Indication: Claim is indicated for the relief of pain and inflammation in both acute and chronic pain like osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, dental pain, post-traumatic pain, low back pain, gynaecological pain etc.
Composition: Claim 100 Tablet Each film-coated tablet contains Aceclofenac BP 100 mg.
Therapeutic Class: Analgesic & Antipyretic
Generic Name: Aceclofenac BP
Pharmacology: Claim is a non-steroidal agent with anti-inflammatory and analgesic properties. Its mode of action is largely based of inhibition of prostaglandin synthesis. Claim is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandins. It also stimulates cartilage matrix (glycosaminoglycans) synthesis.
Dose and Administration:
Adults: The maximum recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening with or after food.
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 100 mg should be administered.
Elderly: The pharmacokinetics of aceclofenac is not altered in elderly patients, therefore it is not considered necessary to modify the dose and dose frequency.
Contraindication: 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.
Warning & Precaution: Claim should be administered with caution to patients with symptoms indicative of gastrointestinal disorders, with a history of peptic ulceration, ulcerative colitis, Crohn’s disease, hepatic porphyria, and coagulation disorders. Patients suffering from severe hepatic impairment must be monitored.
a) Common: Generally aceclofenac is well tolerated. The majority of side effects observed have been reversible and of a minor nature and include gastrointestinal disorders (dyspepsia, abdominal pain, nausea and diarrhoea) and occasional occurrence of dizziness. Dermatological side effects including pruritus and rash.
b) Rare: Abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported.
Use in pregnancy & lactation: There is no information on the use of aceclofenac during pregnancy. Aceclofenac should not be administered pregnancy, unless prescribed by the physician. The lowest effective dose should be administered. There is no information on the secretion of aceclofenac in breast milk. The use of aceclofenac should therefore be avoided during lactation unless the potential benefits to the mother outweigh the possible risks to the children.
Use in children & adolescents:
Children: There is no clinical data on the use of aceclofenac in children.
a) With medicine: Lithium and Digoxin: Aceclofenac, like other NSAIDs, may increase plasma concentrations of lithium and digoxin.
Diuretics: Aceclofenac, like other NSAIDs, may inhibit the activity of diuretics. Anticoagulants: Like other NSAIDs, Aceclofenac may enhance the activity of anticoagulants.
Quinolones: Convulsion may occur due to an interaction between quinolones and NSAIDs. Other NSAIDs and steroids: Concomitant therapy with aspirin, other NSAIDs and steroids may increase the frequency of side effects.
b) With Food and others: when aceclofenac was given to fasting and healthy volunteer only the rate not the extent of absorption was affected. Alcohol should not take with aceclofenac, it may cause stomach bleeding or dried /coffee colored stool.
Overdoes: There is no human data available on the consequences of aceclofenac over dosage. After over dosage, following therapeutic measures to be taken: absorption should be prevented as soon as possible by means of gastric lavage and treatment with activated charcoal. Supportive and symptomatic treatment should be given for complications.
Storage: Store below 30°C, protected from light & moisture. Keep away from the reach of the children.
Packing: Claim 100 mg Tablet: Each box contains 10 X 10’s tablet in blister strips.