Diclofenac 1% Gel 100gm (rx)
WARNING: This drug may raise the risk of heart and blood vessel problems like heart attack and stroke. These effects can be deadly. The risk may be greater if you have heart disease or risks for heart disease. However, it can also be raised even if you do not have heart disease or risks for heart disease. The risk can happen within the first weeks of using this drug and may be greater with higher doses or long-term use. Do not use this drug right before or after bypass heart surgery.This drug may raise the chance of severe and sometimes deadly stomach or bowel problems like ulcers or bleeding. The risk is greater in older people, and in people who have had stomach or bowel ulcers or bleeding before. These problems may occur without warning signs. @ COMMON USES: It is used to treat some types of arthritis.
Drug Class
Nonsteroidal Anti-inflammatory Drug (NSAID)
Pharmacologic Class
Cyclooxygenase (COX) Inhibitor
Pregnancy Category
Not applicable (FDA updated labeling for NSAIDs: Avoid from 20 weeks gestation onwards)
FDA Approved
Oct 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Diclofenac gel is a medicine applied to the skin to help relieve pain and swelling in joints caused by arthritis. It works by reducing substances in the body that cause inflammation and pain. It's absorbed into the skin to work directly at the site of pain, with less medicine getting into your bloodstream compared to pills.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Application Instructions
1. Wash your hands before and after applying the medication.
2. Clean the affected area before use and dry it thoroughly.
3. Apply a thin layer of the medication to the affected skin and gently rub it in.
4. If you accidentally get the medication in your eyes, rinse them immediately with water. If you experience persistent eye irritation or changes in vision, contact your doctor.
Important Precautions
Do not apply sunscreen, insect repellent, or other medications to the treated area.
If you apply the medication to your hands, wait at least 1 hour before washing them.
Avoid using heat or bandages on the treated area.
Allow the medication to dry for at least 10 minutes before covering the area with clothing or gloves.
Do not bathe, shower, or swim for 1 hour after applying the medication.
Do not use this medication on open wounds or infected skin.
Using the Dosing Card
This medication comes with a dosing card. Make sure you understand how to use it. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store this medication at room temperature, away from heat sources, and do not freeze it.
Missed Dose
If you miss a dose, skip it and resume your regular application schedule unless your doctor instructs you otherwise. Do not apply two doses at once or use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for topical use only, meaning it should be applied directly to the affected area of your skin. Avoid getting it in your mouth, nose, or eyes, as it may cause burning.
Application Instructions
1. Wash your hands before and after applying the medication.
2. Clean the affected area before use and dry it thoroughly.
3. Apply a thin layer of the medication to the affected skin and gently rub it in.
4. If you accidentally get the medication in your eyes, rinse them immediately with water. If you experience persistent eye irritation or changes in vision, contact your doctor.
Important Precautions
Do not apply sunscreen, insect repellent, or other medications to the treated area.
If you apply the medication to your hands, wait at least 1 hour before washing them.
Avoid using heat or bandages on the treated area.
Allow the medication to dry for at least 10 minutes before covering the area with clothing or gloves.
Do not bathe, shower, or swim for 1 hour after applying the medication.
Do not use this medication on open wounds or infected skin.
Using the Dosing Card
This medication comes with a dosing card. Make sure you understand how to use it. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store this medication at room temperature, away from heat sources, and do not freeze it.
Missed Dose
If you miss a dose, skip it and resume your regular application schedule unless your doctor instructs you otherwise. Do not apply two doses at once or use extra doses.
Lifestyle & Tips
- Wash your hands thoroughly after applying the gel, unless your hands are the treated area.
- Do not apply the gel to open wounds, cuts, infections, or rashes.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not cover the treated area with bandages, dressings, or heat pads, as this can increase absorption and risk of side effects.
- Avoid showering or washing the treated area for at least 1 hour after application.
- Avoid exposing the treated skin to natural or artificial sunlight (tanning beds) as it may increase sensitivity to light.
- Wait until the gel is dry before dressing.
