Description
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild-to-moderate pain, and helps to relieve symptoms of arthritis (eg, osteoarthritis or rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will only help you as long as you continue to take it.
This medicine is also used to treat ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine, and other painful conditions such as menstrual cramps.
Diclofenac is also used to treat acute migraine attacks, with or without aura, in adults. It will not prevent or lessen the number of migraine attacks.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
- Tablet, Enteric Coated
- Tablet, Extended Release
- Tablet
- Powder for Solution
- Capsule, Liquid Filled
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of diclofenac in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Zipsor® capsules in children 12 to 17 years of age. Safety and efficacy have been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diclofenac in the elderly. However, elderly patients are more likely to have age-related kidney or stomach problems, which may require caution for patients receiving diclofenac.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Ketorolac
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abciximab
- Acenocoumarol
- Amiloride
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Anagrelide
- Apixaban
- Ardeparin
- Argatroban
- Aspirin
- Bemetizide
- Bemiparin
- Bendroflumethiazide
- Benzthiazide
- Betrixaban
- Bivalirudin
- Budesonide
- Bumetanide
- Cangrelor
- Capecitabine
- Ceritinib
- Certoparin
- Chlorothiazide
- Chlorthalidone
- Cilostazol
- Citalopram
- Clomipramine
- Clopamide
- Clopidogrel
- Cyclopenthiazide
- Cyclosporine
- Cyclothiazide
- Dabigatran Etexilate
- Dalteparin
- Danaparoid
- Deferiprone
- Deflazacort
- Desipramine
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acebutolol
- Atenolol
- Azilsartan
- Azilsartan Medoxomil
- Benazepril
- Betaxolol
- Bisoprolol
- Candesartan
- Captopril
- Carteolol
- Carvedilol
- Celiprolol
- Cholestyramine
- Ciprofloxacin
- Colestipol
- Enalapril
- Enalaprilat
- Eprosartan
- Esmolol
- Fosinopril
- Irbesartan
- Labetalol
- Levobunolol
- Lisinopril
- Losartan
- Metipranolol
- Metoprolol
- Moexipril
- Nadolol
- Nebivolol
- Olmesartan
- Oxprenolol
- Penbutolol
- Perindopril
- Pindolol
- Propranolol
- Quinapril
- Ramipril
- Sotalol
- Spirapril
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to bovine protein—Zipsor® capsule contains gelatin and should not be used in patients with this condition.
- Anemia or
- Bleeding problems or
- Blood clots or
- Congestive heart failure or
- Edema (fluid retention) or
- Heart attack, history of or
- Heart disease or
- Hypertension (high blood pressure) or
- Kidney disease or
- Porphyria (blood disorder) or
- Stomach ulcers or bleeding, history of or
- Stroke, history of—Use with caution. May make these conditions worse.
- Aspirin-sensitive asthma, history of or
- Aspirin (or other NSAIDs) sensitivity, history of or
- Kidney disease, severe—Should not be used in patients with these conditions.
- Dehydration or
- Hypovolemia—Must be corrected first before using this medicine.
- Heart surgery (eg, coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right before or after the surgery.
- Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Keep using this medicine for the full time of treatment. However, do not use this medicine more often or for a longer time than your doctor ordered. This medicine is not for long-term use.
This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
When used for severe or continuing arthritis, this medicine must be taken every day as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or longer may pass before you begin to feel better. Several weeks may pass before you feel the full effects of this medicine.
You may take this medicine with or without food. However, diclofenac capsules should be taken on an empty stomach.
To use the oral solution:
- Open the packet of medicine right before you use it.
- Empty the contents of the packet into a cup with 1 to 2 ounces (30 to 60 milliliters [mL]) of water. Do not use any liquid other than water for mixing the medicine.
- Mix well and drink it immediately on an empty stomach.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (Zipsor® capsules):
- For acute pain:
- Adults and children 12 years of age and older—25 milligrams (mg) 4 times a day.
- Children younger than 12 years of age—Use and dose must be determined by your doctor.
- For acute pain:
- For oral dosage form (Zorvolex® capsules):
- For acute pain:
- Adults—18 or 35 milligrams (mg) 3 times a day.
- Children—Use and dose must be determined by your doctor.
- For osteoarthritis:
- Adults—35 milligrams (mg) 3 times a day.
- Children—Use and dose must be determined by your doctor.
- For acute pain:
- For oral dosage forms (delayed-release tablets, enteric-coated tablets):
- For ankylosing spondylitis:
- Adults—25 milligrams (mg) 4 times a day, with an extra 25 mg dose at bedtime if necessary.
- Children—Use and dose must be determined by your doctor.
- For osteoarthritis:
- Adults—50 milligrams (mg) 2 or 3 times a day, or 75 mg two times a day.
- Children—Use and dose must be determined by your doctor.
- For rheumatoid arthritis:
- Adults—50 milligrams (mg)3 or 4 times a day, or 75 mg two times a day.
