What to Know About Zorvolex (Diclofenac)

Zorvolex (diclofenac) is a prescription nonsteroidal anti-inflammatory (NSAID) approved to treat acute pain and osteoarthritis pain. It has analgesic properties and also helps decrease inflammation and swelling, which contribute to pain.

Zorvolex comes in hard gelatin capsules that are taken three times a day. The mechanism of action for NSAIDs is not fully understood, but it is thought to be related to the inhibition of prostaglandins, which are involved in inflammation.

Diclofenac is also available in generic tablets and the brand Zipsor, which comes in liquid capsules that are taken four times a day for pain. There are also topical versions of the drug, such as an over-the-counter gel Voltaren Arthritis Pain that is applied to arthritic joints and a prescription topical solution Pennsaid that's used for osteoarthritis pain in the knees.

Uses

Zorvolex is approved for the treatment of mild to moderate acute pain, such from injuries or menstrual cramps, and osteoarthritis pain in adults.

Osteoarthritis, the most common type of arthritis, is a breakdown and thinning of the protective cartilage in your joints. Over time it leads to an inflammatory response with joint swelling, stiffness, and pain. It can happen in any joint, but common ones that are affected are the knees, hips, hands, wrists, elbows, and spine.

Zorvolex can help to manage arthritis pain, but is not a cure and will not reverse or prevent joint damage. Pain and inflammation will only be reduced while taking the medication.

Off-Label Uses

Diclofenac may also be prescribed off label for conditions such as biliary colic (abdominal pain due to a blockage of bile from the gallbladder) and fever. 

Before Taking

Diclofenac is a second-line treatment for pain that may be prescribed after the use of over-the-counter pain medicines, such as acetaminophen or lower-dose NSAIDs, have not been effective enough in managing pain.

If diclofenac is being considered, your doctor can help determine if Zorvolex would be the best fit or if another brand or a generic would be better in your case.

Zorvolex capsules come in the lowest U.S. Food and Drug Administration (FDA) approved dose of diclofenac. The risk of serious side effects, such as heart attacks or gastrointestinal complications, increases with higher doses and prolonged use of NSAIDs, so your doctor may opt to start you on Zorvolex in order to meet the FDA recommendation to take the lowest effective dose of NSAIDs for the shortest duration possible.

For osteoarthritis, your doctor may prescribe topical diclofenac or oral diclofenac. Research suggests that topical versions may be associated with fewer heart and gastrointestinal side effects. If the topical treatment isn't effective, leads to skin irritation, or you have sensitive skin, your doctor may prescribe Zorvolex instead. Likewise, if you are unable to tolerate Zorvolex or other types of oral dicloflenac, your doctor may have you try a topical treatment.

Those with acute pain may take Zorvolex short term while those with chronic pain may be prescribed Zorvolex for more prolonged periods. Your doctor will adjust the dose and frequency to meet your needs.

Precautions and Contraindications

Zorvolex can have serious and life-threatening heart and gastrointestinal side effects, so your doctor will do a thorough medical history before prescribing it to you.

They may also check your blood pressure and run blood tests to evaluate liver and kidney function to evaluate any added risk factors or contraindications.

Certain medical circumstances can make taking Zorvolex risky or even prohibit its use, including:

• Allergic reactions or asthma: Do not take Zorvolex if you have a hypersensitivity to diclofenac or if you've experienced asthma, urticaria (hives), or allergic-type reactions from gelatin or after taking aspirin or other NSAIDs. Severe and sometimes fatal allergic reactions can occur.
• Heart disease or risk factors for heart disease: NSAIDs may cause an increased risk of cardiovascular events, such as blood clots, heart attack, and stroke, which can be fatal. Patients with existing heart disease, such as coronary artery disease (CAD), or risk factors for heart disease like smoking or hypertension (high blood pressure) may be at greater risk. 
• Pending or recent heart surgery: Do not take Zorvolex right before or after coronary artery bypass graft (CABG) surgery, a procedure to bypass a blocked or narrowed artery that supplies the heart.
• Fluid retention and edema: NSAIDs may lead to fluid retention and edema (swelling) in some people. Tell your doctor if you have a history of edema or congestive heart failure.
• Gastrointestinal ulcers or bleeding: NSAIDs can cause serious ulcers and bleeding or perforation (holes) in the stomach or intestine. Tell your doctor if you have a history of ulcers or gastrointestinal bleeding, have a bleeding disorder, or take oral corticosteroids, anticoagulants (blood thinners), or other NSAID therapies that can increase this risk.
• Kidney effects or advanced renal disease: Long-term use of NSAIDs may cause renal injury. Tell your doctor if you have kidney disease/are on dialysis or if you take diuretics or ACE inhibitors, which can increase kidney risks.
• Liver effects: NSAIDs may cause elevated levels on liver tests or, in rare cases, severe hepatic (liver) reactions including jaundice, fatal fulminant hepatitis, liver necrosis, and liver failure. Tell your doctor if you have liver dysfunction or have had any abnormal liver tests.
• Skin reactions: NSAIDs can cause serious skin reactions, such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. Tell your doctor if you have a history of skin reactions.
• Pregnancy: There are no adequately controlled studies of Zorvolex in those who are pregnant and NSAIDs pass the placental barrier, which can pose risks to the fetus. It's especially important to avoid NSAIDs after 30 weeks gestation since they can cause premature closure of the fetus's ductus arteriosus, a blood vessel that connects major arteries before birth.
• Breastfeeding: Those who are nursing may not want to take Zorvolex, as it may be transferred to the baby via breastmilk.
• Those trying to conceive: NSAIDs may be associated with a delay in ovulation. Those who have difficulties conceiving or who are undergoing fertility treatment should avoid this drug.

