Monday, February 26, 2024

Diclofenac Sodium Topical Gel For Gout

Reach And Maintain A Healthy Weight

Diclofenac Sodium Tablets and Gel | Uses Dosage and Side Effects

Tips for weight loss:

  • Eat less fatty and high sugar foods.
  • Small meals eaten at regular times are best avoid eating large meals or going for many hours without eating.
  • Eat a sensible breakfast, every day .
  • Remember to drink plenty of fluids, at least 8 glasses per day if possible.
  • Avoid fizzy drinks .
  • Regular exercise, such as a brisk walk for 30 minutes five times a week, will reduce your weight and have other good effects on your heart, blood pressure and blood sugar levels.

Renal Toxicity And Hyperkalemia

Renal Toxicity

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.

Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE-inhibitors or ARBs, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

No information is available from controlled clinical studies regarding the use of diclofenac sodium topical gel in patients with advanced renal disease. The renal effects of diclofenac sodium topical gel may hasten the progression of renal dysfunction in patients with preexisting renal disease.

Hyperkalemia Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state.

Before Taking This Medicine

Diclofenac topical can increase your risk of fatal heart attack or stroke, even if you don’t have any risk factors. Do not use diclofenac topical just before or after heart bypass surgery .

Diclofenac topical may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using diclofenac topical, especially in older adults.

You should not use this medicine if you are allergic to diclofenac , or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Diclofenac topical is not approved for use by anyone younger than 18 years old.

Tell your doctor if you have ever had:

Diclofenac can affect ovulation and it may be harder to get pregnant while you are using this medicine.

If you are pregnant, you should not take diclofenac topical unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

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Fourth Stage Chronic Tophaceous Gout

Finally, chronic tophaceous gout, or fourth-stage gout, occurs when gout is left untreated for too long. Most people do not get this far with proper medication and treatment. Often taking several years or more than a decade to develop fully, chronic tophaceous gout entails hard nodules called tophi developing in the joints and tissues surrounding the joints.

Over time, tophi can do permanent damage to the joints and is the most debilitating, causing skin ulcers to appear. This is extremely rare and only if left untreated for decades. Tophi also often appear in other parts of the body, such as the fingers and ears. Permanent kidney damage at this point is also a possibility.

What Are The Symptoms Of Gout Crystals

FDA Approves NDA for Diclofenac Sodium Topical Gel 1% for ...

Gout crystals that have built up can lead to significant joint pain. The pain might be contained to one joint, or you may feel it in different joints throughout your body. Affected joints will generally be red and swollen.

Gout crystals can sometimes build up and cause visible lumps under your skin. These lumps are called tophi, and they are usually not painful or tender. Over time, however, they can lead to permanent joint damage.

The buildup of uric acid that leads to gout crystals can also lead to problems with your kidneys, including painful kidney stones. You might also have a fever and feel very run down or exhausted. For some people with gout crystals, flare-ups of inflammation are rare and resolve quickly. Other people will experience chronic pain.

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How Are Gout Crystals Diagnosed

The first step to getting a diagnosis is contacting a doctor. You and your doctor can discuss your symptoms and your medical history. Your doctor will likely want you to have blood work to look for elevated levels of uric acid. You may also need imaging tests such as X-rays and CT scans to look for crystals.

To make a final diagnosis, your doctor will do a test called arthrocentesis. This procedure is done by inserting a needle into the affected joint and removing some joint fluid. You wont need to have an arthrocentesis every time you have a gout flare-up, but it can help make a diagnosis. You can generally address flare-ups by talking to a doctor about your symptoms and having blood work done.

Interactions Between Topical Diclofenac And Other Medications

Topical diclofenac may interact with certain medications or supplements. Always let your doctor and pharmacist know about any other medications or supplements that you are currently taking. The list below does not include all possible drug interactions with topical diclofenac. Please note that only the generic name of each medication is listed below.

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.

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If You Are Having Repeated Attacks See Your Doctor

Some patients can go a long time between attacks. In fact, for 62 percent of patients the next attack will be more than a year away, and some won’t have another attack in the next 10 years. However, if you begin to have more frequent attacks, talk to your doctor about escalating treatment. People think its normal to have flares every now and then, but its not. The gout can be doing damage to your joints. It means you still have too much uric acid, says Shakouri. In particular, ask about allpurinol. It wont help with an acute attack but will help prevent future attacks by reducing uric acid production.

