Tolfem200 mg

Tolfem is a non-steroidal anti-inflammatory drug (NSAID) of the fenamate class, established for the following uses:

Established / Approved Uses

• Acute treatment of migraine attacks, with or without aura — Tolfem is taken at the onset of an attack to relieve headache and associated symptoms.
• Mild to moderate pain, including musculoskeletal pain, dysmenorrhoea (painful periods), and post-operative or post-traumatic pain.
• Inflammatory conditions such as soft-tissue rheumatism and other painful inflammatory states, where a short course of an anti-inflammatory analgesic is appropriate.

Notes on Use

Tolfem is intended for short-term, symptomatic relief. It does not prevent migraine attacks and is not a substitute for migraine-preventive therapy. It should be used at the lowest effective dose for the shortest duration needed, as with all NSAIDs.

Each tablet contains Tolfenamic acid 200 mg. Formulations and strengths may vary by manufacturer; refer to the specific product label for exact composition.

Tolfem is a non-steroidal anti-inflammatory drug (NSAID) belonging to the fenamate (anthranilic acid derivative) chemical class. It has analgesic, anti-inflammatory, and antipyretic properties, and is particularly recognised for its use in the acute treatment of migraine attacks, in addition to general use for mild-to-moderate pain and inflammation.

Like other fenamates, Tolfem works by inhibiting the cyclo-oxygenase (COX) enzymes responsible for prostaglandin synthesis, and is also thought to have some inhibitory action on leukotriene formation, which may contribute to its efficacy in migraine.

Non-Steroidal Anti-Inflammatory Drug (NSAID) — Fenamate (anthranilic acid) class; Anti-migraine analgesic

Tolfenamic acid is a fenamate-class NSAID that exerts its analgesic and anti-inflammatory effects primarily by non-selectively inhibiting cyclo-oxygenase (COX-1 and COX-2) enzymes, thereby reducing the synthesis of prostaglandins that mediate pain, inflammation, and fever.

In addition to COX inhibition, Tolfenamic acid and other fenamates are believed to have some antagonist activity at prostaglandin receptors and may inhibit leukotriene synthesis, which is thought to contribute to its particular usefulness in the acute treatment of migraine, a condition in which prostaglandins and neurogenic inflammation play a role.

After oral administration, Tolfenamic acid is well absorbed from the gastrointestinal tract, with peak plasma concentrations typically reached within 1–2 hours. It is highly protein-bound and is metabolised in the liver, with metabolites excreted mainly in the urine and, to a lesser extent, in the bile/faeces.

Take Tolfem tablets orally, swallowed whole with a full glass of water, preferably with or immediately after food to minimise gastrointestinal irritation. Do not crush or chew unless the product labelling permits it.

Tolfem should be used cautiously with the following medicines due to well-established, clinically significant interactions:

• Anticoagulants (e.g. warfarin, heparin, DOACs) and antiplatelet agents: increased risk of bleeding due to additive effects on platelet function and, with warfarin, potential displacement from protein binding.
• Other NSAIDs (including aspirin): concurrent use increases the risk of gastrointestinal ulceration and bleeding without added therapeutic benefit, and should generally be avoided.
• ACE inhibitors, angiotensin receptor blockers (ARBs), and diuretics: Tolfem may reduce their antihypertensive effect and, in combination (the "triple whammy"), increases the risk of acute kidney injury, particularly in the elderly or volume-depleted patients.
• Lithium: Tolfem can reduce renal clearance of lithium, raising serum lithium levels and the risk of toxicity; lithium levels should be monitored.
• Methotrexate: Tolfem can reduce renal excretion of methotrexate, increasing the risk of methotrexate toxicity, especially at higher methotrexate doses.
• Corticosteroids and SSRIs: additive increase in the risk of gastrointestinal ulceration or bleeding when combined with Tolfem.

Side effects of Tolfem are generally similar to those of other NSAIDs. Most are dose-related and reversible on stopping treatment.

