Diclofenac 2% Topical Soln 112gm
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
Category C (1st and 2nd trimesters); Category D (3rd trimester)
FDA Approved
Aug 2009
DEA Schedule
Not Controlled
Overview
What is this medicine?
Diclofenac topical solution is a medicine applied to the skin to help reduce pain and swelling caused by osteoarthritis, especially in the knees. It works by blocking certain natural substances in your body that cause inflammation.
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 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 the medication to clean, dry, healthy skin. You can apply it directly to the knee or to your hand and then transfer it to the knee.
4. Spread the medication evenly over the front, back, and side of the knee.
5. Allow the medication to dry before covering the area with clothing.
6. Wait at least 30 minutes after applying the medication before bathing, showering, or swimming.
Important Precautions
Avoid applying the medication to open wounds or infected skin.
Do not use heat or bandages on the treated area.
Let the treated skin dry completely before touching it or allowing it to come into contact with someone else's skin.
You can use cosmetics, lotions, insect repellent, sunscreen, or other skin medications after the treated skin has dried.
Using the Pump or Dropper
If your medication comes in a pump, you will need to prime it before the first use. Follow the instructions in the package insert to prime the pump. If your medication comes in a packet or a bottle with a dropper, follow the instructions provided.
Accidental Exposure
If you accidentally get the medication in your eyes, rinse them immediately with water. If you experience eye irritation that persists or a change in vision, contact your doctor.
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 to do otherwise. Do not apply two doses at the same time 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 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 the medication to clean, dry, healthy skin. You can apply it directly to the knee or to your hand and then transfer it to the knee.
4. Spread the medication evenly over the front, back, and side of the knee.
5. Allow the medication to dry before covering the area with clothing.
6. Wait at least 30 minutes after applying the medication before bathing, showering, or swimming.
Important Precautions
Avoid applying the medication to open wounds or infected skin.
Do not use heat or bandages on the treated area.
Let the treated skin dry completely before touching it or allowing it to come into contact with someone else's skin.
You can use cosmetics, lotions, insect repellent, sunscreen, or other skin medications after the treated skin has dried.
Using the Pump or Dropper
If your medication comes in a pump, you will need to prime it before the first use. Follow the instructions in the package insert to prime the pump. If your medication comes in a packet or a bottle with a dropper, follow the instructions provided.
Accidental Exposure
If you accidentally get the medication in your eyes, rinse them immediately with water. If you experience eye irritation that persists or a change in vision, contact your doctor.
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 to do otherwise. Do not apply two doses at the same time or use extra doses.
Lifestyle & Tips
- Apply only to clean, dry skin. Do not apply to open wounds, cuts, infections, or rashes.
- Avoid showering or bathing for at least 30 minutes after application.
- Do not apply heat (e.g., heating pads) or occlusive dressings (e.g., bandages) over the treated area.
- Avoid exposing the treated area to natural or artificial sunlight, as this may cause a skin reaction.
- Wash hands thoroughly after applying the solution, unless your hands are the treated area.
- Avoid contact with eyes, nose, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
- Do not swallow the solution.
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 40 drops (1.2 mL) of solution to each affected knee, 4 times daily.
Condition-Specific Dosing:
osteoarthritis_knee:
Apply 40 drops (1.2 mL) to each affected knee, 4 times daily. Do not apply to more than 2 knees at any given time. Total daily dose should not exceed 160 drops (4.8 mL) over 4 sites.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dosage adjustment recommended due to low systemic absorption, but use with caution in patients with pre-existing renal disease.
Moderate:
No specific dosage adjustment recommended due to low systemic absorption, but use with caution in patients with pre-existing renal disease.
Severe:
Use with caution; systemic exposure, though low, may contribute to renal dysfunction in severe impairment. Monitor renal function.
Dialysis:
Use with caution; systemic exposure, though low, may contribute to renal dysfunction. Monitor renal function.
