Diclofenac 1.5% Topical Sol 150ml
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/D
FDA Approved
Aug 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Diclofenac 1.5% Topical Solution is a liquid medicine that you apply directly to your skin, usually on joints like the knee. It belongs to a group of medicines called NSAIDs (nonsteroidal anti-inflammatory drugs). It works by reducing pain and swelling caused by conditions like osteoarthritis, 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 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 the medication at room temperature, away from heat, and do not freeze.
Missed Dose
If you miss a dose, skip it and resume your regular 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 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 the medication at room temperature, away from heat, and do not freeze.
Missed Dose
If you miss a dose, skip it and resume your regular 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, intact skin. Do not apply to open wounds, cuts, infections, or rashes.
- Wash your hands thoroughly after applying the solution, unless your hands are the treated area.
- Do not shower or bathe for at least 30 minutes after applying the solution.
- Avoid applying heat (e.g., heating pads) or occlusive dressings (e.g., bandages that don't breathe) over the treated area.
- Protect treated areas from sunlight and artificial UV light (e.g., tanning beds) as this medication can increase sun sensitivity.
- 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:
40 drops (1.2 mL) to each affected knee 4 times daily
Condition-Specific Dosing:
osteoarthritis_knee:
40 drops (1.2 mL) to each affected knee 4 times daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for topical formulation; use with caution if systemic risk factors.
Moderate:
No specific adjustment for topical formulation; use with caution if systemic risk factors.
Severe:
No specific adjustment for topical formulation; use with caution, monitor for systemic adverse effects.
Dialysis:
No specific adjustment for topical formulation; use with caution, monitor for systemic adverse effects.
Hepatic Impairment:
Mild:
No specific adjustment for topical formulation; use with caution if systemic risk factors.
Moderate:
No specific adjustment for topical formulation; use with caution if systemic risk factors.
Severe:
No specific adjustment for topical formulation; use with caution, monitor for systemic adverse effects.
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. In topical application, it provides local analgesic and anti-inflammatory effects by concentrating in the underlying tissues.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 10% (systemic relative to oral diclofenac), but high local tissue concentrations.
Tmax:
10-14 hours (systemic plasma concentration after topical application)
FoodEffect:
Not applicable for topical administration.
Distribution:
Vd:
0.12-0.17 L/kg (systemic)
ProteinBinding:
>99% (primarily to albumin)
CnssPenetration:
Limited (for topical application, systemic levels are low)
Elimination:
HalfLife:
1-2 hours (systemic plasma half-life)
Clearance:
Approximately 263 mL/min (systemic)
ExcretionRoute:
Renal (approx. 60%), Biliary/Fecal (approx. 30-40%)
Unchanged:
<1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 1 week for pain relief (clinical studies)
PeakEffect:
Sustained pain relief with continued application.
DurationOfAction:
Related to dosing frequency (e.g., approximately 6 hours for qid dosing)
Safety & Warnings
BLACK BOX WARNING
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Diclofenac 1.5% Topical Solution is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
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 immediate 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 weight gain.
Signs of high potassium levels: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, 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
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 affect internal organs. Seek immediate medical help 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
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, 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 immediate 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 weight gain.
Signs of high potassium levels: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, 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
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 affect internal organs. Seek immediate medical help 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience:
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, 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, blistering, or peeling skin
- Signs of bleeding: black, tarry stools; vomiting blood or material that looks like coffee grounds; unusual bruising or bleeding
- Severe stomach pain or persistent heartburn
- Swelling of your ankles, feet, or hands (edema)
- Unexplained weight gain
- Shortness of breath, chest pain, or weakness on one side of the body (signs of heart problems or stroke)
- Yellowing of your skin or eyes (jaundice), dark urine, or unusual fatigue (signs of liver problems)
- Signs of allergic reaction: rash, hives, itching, difficulty breathing or swallowing, swelling of the face, lips, tongue, or 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 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 checked, or are pregnant, inform your doctor.
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 under your doctor's guidance.
Do not take this medication if you are more than 30 weeks pregnant.
Interactions with Other Medications and Health Conditions:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist.
Verify that it is safe to take this medication with your existing medications and health conditions.
Never start, stop, or adjust the dosage 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 checked, or are pregnant, inform your doctor.
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 under your doctor's guidance.
Do not take this medication if you are more than 30 weeks pregnant.
Interactions with Other Medications and Health Conditions:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist.
Verify that it is safe to take this medication with your existing medications and health conditions.
Never start, stop, or adjust 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.
High blood pressure is a potential side effect of this medication. Your doctor will instruct 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 inform your doctor.
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 direct sunlight. It is also important to note that the use of this medication may increase the risk of heart failure. If you have pre-existing 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 recently experienced a heart attack may have 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 heart attacks, consult with your doctor to discuss the potential interactions.
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 yellowing of the skin or eyes, contact your doctor immediately.
In the event that this medication is swallowed, seek medical attention or contact a poison control center right away, as it may cause harm. 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 breast-feeding, inform your doctor, as they will need to assess the potential risks to your baby and discuss alternative options with you.
High blood pressure is a potential side effect of this medication. Your doctor will instruct 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 inform your doctor.
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 direct sunlight. It is also important to note that the use of this medication may increase the risk of heart failure. If you have pre-existing 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 recently experienced a heart attack may have 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 heart attacks, consult with your doctor to discuss the potential interactions.
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 yellowing of the skin or eyes, contact your doctor immediately.
