Diclofenac 1% Gel 100gm (otc)

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. When applied topically, diclofenac penetrates the skin to reach underlying inflamed tissues, where it exerts its local 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, 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 changes, drooping on one side of the face, or blurred vision.
Extreme fatigue or weakness, flu-like symptoms, or severe back pain.

Severe Skin Reactions

This medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, which can be life-threatening. If you experience any of the following symptoms, seek medical help immediately:

Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever, chills, body aches, shortness of breath, or swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:

Dizziness or headache
Constipation, diarrhea, stomach pain, upset stomach, or vomiting
* Gas or heartburn

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 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, planned pregnancy, or potential pregnancy. This medication may harm an unborn baby if taken after 20 weeks of gestation. 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.

This list is not exhaustive, and it is crucial 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 existing treatments and health status. Never start, stop, or adjust the dosage 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 advised by your doctor. If you smoke, discuss this with your doctor, as it may impact your treatment. Additionally, if you have asthma, consult your doctor, as you may be more sensitive to this medication.

Before consuming alcohol, talk to your doctor to understand any potential risks. This medication should only be applied to healthy skin, avoiding any areas with problems. 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.

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, the risk of heart attack, hospitalization due to heart failure, and death may be higher. Discuss this with your doctor to understand the potential risks.

For individuals who have recently experienced a heart attack, the use of this medication may increase the risk of another heart attack and heart-related death. Furthermore, people taking this medication after a first heart attack may have a higher likelihood of death in the following year compared to those not taking this medication. If you are taking aspirin to prevent a heart attack, consult your doctor.

Liver problems, which can be fatal, have been associated with this medication. Immediately contact your doctor if you experience symptoms such as dark urine, fatigue, decreased appetite, stomach upset or pain, pale stools, vomiting, or yellowing of the skin or eyes.

If this medication is accidentally ingested, seek medical attention or contact a poison control center immediately. 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 NSAIDs like this medication may affect ovulation, potentially impacting fertility. However, this effect is reversible upon stopping the medication. Discuss any concerns with your doctor.

If you are breastfeeding, consult your doctor to discuss any potential risks to your baby.

• Aspirin (concurrent use with other NSAIDs increases risk of GI bleeding and ulceration)
• Other NSAIDs (oral or topical, due to increased risk of systemic adverse effects)

• Anticoagulants (e.g., Warfarin): Increased risk of bleeding.
• Lithium: Increased lithium plasma concentrations and potential for toxicity.
• Methotrexate: Increased methotrexate plasma concentrations and potential for toxicity.
• Cyclosporine: Increased risk of nephrotoxicity.
• Diuretics (e.g., Furosemide, Thiazide diuretics): Reduced natriuretic and antihypertensive effects.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect and increased risk of renal impairment.

• SSRIs/SNRIs: Increased risk of gastrointestinal bleeding.
• Digoxin: Increased digoxin plasma concentrations.
• Phenytoin: Increased phenytoin plasma concentrations.
• Oral Hypoglycemics: Potential for altered blood glucose control (rare for topical).

• Not many specific minor interactions for topical diclofenac due to low systemic absorption, but general caution with other medications.

• Local skin irritation (redness, itching, dryness, rash, blistering)
• Unusual bleeding or bruising
• Black, tarry stools or vomit that looks like coffee grounds (signs of GI bleeding)
• Severe stomach pain
• Swelling of hands, feet, or ankles
• Unexplained weight gain
• Shortness of breath or difficulty breathing
• Chest pain
• Weakness or numbness on one side of the body
• Slurred speech
• Yellowing of the skin or eyes (jaundice)
• Dark urine
• Flu-like symptoms (fever, body aches, rash)

Avoid use 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 only if the potential benefit justifies the potential risk to the fetus, and use the lowest effective dose for the shortest possible duration.

Diclofenac is excreted in breast milk in small amounts. Due to the low systemic absorption from topical application, the risk to a breastfed infant is considered low. Use with caution, and avoid applying the gel to areas that may come into direct contact with the infant (e.g., breasts).

Not recommended for use in children under 18 years of age for OTC pain relief. Safety and efficacy have not been established in this population for this indication.

No specific dose adjustment is needed for elderly patients. However, elderly patients may be at higher risk for NSAID-related adverse effects (e.g., gastrointestinal bleeding, renal impairment, cardiovascular events) if significant systemic absorption occurs. Use with caution and monitor for adverse effects.

• Emphasize that diclofenac gel is for external use only and should not be ingested.
• Instruct patients to use the dosing card provided with the product to ensure accurate measurement of the gel amount for each application.
• Advise patients that pain relief may not be immediate and can take up to 7 days of consistent use for noticeable improvement, with full effect potentially taking up to 2 weeks.
• Caution patients against using the gel on large body areas or for prolonged periods without consulting a healthcare professional, as this can increase systemic absorption and the risk of systemic side effects.
• Remind patients to wash their hands thoroughly after each application to prevent accidental transfer of the gel to eyes or other sensitive areas.

• Other topical analgesics (e.g., capsaicin cream, lidocaine patches, menthol/methyl salicylate rubs)
• Oral NSAIDs (e.g., ibuprofen, naproxen) for systemic pain relief
• Acetaminophen for pain relief
• Non-pharmacological therapies (e.g., RICE - Rest, Ice, Compression, Elevation; physical therapy, exercise, heat/cold therapy, assistive devices)

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 is a valuable resource 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, we encourage you to discuss them with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount, and the time it occurred.