Diclofenac Gel: How To Apply It

Diclofenac Sodium Topical Gel 1% or Vytorin Gel

Diclofenac gel is for external use only , it should be applied directly to clean, dry skin where the lesion is located. To do this, it is necessary to spread it over the entire affected area with gentle and circular movements to ensure better absorption. It is important to take certain steps to apply diclofenac gel correctly:

  • Wash your hands before and after applying the product.
  • The area where the gel was applied should not be covered or heat applied to accelerate its absorption.
  • It should not be applied at the level of wounds, cracked, infected skin, with the presence of a rash or on mucous membranes.
  • Care must be taken during application to the eyes, nose and mouth. In case of coming into contact with these areas, the product must be removed with plenty of water.
  • If the hands are being treated with this product, they should be washed one hour after the application of the diclofenac gel to take advantage of the properties of the product.

In general, it is recommended to apply diclofenac gel about 3 or 4 times a day to the affected area and not use it for more than 7 days in a row. However, it is important to follow the doctors instructions regarding the dose and duration of treatment.

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Typical Dosing For Topical Diclofenac

Diclofenac 1% gel: Use the plastic dosing card found inside your box to measure out the amount of gel needed. Apply to the affected area of your body 4 times a day. Don’t use more than 32 grams total per day.

  • Joints on lower body : Use up to 4 grams of gel for each dose. Don’t use more than 16 grams per day on any single joint.
  • Joints on upper body : Use up to 2 grams for each dose. Don’t use more than 8 grams per day on any single joint.

Diclofenac 1.5% topical solution: The typical dose is to apply 40 drops to each affected knee 4 times a day.

Diclofenac 2% topical solution: The typical dose is to apply 2 pumps to each affected knee 2 times a day.

Lower Extremities Including The Feet Ankles Or Knees

Apply the gel to the affected foot, ankle, or knee 4 times daily. Diclofenac sodium topical gel, 1% should be gently massaged into the skin ensuring application to the entire affected foot, or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.

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Voltaren Gel Real Performance

The real performance of the Voltaren gel doesnt really live up that it has on its name. Whats true is that it is a bit better in comparison to some other NSAIDs or Non-Steroidal Anti-inflammatory Drugs. This is in a sense that it encourages lesser side effects. However, it is usually outpaced because its base is actually sodium salt and potassium salt. Some other NSAIDs use the potassium salt that is much faster. Therefore, if you somehow decide to use the Voltaren gel in treating gout, the flare-ups will not directly subside, however, you can expect there therell be lesser stomach issues.

All the other NSAIDs or Non-Steroidal Anti-inflammatory Drugs may cause damage to the stomach or in the gastrointestinal tract. This is mainly due to the epithelium, which becomes thinner when you take them. This actually has something to do with the mechanism that it does to be able to relieve the pain.

Who Is At Risk Of Getting Gout

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High uric acid levels are caused by the following factors:

  • Genetics some Mori and Pasifika people have genes that make it harder to get rid of uric acid from their bodies.
  • Being overweight carrying extra weight slows down the removal of uric acid by your kidneys.
  • Increasing age in about 90% of cases, gout affects men aged over 40 years and women after menopause.
  • What you eat and drink you increase your risk if you drink a lot of sugary drinks or alcohol, or eat too much food that is rich in purines, such as liver, meat or seafood.
  • Having high blood pressure .
  • Taking certain medicines, such as water or fluid tablets for high blood pressure or heart failure. Read more about medicines that increase uric acid levels.
  • Existing kidney problems and some other conditions.

In people with known gout, there are changes you can make to reduce the risk of developing gout.

Tip: Ask your doctor whether you need to change any medications you take for other health problems.

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Severe Allergic Or Skin Reaction

Topical diclofenac might cause sudden, very serious, and sometimes life-threatening allergic and skin reactions. Symptoms include fever, body aches, rash, peeling skin, painful blisters all over your body, and swelling of the face. Stop the medication and get help right away if you experience these symptoms.

Pivotal Studies In Osteoarthritis Of The Superficial Joints Of The Extremities

Study 1 evaluated the efficacy of diclofenac sodium topical gel for the treatment of osteoarthritis of the knee in a 12-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group trial. Diclofenac sodium topical gel was administered at a dose of 4 g, 4 times daily, on 1 knee . Pain as assessed by the patients at Week 12 using the WOMAC Pain Subindex was lower in the diclofenac sodium topical gel group than the placebo group.

