Suvexx

How does this medication work? What will it do for me?

This medication contains two active ingredients: naproxen and sumatriptan. Naproxen belongs to a group of medications called nonsteroidal anti-inflammatory drugs(NSAIDs). Sumatriptan belongs to a class of medications known as 5-hydroxytryptamine agonists (also called "triptans").

Together, these ingredients are used to treat migraine headaches with or without aura (warning signs that occur prior to the onset of a migraine). Naproxen stops the body from producing chemicals that cause pain and swelling. The pain of migraine headaches is thought to be caused by dilated blood vessels inside the head.

Sumatriptan relieves migraine headaches by constricting these blood vessels.

Naproxen - sumatriptan is not recommended for other types of headache or for headache prevention.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each blue, film-coated tablet, debossed "85/500" on one side, contains 119 mg of sumatriptan succinate equivalent to 85 mg of sumatriptan and 500 mg of naproxen sodium. Nonmedicinal ingredients: croscarmellose sodium, dibasic calcium phosphate, FD&C Blue No. 2, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, sodium bicarbonate, talc, titanium dioxide, and triacetin.

How should I use this medication?

The recommended adult dose of naproxen – sumatriptan is one (1) tablet, taken by mouth as early as possible after a migraine headache starts. It may be taken with or without food, however it should be swallowed whole and not crushed or chewed. If you experience relief with the first dose, but the migraine returns after more than 2 hours, another dose may be taken.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. Naproxen – sumatriptan is taken only when needed. No more than 2 doses should be taken within a 24-hour period and these 2 doses must be taken at least 2 hours apart. If you take the first dose and it does not help to relieve your migraine, do not take another dose to treat this headache. If you have mild kidney or liver problems you should only take one dose of naproxen – sumatriptan in a 24-hour period.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children. 

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

• are allergic to naproxen, sumatriptan, or any ingredients of the medication
• are in your third trimester (last 3 months) of pregnancy
• are breastfeeding
• are allergic to ASA or other NSAIDs (e.g., ibuprofen, ketorolac, diclofenac) or have had allergic symptoms (e.g., runny nose, asthma, itchy skin rash, nasal polyps, swelling of the face, throat, or tongue) caused by these medications
• are taking monoamine oxidase (MAO) inhibitors (e.g., phenelzine, tranylcypromine) or have taken them within the past 2 weeks
• have angina (chest pain), including Prinzmetal's angina (coronary vasospasm)
• have blood vessel disease (e.g., ischemic bowel disease, Raynaud's syndrome, stroke, transient ischemic attacks [TIAs])
• have certain types of migraine headaches (including hemiplegic, basilar, or ophthalmoplegic migraine)
• have recently had or are going to have coronary artery bypass graft (CABG) surgery
• have irregular heartbeat caused by problems with the electrical impulses of the heart
• have severe, uncontrolled heart failure
• have high blood pressure that is severe or not under control
• have inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease)
• have severely reduced or worsening kidney function
• have moderately-to-severely reduced liver function or active liver disease
• have high levels of potassium in the blood
• have a history of stroke or transient ischemic attack (TIA)
• have taken another 5-hydroxytryptamine agonist (i.e., naratriptan, rizatriptan, zolmitriptan) in the past 24 hours
• have taken ergotamine-containing or ergot-type medications (such as dihydroergotamine, ergotamine, or methysergide) in the past 24 hours
• have an active or bleeding ulcer in the stomach or intestines

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• dizziness or lightheadedness
• dry mouth
• general feeling of being unwell
• heartburn
• loss of appetite
• muscle tightness
• nausea
• sleepiness
• stomach pain
• sun sensitivity
• tiredness
• vomiting
• weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• circulation problems (e.g., cold or numbness in the fingers and toes, nose, lips, or ears; prickly or stinging feeling; skin colour changes to white or blue)
• confusion
• depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• fast or irregular heart beat
• flu-like symptoms (e.g., fever or chills, achiness, sore throat)
• hearing problems
• pain or difficulty passing urine
• pain, discomfort, or stiffness in the neck, throat, jaw, abdomen, or chest
• persistent heartburn
• swelling of the arms, legs, hands, and feet
• tenderness in the upper right side
• unusually severe nausea
• unusual weight gain
• worsening headache