Available Forms & Alternatives
Available Strengths:
- Diclofenac Potassium 50mg Tablets
- Diclofenac Sod 0.1% Ophth Soln 5ml
- Diclofenac Sodium 75mg DR Tablets
- Diclofenac Sod 0.1% Ophth Sol 2.5ml
- Diclofenac Sodium 25mg DR Tablets
- Diclofenac Sodium 75mg DR Tablets
- Diclofenac Sodium 50mg DR Tablets
- Diclofenac Sodium 50mg DR Tablets
- Diclofenac 1.5% Topical Sol 150ml
- Diclofenac 3% Gel 100gm
- Diclofenac Sodium 100mg ER Tablets
- Diclofenac 75mg DR Tablets
- Diclofenac 1% Gel 100gm (rx)
- Diclofenac Epolamine 1.3% Top Patch
- Diclofenac 1% Gel 100gm (rx)
- Diclofenac 1% Gel 100gm (otc)
- Diclofenac 1% Gel 50gm (otc)
- Diclofenac 25mg Capsules
- Diclofenac 2% Topical Soln 112gm
- Diclofenac Potassium 25mg Tablets
- Diclofenac 25mg Capsules
- Diclofenac 50mg Powder
- Diclofenac 2% Topical Soln 112gm
- Diclofenac Sodium 25mg DR Tablets
- Diclofenac 2% Topical Soln 112gm
- Diclofenac Potassium 25mg Tablets
- Diclofenac 50mg Powder
Dosing & Administration
Adult Dosing
Standard Dose:
Apply 2 grams to the affected upper body joint (hand, wrist, elbow) or 4 grams to the affected lower body joint (foot, ankle, knee) 4 times daily.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
upper_extremity_joints:
2 grams per application, 4 times daily, not to exceed 8 grams/day per joint.
lower_extremity_joints:
4 grams per application, 4 times daily, not to exceed 16 grams/day per joint.
maximum_total_body_dose:
Not to exceed 32 grams per day over all affected joints.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established for patients under 18 years of age).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to low systemic absorption.
Moderate:
No specific adjustment needed due to low systemic absorption. Use with caution if extensive application.
Severe:
Use with caution; monitor for systemic adverse effects if extensive application, as NSAIDs can worsen renal function.
Dialysis:
Considerations: Not dialyzable. Use with caution if extensive application.
Hepatic Impairment:
Mild:
No specific adjustment needed due to low systemic absorption.
Moderate:
No specific adjustment needed due to low systemic absorption. Use with caution if extensive application.
Severe:
Use with caution; monitor for systemic adverse effects if extensive application, as NSAIDs are metabolized in the liver.
Pharmacology
Mechanism of Action
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities. Its mechanism of action, like that of other NSAIDs, is believed to be due to the inhibition of prostaglandin synthesis, primarily through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. When applied topically, diclofenac penetrates the skin and accumulates in underlying tissues, including synovial fluid, where it exerts its local effects.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6% of the systemic exposure of an oral diclofenac dose (due to first-pass metabolism and low topical absorption).
Tmax:
Plasma Tmax is approximately 10-14 hours after topical application.
FoodEffect:
Not applicable for topical formulation.
Distribution:
Vd:
Not readily quantifiable for topical application; systemic Vd is approximately 1.3 L/kg.
ProteinBinding:
>99% (primarily to albumin).
CnssPenetration:
Limited (systemic exposure is low).
Elimination:
HalfLife:
Systemic plasma half-life is approximately 1-2 hours (for parent drug); metabolite half-lives can be longer.
Clearance:
Approximately 263 mL/min (systemic).
ExcretionRoute:
Primarily renal (approximately 60% as metabolites), with a smaller portion in bile/feces (approximately 35% as metabolites).
Unchanged:
<1% (systemic, in urine).
Pharmacodynamics
OnsetOfAction:
Within 1 week (for pain relief in osteoarthritis).
PeakEffect:
Typically within 2-4 weeks of consistent use.
DurationOfAction:
Maintained with 4 times daily application.
Safety & Warnings
BLACK BOX WARNING
CARDIOVASCULAR THROMBOTIC EVENTS: NSAIDs, including diclofenac, 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. Diclofenac is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. GASTROINTESTINAL RISK: NSAIDs, including diclofenac, cause an increased risk of serious gastrointestinal 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 peptrolic ulcer disease and/or GI bleeding are at greater risk for serious GI events. PREGNANCY: NSAIDs, including diclofenac, can cause premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women at 30 weeks gestation and later. NSAIDs can cause oligohydramnios and renal dysfunction in the fetus. If an NSAID is necessary between 20 and 30 weeks gestation, use the lowest effective dose and shortest duration possible. Monitor amniotic fluid if treatment extends beyond 48 hours.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of bleeding: vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of high potassium levels: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
Skin irritation, chest pain or pressure, rapid heartbeat, shortness of breath, significant weight gain, or swelling in the arms or legs.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Extreme fatigue or weakness, flu-like symptoms, or severe back pain.
