See Table 2 for clinically significant drug interactions with Hifenac.
Table 2: Clinically Significant Drug Interactions with HifenacDrugs That Interfere with HemostasisClinical Impact:
- Hifenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of Hifenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
- Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
- Gastrointestinal risk
- NSAIDs increase risk of serious GI adverse events, including bleeding, ulceration, and gastric or intestinal perforation, which can be fatal
- GI adverse events may occur at any time during use and without warning symptoms
- Elderly patients are at greater risk for serious GI events
This medication contains Hifenac. Do not take Cataflam, Voltaren-XR, Dyloject, Cambia, Zipsor, or Zorvolex if you are allergic to Hifenac or any ingredients contained in this drug.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.
Why is this medication prescribed?
Hifenac capsules (Zipsor, Zorvolex) and tablets (Cataflam) are used to relieve mild to moderate pain. Hifenac extended-release tablets (Voltaren XR), tablets (Cataflam), and delayed release tablets (available generically) are used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints), and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Hifenac extended-release tablets and delayed-release tablets are also used to treat ankylosing spondylitis (arthritis that mainly affects the spine). Hifenac tablets (Cataflam) are also used to treat painful menstrual periods. Hifenac solution (Cambia) is used to treat migraine headaches in adults, but cannot be used to prevent migraines or to treat other types of headaches. Hifenac is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.
In clinical trials of Hifenac- containing products, meaningful elevations (i.e., more than 3 times the ULN) of AST (SGOT) were observed in about 2% of approximately 5,700 patients at some time during Hifenac treatment (ALT was not measured in all studies).
In a large, open-label, controlled trial of 3,700 patients treated with oral Hifenac sodium for 2-6 months, patients were monitored first at 8 weeks and 1,200 patients were monitored again at 24 weeks. Meaningful elevations of ALT and/or AST occurred in about 4% of patients and included marked elevations (greater than 8 times the ULN) in about 1% of the 3,700 patients. In that open-label study, a higher incidence of borderline (less than 3 times the ULN), moderate (3-8 times the ULN), and marked (greater than 8 times the ULN) elevations of ALT or AST was observed in patients receiving Hifenac when compared to other NSAIDs. Elevations in transaminases were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis.
Almost all meaningful elevations in transaminases were detected before patients became symptomatic. Abnormal tests occurred during the first 2 months of therapy with Hifenac in 42 of the 51 patients in all trials who developed marked transaminase elevations.
In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with Hifenac. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.
In a European retrospective population-based, case-controlled study, 10 cases of Hifenac associated drug-induced liver injury with current use compared with non-use of Hifenac were associated with a statistically significant 4-fold adjusted odds ratio of liver injury. In this particular study, based on an overall number of 10 cases of liver injury associated with Hifenac, the adjusted odds ratio increased further with female gender, doses of 150 mg or more, and duration of use for more than 90 days.
Physicians should measure transaminases at baseline and periodically in patients receiving long-term therapy with Hifenac, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with Hifenac. However, severe hepatic reactions can occur at any time during treatment with Hifenac.
If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, abdominal pain, diarrhea, dark urine, etc.), VOLTAREN should be discontinued immediately.
Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), discontinue VOLTAREN immediately, and perform a clinical evaluation of the patient.
To minimize the potential risk for an adverse liver related event in patients treated with VOLTAREN, use the lowest effective dose for the shortest duration possible. Exercise caution when prescribing VOLTAREN with concomitant drugs that are known to be potentially hepatotoxic (e.g., acetaminophen, antibiotics, anti-epileptics).
Q: Arthrotrec is known for weight gain due to fluid retention and renal difficulties. Should I consult a doctor for a diuretic to lose excess fluid weight?
