactation.
Store below 25°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.