Treximet Special Warnings

Treximet Special Warnings Overview

  • Treximet and Overuse

  • Caution: Treximet and Blood Pressure

  • Caution: Treximet and Heart Disease

  • Caution: Treximet and Gastrointestinal Risk

 

Frequent Treximet Use and Overuse Headaches

Using Treximet and other medications like Treximet two or more days a week for more than 3 months can cause medication-overuse headache, a dull or migraine-like headache that is present at least 15 days per month. You can prevent medication-overuse headache by not using Treximet as often (per attack, per week and per month) and starting preventive treatment when necessary. Talk with your doctor about whether or not you would benefit from trying a medicine that prevents migraines.

By keeping a migraine journal of what doses you are taking when you experience a migraine, you can be prepared to discuss if you might be experiencing overuse headaches.

 

Caution: Treximet and Blood Pressure

Treximet has been reported to raise blood pressure on rare occasions in patients with and without high blood pressure. You should not use Treximet if you have high blood pressure that is not under control.

Significant rises in blood pressure, including hypertensive crisis, have been reported in patients with and without a history of high blood pressure receiving sumatriptan (an ingredient in Treximet).

NSAID-containing products can lead to new high blood pressure or worsening of existing high blood pressure, which may increase your risk of heart problems. Thiazides or loop diuretics may not work effectively if you are also taking NSAIDs. The effect of long-term use of Treximet on blood pressure has not been studied. Blood pressure should be monitored closely when starting and using Treximet.

What is your blood pressure? Keeping a blood pressure log if you have been diagnosed with high blood pressure is a very good way to be prepared to speak with your physician and be aware of any changes in your condition.

 

 

Caution: Treximet and Heart Disease

Treximet may increase your risk of serious blood clots in your heart, heart attack, and stroke, which can be fatal. This risk may increase the longer you use Treximet. If you have heart disease or risk factors for heart disease you may be at greater risk.

Cardiac

, Cerebrovascular, or Peripheral Vascular Disease:

Treximet should not be taken if you have a history, symptoms, or signs of inadequate blood supply to your heart, brain or blood vessels in your legs and feet. Signs may include:

  • Chest pain
  • Heart attack
  • Stroke
  • Ischemic bowel disease

In addition, if you have other significant heart disease, or have had coronary artery bypass graft (CABG) surgery, you should not take Treximet.

You should not take Treximet if you have risk factors for coronary artery disease (CAD) such as:

  • High blood pressure
  • High cholesterol
  • Smoker
  • Obesity
  • Diabetes
  • Strong family history of CAD
  • Female with menopause
  • Male over 40 years of age

If you have any of these risk factors, have your doctor evaluate your heart and physical condition to determine if you are reasonably free of heart disease and risk of stroke, before taking Treximet.

If you do have risk factors and your doctor decides you can take Treximet, it is strongly recommended that you take your first dose of Treximet in your doctor’s office or a similar setting with medical staff present unless you have previously taken Treximet.

Because stroke can occur your doctor may choose to do an electrocardiogram (ECG) immediately following a dose of Treximet if you have heart disease risk factors.

 

What should you do if you experience possible heart symptoms while taking Treximet?

Get emergency help right away if you have any of the following symptoms:

  • Shortness of breath or trouble breathing
  • Chest pain
  • Weakness in one part or on one side of your body
  • Slurred speech.

Heart Problems and Death Associated With 5-HT Agonists:

Very rarely, serious heart problems, including heart attack, life-threatening disturbances of heart beat, and death have been reported within a few hours of taking Treximet along with 5-HT agonists.

Blood Clots and Death Associated With Nonsteroidal Anti-inflammatory Drugs:

People taking NSAIDS for up to 3 years have shown an increased risk of serious blood clots, heart attack and stroke, which can be fatal. To decrease your risk, the lowest effective dose should be used for the shortest amount of time possible.

 

 

Caution: Treximet and Gastrointestinal Risk

Gastrointestinal (Stomach and Intestines) Risk

:

Treximet contains a nonsteroidal anti-inflammatory drug (NSAID). NSAID-containing products increase your risk of serious gastrointestinal problems including bleeding, ulcers, and holes in the stomach or intestines, which can be fatal. These problems can occur at any time when you’re using Treximet and there may be no warning symptoms. Older adults are at greater risk for serious gastrointestinal problems.

To minimize the risk for gastrointestinal problems the lowest effective dose should be used for the shortest possible time. If you are at high risk, you should consider an alternate medicine that does not contain NSAIDs.

If you have a history of inflammatory bowel disease (such as ulcerative colitis, Crohn’s disease) you should take NSAIDs with care as your condition may get worse.

NSAID-containing medicines, such as Treximet, can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • Can happen without warning symptoms
  • May cause death.

Your chance of getting an ulcer or bleeding increases with:

  • Use of steroid hormones (corticosteroids) and blood thinners (anticoagulants)
  • Longer use
  • More frequent use
  • Smoking
  • Drinking alcohol
  • Older age
  • Having poor health

What should you do if you experience possible symptoms of gastric bleeding while taking Treximet?

Stop taking Treximet and call your doctor right away if you have any of the following symptoms:

  • Nausea that seems out of proportion to your migraine
  • Stomach pain
  • Sudden/severe pain in your belly
  • Vomit blood
  • Blood in your bowel movement or it is black and sticky like tar
  • More tired or weaker than usual

Medications to prevent NSAID-induced ulcers

Medicines such as misoprostol, proton pump inhibitors, and double doses of H2-receptor antagonists are effective at reducing the risk of gastric ulcers due to non steroidal anti-inflammatory (NSAID) medications. Ask your doctor for more information.

Written & reviewed by: Lisa Erwin R.Ph. CGP | Last review date: Dec 2010. Click the References Link below for a complete list of references.

Written & reviewed by: Lisa Erwin R.Ph. CGP | Last review date: Dec 2010.
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