Tolfedol [Tolfenamic acid BP] NSAID
Composition Tolfedol tablet: Each tablet contains Tolfenamic Acid BP 200 mg.
Pharmacology Tolfenamic acid (N-(2-methyl-3-chlorophenyl) anthranilic acid) belongs to the fenamate group and is a potent inhibitor of cyclooxygenase enzyme, thus it inhibits the synthesis of important inflammatory mediators such as thromboxane (TX) B2 and prostaglandin (PG) E2. Prostaglandins are responsible for causing swelling pain and inflammation associated with these conditions. It acts not only by inhibiting prostaglandin synthesis, but it also has direct antagonistic action on its receptors.
Indication Tolfenamic acid is indicated for Relieving the pain of migraine headache and recommended for use as an analgesic in post-operative pain and fever.
Dosage & administration Adult: • Acute migraine attacks: 200 mg when 1st symptoms of migraine appear. The treatment can be repeated once after 1-2 hours if a satisfactory response is not obtained. • Mild to moderate pain: 100-200 mg tid. • Renal impairment: Dose adjustments may be needed. • Severe renal impairment: Avoid. Children: A pediatric dosage regimen has not yet been established. Tolfenamic acid should be taken with food. Take water during or immediately after meals.
Contra-indication • Hypersensitivity to Tolfenamic acid / Other NSAIDs • Active gastro-intestinal bleeding, active gastro-intestinal ulceration, history of gastro-intestinal bleeding related to previous NSAID therapy, history of gastro-intestinal haemorrhage, history of gastro-intestinal perforation related to previous NSAID therapy. history of recurrent gastro- intestinal ulceration. • Severe heart / renal / liver failure.
Warning & precaution Precaution should be needed for patients with asthma, bronchospasm, bleeding disorders, cardiovascular diseases, peptic ulceration, hypertension, liver infection, cardiac or renal function impairment and elderly. Increase water intake or dose reduction to reduce dysuria.
Side effects Side effects which include rare alveolitis, hepatic damage, pancreatitis, pulmonary eosinophilia, Stevens-Johnson syndrome, angioedema, blood disorder, depression, diarrhea, dizziness, drowsiness, dysuria, euphoria, gastro-intestinal bleeding, gastro-intestinal discomfort, insomnia, malaise, nausea, hearing disturbances, rash, visual disturbances, vertigo, raised blood pressure.
Use in pregnancy & lactation This medicine is not recommended for using during pregnancy unless considered essential by doctor. Not to be given during the third trimester of pregnancy. NSAID's can appear in breast milk in very low concentrations. If possible NSAID's should be avoided when breastfeeding.
Use in children & adolescents Not recommended for use in patients under 18 years of age.
Drug interaction The rate of absorption of Tolfenamic Acid increases with Metoclopramide and Magnesium hydroxide but decreases with Aluminium hydroxide. Risk of bleeding with anticoagulants and other NSAIDS increases when use with Tolfenamic Acid. It decreases antihypertensive response to loop diuretics, B-blockers and ACE Inhibitors. Co-administration increases plasma concentration of Lithium. Methotrexate and cardiac glycosides. It also increases the risk of nephrotoxicity with ACE inhibitors, Cyclosporin, Tacrolimus or diuretics.
Overdose Overdose symptoms include headache, nausea, vomiting, gastro-intestinal bleeding, drowsiness, dizziness, convulsion. In case of significant poisoning acute renal failure and liver damage are possible.
Storage Keep out of the reach of children.
Keep below 300C, protect from light.
Packing Tolfedol tablet: Each box contains 3x10's tablets in blister pack.
