Diclofenac 1% Gel 50gm (otc)
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 Inhibitor
Pregnancy Category
Category C (first and second trimesters); Category D (third trimester)
FDA Approved
Feb 2020
DEA Schedule
Not Controlled
Overview
What is this medicine?
Diclofenac gel is a topical medicine applied to the skin to relieve pain and swelling caused by arthritis in joints like knees, ankles, feet, elbows, wrists, and hands. It works by reducing substances in the body that cause inflammation and pain.
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 irritation.
Application Instructions
1. Wash your hands before and after applying the medication.
2. Clean the affected area before application 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 eye irritation persists or you experience changes in your 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 application.
Do not apply the medication to open wounds or infected skin.
Using the Dosing Card
This medication comes with a dosing card. Make sure you understand how to use it correctly. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store the medication at room temperature, away from heat sources, and do not freeze.
Missed Dose
If you miss a dose, skip it and resume your regular application schedule unless your doctor advises you to do otherwise. Do not apply two doses at the same time or use extra doses to make up for a missed one.
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 irritation.
Application Instructions
1. Wash your hands before and after applying the medication.
2. Clean the affected area before application 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 eye irritation persists or you experience changes in your 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 application.
Do not apply the medication to open wounds or infected skin.
Using the Dosing Card
This medication comes with a dosing card. Make sure you understand how to use it correctly. If you have any questions, consult your doctor or pharmacist.
Storage and Disposal
Store the medication at room temperature, away from heat sources, and do not freeze.
Missed Dose
If you miss a dose, skip it and resume your regular application schedule unless your doctor advises you to do otherwise. Do not apply two doses at the same time or use extra doses to make up for a missed one.
Lifestyle & Tips
- Wash hands thoroughly after applying the gel, unless hands are the treated area.
- Do not apply to open wounds, damaged skin, or infected areas.
- Avoid contact with eyes, nose, mouth, and other mucous membranes.
- Do not use with heating pads or external heat.
- Avoid showering or rinsing the treated area for at least 1 hour after application.
- Do not cover the treated area with bandages or dressings that do not breathe (occlusive dressings).
- Limit sun exposure and use sunscreen on treated areas, as diclofenac can increase sun sensitivity.
- 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 area (hand, wrist, elbow) or 4 grams to the affected lower body area (foot, ankle, knee) 4 times a day. Do not apply to more than 2 body areas at the same time.
Dose Range:
2 - 4 mg
Condition-Specific Dosing:
upperBody:
2 grams per application
lowerBody:
4 grams per application
maximumDaily:
16 grams total (across 2 body areas)
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Not for use in persons under 18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for topical application due to low systemic absorption. Use with caution if severe renal impairment and large areas are treated.
Moderate:
No specific adjustment needed for topical application due to low systemic absorption. Use with caution if severe renal impairment and large areas are treated.
Severe:
Use with caution. Systemic exposure is low, but risk of systemic NSAID effects (e.g., worsening renal function) cannot be entirely excluded, especially with prolonged use or large application areas.
Dialysis:
Considerations: Not typically removed by dialysis. Use with caution as with severe renal impairment.
Hepatic Impairment:
Mild:
No specific adjustment needed for topical application due to low systemic absorption.
Moderate:
No specific adjustment needed for topical application due to low systemic absorption. Use with caution if severe hepatic impairment and large areas are treated.
Severe:
Use with caution. Systemic exposure is low, but risk of systemic NSAID effects (e.g., liver enzyme elevation) cannot be entirely excluded, especially with prolonged use or large application areas.
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, providing localized pain relief and reducing inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 6% (systemic, relative to oral), but local tissue concentrations are significantly higher.
Tmax:
Plasma Tmax: 10-16 hours (for topical 1% gel)
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
Not specifically quantified for topical, but systemic Vd is approximately 0.12-0.17 L/kg.
ProteinBinding:
Greater than 99% (primarily to albumin) systemically.
CnssPenetration:
Limited (for topical application, systemic levels are low)
Elimination:
HalfLife:
Plasma half-life: Approximately 1-2 hours (systemic, but longer for local tissue retention).
Clearance:
Systemic clearance: Approximately 263 mL/min.