A: Arthrotec is a combination of Hifenac and misoprostol. Hifenac belongs to the group of drugs known as nonsteroidal anti-inflammatory drug (NSAIDs) and has analgesic and anti-inflammatory effects. Misoprostol is a gastrointestinal protective agent that is used in combination with NSAIDs to reduce the risk of stomach or intestinal ulcers. Arthrotec is used for the treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients who are at high risk of developing a stomach or intestinal ulcer with NSAID therapy. Patients who have had a stomach ulcer or gastrointestinal bleeding are at 10 times greater risk of having gastrointestinal bleeding when taking a NSAID. Other factors that increase the risk of gastrointestinal bleeding in patients taking NSAIDs include use of oral corticosteroids or blood thinners, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. The most common side effects of Arthrotec are abdominal pain, diarrhea, upset stomach, nausea, and gas. Arthrotec, like other NSAIDs, can cause heart, kidney, and/or liver problems. Patients should be aware of the signs and symptoms of these possible conditions, including chest pain, shortness of breath, weakness, slurring of speech, swelling, unexplained weight gain, nausea, fatigue, itching, yellowing of the skin or eyes, or right upper quadrant tenderness. If you develop these signs or symptoms, please consult with your health care provider for guidance based on your health status and current medications, particularly before taking any action. Michelle McDermott, PharmD
By Frieda Wiley, PharmD, CGP, RPh | Medically Reviewed by Robert Jasmer, MD
Latest Update: 2015-01-14 Copyright © 2014 Everyday Health Media, LLC
- High blood pressure warning: This drug can cause high blood pressure, or worsen high blood pressure if you already have it. Your doctor will likely monitor your blood pressure while you use this drug.
- Water retention warning: This drug can cause your body to retain water, leading to edema (swelling or puffiness).
- Liver function warning: Using Hifenac may affect some of your liver function tests. Your doctor should monitor your liver function while you use Hifenac.
- Allergic reaction warning: If you have an allergy to aspirin or other nonstero >
Hifenac is a prescription drug. It comes as a topical gel, oral capsule, oral tablet, eye drops, transdermal patch, topical solution, and powder packets for oral solution.
Hifenac topical gel is available as the brand-name drugs Solaraze and Voltaren. It’s also available as a generic drug. Generic drugs usually cost less than brand-name versions. In some cases, they may not be available in every strength or form as a brand-name drug.
Can you take Hifenac and Ibuprofen together?
No, these drugs should not be used together, as they are from the same class, thus their effects will become additive increasing the risk of side effects such as bleeding and gastrointestinal ulcers to happen.
If you need additional medicine for your pain relieving treatment, and you already use Hifenac or ibuprofen consult your doctor. Your doctor may prescribe you acetaminophen of 500 mg as additional treatment, because it is much safer to be combined with ibuprofen or Hifenac.
Hifenac comes in several brands with different formulations, so depending on the brand and the condition you are treating, the recommended dose may range from 50 milligrams (mg) to 100 mg in eight- to 12-hour intervals.
You should take no more than 225 mg in a day of the regular-release form. Doses of the extended-release form should not exceed 200 mg in a day.
Always take Hifenac with at least 8 ounces of water. Hifenac can be very hard on the stomach, so for best results, try taking it with food or milk.
It may also help to take a drug that reduces your stomach acid, but some antacids interact with Hifenac, so you should talk to your doctor about what to take and how to time it with your Hifenac doses.
Another option is to ask your doctor to write a prescription for Arthrotec, a combination drug that contains Hifenac and a stomach-protecting drug called misoprostol. If the prescription for Arthrotec is too expensive, ask your doctor to consider writing two separate prescriptions for Hifenac and misoprostol.
10. Common questions
Hifenac is a non-steroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.
When you apply Hifenac gel to your skin, it works in the same way as when you take it as a tablet or capsule. But the gel only works on the area you have put it on.
Hifenac takes 20 to 30 minutes to work if you take it as tablets or capsules.
Suppositories take a few hours to work. There's no difference in how well the tablets, capsules or suppositories work. The doses of Hifenac are the same for each.
If you're using Hifenac gel on your skin, it usually takes 1 to 2 days to work. For arthritis, you may need to use the gel for up to 7 days on the painful joint in order to feel the full effect.
Depending on why you're taking Hifenac, you may only need to take it for a short time. For example, if you have a sore back or toothache, you may only need to take Hifenac for a day or two.
You may need to take it for longer if you have a long-term condition, such as rheumatoid arthritis.
If you need to take Hifenac for a long time, your doctor may prescribe a medicine to protect your stomach from side effects. It's best to take the lowest dose of Hifenac for the shortest time to control your symptoms.
Talk to your doctor if you're unsure how long you need to take it for.
Hifenac can cause an ulcer in your stomach or gut if you take it for a long time or in big doses.
There's also a small risk that people taking very big doses (150mg a day) for a long time may get heart failure or kidney failure.