Hepatic Impairment:
Mild:
No specific dosage adjustment recommended due to low systemic absorption.
Moderate:
No specific dosage adjustment recommended due to low systemic absorption, but use with caution in patients with severe hepatic impairment.
Severe:
Use with caution; systemic exposure, though low, may contribute to hepatic dysfunction. Monitor liver function.
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 inhibition of prostaglandin synthesis, primarily through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 10% (systemic, relative to oral diclofenac)
Tmax:
Approximately 10-16 hours (for plasma concentrations after topical application)
FoodEffect:
Not applicable for topical solution
Distribution:
Vd:
Not specifically quantified for topical, but distributes into synovial fluid and other inflamed tissues.
ProteinBinding:
Greater than 99% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 1-2 hours (systemic plasma half-life); longer in synovial fluid (up to 17 hours)
Clearance:
Approximately 263 mL/min (systemic)
ExcretionRoute:
Primarily renal (approximately 65%), with a smaller portion via biliary/fecal excretion (approximately 35%)
Unchanged:
Less than 1% (systemic)
Pharmacodynamics
OnsetOfAction:
Within 1-2 weeks for significant pain relief in osteoarthritis
PeakEffect:
Not precisely defined for topical, but clinical effect builds over several days to weeks.
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 peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
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 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 significant 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, or shortness of breath.
Sudden 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.
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. These conditions can be life-threatening and may also affect internal organs. Seek immediate medical attention 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.
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. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor:
Dizziness or headache.
Constipation, diarrhea, stomach pain, upset stomach, or vomiting.
Gas.
Heartburn.
This is not an exhaustive list of possible side effects. If you have 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 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 significant 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, or shortness of breath.
Sudden 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.
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. These conditions can be life-threatening and may also affect internal organs. Seek immediate medical attention 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.
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. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor:
Dizziness or headache.
Constipation, diarrhea, stomach pain, upset stomach, or vomiting.
Gas.
Heartburn.
This is not an exhaustive list of possible side effects. If you have 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 reactions (e.g., blistering, peeling, widespread rash)
- Signs of stomach bleeding (e.g., black, tarry stools; vomiting blood or material that looks like coffee grounds)
- Symptoms of heart attack (e.g., chest pain, shortness of breath, pain spreading to arm or shoulder)
- Symptoms of stroke (e.g., sudden numbness or weakness on one side of the body, sudden severe headache, slurred speech, vision changes)
- Unusual weight gain or swelling (signs of fluid retention or kidney problems)
- Yellowing of the skin or eyes, dark urine, or unusual tiredness (signs of liver problems)
- Allergic reactions (e.g., hives, difficulty breathing, swelling of face/lips/tongue/throat)
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:
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.
If you are allergic to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
If you have ever experienced asthma triggered by a salicylate medication, such as aspirin, or an NSAID.
If you have any of the following health conditions:
+ Dehydration
+ Gastrointestinal (GI) bleeding
+ Heart failure (weak heart)
+ Kidney disease
+ Liver disease
If you have recently had a heart attack.
If you are currently taking any other NSAID, a salicylate medication like aspirin, or pemetrexed.
If you are having difficulty conceiving or undergoing fertility evaluation.
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. This medication may harm an unborn baby if taken after 20 weeks of pregnancy. If you are between 20 and 30 weeks pregnant, only take this medication if your doctor has instructed you to do so. Do not take this medication if you are more than 30 weeks pregnant.
Additional Considerations:
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any health problems you may have. Ensure that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
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.
If you are allergic to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
If you have ever experienced asthma triggered by a salicylate medication, such as aspirin, or an NSAID.
If you have any of the following health conditions:
+ Dehydration
+ Gastrointestinal (GI) bleeding
+ Heart failure (weak heart)
+ Kidney disease
+ Liver disease
If you have recently had a heart attack.
If you are currently taking any other NSAID, a salicylate medication like aspirin, or pemetrexed.