Severe Skin Reactions
This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. If you experience any of the following symptoms, seek medical help immediately:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever, chills, body aches, shortness of breath, or swollen glands
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness or headache
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
* Gas or heartburn
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of bleeding: vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of high potassium levels: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
Skin irritation, chest pain or pressure, rapid heartbeat, shortness of breath, significant weight gain, or swelling in the arms or legs.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Extreme fatigue or weakness, flu-like symptoms, or severe back pain.
Severe Skin Reactions
This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. If you experience any of the following symptoms, seek medical help immediately:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever, chills, body aches, shortness of breath, or swollen glands
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness or headache
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
* Gas or heartburn
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe skin irritation, redness, itching, or rash at the application site.
- Signs of an allergic reaction: swelling of face, lips, tongue, or throat; difficulty breathing; severe rash.
- Unusual bruising or bleeding.
- Black, tarry stools or vomit that looks like coffee grounds (signs of stomach bleeding).
- Swelling of the ankles, feet, or hands.
- Sudden chest pain or shortness of breath.
- Yellowing of the skin or eyes (jaundice).
- Severe stomach pain.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
A history of asthma triggered by salicylate medications, such as aspirin, or NSAIDs.
Presence of certain health conditions, including:
+ Dehydration
+ Gastrointestinal (GI) bleeding
+ Heart failure (weak heart)
+ Kidney disease
+ Liver disease
Recent heart attack
Current use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed
Fertility issues or ongoing fertility evaluation
Pregnancy and Fertility Considerations:
If you are trying to conceive, having fertility issues, or undergoing fertility evaluation, inform your doctor.
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication, discuss the risks with your doctor. This medication may harm an unborn baby if taken after 20 weeks of pregnancy.
Between 20 to 30 weeks of pregnancy, only take this medication if your doctor advises you to do so.
Do not take this medication if you are more than 30 weeks pregnant.
Interactions with Other Medications and Health Conditions:
Provide your doctor and pharmacist with a comprehensive list of all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Inform them about your health problems to ensure it is safe to take this medication with your other treatments.
Never start, stop, or change the dose of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
Allergies to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
A history of asthma triggered by salicylate medications, such as aspirin, or NSAIDs.
Presence of certain health conditions, including:
+ Dehydration
+ Gastrointestinal (GI) bleeding
+ Heart failure (weak heart)
+ Kidney disease
+ Liver disease
Recent heart attack
Current use of other NSAIDs, salicylate drugs like aspirin, or pemetrexed
Fertility issues or ongoing fertility evaluation
Pregnancy and Fertility Considerations:
If you are trying to conceive, having fertility issues, or undergoing fertility evaluation, inform your doctor.
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication, discuss the risks with your doctor. This medication may harm an unborn baby if taken after 20 weeks of pregnancy.
Between 20 to 30 weeks of pregnancy, only take this medication if your doctor advises you to do so.
Do not take this medication if you are more than 30 weeks pregnant.
Interactions with Other Medications and Health Conditions:
Provide your doctor and pharmacist with a comprehensive list of all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Inform them about your health problems to ensure it is safe to take this medication with your other treatments.
Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor.
High blood pressure is a potential side effect of this medication. Your doctor will advise you on how often to have your blood pressure checked. If you smoke, it is crucial to discuss this with your doctor, as smoking may affect your treatment. Additionally, if you have asthma, you may be more sensitive to this medication, so be sure to talk to your doctor about any concerns.
Before consuming alcohol, consult with your doctor to discuss any potential risks. When using this medication, avoid applying it to skin with any problems or irritations. Do not exceed the recommended dosage, as this may lead to unsafe side effects. Use this medication only for the duration prescribed by your doctor.
To minimize the risk of adverse effects, avoid exposing the treated area to sunlight. It is also important to note that the use of this medication may increase the risk of heart failure. If you already have heart failure, your risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss this with your doctor to understand the potential risks.
