Arain® 200 mg Tablet: Each film coated tablet contains Tolfenamic acid BP 200 mg.
Tolfenamic acid (Arain®) is one of the class of non-steroidal anti-inflammatory drugs (NSAIDs). It is used to treat the symptoms of migraine.
Mode of action:
Tolfenamic acid (Arain®) inhibit both the cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) isoenzymes which catalyze the formation of prostaglandins which act as messenger molecules in the process of inflammation. This leads to relief of acute migraine.
Pharmacokinetics:
Tolfenamic acid (Arain®) is rapidly absorbed after oral doses with peak plasma concentrations being reached in 1.9-6.5 hours. Bioavailability is averaged 60%. The binding of Tolfenamic acid to plasma protein averaged 99.7% and elimination half-life of about 6.5 hours has been reported. Excretion is mainly in the urine.
Acute migraine.
Adults: 200 mg when the first symptoms of migraine appear. The treatment can be repeated once after 1-2 hours if a satisfactory response is not obtained.
Children: A paediatric dosage regimen has not yet been established.
Elderly: Normal adult dose.
In patients treated with anticoagulants, close monitoring of blood coagulation is recommended. The effect of loop diuretics may be reduced. The effect of lithium may be increased.
Pregnancy: Reproduction studies in animals have not shown any signs of fetal damage. Controlled studies in pregnant women are not available. As is the case with the use of other NSAIDs, tolfenamic acid should not be given in the last trimester, due to risks of premature closure of the ductus arteriosus and prolonged parturition.
Lactation: Tolfenamic acid is excreted to such a very small extent in mothers’ milk that it should be without risk to the breast-fed baby.
As is the case with other NSAIDs, tolfenamic acid should be used with caution in patients with a history of gastrointestinal ulceration, or impaired liver or kidney function.
Keep out of reach of children. Store in a dry place, below 25°C temperature and protected from light.