If you are having difficulty conceiving or undergoing fertility evaluation.
If you are pregnant, plan to become pregnant, or become pregnant while taking this medication. This medication may harm an unborn baby if taken after 20 weeks of pregnancy. If you are between 20 and 30 weeks pregnant, only take this medication if your doctor has instructed you to do so. Do not take this medication if you are more than 30 weeks pregnant.
Additional Considerations:
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any health problems you may have. Ensure that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dosage 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.
As this medication can cause high blood pressure, it is crucial to have your blood pressure checked regularly, as advised by your doctor. If you smoke, you should discuss this with your doctor, as it may affect your treatment. Additionally, if you have asthma, you may be more sensitive to this medication, so it is vital to consult with your doctor.
Before consuming alcohol, talk to your doctor to understand 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 can 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 can 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.
Furthermore, 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, consult with your doctor to determine the best course of action.
Liver problems, including fatal cases, have been associated with 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.
In case of accidental ingestion, this medication can cause harm. If you or someone else swallows this medication, contact a doctor or poison control center right away. This medication is not approved for use in children, so it is essential to discuss any concerns with your doctor.
If you are 60 years 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, potentially impacting fertility. However, this effect is reversible when the medication is stopped. If you are trying to conceive, discuss this with your doctor.
Finally, if you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
As this medication can cause high blood pressure, it is crucial to have your blood pressure checked regularly, as advised by your doctor. If you smoke, you should discuss this with your doctor, as it may affect your treatment. Additionally, if you have asthma, you may be more sensitive to this medication, so it is vital to consult with your doctor.
Before consuming alcohol, talk to your doctor to understand 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 can 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 can 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.
Furthermore, 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, consult with your doctor to determine the best course of action.
Liver problems, including fatal cases, have been associated with 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.
In case of accidental ingestion, this medication can cause harm. If you or someone else swallows this medication, contact a doctor or poison control center right away. This medication is not approved for use in children, so it is essential to discuss any concerns with your doctor.
If you are 60 years 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, potentially impacting fertility. However, this effect is reversible when the medication is stopped. If you are trying to conceive, discuss this with your doctor.
Finally, 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 significant amount is ingested or absorbed systemically, symptoms may include: lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding. Rarely: hypertension, acute renal failure, respiratory depression, coma.
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Management is generally supportive and symptomatic. Gastric decontamination (e.g., activated charcoal) may be considered if ingestion is recent and substantial.
Drug Interactions
Contraindicated Interactions
- Aspirin or other NSAIDs (history of asthma, urticaria, or other allergic-type reactions)
- Peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery
Major Interactions
- Anticoagulants (e.g., warfarin, dabigatran): Increased risk of bleeding
- Antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of bleeding
- SSRIs/SNRIs: Increased risk of GI bleeding
- Lithium: Increased lithium levels and toxicity
- Methotrexate: Increased methotrexate levels and toxicity
- Cyclosporine: Increased nephrotoxicity
- Digoxin: Increased digoxin levels
Moderate Interactions
- ACE inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment
- Diuretics (e.g., furosemide, hydrochlorothiazide): Reduced diuretic and antihypertensive effect, increased risk of renal impairment
- Corticosteroids: Increased risk of GI ulceration/bleeding
- Pemetrexed: Increased myelosuppression (avoid in patients with renal impairment)
Minor Interactions
- Cholestyramine/Colestipol: May reduce diclofenac absorption (oral, less relevant for topical)
- Phenytoin: May increase phenytoin levels
Monitoring
Baseline Monitoring
Pain and inflammation assessment
Rationale: To establish baseline efficacy parameters.
Timing: Prior to initiation of therapy
Skin integrity of application site
Rationale: To ensure no open wounds or active skin conditions that would contraindicate use.
Timing: Prior to initiation of therapy
Renal function (SCr, BUN)
Rationale: Although systemic absorption is low, caution is advised in patients with pre-existing renal impairment.