People who have had a recent heart attack may be at a higher risk of heart attack and heart-related death when taking this medication. In fact, studies have shown that individuals taking this medication after a first heart attack were more likely to die within the year following the heart attack compared to those not taking this medication. If you are taking aspirin to prevent a heart attack, consult with your doctor to discuss the potential risks and benefits.
Liver problems, including fatal cases, have been reported with the use of this medication. If you experience any symptoms of liver problems, such as dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin and eyes, contact your doctor immediately.
If this medication is accidentally ingested, call a doctor or poison control center right away, as it may cause harm. This medication is not approved for use in children, so be sure to discuss any concerns with your doctor. If you are 60 or older, use this medication with caution, as you may be more susceptible to side effects.
Women of childbearing age should be aware that this medication, an NSAID, may affect ovulation, which can impact fertility. However, this effect is typically reversible when the medication is stopped. If you are trying to become pregnant, discuss this with your doctor. Additionally, if you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
High blood pressure is a potential side effect of this medication. Your doctor will advise you on how often to have your blood pressure checked. If you smoke, it is crucial to discuss this with your doctor, as smoking may affect your treatment. Additionally, if you have asthma, you may be more sensitive to this medication, so be sure to talk to your doctor about any concerns.
Before consuming alcohol, consult with your doctor to discuss any potential risks. When using this medication, avoid applying it to skin with any problems or irritations. Do not exceed the recommended dosage, as this may lead to unsafe side effects. Use this medication only for the duration prescribed by your doctor.
To minimize the risk of adverse effects, avoid exposing the treated area to sunlight. It is also important to note that the use of this medication may increase the risk of heart failure. If you already have heart failure, your risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss this with your doctor to understand the potential risks.
People who have had a recent heart attack may be at a higher risk of heart attack and heart-related death when taking this medication. In fact, studies have shown that individuals taking this medication after a first heart attack were more likely to die within the year following the heart attack compared to those not taking this medication. If you are taking aspirin to prevent a heart attack, consult with your doctor to discuss the potential risks and benefits.
Liver problems, including fatal cases, have been reported with the use of this medication. If you experience any symptoms of liver problems, such as dark urine, fatigue, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin and eyes, contact your doctor immediately.
If this medication is accidentally ingested, call a doctor or poison control center right away, as it may cause harm. This medication is not approved for use in children, so be sure to discuss any concerns with your doctor. If you are 60 or older, use this medication with caution, as you may be more susceptible to side effects.
Women of childbearing age should be aware that this medication, an NSAID, may affect ovulation, which can impact fertility. However, this effect is typically reversible when the medication is stopped. If you are trying to become pregnant, discuss this with your doctor. Additionally, if you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Topical overdose is unlikely to cause systemic symptoms due to low absorption. Local symptoms may include severe skin irritation, redness, or blistering.
- If significant amount is ingested orally (e.g., by a child), systemic NSAID overdose symptoms may occur: nausea, vomiting, stomach pain, drowsiness, lethargy, headache, tinnitus, dizziness. More severe cases may involve GI bleeding, renal failure, respiratory depression, or coma.
What to Do:
For topical overdose, wash the area thoroughly with soap and water. For suspected oral ingestion, seek immediate medical attention. Call 911 or your local poison control center (1-800-222-1222 in the US).
Drug Interactions
Major Interactions
Moderate Interactions
- Diuretics (e.g., furosemide, hydrochlorothiazide) - reduced diuretic effect, increased risk of renal impairment
- ACE inhibitors/ARBs (e.g., lisinopril, valsartan) - reduced antihypertensive effect, increased risk of renal impairment
- Cyclosporine (increased nephrotoxicity)
- Digoxin (increased digoxin levels)
- SSRIs/SNRIs (increased risk of GI bleeding)
Minor Interactions
- Corticosteroids (increased risk of GI ulceration)
Monitoring
Baseline Monitoring
Baseline renal function (SCr, BUN)
Rationale: To assess baseline kidney health, especially in patients with pre-existing renal impairment or those at risk for NSAID-induced nephrotoxicity (e.g., elderly, dehydrated, on diuretics/ACE inhibitors).
Timing: Prior to initiation in high-risk patients.
Baseline hepatic function (ALT, AST)
Rationale: To assess baseline liver health, especially in patients with pre-existing hepatic impairment.
