Vivlodex

Vivlodex is a prescription medication used to treat the pain of osteoarthritis.

Vivlodex belongs to a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). These medicines work by inhibiting prostaglandins (hormones) that cause inflammation and pain in the body.

Vivlodex comes in capsule form and is available in two strengths, 5 mg and 10 mg. This once-daily medication is made using a special technology that produces very small particles of the active ingredient, meloxicam, which allows for smaller-than-normal doses that dissolve more quickly.

Common side effects include diarrhea, nausea and stomach discomfort. Vivlodex may cause dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Vivlodex is a prescription medication used to treat the pain of osteoarthritis (OA).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Iroko Pharmaceuticals, LLC

Serious side effects have been reported. See “Vivlodex Precautions” section.

Common side effects include:

• diarrhea
• nausea
• stomach discomfort 
• joint pain
• urinary tract infection
• dizziness

This is not a complete list of Vivlodex side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ACE inhibitors such as lisinopril (Prinivil), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec) and others
• angiotensin II receptor blockers (ARBs) such as candesartan (Atacand), irbesartan (Avapro) and others
• beta blockers such as atenolol (Tenormin), metoprolol (Lopressor, Toprol XL) and others
• aspirin (Ecotrin) and other non-steroidal anti-inflammatory drugs (NSAIDs)
• diuretics, or water pills, such as thiazides (hydrochlorothiazide) and furosemide (Lasix)
• lithium (Eskalith, Lithobid, others)
• methotrexate (Rheumatrex, Trexall)
• cyclosporine (Neoral, Gengraf, Sandimmune)
• warfarin (Coumadin)
• cholestyramine (Questran) and other bile acid sequestrant medications
• cimetidine (Tagamet)
• digoxin (Digitek, Lanoxin)

This is not a complete list of Vivlodex drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Vivlodex including:

• Cardiovascular thrombotic events. Vivlodex can increase your risk of cardiovascular and heart diseases such as strokes and myocardial infarctions, which can lead to death. Tell your doctor if you have a history of heart disease.
• Gastrointestinal effects. Vivlodex can cause digestive tract problems such as ulcers, bleeding, inflammation, and perforations (small holes). Tell your doctor if you have a history of digestive problems, or if you smoke or frequently drink alcohol. Alert your doctor if you take anticoagulants (blood-thinners) or corticosteroids such as prednisone.
• Hepatic events. Vivlodex c­­an cause damage to the liver and increase liver tests. Tell your doctor if you have a history of liver disease.
• Hypertension. Vivlodex may raise your blood pressure. Tell your doctor if you have a history of high blood pressure or take ACE inhibitors (such as lisinopril and enalapril) or diuretics (water pills).
• Congestive heart failure and edema. Vivlodex can increase the chance of congestive heart failure, fluid retention, and weight gain.
• Renal effects. Kidney damage can result from the use of Vivlodex. Tell your doctor if you have a history of kidney disease or take ACE inhibitors (such as lisinopril and enalapril) or diuretics (water pills).
• Hypersensitivity reaction. An allergic reaction to Vivlodex can occur. Symptoms of a hypersensitivity reaction include:
  • hives
  • rash
  • difficulty breathing or swallowing
  • itching
  • swelling
• Adverse skin reactions. Vivlodex can lead to dangerous skin reactions. Symptoms of a skin reaction include:
  • rash
  • red, itchy, or scaly skin
  • blisters
  • fever
• Pregnancy. Vivlodex should not be taken past the 30th week of pregnancy.

Vivlodex can cause dizziness. Do not drive or operate heavy machinery until you know how Vivlodex affects you.

Do not take Vivlodex if you:

• are allergic to meloxicam (the active ingredient in Vivlodex)
• have a history of asthma, hives, or other allergic-type reactions after taking aspirin or other NSAIDs
• will have or have recently had coronary (heart) surgery

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Vivlodex, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Vivlodex, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to meloxicam
• have a history of heart, liver, or kidney disease
• have a history of gastrointestinal (digestive) problems
• have high blood pressure
• have a history of asthma
• take ACE inhibitors such as lisinopril (Prinivil) and enalapril (Vasotec)
• take aspirin (Ecotrin) and other non-steroidal anti-inflammatory drugs (NSAIDs)
• take diuretics, or water pills, such as thiazides (hydrochlorothiazide) and furosemide (Lasix)
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Use of NSAIDs, including Vivlodex, are not recommended for women in the third trimester of pregnancy because they could cause injury and even death to the unborn child. Avoid use of NSAIDs, including Vivlodex, in pregnant women starting at 30 weeks of gestation (third trimester).

In animal studies, pregnant animals were given this medication and some babies were harmed. There are no adequate and well-controlled studies of Vivlodex in pregnant women.

This medication should only be used during pregnancy (before 30 weeks gestation) if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Vivlodex passes into your breast milk. You and your doctor should decide if you will take Vivlodex or breastfeed. You should not do both without talking to your doctor.

Take Vivlodex exactly as prescribed.

• This medication comes in capsule form and is taken once a day, with or without food.
• Take this medication with food to help prevent stomach upset. 
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Vivlodex at the same time.

For management of osteoarthritis pain, the recommended starting Vivlodex dosage is 5 mg by mouth, once daily. The dose may be increased to 10 mg if necessary. The maximum recommended dose of Vivlodex is 10 mg per day. In patients on hemodialysis, the maximum daily dosage is 5 mg.

If you take too much Vivlodex, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F)
• Store in the original container and keep the bottle tightly closed to protect from moisture.
• Keep this and all medicines away from children. 

Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction and stroke, which can be fatal.  This risk may occur early in treatment and may increase with duration of use.

Vivlodex is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal.  These events can occur at any time during use and without warning symptoms.  Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.