Timing: Prior to initiation of therapy, especially in at-risk patients
Liver function tests (ALT, AST)
Rationale: Although systemic absorption is low, caution is advised in patients with pre-existing hepatic impairment.
Timing: Prior to initiation of therapy, especially in at-risk patients
Routine Monitoring
Efficacy (pain reduction, improved function)
Frequency: Periodically, as clinically indicated
Target: Patient-reported improvement
Action Threshold: Lack of improvement after 2-4 weeks may warrant re-evaluation of therapy.
Local skin reactions (e.g., dryness, erythema, pruritus, rash)
Frequency: Daily, or with each application
Target: Absence of significant irritation
Action Threshold: Discontinue if severe skin reactions occur.
Signs/symptoms of systemic NSAID adverse effects (e.g., GI bleeding, cardiovascular events, renal dysfunction)
Frequency: Periodically, as clinically indicated, especially in patients with risk factors
Target: Absence of symptoms
Action Threshold: Promptly evaluate and discontinue if serious adverse events are suspected.
Symptom Monitoring
- Pain level
- Swelling/inflammation at application site
- Skin irritation, redness, itching, dryness, blistering at application site
- Unusual bleeding or bruising
- Black, tarry stools or vomiting blood (signs of GI bleeding)
- Chest pain, shortness of breath, weakness on one side of the body, slurred speech (signs of cardiovascular events)
- Unusual weight gain, swelling, decreased urination (signs of renal dysfunction)
- Yellowing of skin or eyes, dark urine, unusual fatigue (signs of liver problems)
Special Patient Groups
Pregnancy
Use of NSAIDs, including diclofenac topical solution, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. Avoid use in the third trimester. Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of miscarriage and cardiac malformation (limited data for NSAIDs).
Second Trimester:
Potential for fetal renal dysfunction and oligohydramnios (rare, but possible with prolonged use).
Third Trimester:
Increased risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, and fetal renal dysfunction. Contraindicated.
Lactation
Diclofenac is excreted in human milk in small amounts after oral administration. Due to low systemic absorption with topical application, the amount transferred to breast milk is expected to be very low. Use with caution; consider the benefit of breastfeeding and the potential risk to the infant.
Infant Risk:
Low risk of adverse effects to the breastfed infant due to minimal systemic absorption. Avoid applying to the breast area to prevent direct infant exposure.
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Not recommended for use in this population.
Geriatric Use
Elderly patients may be at greater risk for serious cardiovascular, gastrointestinal, and renal adverse events associated with NSAID use. While systemic absorption is low, monitor elderly patients more closely for these potential effects. Use the lowest effective dose for the shortest duration possible.
Clinical Information
Clinical Pearls
- Diclofenac 2% topical solution is specifically formulated for osteoarthritis of the knee. Its efficacy for other joints or conditions may vary.
- Ensure patients understand the correct application technique (40 drops per knee, 4 times daily) and the importance of not exceeding the maximum dose or applying to more than two knees at a time.
- Remind patients that while topical, it is still an NSAID and carries the same class warnings (GI, CV, renal) as oral NSAIDs, albeit with a lower systemic risk.
- Advise patients to wash their hands thoroughly after application and to avoid contact with eyes and mucous membranes.
- Inform patients about the potential for local skin reactions and to report any severe or persistent irritation.
Alternative Therapies
- Other topical NSAIDs (e.g., diclofenac 1% gel, diclofenac 1.5% topical solution)
- Oral NSAIDs (e.g., ibuprofen, naproxen, celecoxib)
- Acetaminophen
- Topical analgesics (e.g., capsaicin cream, lidocaine patches)
- Intra-articular corticosteroid injections
- Hyaluronic acid injections
- Physical therapy
- Weight management (for knee osteoarthritis)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$400+ per 112gm bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may require prior authorization for brand, generic often preferred)
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 provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or 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.