Common

• Dyspepsia, nausea, abdominal pain, diarrhoea
• Headache, dizziness, drowsiness

Less Common / Uncommon

• Gastrointestinal ulceration or bleeding
• Skin rash or itching
• Fluid retention, mild elevation in blood pressure

Rare but Serious

• Renal impairment or acute kidney injury
• Hepatic dysfunction
• Bronchospasm or hypersensitivity reactions in susceptible individuals
• Serious skin reactions (e.g. Stevens-Johnson syndrome) — rare

Patients should seek prompt medical attention for signs of gastrointestinal bleeding (black stools, vomiting blood), severe skin reaction, or breathing difficulty.

Pregnancy: Tolfem is contraindicated during the third trimester of pregnancy, as NSAIDs used late in pregnancy can cause premature closure of the fetal ductus arteriosus, reduced fetal renal function, and other complications. Use during the first and second trimesters should be avoided unless clearly necessary; if required, Tolfem should be used at the lowest effective dose for the shortest possible time, and only if the potential benefit justifies the potential risk to the fetus. A physician should always be consulted before use in pregnancy.

Lactation: There is limited data on the excretion of Tolfem into breast milk. As a precaution, Tolfem should be used during breastfeeding only if clearly needed and under medical advice, with the infant monitored for any adverse effects.

Tolfem, like other NSAIDs, carries class-wide cardiovascular and gastrointestinal risks and should be used with caution:

• Cardiovascular risk: NSAIDs may increase the risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, particularly with long-term use or in patients with existing cardiovascular risk factors.
• Gastrointestinal risk: NSAIDs can cause serious GI adverse events including bleeding, ulceration, and perforation, which can occur without warning symptoms, especially in the elderly. Taking Tolfem with food helps reduce but does not eliminate this risk.
• Renal caution: use with care in patients with pre-existing renal impairment, dehydration, heart failure, or in the elderly, and avoid prolonged use.
• Hepatic caution: use with care in patients with mild hepatic impairment; discontinue if signs of liver dysfunction develop.
• Asthma/allergic patients: use with caution in patients with a history of asthma, nasal polyps, or allergic disease, due to the risk of NSAID-induced bronchospasm.
• Elderly patients: are at higher risk of NSAID-related GI, renal, and cardiovascular adverse effects; use the lowest effective dose.
• Avoid concurrent use of alcohol, as it may increase the risk of gastrointestinal irritation and bleeding.
• Tolfem should be used for the shortest duration necessary to control symptoms.

Symptoms of Tolfem overdose may include nausea, vomiting, abdominal pain, gastrointestinal bleeding, drowsiness, dizziness, headache, and in severe cases, seizures, kidney impairment, or low blood pressure.

If an overdose of Tolfem is suspected, seek immediate medical attention or contact a poison control centre / emergency services right away. Do not attempt to treat an overdose at home. Supportive care and monitoring in a medical facility are required; there is no specific antidote.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Elderly: Elderly patients are at increased risk of NSAID-related gastrointestinal, renal, and cardiovascular adverse effects when using Tolfem; treatment should start at the lowest effective dose with close monitoring.

Children/Adolescents: Safety and efficacy of Tolfem have not been established in patients under 18 years of age; it is generally not recommended for this group.

Renal impairment: Use with caution in mild-moderate renal impairment; contraindicated in severe renal impairment (see Contraindications).

Hepatic impairment: Use with caution in mild hepatic impairment; contraindicated in severe hepatic impairment (see Contraindications).

Pregnancy/Lactation: See Pregnancy and Lactation section for full detail.

Tolfem is intended for short-term, symptomatic use. For an acute migraine attack, treatment is a single episode (one or two doses); for pain or inflammatory conditions, use should generally be limited to a few days at the lowest effective dose. Prolonged or frequent use should only occur under medical supervision, due to cumulative GI, renal, and cardiovascular risk.

Non-Steroidal Anti-Inflammatory Drug (NSAID), Fenamate (anthranilic acid derivative), Analgesic, Antipyretic, Anti-inflammatory agent, Anti-migraine agent

Tolfenamic acid inhibits cyclo-oxygenase (COX-1 and COX-2) enzymes, reducing prostaglandin synthesis and thereby producing analgesic, anti-inflammatory, and antipyretic effects; it may also have additional antagonist activity against prostaglandins and inhibit leukotriene formation, contributing to its efficacy in acute migraine.

Safety and efficacy of Tolfem have not been established in children and adolescents under 18 years of age. Use in this population is generally not recommended; consult a pediatrician if use is being considered.