Generic drug: diclofenac sodium
Brand name: Pennsaid
What is Pennsaid (diclofenac sodium), and how does it work?
Pennsaid (diclofenac sodium) is a topical non-steroidal anti-inflammatory drug (NSAID) used to treat the symptoms of Acute Pain, Arthritis Pain, Actinic Keratosis, and Osteoarthritis. Pennsaid may be used alone or with other medications.
Pennsaid belongs to a class of drugs called Topical Skin Products.
It is not known if Pennsaid is safe and effective in children younger than 6 years of age.
What are the side effects of Pennsaid?
RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular 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.
- Pennsaid 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.
Pennsaid may cause serious side effects including:
- runny or stuffy nose,
- trouble breathing,
- swelling in your face or throat,
- sore throat,
- burning eyes,
- skin pain,
- red or purple skin rash with blistering and peeling,
- chest pain spreading to your jaw or shoulder,
- sudden numbness or weakness on one side of the body,
- slurred speech,
- shortness of breath,
- first sign of any skin rash (no matter how mild),
- rapid weight gain,
- severe headache,
- blurred vision,
- pounding in your neck or ears,
- little or no urination,
- stomach pain (upper right side),
- dark urine,
- clay-colored stools,
- yellowing of the skin or eyes (jaundice),
- pale skin,
- unusual tiredness,
- cold hands and feet,
- bloody or tarry stools,
- coughing up blood, and
- vomit that looks like coffee grounds
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Pennsaid include:
- stomach pain,
- stuffy nose,
- increased sweating,
- increased blood pressure, and
- skin redness, itching, dryness, scaling, or peeling where the medicine was applied
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Pennsaid. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Pennsaid?
General Dosing Instructions
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
For relief of the pain of osteoarthritis (OA) of the knee(s), the recommended dose is 40 mg of diclofenac sodium (2 pump actuations) on each painful knee, 2 times a day.
Apply Pennsaid to clean, dry skin.
The pump must be primed before first use. Instruct patients to fully depress the pump mechanism (actuation) 4 times while holding the bottle in an upright position. This portion should be discarded to ensure proper priming of the pump. No further priming of the bottle should be required.
After the priming procedure, Pennsaid is properly dispensed by completely depressing the pump 2 times to achieve the prescribed dosage for one knee. Deliver the product directly into the palm of the hand and then apply evenly around front, back, and sides of the knee.
Application of Pennsaid in an amount exceeding or less than the recommended dose has not been studied and is therefore not recommended.
- Avoid showering/bathing for at least 30 minutes after the application of Pennsaid to the treated knee.
- Wash and dry hands after use.
- Do not apply Pennsaid to open wounds.
- Avoid contact of Pennsaid with eyes and mucous membranes.
- Do not apply external heat and/or occlusive dressings to treated knees.
- Avoid wearing clothing over the Pennsaid-treated knee(s) until the treated knee is dry.
- Protect the treated knee(s) from natural and artificial sunlight.
- Wait until the treated area is dry before applying sunscreen, insect repellant, lotion, moisturizer, cosmetics, or other topical medication to the same knee you have just treated with Pennsaid.
- Until the treated knee(s) is completely dry, avoid skin-to-skin contact between other people and the treated knee(s).
- Do not use combination therapy with Pennsaid and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.
What drugs interact with Pennsaid?
See Table 3 for clinically significant drug interactions with diclofenac.
Table 3: Clinically Significant Drug Interactions with Diclofenac
|Drugs That Interfere with Hemostasis|
|Intervention:||Monitor patients with concomitant use of Pennsaid with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding|
|Clinical Impact:||Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone|
|Intervention:||Concomitant use of Pennsaid and analgesic doses of aspirin is
not generally recommended because of the increased risk of bleeding.
Pennsaid is not a substitute for low dose aspirin for cardiovascular protection.
|ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers|
|Clinical Impact:||Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of Pennsaid with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects.|
|Clinical Impact:||The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.|
|Intervention:||During concomitant use of Pennsaid and digoxin, monitor serum digoxin levels.|
|Clinical Impact:||NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of Pennsaid and lithium, monitor patients for signs of lithium toxicity.|
|Clinical Impact:||Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction)|
|Intervention:||During concomitant use of Pennsaid and methotrexate, monitor patients for methotrexate toxicity.|
|Clinical Impact:||Concomitant use of Pennsaid and cyclosporine may increase cyclosporine's nephrotoxicity.|
|Intervention:||During concomitant use of Pennsaid and cyclosporine, monitor patients for signs of worsening renal function.|
|NSAIDs and Salicylates|
|Clinical Impact:||Concomitant use of diclofenac with other NSAIDs or salicylates
(e.g., diflunisal, salsalate) increases the risk of GI toxicity,
with little or no increase in efficacy.