In the event that this medication is swallowed, seek medical attention or contact a poison control center right away, as it may cause harm. 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 breast-feeding, inform your doctor, as they will need to assess the potential risks to your baby and discuss alternative options with you.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Stomach pain
- Drowsiness
- Lethargy
- Tinnitus (ringing in the ears)
- Headache
- Dizziness
- Convulsions (rarely)
What to Do:
In case of suspected overdose, immediately contact a poison control center (1-800-222-1222) or seek emergency medical attention. Management is primarily supportive and symptomatic. Gastric lavage and/or activated charcoal may be considered if ingestion was recent and significant. Monitor vital signs and provide supportive care as needed.
Drug Interactions
Major Interactions
Moderate Interactions
- SSRIs (Selective Serotonin Reuptake Inhibitors)
- Corticosteroids
- Digoxin
- Pemetrexed
- Phenytoin
Monitoring
Baseline Monitoring
Renal function (BUN, Creatinine)
Rationale: To assess baseline kidney function, especially in patients with pre-existing renal impairment or risk factors, as NSAIDs can affect renal function.
Timing: Prior to initiation, especially for prolonged use or in at-risk patients.
Liver function (ALT, AST)
Rationale: To assess baseline liver function, particularly in patients with pre-existing hepatic impairment or risk factors, as NSAIDs can cause liver enzyme elevations.
Timing: Prior to initiation, especially for prolonged use or in at-risk patients.
Routine Monitoring
Pain assessment
Frequency: Regularly, as clinically indicated (e.g., weekly initially, then monthly)
Target: Reduction in pain score (e.g., >30% reduction on VAS/NRS)
Action Threshold: Lack of efficacy after 2-4 weeks; consider alternative therapy.
Signs of GI bleeding (e.g., black/tarry stools, abdominal pain)
Frequency: Patient education for self-monitoring; clinician inquiry at follow-up visits.
Target: Absence of symptoms
Action Threshold: Presence of symptoms; discontinue drug and investigate.
Edema/Weight gain
Frequency: Patient education for self-monitoring; clinician inquiry at follow-up visits.
Target: Absence of significant swelling or unexplained weight gain
Action Threshold: Significant edema or rapid weight gain; assess for fluid retention/cardiac issues.
Blood pressure
Frequency: Periodically, especially in hypertensive patients or those at risk for cardiovascular events.
Target: Within patient's target range
Action Threshold: Significant increase in blood pressure; adjust antihypertensive therapy or discontinue diclofenac.
Skin irritation at application site
Frequency: Daily self-monitoring by patient; clinician inspection at follow-up visits.
Target: Minimal to no irritation, redness, or rash
Action Threshold: Severe rash, blistering, or persistent irritation; discontinue use.
Symptom Monitoring
- Unusual bleeding or bruising
- Black, tarry stools or vomiting blood
- Severe stomach pain
- Swelling of ankles, feet, or hands
- Unexplained weight gain
- Shortness of breath or chest pain
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Unusual fatigue or weakness
- Severe skin rash or blistering
- Signs of allergic reaction (e.g., difficulty breathing, swelling of face/throat)
Special Patient Groups
Pregnancy
Use of NSAIDs, including diclofenac topical solution, should be avoided in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and fetal renal dysfunction. Use in the first and second trimesters should only be considered if the potential benefit justifies the potential risk to the fetus, and at the lowest effective dose for the shortest possible duration.
Trimester-Specific Risks:
First Trimester:
Potential for increased risk of miscarriage and cardiac malformation (limited data, not conclusive).
Second Trimester:
Generally considered lower risk than third trimester, but still use with caution and only if clearly needed.
Third Trimester:
High risk of premature closure of the fetal ductus arteriosus, persistent pulmonary hypertension of the newborn, and fetal renal dysfunction leading to oligohydramnios. Contraindicated.
Lactation
Diclofenac is excreted in breast milk in small amounts following systemic administration. While systemic absorption from topical application is low, caution should be exercised when diclofenac topical solution is administered to a nursing mother. Monitor the infant for potential adverse effects such as drowsiness or feeding difficulties.
Infant Risk:
Low risk, but potential for adverse effects exists. Monitor infant.
Pediatric Use
Safety and effectiveness in pediatric patients (under 18 years of age) have not been established. Use is generally not recommended in this population.
Geriatric Use
Elderly patients may be at increased risk for serious adverse reactions associated with NSAIDs, including gastrointestinal bleeding, renal impairment, and cardiovascular events, due to age-related decline in renal and hepatic function and increased comorbidity. Use the lowest effective dose for the shortest duration necessary, and monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Diclofenac 1.5% Topical Solution is specifically formulated for osteoarthritis of the knee. While it may be used off-label for other joints, efficacy data is primarily for the knee.
- Ensure the patient understands the correct application technique: 40 drops per knee, 4 times daily, spread evenly over the entire knee.
- Advise patients not to apply the solution to open wounds, infected areas, or areas with skin conditions like eczema or psoriasis.
- Remind patients about the potential for photosensitivity (increased sensitivity to sunlight) at the application site; advise protective clothing or sunscreen.
- Although systemic absorption is low, patients should still be aware of the potential for systemic NSAID side effects, especially GI and cardiovascular risks, particularly if they have pre-existing conditions or are on other medications that interact with NSAIDs.
- Patients should avoid showering or bathing for at least 30 minutes after application to allow for adequate absorption.
Alternative Therapies
- Oral NSAIDs (e.g., ibuprofen, naproxen, celecoxib)
- Acetaminophen
- Topical analgesics (e.g., capsaicin cream, lidocaine patch)
- Corticosteroid injections (intra-articular)
- Hyaluronic acid injections (intra-articular)
- Physical therapy
- Heat/cold therapy
- Weight management (for osteoarthritis)
Cost & Coverage
Average Cost:
Variable, typically $100-$400 per 150ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (varies by insurance plan)
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 crucial patient fact sheet. Please read it carefully and review it again each time you receive a refill. 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 seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.