Certain medications can interact with Zorvolex and increase the risk of serious side effects. Your doctor will weigh the pros and cons of your medication regimen and may consider changing your other prescriptions if you have to take Zorvolex.

Medications that interact with Zorvolex include:

• Angiotensin converting enzyme (ACE) inhibitors: NSAIDs may diminish the antihypertensive effect of these drugs.
• Blood-thinning medications, such as Jantoven or Coumadin (warfarin): Both wafarin and Zorvolex carry serious risks of gastrointestinal bleeding and other bleeding problems, which increases when taken with Zorvolex.
• Rheumatrex or Trexall (methotrexate): NSAIDs may reduce the elimination of methotrexate from the body, increasing risk of toxicity.
• Sandimmune (cyclosporine): Zorvolex may increase the renal toxicity of Sandimmune.

Other NSAIDs

The brand Cambia is an oral solution of diclofenac that's approved specifically for migraines.

There are also a variety of NSAIDs that may be prescribed for pain or symptoms of arthritis. Other prescription NSAIDS include:

• Celebrex, Elyxyb (celecoxib)
• Naprosyn, Anaprox, Naprelan (naproxen)
• Mobic (meloxicam)
• Diflunisal
• Etodolac
• Nalfon (fenoprofen)
• Flurbirofen
• Indocin, Tivorbex (indomethacin)
• Ketroprofen
• Ketorolac
• Ponstel (mefenamic acid)
• Nabumetone
• Daypro (oxaprozin)
• Feldene (piroxicam)
• Sulindac
• Tolmetin

Dosage

Zorvolex capsules come in 18 milligram (mg) and 35 mg capsules that are taken three times per day.

If you are taking Zorvolex for osteoarthritis, your doctor may have you take the 35 mg capsules twice a day since the recommended dose for osteoarthritis is 100 mg to 150 mg per day.

Zorvolex capsules contain a free acid, while other brands of diclofenac contain a potassium or sodium salt of the drug. These differences alter how the medication is released in your body, so you should not substitute Zorvolex with other forms of diclofenac even at the same dosage unless it a switch that is done under the care of a physician.

The diclofenac brand Zipsor comes in 25 mg liquid capsules taken four times a day. Generic diclofenac comes delayed-release tablets that are either 50 mg taken up to three times a day or 75 mg taken up to twice a day. There are also generic immediate-release 50 mg tablets taken taken up to four times a day, and extended-release tablets in 100 mg that is taken once daily.

All listed dosages are according to the drug manufacturer. Check your prescription and talk to your doctor to make sure you are taking the right dose for you.

Modifications

Elderly patients are more likely to have impaired liver, kidney, and heart function and are at an increased risk of gastrointestinal complications. If you are 65 or older, you may need to stay at the lowest dosages and have a shorter duration of treatment.

How to Take and Store

Take Zorvolex on an empty stomach since taking it with food may reduce its effectiveness.

Store it at room temperature that's ideally 77 degrees F and keep the bottle or container tightly closed to protect the medication from moisture. It is OK to take it on excursions at temperatures that are 59 to 86 degrees F.

If you miss a dose, take it as soon as you remember; but if it's close to your next dose, just skip the missed dose.

Side Effects

As with all NSAIDs and other drugs, Zorvolex comes with the risk of side effects. As some can be serious, it's important to be aware of them when you begin taking the drug.

Common

• Headache
• Constipation
• Gas
• Stomach upset
• Dizziness

Contact your physician if any of these symptoms are severe, bothersome, or don't go away over time.

Severe

Severe and life-threatening adverse events can happen when taking Zorvolex, such as allergic reactions, heart attack or stroke, stomach bleeding and ulceration, or kidney or liver failure that can result in hospitalization or death.

Seek prompt medical attention if you have any of the following symptoms while taking Zorvolex:

• Severe stomach upset or pain
• Nausea or vomiting
• Diarrhea
• Black or tarry stools
• Chest or back pain
• Weakness, falling
• Pain in arms or legs
• Unusual weight gain
• Trouble speaking or confusion
• Asthma, hives, shortness of breath, or other allergic-like reactions
• Flu-like symptoms
• Fever
• Fatigue
• Appetite loss
• Itching
• Yellowing of the skin or eyes
• Dark or decreased urine output
• Fluid retention and swelling in the body
• Rash
• Skin peeling or itchiness
• Severe dehydration

Abnormal liver or kidney function tests or high blood pressure can also be signs of severe complications.

Warnings and Interactions

If you are taking Zorvolex for prolonged periods for osteoarthritis or other chronic pain or if you have risk factors for certain side effects, your doctor may have you come in for periodic appointments. They may want to monitor blood pressure and run blood tests to check liver and kidney function and for signs of anemia—a possible complication of long-term NSAID use.

There are also drugs interactions that can increase the risk of certain side effects. Drugs that can interact with Zorvolex include:

• Aspirin: Taking aspirin and NSAIDs together may increase risks of side effects and complications, such as gastrointestinal ulcers.
• Corticosteroids: Taking both medications together increases the risk of gastrointestinal side effects. If your doctor has you stop taking corticosteroids while on Zorvolex, you will need to taper off corticosteroids to avoid withdrawal symptoms.
• Lithobid (lithium): Zorvolex can increase lithium concentrations and slow the clearance of lithium from your body, so patients on both medications need to be monitored for lithium toxicity, and dosages may need to be adjusted.
• Diuretics, such as Lasix (furosemide) or thiazide: Certain effects of diuretics may be reduced in people who take NSAIDs. Patients on both medications also need to be monitored for signs of renal failure.

Do not take Zorvolex with other types of NSAIDs, including OTC medicines.

Frequent alcohol use or smoking can also increase the risk of side effects and should be avoided or limited.