Concomitant use of oral NSAIDs with Pennsaid has been evaluated in one Phase 3 controlled trial and in combination with oral diclofenac, compared to oral diclofenac alone, resulted in a higher rate of rectal hemorrhage (3% vs. less than 1%), and more frequent abnormal creatinine (12% vs. 7%), urea (20% vs. 12%) and hemoglobin (13% vs. 9%).
|Intervention:||The concomitant use of diclofenac with other NSAIDs or salicylates is not recommended.
Do not use combination therapy with Pennsaid and an oral NSAID unless the benefit outweighs the risk and conduct periodic laboratory evaluations.
|Clinical Impact:||Concomitant use of Pennsaid and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
|Intervention:||During concomitant use of Pennsaid and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.
NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed.In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.
Is Pennsaid safe to use while pregnant or breastfeeding?
- Use of NSAIDs, including Pennsaid, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
- Avoid use of NSAIDs, including Pennsaid, in pregnant women starting at 30 weeks of gestation (third trimester).
- There are no adequate and well-controlled studies of Pennsaid in pregnant women.
- Based on available data, diclofenac may be present in human milk.
- The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Pennsaid and any potential adverse effects on the breastfed infant from the Pennsaid or from the underlying maternal condition.
Pennsaid (diclofenac sodium) is a topical non-steroidal anti-inflammatory drug (NSAID) used to treat the symptoms of Acute Pain, Arthritis Pain, Actinic Keratosis, and Osteoarthritis. Serious side effects of Pennsaid include risk of serious cardiovascular (heart attack, stroke) and gastrointestinal events (bleeding, ulceration, and perforation of the stomach or intestines), which can be fatal.
Multimedia: Slideshows, Images & Quizzes
Osteoarthritis (OA): Treatment, Symptoms, Diagnosis
Osteoarthritis (OA) is a degenerative joint disease most often affecting major joints such as knees, hands, back, or hips....
Arthritis: Supplements for Joint Pain
Can supplements help relieve joint pain and swelling? Find out how certain compounds may aid your stiff, tender joints.
Exercises for Knee Osteoarthritis and Joint Pain
Learn about osteoarthritis and exercises that relieve knee osteoarthritis pain, stiffness and strengthen the knee joint and...
Osteoarthritis Quiz: Test Your Medical IQ
How does osteoarthritis differ from other types of arthritis? Learn about osteoarthritis with this quiz.
Picture of Actinic Keratosis (Solar Keratosis)
A small rough spot on skin chronically exposed to the sun, precancerous, can develop into a skin cancer called squamous cell...
Picture of Osteoarthritis
Osteoarthritis is a type of arthritis that is caused by the breakdown and eventual loss of the cartilage of one or more...
Tips for Healthy Joints: Exercise, Nutrition, & More
Dealing with joint pain and arthritis? Learn why weight matters--and why NOT to stretch before exercise. See these solutions for...
Arthritis: 16 Bad Habits That Cause Joint Pain
Being overweight, wearing uncomfortable shoes, or carrying a heavy purse can make joint pain and arthritis symptoms worse. Some...
Osteoarthritis: 15 Tips to Improve Daily Living With OA
Have arthritis in the knee? Osteoarthritis joint pain can make it hard to carry out activities of daily living. Cartilage...
Arthritis: Causes and Treatment for Joint Stiffness and Pain
Arthritis and injuries can leave your joints swollen, tender, and damaged. Discover treatments for morning stiffness, sore...
Arthritis: Ways to Ease Hip Pain
Health habits, home remedies, and other ways you can find relief when your hips hurt.
Osteoarthritis: Guide to Hip Replacement
Ready for a hip replacement? Find out what to expect, from the day of hip surgery until months after your hip replacement.
Fun With Kids? Don't Let Arthritis Stop You
You can still have lots of fun with children despite arthritis. Our experts uncover ways to spend time with your kids or...
Active Living with Osteoarthritis
Check out this slideshow on Active Living From Day to Night with Osteoarthritis. Even with arthritis you can keep your active...
Related Disease Conditions
What Is the Safest Anti-Inflammatory to Take?
Non-steroidal anti-inflammatory drugs or NSAIDs are some of the most commonly used medicines available. Experts say that taking NSAIDs for a short time at the lowest effective dose is generally safe.