- Children—Use and dose must be determined by your doctor.
- For ankylosing spondylitis:
- For oral dosage form (immediate-release tablets):
- For osteoarthritis:
- Adults—50 milligrams (mg) 2 or 3 times a day.
- Children—Use and dose must be determined by your doctor.
- For pain or menstrual cramps:
- Adults—50 milligrams (mg) 3 times a day. Your doctor may direct you to take 100 mg for the first dose only.
- Children—Use and dose must be determined by your doctor.
- For rheumatoid arthritis:
- Adults—50 milligrams (mg) 3 or 4 times a day.
- Children—Use and dose must be determined by your doctor.
- For osteoarthritis:
- For oral dosage form (solution):
- For migraine headaches:
- Adults—One packet (50 milligrams) as a single, one time dose.
- Children—Use and dose must be determined by your doctor.
- For migraine headaches:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease or in people who use this medicine for a long time.
This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain medicines (eg, steroid medicine, blood thinner).
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Serious skin reactions, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur during treatment with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.
Some possible warning signs of serious side effects that can occur during treatment with this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting of blood or material that looks like coffee grounds, or yellow skin or eyes. Also, signs of serious heart problems could occur, including chest pain or tightness, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Check with your doctor right away if you notice any of these warning signs.
Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.
Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.
This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. It may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Call your doctor right away if you have a rash, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.
Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.
Using too much of Cambia® or any other migraine medicines (eg, ergotamine, triptans, opioids, NSAIDs, or a combination treatment for 10 or more days per month) may worsen your headache. Talk to your doctor about this risk. It may also be helpful to note of how often your migraine attacks occur and how much medicines you use.
Call your doctor right away if you have confusion, drowsiness, fever, general feeling of illness, headache, loss of appetite, nausea, stiff neck or back, or vomiting. These could be symptoms of meningitis.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
Before having any kind of surgery or medical tests, tell your doctor that you are using this medicine. It may be necessary for you to stop treatment for awhile, or to change to a different nonsteroidal antiinflammatory drug before your procedure.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Acid or sour stomach
- belching
- bleeding gums
- blood in the urine or stools
- bloody or black, tarry stools
- burning while urinating
- chest pain
- chills
- cough
- clay-colored stools
- cloudy urine
- constipation
- dark urine
- decrease in urine output or decrease in urine-concentrating ability
- diarrhea
- dizziness
- feeling of indigestion
- fever
- frequent urge to urinate
- headache
- heartburn
- increased bleeding time
- indigestion
- itching skin or rash
- light-colored stools
- loss of appetite
- nausea and vomiting
- pain in the chest below the breastbone
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- stomach bloating, burning, cramping, discomfort, upset, or pain
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling or inflammation of the mouth
- swollen glands
- trouble breathing
- unpleasant breath odor
- unusual bleeding or bruising
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- vomiting of blood or material that looks like coffee grounds
- weight loss
- yellow eyes and skin
Less common
- Blistering, peeling, loosening of the skin
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings
- confusion
- change in consciousness
- discouragement
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of constant movement of self or surroundings
- feeling sad or empty
- irritability
- joint or muscle pain
- lack of appetite
- lack or loss of strength
- loss of consciousness
- loss of interest or pleasure
- nervousness
- pain or discomfort in the arms, jaw, back, or neck
- pale or blue lips, fingernails, or skin
- red irritated eyes
- red skin lesions, often with a purple center
- redness, soreness, or itching skin
- sensation of spinning
- shakiness in the legs, arms, hands, or feet
- sleepiness or unusual drowsiness
- stiff neck or back
- trembling or shaking of the hands or feet
- trouble concentrating
- trouble sleeping
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Agitation
- blurred vision
- change in consciousness
- change in the ability to see colors, especially blue or yellow
- confusion
- depression
- difficult or trouble breathing
- hives
- hostility
- irregular, fast or slow, or shallow breathing
- irritability
- loss of consciousness
- muscle twitching
- nervousness
- pain or discomfort in the chest, upper stomach, or throat
- pale or blue lips, fingernails, or skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- seizures
- sleepiness
- slow or fast heartbeat
- stupor
- swelling of the face, ankles, or hands
- tightness in the chest
- trouble sleeping
- unusual drowsiness, dullness, or feeling of sluggishness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Bloated
- continuing ringing or buzzing or other unexplained noise in the ears
- difficulty in swallowing
- excess air or gas in the stomach or intestines
- hearing loss
- lack or loss of strength
- pain or burning in the throat
- passing gas
Less common
- Burning, dry or itching eyes
- discharge, excessive tearing
- hair loss, thinning of the hair
- increased sensitivity of the skin to sunlight
- pain in the arms or legs
- redness, pain, swelling of the eye, eyelid, or inner lining of eyelid
- redness or other discoloration of the skin
- severe sunburn
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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