Study 2 evaluated the efficacy of diclofenac sodium topical gel for the treatment of osteoarthritis in subjects with osteoarthritis of the hand in an 8-week, randomized, double-blind, multicenter, placebo-controlled, parallel-group study. Diclofenac sodium topical gel was administered at a dose of 2 g per hand, 4 times daily, on both hands . Pain in the target hand as assessed by the patients at Weeks 4 and 6 on a visual analog scale from 0 to 100 was lower in the diclofenac sodium topical gel group than the placebo group.

Table 4. Efficacy Outcomes of Diclofenac Sodium Topical Gel in Studies 1 and 2

Diclofenac sodium topical gel

* WOMAC = Western Ontario McMaster Osteoarthritis Index.

# Scale from 0 to 100 .

â Difference is adjusted using an analysis of covariance model with main effects of treatment and center and baseline covariate.

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Use In Specific Populations

Pregnancy Category C prior to 30 weeks gestation Category D starting 30 weeks gestation

Risk Summary

Use of NSAIDs, including diclofenac sodium topical gel, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including diclofenac sodium topical gel, in pregnant women starting at 30 weeks of gestation .

Clinical ConsiderationsLabor or Delivery

There are no studies on the effects of diclofenac sodium topical gel during labor or delivery. In animal studies, NSAIDS, including diclofenac, inhibit prostaglandin synthesis, cause delayed parturition, and increase the incidence of stillbirth.

DataAnimal data

Reproductive and developmental studies in animals demonstrated that diclofenac sodium administration during organogenesis did not produce teratogenicity despite the induction of maternal toxicity and fetal toxicity in mice at oral doses up to 20 mg/kg/day of diclofenac sodium topical gel based on bioavailability and body surface area comparison), and in rats and rabbits at oral doses up to 10 mg/kg/day .

In a study in which pregnant rats were orally administered 2 or 4 mg/kg diclofenac from Gestation Day 15 through Lactation Day 21, significant maternal toxicity was noted. These maternally toxic doses were associated with dystocia, prolonged gestation, reduced fetal weights and growth, and reduced fetal survival.

How Can Losing Weight Help My Gout

Diclofenac Side Effects and Uses – Diclofenac Tablet 75mg, 150mg – Tab Volteren Voveran

Being overweight can increase your risk of gout because carrying extra weight slows down the removal of uric acid by your kidneys. Gout is caused by high uric acid levels in your blood as your level of uric acid rises, your risk of gout increases. If you are overweight, gradual weight loss can help to lower your uric acid levels and reduce your risk of gout attacks.

Weight loss is best achieved by eating a balanced diet and regular physical activity.

  • Avoid fasting or crash diets, where you go without adequate food for long periods and lose weight rapidly. This type of dieting can increase uric acid levels and trigger a gout attack.
  • Examples of foods to include in your diet are low-fat dairy, soy-based foods, vegetable sources of protein and foods high in vitamin C.
  • Exercise moderately, but during an acute attack rest, elevate and cool affected joints.

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Diclofenac: Is It Effective For Gout

There is no doubt that diclofenac is very effective in eliminating migraine and headache. But there is a doubt when it comes to treating gout. As we all know, gout is very far from a headache. Well, in the actual fact, in comparison to some other Non-Steroidal Anti-inflammatory Drugs or NSAIDs, the diclofenac performs better in treating gout. Maybe it is a bit slower than the others, but at least, it has lesser side effects.

Do you also wonder what happens to the diclofenac once it enters the body? Well, lets see!

What Are The Possible Side Effects Of Diclofenac Topical

Get emergency medical help if you have signs of an allergic reaction or a severe skin reaction .

Although the risk of serious side effects is low when diclofenac is applied to the skin, this medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Stop using diclofenac and seek emergency medical attention if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Also call your doctor at once if you have:

  • a skin rash, no matter how mild
  • severe headache, blurred vision, pounding in your neck or ears
  • little or no urination
  • liver problems–nausea, diarrhea, stomach pain , tiredness, itching, dark urine, clay-colored stools, jaundice
  • low red blood cells pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet or
  • signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

  • increased blood pressure or
  • skin redness, itching, dryness, scaling, or peeling where the medicine was applied.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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The Diclofenac Epolamine Topical Patch 13%

One of the topical NSAID formulations approved in the United States is the DETP. In contrast to other conventional formulations , DETP provides a defined dose to a defined area of skin for 12 h, requiring twice per day application . DETP has recently been approved for use in the United States for the topical treatment of acute pain caused by minor strains, sprains and contusions .

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