Timing: Prior to initiation in high-risk patients.
Routine Monitoring
Local skin reactions (redness, itching, dryness, rash)
Frequency: Daily, with each application.
Target: Absence of significant irritation.
Action Threshold: Discontinue if severe irritation, rash, or allergic reaction occurs.
Pain and swelling assessment
Frequency: Regularly, as clinically indicated.
Target: Reduction in pain and swelling.
Action Threshold: Re-evaluate treatment if no improvement after 2-4 weeks.
Signs of systemic adverse effects (e.g., GI bleeding, cardiovascular events, renal dysfunction)
Frequency: Periodically, especially with extensive use or in high-risk patients.
Target: Absence of symptoms.
Action Threshold: Seek immediate medical attention if symptoms occur.
Symptom Monitoring
- Pain level
- Joint swelling
- Skin redness or irritation at application site
- Itching or dryness at application site
- Rash or blistering
- Unusual bruising or bleeding
- Black, tarry stools or coffee-ground vomit (signs of GI bleeding)
- Swelling of ankles, feet, or hands (fluid retention)
- Shortness of breath or chest pain (cardiovascular events)
- Unexplained weight gain
- Changes in urination (renal dysfunction)
Special Patient Groups
Pregnancy
Avoid use of NSAIDs, including diclofenac gel, in pregnant women at 30 weeks gestation and later due to the risk of premature closure of the fetal ductus arteriosus. Avoid use between 20 and 30 weeks gestation unless clearly necessary, and if used, limit to the lowest effective dose for the shortest duration possible, monitoring amniotic fluid if treatment extends beyond 48 hours. Use before 20 weeks gestation should only be if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited data, potential for increased risk of miscarriage and cardiac malformations. Use only if clearly needed.
Second Trimester:
Risk of fetal renal dysfunction leading to oligohydramnios (low amniotic fluid) and, in some cases, neonatal renal impairment. Avoid use from 20 weeks gestation onwards.
Third Trimester:
Risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, and impaired renal function in the fetus. Contraindicated from 30 weeks gestation onwards.
Lactation
Diclofenac is excreted in breast milk in small amounts after systemic administration. Due to low systemic absorption with topical application, the amount transferred to breast milk is expected to be very low. However, use with caution. Avoid applying to the breast area to prevent direct infant exposure.
Infant Risk:
Low risk of adverse effects in breastfed infants due to minimal systemic absorption. Monitor infant for potential adverse effects (e.g., rash, irritability).
Pediatric Use
Safety and efficacy have not been established in pediatric patients (under 18 years of age). Not recommended for use in this population.
Geriatric Use
Elderly patients may be at increased risk for adverse reactions to NSAIDs, including serious gastrointestinal and cardiovascular events, and renal impairment. Use the lowest effective dose for the shortest duration necessary. Monitor for adverse effects.
Clinical Information
Clinical Pearls
- Diclofenac 1% gel is specifically formulated for topical application to joints affected by osteoarthritis, providing local pain relief with minimal systemic exposure compared to oral NSAIDs.
- Patients should be instructed on the correct dosing amount (using the dosing card provided) and application technique to ensure efficacy and minimize waste.
- Emphasize the importance of washing hands after application and avoiding contact with eyes and mucous membranes.
- Advise patients not to apply heat or occlusive dressings over the treated area, as this can increase systemic absorption and potential side effects.
- While systemic side effects are less common with topical use, patients should still be monitored for signs of GI bleeding, cardiovascular events, or renal dysfunction, especially with extensive use or in high-risk individuals.
- Inform patients that full therapeutic effect may take up to 2-4 weeks of consistent use.
Alternative Therapies
- Other topical NSAIDs (e.g., ibuprofen gel, ketoprofen gel)
- Topical analgesics (e.g., capsaicin cream, lidocaine patches)
- Oral NSAIDs (e.g., ibuprofen, naproxen, celecoxib) - for more widespread or severe pain, but with higher systemic risk.
- Acetaminophen (for mild to moderate pain)
- Non-pharmacological therapies (e.g., physical therapy, exercise, heat/cold therapy, assistive devices, weight management, acupuncture).
Cost & Coverage
Average Cost:
$30 - $100 per 100gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a valuable resource that provides important information. Please read this guide carefully and review it again each time you receive a refill of this medication. If you have any questions or concerns about this medication, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.