Stop taking the medication and seek immediate medical attention if any of the following occur:

• blurred vision or vision changes
• nausea that seems too severe for your migraine
• seizures
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee)
• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
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• sudden, severe abdominal pain
• symptoms of serotonin syndrome (e.g., confusion, fast heartbeat, hallucinations, restlessness, shaking, shivering, sudden jerking of muscles, sweating)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are any nutrients depleted by this medication?

Some medications can affect vitamin and nutrient levels in the body. Below is a list of nutrient depletions associated with this medication. Talk to your doctor or pharmacist about whether taking a supplement is recommended or if you have any questions or concerns.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergy: If you are allergic to sulphonamides (sulfa medications) you may experience an allergic reaction to sumatriptan. Reactions range from a skin allergy to a serious allergic reaction. If you are allergic to other medications in this class (5-hydroxytryptamine agonists such as rizatriptan and naratriptan) you can also have an allergic reaction to sumatriptan.

If you have had a reaction to acetylsalicylic acid (ASA) or other NSAIDs (e.g., ibuprofen, ketoprofen, ketorolac) that included a runny nose, itchy skin rash, nasal polyps, or shortness of breath and wheezing, you should not take this medication.

If you experience symptoms of a severe allergic reaction (e.g., hives; difficulty breathing; wheezing; or swelling of the face, tongue, or throat), get immediate medical attention.

Blood clotting: This medication may reduce the ability of the blood to clot. If you are taking anticoagulants (e.g., warfarin, heparin) or other medications that affect blood clotting, or have hemophilia or other blood disorders (e.g., low platelets), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you have a bleeding disorder, do not take this medication.

Blood pressure: This medication can cause fluid to build up in the body and narrowing of the blood vessels. Both actions increase the amount of effort it takes for the heart to pump blood through the body. As a result, blood pressure can increase when taking naproxen - sumatriptan. If you have high blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you have severe or uncontrolled high blood pressure, do not take naproxen - sumatriptan.

Drowsiness/reduced alertness: You may experience drowsiness, dizziness, and blurred vision when you take this medication. Avoid driving and other activities that require alertness and concentration until you determine how this medication affects you.

Heart disease: Sumatriptan may cause narrowing of the blood vessels that supply the heart. This can lead to chest pain, increased blood pressure, heart attacks, and other heart problems. Naproxen can cause fluid to build up in the body, decreasing the effectiveness of the heart and contributing to heart failure.

If you have certain risk factors for heart disease (e.g., high blood pressure, high cholesterol, smoking, obesity, diabetes, family history of coronary artery disease, menopause, men over 40 years of age), tell your doctor. If you experience symptoms of a heart attack (e.g., pain, pressure, tightness, or heaviness in the chest, jaw, neck, or shoulder; sweating; or shortness of breath), get immediate medical attention.

Heart attack and stroke: This medication may be associated with an increased risk of heart attack and stroke. The risk may increase with taking the medication over long periods of time. If you have a history of heart disease (e.g., heart attack, stroke, heart failure) or have risk factors for heart disease (e.g., high blood pressure, high cholesterol, diabetes, smoking, kidney disease), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: The effect of reduced kidney function on how sumatriptan acts in the body has not been evaluated. NSAIDs like naproxen may cause reduced kidney function. If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: This medication is not recommended for people with reduced liver function. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Medication overuse headaches: As with other pain relief medications, overuse of naproxen - sumatriptan may lead to medication overuse headaches, or "rebound headaches" where the headache returns as the medication wears off. Avoid taking more of this medication than is recommended by your doctor. If you experience more frequent headaches, contact your doctor as soon as possible.

