TM Owner Currax Pharmaceuticals
Treximet 85mg/500mg Tablet
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Indications & Clinical Uses
- Treximet 85 mg/500 mg (sumatriptan and naproxen sodium) tablets combine a triptan (sumatriptan), which narrows overactive blood vessels involved in migraine, with an NSAID (naproxen sodium), which reduces the inflammation that accompanies a migraine attack.
- It is approved in the United States for the acute treatment of migraine with or without aura in adults and in adolescents aged 12 years and older; it is not for preventing migraine and is not approved for cluster headache.
- Treximet should be used only after a clear diagnosis of migraine has been made, to rule out other, more serious causes of headache.
- It is taken by mouth as a single tablet as soon as possible after migraine symptoms start, with a second tablet allowed after 2 hours if needed, up to a maximum of 2 tablets in 24 hours.
- Treximet is not interchangeable with sumatriptan-only or naproxen-only products because the fixed 85 mg/500 mg combination and its onset are specific to this formulation.
Side Effects
- Treximet carries a boxed warning shared by all NSAIDs: an increased risk of serious, potentially fatal cardiovascular events such as heart attack and stroke, and an increased risk of serious gastrointestinal problems including bleeding, ulceration and perforation of the stomach or intestine, which can happen without warning symptoms.
- Commonly reported effects in adults include dizziness, sleepiness, nausea, chest discomfort or tightness, tingling sensations, indigestion and dry mouth; adolescents most often report a hot flushing sensation and muscle tightness.
- Get emergency help immediately for chest pain, sudden weakness on one side, slurred speech, black or bloody stools, vomiting blood, or severe abdominal pain.
- Also seek urgent care for a tight, band-like sensation around the chest or throat, which can be a sumatriptan effect but should always be checked, especially in anyone with heart disease risk factors.
Precautions & Warnings
- Do not use Treximet if you have coronary artery disease, a history of heart attack, stroke, transient ischaemic attack, hemiplegic or basilar migraine, uncontrolled high blood pressure, or if you have had recent coronary bypass surgery.
- It is also contraindicated with aspirin-sensitive asthma, active peptic ulcer disease or a history of NSAID-related gastrointestinal bleeding.
- Treximet should be avoided in the last trimester of pregnancy, as NSAIDs can cause fetal harm and delivery complications; use earlier in pregnancy only if the benefit outweighs the risk.
- It is not recommended in significant kidney or liver impairment, and NSAIDs can worsen high blood pressure and fluid retention, so blood pressure is monitored, especially with long-term or frequent use.
- Treximet is not recommended for basilar or hemiplegic migraine.
- Use no more than the labelled maximum, since overuse of migraine medicines can itself cause more frequent headaches (medication-overuse headache).
Avoid Interactions
- Do not take Treximet within 24 hours of another triptan, ergotamine or an ergot-type medicine, because of an added risk of prolonged blood vessel narrowing.
- Do not use with, or within 2 weeks of stopping, an MAO-A inhibitor, since this can raise sumatriptan levels roughly sevenfold and increase toxicity.
- Combining Treximet with SSRIs or SNRIs (common antidepressants) can rarely cause serotonin syndrome, with symptoms such as agitation, rapid heartbeat, muscle twitching and sweating; report these promptly.
- The naproxen component increases bleeding risk with anticoagulants such as warfarin, and taking it with aspirin is generally avoided because it adds to gastrointestinal and bleeding risk without extra pain relief.
- NSAIDs can reduce the effect of some blood pressure medicines and raise lithium and methotrexate levels.
- Tell your healthcare provider about every medicine, herbal product and supplement you take.
References
Frequently Asked Questions
Treximet (sumatriptan and naproxen sodium) treats an acute migraine attack, with or without aura, in adults and in adolescents aged 12 and over. It combines a triptan and an anti-inflammatory in one tablet. It does not prevent migraines and is not used for cluster headache.
Take one Treximet tablet by mouth as soon as migraine symptoms begin. If the migraine returns, a second tablet may be taken at least 2 hours after the first. Do not take more than 2 tablets (170 mg sumatriptan total) in any 24-hour period.
Treximet carries a boxed warning for serious cardiovascular events like heart attack and stroke, and for gastrointestinal bleeding or ulcers, from its NSAID component. Common effects include dizziness, sleepiness, nausea and chest tightness. Get emergency help for chest pain, one-sided weakness or black, bloody stools.
Avoid other triptans, ergotamine medicines and MAO-A inhibitors, which raise the risk of dangerous interactions. Be cautious combining Treximet with SSRIs or SNRIs, which can rarely cause serotonin syndrome. Avoid regular aspirin use alongside it, since this adds bleeding risk without extra benefit.
Avoid Treximet if you have coronary artery disease, a past heart attack or stroke, hemiplegic or basilar migraine, uncontrolled high blood pressure, active stomach ulcers, or aspirin-sensitive asthma. It should also be avoided late in pregnancy, since the naproxen component can affect the baby and delivery.
Treximet 85 mg/500 mg is approved for adolescents aged 12 years and older, as well as adults, for acute migraine attacks. It is not approved for children under 12. A lower-strength 10 mg/60 mg tablet also exists for younger adolescents; do not substitute strengths without medical advice.
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