ExcretionRoute:
Renal (approximately 60%) and biliary/fecal (approximately 35%).
Unchanged:
Less than 1% (systemically)
Pharmacodynamics
OnsetOfAction:
Within 1 week for pain relief, full effect may take up to 7 days.
PeakEffect:
Peak pain relief typically observed after 1-2 weeks of consistent use.
DurationOfAction:
Provides sustained local pain relief with 4 times daily application.
Safety & Warnings
BLACK BOX WARNING
Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. NSAIDs 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 are at greater risk for serious gastrointestinal events. Diclofenac is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
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 or seek medical attention immediately:
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, trouble 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: abnormal 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, speech or thinking difficulties, balance changes, facial drooping, or blurred vision.
Extreme fatigue or weakness, flu-like symptoms, or severe back pain.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help immediately if you experience: 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 mild ones. If you notice any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Dizziness or headache
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Gas or heartburn
This is not an exhaustive list of possible 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 or seek medical attention immediately:
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, trouble 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: abnormal 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, speech or thinking difficulties, balance changes, facial drooping, or blurred vision.
Extreme fatigue or weakness, flu-like symptoms, or severe back pain.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek medical help immediately if you experience: 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 mild ones. If you notice any of the following side effects or any other symptoms that bother you or persist, contact your doctor:
Dizziness or headache
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Gas or heartburn
This is not an exhaustive list of possible 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 rash, redness, or itching at the application site.
- Signs of allergic reaction: swelling of face, lips, tongue, or throat; difficulty breathing; hives.
- Unusual bleeding or bruising.
- Black, tarry stools or vomit that looks like coffee grounds (rare, but seek immediate medical attention).
- Swelling in your hands or feet.
- Sudden chest pain, shortness of breath, weakness on one side of the body, or slurred speech (rare, but seek immediate medical attention).
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
If you are pregnant, planning to become pregnant, or become pregnant while taking this medication, it is crucial to discuss the potential 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.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems
Verify that it is safe to take this medication with your existing medications and health conditions. 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
If you are pregnant, planning to become pregnant, or become pregnant while taking this medication, it is crucial to discuss the potential 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.
To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications
Natural products
Vitamins
* Health problems
Verify that it is safe to take this medication with your existing medications and health conditions. 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 in the following year compared to those not taking this medication. If you are taking aspirin to prevent a heart attack, be sure to discuss this with your doctor.
Liver problems, including severe and potentially life-threatening 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 swallowed, it can cause harm, so it is essential to seek medical attention or contact a poison control center right away. 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 in the following year compared to those not taking this medication. If you are taking aspirin to prevent a heart attack, be sure to discuss this with your doctor.
Liver problems, including severe and potentially life-threatening 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 swallowed, it can cause harm, so it is essential to seek medical attention or contact a poison control center right away. 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:
- Unlikely with topical application due to low systemic absorption.
- If ingested or excessively applied: nausea, vomiting, stomach pain, drowsiness, black or bloody stools, difficulty breathing, kidney problems.
What to Do:
If accidental ingestion or excessive application occurs, contact a poison control center immediately. Call 1-800-222-1222. Treatment is supportive and symptomatic.
Drug Interactions
Major Interactions
- Other systemic NSAIDs (increased risk of GI bleeding, renal toxicity)
- Anticoagulants (e.g., warfarin, dabigatran) - increased bleeding risk
- Antiplatelet agents (e.g., aspirin, clopidogrel) - increased bleeding risk
- Lithium (increased lithium levels)
- Methotrexate (increased methotrexate toxicity)
- Cyclosporine (increased nephrotoxicity)
- Diuretics (e.g., furosemide, hydrochlorothiazide) - reduced diuretic effect, increased risk of renal impairment
- ACE inhibitors/ARBs (reduced antihypertensive effect, increased risk of renal impairment)
Moderate Interactions
- SSRIs/SNRIs (increased risk of GI bleeding)
- Corticosteroids (increased risk of GI ulceration/bleeding)
- Digoxin (increased digoxin levels)
- Phenytoin (increased phenytoin levels)
- Sulfonylureas (potential for hypoglycemia)
Minor Interactions
- Alcohol (increased risk of GI irritation, though minimal with topical)
Monitoring
Routine Monitoring
Local skin reactions (e.g., rash, itching, dryness, redness)
Frequency: Daily, during use
Target: Absence of significant irritation
Action Threshold: Discontinue use if severe irritation, rash, or allergic reaction occurs.