Which Foods Make Arthritis Worse?
Foods that may worsen arthritis include processed foods, salt, red meat, and alcohol. Check out the center below for more medical references on arthritis, including multimedia (slideshows, images, and quizzes), related disease conditions, treatment and diagnosis, medications, and prevention or wellness.
Osteoarthritis is a type of arthritis caused by inflammation, breakdown, and eventual loss of cartilage in the joints. Also known as degenerative arthritis, osteoarthritis can be caused by aging, heredity, and injury from trauma or disease.
Arthritis (Joint Inflammation)
Arthritis is inflammation of one or more joints. When joints are inflamed they can develop stiffness, warmth, swelling, redness and pain. There are over 100 types of arthritis, including osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, lupus, gout, and pseudogout.
14 Early Signs of Arthritis in the Legs
Leg arthritis affects the joints of the hips, knees, ankles or feet. The early signs and symptoms of arthritis in the legs include pain, swelling, stiffness, decreased range of motion, trouble walking, fever, bump-like swelling, and other symptoms.
16 Early Rheumatoid Arthritis (RA) Signs & Symptoms
Early rheumatoid arthritis (RA) symptoms and signs vary differently from person to person. The most common body parts that are initially affected by RA include the small joints of the hands, wrists, and feet, and the knees and hip joints. Joint inflammation causes stiffness. Warmth, redness, and pain may vary in degree.
Early Signs and Symptoms of Arthritis in Knuckles
Pain, swelling, and tenderness are usually considered as early signs and symptoms of knuckle arthritis. Tiny bumps pop out on the top knuckles of some of the fingers, and fingers become stiff.
12 Early Signs of Arthritis in Hands
Hand arthritis occurs when there is inflammation in one or more joints of the hand and wrist. A few of the common types of arthritis that affect the hands are osteoarthritis, rheumatoid arthritis, post-traumatic arthritis (arthritis as a result of an injury), psoriatic arthritis and gout.
Osteoarthritis vs. Osteoporosis Differences and Similarities
Arthritis is defined as painful inflammation and joint stiffness. Osteoarthritis is a type of arthritis and the most common cause of chronic joint pain, affecting over 25 million Americans. Osteoarthritis is a type of arthritis that involves the entire joint. Osteoporosis is not a type of arthritis. It is a disease that mainly is caused by a loss of bone tissue that is not limited to the joint areas. It is possible for one person to have both osteoarthritis and osteoporosis. The differences in the signs and symptoms of osteoarthritis and osteoporosis include; pain, stiffness, and joint swelling, joint deformity, crackle sounds when the joint is moving, and walking with a limp. Osteoporosis is called the "silent disease" because it can progress for years without signs and symptoms before it is diagnosed, severe back pain, bone fractures, height loss, and difficulty or inability to walk. The differences in the causes of osteoarthritis and osteoporosis are that osteoarthritis usually is caused by wear and tear on the joints. Osteoporosis usually is caused by one or more underlying problems, for example, calcium and vitamin D deficiencies. Treatment for osteoarthritis and osteoporosis are not the same. There is no cure for osteoarthritis or osteoporosis.
Arthritis in Knee: 4 Stages of Osteoarthritis
Painful joint swelling is called arthritis. Osteoarthritis is due to wear and tear of the joints over many years. Arthritis maye develop in any joint, including the fingers, hips and knees. Usually, patients with arthritis feel pain in their joints even after moderate movements. There are four stages of osteoarthritis of the knee.
17 Early Signs of Arthritis in the Back
Arthritis in the back arises due to the inflammation of facet joints in the spine or sacroiliac joints between the spine and the pelvis. Some of the early signs of arthritis in the back include back pain, stiffness, swelling, bone grinding, loss of flexibility, fatigue, muscle spasms and other symptoms.
Do Steroids Help With Arthritis?
Arthritis is the inflammation of one or more joints in the body. The disease is one of the most common chronic health conditions in the United States. Steroids are a class of drugs that reduce inflammation and have a suppressing effect on the immune system.
Rheumatoid Arthritis vs. Fibromyalgia
Though rheumatoid arthritis (RA) and fibromyalgia have similar symptoms, RA is an autoimmune disease and fibromyalgia is a chronic pain syndrome. RA symptoms include joint redness, swelling, and pain that lasts more than 6 weeks. Fibromyalgia symptoms include widespread pain, tingling feet or hands, depression, and bowel irritability. Home remedies for both include stress reduction, exercise, and getting enough sleep.
