Diclofenac 3% Gel 100gm

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. In actinic keratosis, its effect is thought to be related to inhibition of COX-2, which is overexpressed in these lesions.

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 or bruises that enlarge, or uncontrollable bleeding.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of high potassium levels: irregular heartbeat, confusion, weakness, lightheadedness, dizziness, feeling faint, numbness or tingling, or shortness of breath.
Skin irritation, chest pain or pressure, rapid heartbeat, shortness of breath, significant weight gain, or swelling in the arms or legs.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Extreme fatigue or weakness, flu-like symptoms, severe back pain, or abnormal burning, numbness, or tingling sensations.
Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. Seek immediate medical help if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your 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, although many people may not experience any or may only have mild symptoms. If you are concerned about any of the following side effects or if they 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.

Before Taking This Medication: Important Information to Share with Your Doctor

It is crucial 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 drugs (e.g., 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 (e.g., aspirin), or pemetrexed.
Fertility issues or ongoing fertility evaluation.

Pregnancy and Fertility Considerations:

If you are pregnant, plan to become pregnant, or become pregnant while taking this medication, inform your doctor. This drug may harm an unborn baby if taken after 20 weeks of pregnancy.
Between 20 and 30 weeks of pregnancy, only take this medication if your doctor advises you to do so.
Do not take this medication if you are more than 30 weeks pregnant.

Interactions with Other Medications and Health Conditions:

This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist.
Verify that it is safe to take this medication with your other medications and health conditions.
* Never start, stop, or change the dose of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests, as directed by your doctor, are crucial to monitor your condition.

High blood pressure is a potential side effect of this medication. Ensure that your blood pressure is checked as frequently as advised by your doctor. If you are a smoker, discuss this with your doctor, as smoking may impact your treatment. Additionally, if you have asthma, consult with your doctor, as you may be more sensitive to this medication.

Before consuming alcohol, talk to your doctor to understand any potential risks. It is vital to use this medication only on healthy skin, avoiding any areas with problems. Do not exceed the prescribed dosage, as this may lead to severe side effects. Also, do not use this medication for a longer duration than recommended by your doctor.

To minimize potential risks, avoid exposing the treated area to sunlight. It is crucial to be aware 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 due to heart failure, and death may be higher. Discuss these risks with your doctor.

Furthermore, people who have had a recent 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 a year compared to those not taking it. If you are taking aspirin to prevent a heart attack, consult with your doctor.

Liver problems, which can be fatal, have been associated with this medication. Be vigilant for signs of liver problems, including dark urine, fatigue, decreased appetite, stomach upset or pain, pale stools, vomiting, or yellowing of the skin and eyes. If you experience any of these symptoms, contact your doctor immediately.

In case of accidental ingestion, this medication can cause harm. If swallowed, promptly call a doctor or a poison control center. 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. It is also important to note that NSAIDs, like this medication, may affect ovulation, potentially impacting fertility. However, this effect is reversible once the medication is stopped. Discuss any concerns with your doctor.

Finally, if you are breastfeeding, consult with your doctor to weigh the potential risks to your baby.

• In the setting of coronary artery bypass graft (CABG) surgery (due to systemic NSAID risk).

• Anticoagulants (e.g., warfarin): Increased risk of bleeding.
• Antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of bleeding.
• Lithium: Increased lithium levels and potential for toxicity.
• Methotrexate: Increased methotrexate levels and potential for toxicity.
• Diuretics (e.g., furosemide, hydrochlorothiazide): Reduced diuretic and antihypertensive effects, potential for renal impairment.
• ACE inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment and hyperkalemia.
• Other NSAIDs (systemic or topical): Increased risk of adverse effects (GI, renal).

• Digoxin: Increased digoxin levels.
• Cyclosporine: Increased risk of nephrotoxicity.
• Tacrolimus: Increased risk of nephrotoxicity.
• SSRIs/SNRIs: Increased risk of GI bleeding.

• Not many specific minor interactions for topical diclofenac due to low systemic absorption. However, general caution with drugs metabolized by CYP2C9/2C19.

• Skin irritation (redness, itching, burning, dryness, rash, scaling)
• Photosensitivity (sunburn-like reaction)
• Signs of systemic NSAID effects (rare with topical use but possible with extensive application or compromised skin):
• Gastrointestinal symptoms (e.g., abdominal pain, indigestion, black/tarry stools, vomiting blood)
• Cardiovascular symptoms (e.g., chest pain, shortness of breath, swelling of ankles/feet)
• Renal symptoms (e.g., decreased urine output, swelling)
• Unusual bleeding or bruising
• Allergic reactions (e.g., hives, swelling of face/lips/tongue/throat, difficulty breathing)

Diclofenac, like other NSAIDs, should be avoided in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Use in the first and second trimesters should only occur if the potential benefit justifies the potential risk to the fetus, and at the lowest effective dose for the shortest duration possible. The FDA's Pregnancy and Lactation Labeling Rule (PLLR) advises against NSAID use after 20 weeks gestation due to risk of fetal renal dysfunction and oligohydramnios.

Diclofenac is excreted in human milk in small amounts after systemic administration. While systemic absorption from topical application is minimal, caution should be exercised when diclofenac gel is administered to a nursing woman. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for diclofenac and any potential adverse effects on the breastfed infant from diclofenac or from the underlying maternal condition.

Safety and effectiveness of diclofenac 3% gel for actinic keratosis have not been established in pediatric patients.

No specific dose adjustment is required for elderly patients. However, elderly patients may be more susceptible to the adverse effects of NSAIDs, particularly gastrointestinal bleeding and renal impairment, if significant systemic absorption occurs. Use with caution and monitor for adverse reactions.

• Diclofenac 3% gel (Solaraze) is specifically indicated for the topical treatment of actinic keratosis, not for general pain relief.
• Treatment typically requires 60 to 90 days for optimal results, and complete healing may not be evident until 30 days after stopping therapy.
• Patients should be advised to protect treated areas from sun exposure and artificial UV light due to potential photosensitivity.
• Wash hands thoroughly after applying the gel to avoid accidental transfer to eyes or other sensitive areas.
• While systemic absorption is low, patients should be monitored for signs of systemic NSAID adverse effects, especially if large areas are treated or skin integrity is compromised.

• 5-Fluorouracil topical (e.g., Efudex, Carac)
• Imiquimod topical (e.g., Aldara, Zyclara)
• Ingenol mebutate topical (e.g., Picato - Note: Picato was voluntarily withdrawn from market due to safety concerns)
• Photodynamic therapy (PDT) with aminolevulinic acid (e.g., Levulan Kerastick)
• Cryosurgery (liquid nitrogen)
• Curettage and electrodessication
• Excisional surgery

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 whenever 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 medication taken, the amount, and the time it occurred.