Pain and inflammation assessment
Frequency: Regularly, as needed
Target: Reduction in pain and swelling
Action Threshold: Consult healthcare provider if no improvement after 7 days or if condition worsens.
Symptom Monitoring
- Skin irritation (redness, itching, rash, dryness, scaling)
- Signs of allergic reaction (hives, swelling of face/throat, difficulty breathing)
- Unusual bleeding or bruising
- Black, tarry stools or vomit that looks like coffee grounds (signs of GI bleeding, rare with topical)
- Swelling of hands or feet (fluid retention, rare with topical)
- Unexplained weight gain
- Changes in urination (signs of kidney problems, rare with topical)
- Yellowing of skin or eyes (jaundice, signs of liver problems, rare with topical)
- Chest pain, shortness of breath, weakness on one side of body, slurred speech (signs of cardiovascular events, rare with topical)
Special Patient Groups
Pregnancy
Avoid use in the third trimester (starting at 30 weeks of gestation) due to risk of premature closure of the fetal ductus arteriosus. Use in the first and second trimesters should only be if clearly needed and the potential benefit outweighs the potential risk to the fetus, as systemic NSAID exposure can lead to adverse effects.
Trimester-Specific Risks:
First Trimester:
Potential risk of miscarriage and cardiac malformations (low, but cannot be excluded for systemic NSAIDs).
Second Trimester:
Potential risk of renal dysfunction in the fetus leading to oligohydramnios (low amniotic fluid) and, in some cases, neonatal renal impairment.
Third Trimester:
Risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, and inhibition of uterine contractions.
Lactation
Diclofenac is excreted in breast milk in small amounts after systemic administration. While topical absorption is low, caution is advised. Consider the developmental and health benefits of breastfeeding, the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
Infant Risk:
Low risk of adverse effects due to low systemic absorption, but monitor infant for potential adverse reactions (e.g., gastrointestinal upset, rash).
Pediatric Use
Not recommended for use in persons under 18 years of age for OTC indications due to lack of established safety and efficacy data in this population.
Geriatric Use
Elderly patients may be at greater risk for serious gastrointestinal and cardiovascular adverse events with systemic NSAIDs. While systemic absorption from topical diclofenac is low, caution is advised. Use the lowest effective dose for the shortest duration possible. Monitor for adverse effects.
Clinical Information
Clinical Pearls
- Diclofenac 1% gel is specifically formulated for topical application to joints affected by osteoarthritis, providing localized pain relief with minimal systemic exposure compared to oral NSAIDs.
- Ensure the application area is clean and dry before applying the gel.
- Measure the correct amount of gel using the dosing card provided (if applicable) or by estimating the length of the gel strip (e.g., 2.25 inches for 2 grams, 4.5 inches for 4 grams).
- Rub the gel gently into the skin until it is completely absorbed.
- Do not wash the treated area for at least 1 hour after application, and avoid applying other topical products to the same area.
- Patients should be advised that full pain relief may not be immediate and can take up to 7 days of consistent use.
- It is crucial to avoid applying the gel to open wounds, infected skin, or mucous membranes.
Alternative Therapies
- Other topical analgesics (e.g., capsaicin cream, lidocaine patches, methyl salicylate/menthol rubs)
- Oral NSAIDs (e.g., ibuprofen, naproxen, celecoxib - for more widespread or severe pain, but with higher systemic risks)
- Acetaminophen (for pain relief, no anti-inflammatory effect)
- Physical therapy
- Heat/cold therapy
- Corticosteroid injections (intra-articular)
- Hyaluronic acid injections (intra-articular)
Cost & Coverage
Average Cost:
Approximately $15-$30 per 50gm tube
Generic Available:
Yes
Insurance Coverage:
OTC products are generally not covered by prescription insurance, but may be eligible for FSA/HSA.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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 quantity, and the time it occurred.