Rheumatoid Arthritis vs. Arthritis
Arthritis is a general term used to describe joint disease. Rheumatoid arthritis (RA) is a type of arthritis in which the body’s immune system mistakenly attacks the joints, causing chronic inflammation.
Early Signs of Arthritis in the Fingers
The earliest signs of arthritis are pain, swelling and stiffness. If these symptoms are experienced in the fingers, it is likely because of rheumatoid arthritis. The signs and symptoms of arthritis in the fingers include popping sounds, joint deformity, warmth, mucus cysts and bone spurs.
Early Signs of Arthritis in the Feet
There are more than 30 joints in the ankle and feet. Arthritis can affect one or multiple joints in the feet. Excess weight, hereditary tendencies, old injuries, and poor footwear are a few predisposing factors of arthritis.
Osteoarthritis vs. Rheumatoid Arthritis
Osteoarthritis (OA) and rheumatoid arthritis (RA) are chronic joint disorders. RA is also an autoimmune disease. OA and RA symptoms and signs include joint pain, warmth, and tenderness. Over-the-counter pain relievers treat both diseases. There are several prescription medications that treat RA.
Early Signs of Arthritis in the Knee
Arthritis refers to the redness and swelling of the joints. It usually develops slowly over 10 to 15 years, interfering with daily life activities. Knowing the early signs of arthritis can help you take appropriate treatment and incorporate modifications in your diet and lifestyle.
Early Signs of Arthritis in Shoulder
Early signs and symptoms of arthritis in the shoulder include pain in the shoulder joint that's worse when lifting heavy objects, pain that radiates down the arm and shoulder joint sounds like grinding, clicking, and crackling.
Early Signs of Arthritis in the Wrist
Wrist arthritis is inflammation (swelling) of one or more joints of the wrist. Wrist arthritis is long-lasting or permanent and eventually causes severe joint damage. The early signs of arthritis in the wrist include morning stiffness, redness, tenderness, pain, swelling, weakness, warmth and other symptoms.
What Is the Main Cause of Osteoarthritis?
Osteoarthritis (OA) is a chronic degenerative disease of the joints affecting middle-aged and elderly people. It involves the breakdown of cartilage and associated inflammatory changes in the adjacent bone. It is a leading cause of chronic disability, affecting 30 million people in the United States alone.
Osteoarthritis and Treatment
Painful swelling of the joints due to wear and tear over many years is called osteoarthritis. Osteoarthritis may develop in any joint that includes the fingers, hips, and knees. There are many treatment options available to curb the complications of arthritis.
Treatment & Diagnosis
- Osteoarthritis FAQs
- Rheumatoid Arthritis vs. Osteoarthritis
- Arthritis or Injury: Ice or Heat - Which To Apply
- Understanding Actinic Keratosis
- Osteoarthritis - Vitamin D May Prevent Progression
- Arthritis Roller Coaster
- Arthritis - Whether Weather Affects Arthritis
- Arthritis Foot Care - It's In the Shoes
- Arthritis Medications
- What Not to Eat When You Have Arthritis
- How Do Arthritis Symptoms Start?
- Do Crohn's Patients Get a Specific Type of Arthritis?
- Does Crohn's Disease Cause Arthritis?
- What Is the Prognosis for Osteoarthritis?
- What Kind of Joint Injections Treat Osteoarthritis?
- Does Magnetic Therapy for Arthritis Work?
- What Are the Side Effects of Glucosamine?
- What Causes Arthritis and Baker's Cyst?
- Can You Be Too Young for a Knee Replacement?
- Can Fifth Disease Cause Arthritis Pain?
- What Causes Early Onset of Hip Osteoarthritis?
- What Is Cervical Osteoarthritis?
- Can You Get a Cartilage Transplant?
- Does Glucosamine Cream Work for Arthritis?
- Are Women More Susceptible to Osteoarthritis?
- Osteoarthritis of the Hands
- Osteoarthritis vs. Carpal Tunnel: What's the Difference?
- Can You Prevent Osteoarthritis?
- Can My Diet Improve Arthritis?
- Osteoarthritis Symptoms
Medications & Supplements
- Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
- diclofenac - ophthalmic, Voltaren
- diclofenac sodium enteric-coated tablet - oral, Voltaren
- diclofenac 3% - topical, Solaraze
- diclofenac - oral, Cataflam, Zipsor
- DICLOFENAC-RECTAL SUPPOSITORY
- Side Effects of Voltaren (diclofenac)
- Types of Osteoarthritis Medications and Treatments
- Types of Arthritis Medications
Prevention & Wellness
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.