Indications of Tolmic 200 mg
Tolmic 200 mg is used specifically for relieving the pain of migraine headache and also recommended for use as an analgesic in post-operative pain and fever.
Theropeutic Class
Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs), Other drugs for migraine
Pharmacology
Tolmic 200 mg inhibits the biosynthesis of prostaglandins, and it also presents inhibitory actions on the prostaglandin receptors. As commonly thought, the mechanism of action of Tolmic 200 mg is based on the major mechanism of NSAIDs which consists of the inhibition of COX-1 and COX-2 pathways to inhibit prostaglandin secretion and action and thus, to exert its anti-inflammatory and pain-blocking action. Nonetheless, some report currently indicates that Tolmic 200 mg inhibits leukotriene B4 chemotaxis of human polymorphonuclear leukocytes leading to an inhibition of even 25% of the chemotactic response. This activity is a not ligand specific additional anti-inflammatory mechanism of Tolmic 200 mg
Dosage & Administration of Tolmic 200 mg
Acute migraine attacks:
Adult: 200 mg when 1st symptoms appear may be repeated once after 1-2 hr.
Renal impairment: Dose adjustments may be needed. Severe: Avoid.
Mild to moderate pain:
Children: A pediatric dosage regimen has not yet been established.
Adult: 100-200 mg tid.
Renal impairment: Dose adjustments may be needed. Severe: Avoid. It should be taken with food. Take water/ or immediately after meals.
Preclinical safety data: The therapeutic index for Tolmic 200 mg is high, and gastrointestinal ulceration and kidney changes have only been seen with oral doses approximately 6-10 times the maximum therapeutic dose recommended for Tolmic 200 mg. Special Precautions: Asthma, bronchospasm, bleeding disorders, cardiovascular diseases, history of peptic ulceration, hypertension, patients with infections, liver, cardiac, or renal function impairment. Increase water intake or dose reduction to reduce dysuria. CHF; elderly; lactation.
Dosage of Tolmic 200 mg
Adult:
Acute migraine attacks: 200 mg when symptoms appear may be repeated once after 1-2 hour.
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.Tolmic 200 mg should be taken with food. Take water during or immediately after meals.
Interaction of Tolmic 200 mg
The rate of absorption of Tolmic 200 mg increases with Metoclopramide and Magnesium hydroxide but decreases with Aluminium hydroxide. Risk of bleeding with anticoagulants and other NSAIDS increases when use with Tolmic 200 mg. 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, Ciclosporin, Tacrolimus or diuretics
Contraindications
Active peptic ulcer or bleeding in the gut. Severe heart, kidney or liver failure.
Side Effects of Tolmic 200 mg
Dysuria especially in males, diarrhoea, nausea epigastric pain, vomiting, dyspepsia, erythema, headache, tremor, euphoria, fatigue, pulmonary infiltration & haematuria. Potentially fatal: Blood dyscrasias and hepatitis.
Pregnancy & Lactation
Pregnancy: This medicine is not recommended for use during pregnancy unless considered essential by your doctor. This is particularly important in the first and third trimesters. Not to be given during the third trimester of pregnancy. Lactation: In limited studies so far available, NSAIDs can appear in breast milk in very low concentrations. NSAIDs should, if possible, be avoided when breastfeeding.
Precautions & Warnings
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.
Overdose Effects of Tolmic 200 mg
Symptoms include headache, nausea, vomiting, epigastric pain. gastrointestinal bleeding, diarrhoea excitation, coma, drowsiness dizziness, tinnitus, fainting and convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible. Patients should be treated symptomatically as required.
Storage Conditions
Store in a cool and dry place, away from light Keep out of the reach of children.
Drug Classes
Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs), Other drugs for migraine
Mode Of Action
Tolmic 200 mg (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.Pharmacokinetic properties: Absorption Readily absorbed from GI tract. Peak plasma concentration: 60-90 min. Bioavailability 85%. Distribution: Protein-binding: 99% Plasma half-life 2 hours. Metabolism: Metabolised in the liver. Tolmic 200 mg undergoes enterohepatic circulation. Excretion: Excreted in urine (90%) and faces.
Pregnancy
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 NSAID's should, if possible, be avoided when breastfeeding.