Seizures: There have been rare reports of seizures experienced by people taking this medication. Most of these people had a previous history of epilepsy or medical conditions that increase the risk of seizures. If you have a history of epilepsy or other condition that increase your risk for seizure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Serotonin syndrome: People who use sumatriptan along with serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, citalopram, fluoxetine), serotonin norepinephrine reuptake inhibitors (SNRIs; e.g., venlafaxine), or other medications that act on serotonin may experience serotonin syndrome. This syndrome is severe and can be life-threatening. If you are taking antidepressants, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of serotonin syndrome (e.g., agitation, hallucinations, fast heartbeat, fever, increased reflexes, nausea, vomiting, diarrhea) after using sumatriptan, get immediate medical attention.

Stroke: Rarely, this medication may cause cerebrovascular events such as stroke and bleeding around the brain. If you have had a previous stroke or are at risk for it, talk to your doctor about taking this medication. If you experience signs and symptoms of a stroke (e.g., sudden numbness or weakness, especially on one side of the body; sudden confusion or problems with speech; sudden vision problems in one or both eyes; sudden dizziness or loss of coordination; sudden severe headache, especially if it seems different from your usual headaches), get immediate medical attention.

Ulcers or bleeding in the stomach or intestines: Regular use of naproxen can cause stomach ulcers, perforation (holes), and bleeding from the stomach, or can make these conditions worse. 

Although naproxen – sumatriptan is only taken when it is needed, the risk of ulcers and bleeding still exists and increases if you have been taking this medication for longer periods of time. 

If you currently have bleeding ulcers in the stomach or intestines, or have an inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), you should not take this medication. Stop taking the medication and get immediate medical attention if you experience symptoms or signs of stomach ulcers or bleeding in the stomach (black and tarry stools, vomit that looks like coffee grounds, stomach pain).

Pregnancy: This medication should not be used during the third trimester (last 3 months) of pregnancy. This medication should not be used during the first and second trimester (first 6 months) of pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Both sumatriptan and naproxen pass into breast milk. If you are breast-feeding and are taking naproxen-sumatriptan, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

Seniors: The safety and effectiveness of this medication have not been established for people over 65 years old. In general, seniors tend to be more likely to experience severe side effects of medications like naproxen – sumatriptan. 

What other drugs could interact with this medication?

There may be an interaction between naproxen - sumatriptan and any of the following:

• 5-ASA medications (e.g., mesalamine, olsalazine, sulfasalazine)
• acalabrutinib
• acetylsalicylic acid (ASA)
• alcohol
• aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
• angiotensin converting enzyme inhibitors (ACEIs; captopril, ramipril)
• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• apixaban
• beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
• bisphosphonates (e.g., alendronate, etidronate, risedronate)
• celecoxib
• cholestyramine
• clopidogrel
• colestipol
• oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• cyclosporine
• dabigatran
• dasatinib
• deferasirox
• desmopressin
• digoxin
• disopyramide
• diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
• edoxaban
• eplerenone
• ergot alkaloids (e.g., ergotamine, dihydroergotamine)
• fentanyl
• glucosamine
• heparin
• herbal products that affect blood clotting (e.g., cat's claw, chamomile, Dong Quai, evening primrose, fenugreek, feverfew, garlic, ginger, ginkgo biloba, ginseng, green tea, licorice, turmeric)
• hydralazine
• lithium
• low molecular weight heparin (e.g., dalteparin, enoxaparin, tinzaparin)
• meperidine
• metformin
• methotrexate
• mirtazapine
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, tranylcypromine)
• obinutuzumab
• pentoxifylline
• prostaglandin eye drops (e.g., latanoprost, bimatoprost)
• quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
• rivaroxaban
• selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
• sodium phosphates
• tacrolimus
• tapentadol
• tenofovir
• tipranavir
• tramadol
• trazodone
• tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
• "triptan" migraine medications (e.g., eletriptan, rizatriptan,)
• tryptophan
• vancomycin
• vitamin E
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

 

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Suvexx