It's best to take the lowest dose that works for the shortest possible time.
If you need to take Hifenac very often or you're taking a big dose, talk to your doctor about your pain.
The type of painkiller that's best depends on what type of pain you have and the cause of your pain.
Hifenac is a non-steroidal anti-inflammatory drug (NSAID) - ibuprofen and naproxen also belong to this group of painkillers.
If you need to take an NSAID long term, your doctor or pharmacist may recommend ibuprofen or naproxen instead of Hifenac. This is because they're less likely to cause heart problems.
If NSAIDs don't get rid of your pain, you can try painkillers that you can buy from pharmacies and shops, such as paracetamol or co-codamol (paracetamol combined with low-dose codeine).
If the medicine you buy isn't controlling your pain, your doctor may recommend another type of treatment to help your pain, such as exercise or physiotherapy.
Your doctor may also be able to prescribe a stronger painkiller, such as higher dose co-codamol or codeine.
Hifenac doesn't work for some types of pain, such as nerve pain. Your doctor will have to prescribe a different medicine to relieve nerve pain.
Hifenac can cause an ulcer in your stomach or gut if you take it for a long time or in big doses, or if you're elderly or in poor general health.
Your doctor may tell you not to take Hifenac if you have a stomach ulcer or have had one in the past. If you need to take Hifenac but you're at risk of getting a stomach ulcer, your doctor may prescribe another medicine for you to take alongside Hifenac to protect your stomach.
It's important to take your Hifenac tablets or capsules after a meal or snack, or with a drink of milk. They'll be less likely to upset or irritate your stomach.
The most common symptom of a stomach ulcer is a burning or gnawing pain in the centre of the stomach. But stomach ulcers are not always painful and some people may have other symptoms, such as indigestion, heartburn and feeling sick.
If you're prone to stomach ulcers or have had one before, take paracetamol instead of Hifenac as it's gentler on your stomach.
2. Key facts
- Take Hifenac tablets or capsules with a meal or snack, or just after eating.
- It's best to take the lowest dose of Hifenac for the shortest time to control your symptoms.
- The most common side effects are headaches, dizziness, stomach pain, feeling or being sick, diarrhoea and rashes.
- Hifenac tablets come as either Hifenac potassium or Hifenac sodium. They work as well as each other.
- Hifenac is also called by the brand names Voltarol, Dicloflex, Econac and Fenactol.
DOSAGE AND ADMINISTRATION
Carefully consider the potential benefits and risks of VOLTAREN ® (Hifenac sodium enteric-coated tablets) and other treatment options before deciding to use VOLTAREN. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, And Perforation).
After observing the response to initial therapy with VOLTAREN, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100-150 mg/day in divided doses (50 mg twice a day or three times a day, or 75 mg twice a day).
For the relief of rheumatoid arthritis, the recommended dosage is 150-200 mg/day in divided doses (50 mg three times a day. or four times a day, or 75 mg twice a day.).
For the relief of ankylosing spondylitis, the recommended dosage is 100-125 mg/day, administered as 25 mg four times a day, with an extra 25-mg dose at bedtime if necessary.
Different formulations of Hifenac are not necessarily bioequivalent even if the milligram strength is the same.
Hifenac sodium administered to male and female rats at 4 mg/kg/day (approximately 0.2 times the MRHD based on BSA comparison) did not affect fertility.
Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including VOLTAREN, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women. Published animal studies have shown that administration of prostaglandin synthesis inhibitors has the potential to disrupt prostaglandin-mediated follicular rupture required for ovulation. Small studies in women treated with NSAIDs have also shown a reversible delay in ovulation. Consider withdrawal of NSAIDs, including VOLTAREN, in women who have difficulties conceiving or who are undergoing investigation of infertility.
What Other Drugs Interact with Hifenac?
If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.
Severe interactions of Hifenac include:
Serious Interactions of Hifenac include:
Hifenac has moderate interactions with at least 247 different drugs.
Hifenac has mild interactions with at least 109 different drugs.
This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.
References updated: 13 December 2017
10%; metabolic idiosyncrasy is suspected to be the cause).
10 cases per 100,000 patient-years of use, ranging from 6 to 18 per 100,000 for Hifenac ).
50,000 liver transplants done in the US between 1990 and 2002, 270 were done for drug induced acute liver failure, but none were attributed to Hifenac).