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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Diclofenac Sodium And Misoprostol
Brand Name
Diclofenac Sodium Misoprostol
Generic Name
Diclofenac Sodium And Misoprostol
Active Ingredient
DiclofenacCategory
Prostaglandin E1 Analog [EPC]
Salt Form
Sodium
Variants
7
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 75 mg/1 | TABLET, DELAYED RELEASE | ORAL | 71335-2441 |
| 50 mg/1 | TABLET, DELAYED RELEASE | ORAL | 72162-2518 |
| 75 mg/1 | TABLET, DELAYED RELEASE | ORAL |
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Diclofenac Sodium Misoprostol, you must consult a qualified healthcare professional.
| 50 mg/1 | TABLET, DELAYED RELEASE | ORAL | 75834-264 |
| 75 mg/1 | TABLET, DELAYED RELEASE | ORAL | 75834-265 |
| 50 mg/1 | TABLET, DELAYED RELEASE | ORAL | 71205-865 |
| 75 mg/1 | TABLET, DELAYED RELEASE | ORAL | 71205-866 |
Detailed information about Diclofenac Sodium Misoprostol
Diclofenac is a potent nonsteroidal anti-inflammatory drug (NSAID) used to manage pain and inflammation. It works by inhibiting cyclooxygenase enzymes to reduce prostaglandin production, making it a cornerstone therapy for arthritis and acute musculoskeletal injuries.
The dosage of Diclofenac must be individualized to the lowest effective dose for the shortest possible duration to minimize the risk of cardiovascular and gastrointestinal adverse events. Healthcare providers typically follow these general guidelines for adults:
Diclofenac is generally not recommended for use in children for general pain. However, some formulations are specifically approved for the treatment of Juvenile Rheumatoid Arthritis (JRA). For children aged 2 to 16 years with JRA, the typical dosage is 2 mg/kg to 3 mg/kg of body weight per day, divided into two or three doses. Safety and efficacy for other conditions in pediatric patients have not been established. Never give Diclofenac to a child or adolescent unless specifically directed by a pediatrician, as NSAIDs can occasionally be associated with serious risks in younger populations.
Diclofenac is not recommended for patients with advanced renal (kidney) disease. In patients with mild to moderate renal impairment, healthcare providers will monitor kidney function closely (serum creatinine and GFR). If kidney function declines during treatment, the medication may need to be discontinued.
Patients with mild hepatic (liver) impairment typically do not require an initial dose adjustment, but they must be monitored for signs of hepatotoxicity. Diclofenac should be used with extreme caution in patients with severe hepatic impairment, and lower doses are usually warranted.
Patients over the age of 65 are at a significantly higher risk for serious side effects, particularly gastrointestinal bleeding and kidney dysfunction. Clinical guidelines suggest starting at the lowest possible dose and monitoring these patients frequently for any signs of adverse reactions.
To ensure the medication works effectively and safely, follow these specific instructions:
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to make up for a missed one, as this significantly increases the risk of gastrointestinal toxicity.
Symptoms of a Diclofenac overdose may include severe epigastric pain (pain in the upper abdomen), nausea, vomiting, drowsiness, lethargy, and in severe cases, gastrointestinal bleeding, hypertension (high blood pressure), acute renal failure, or coma. If an overdose is suspected, contact your local poison control center or seek emergency medical attention immediately. Emergency management typically involves gastric lavage (stomach pumping) and the administration of activated charcoal if the overdose occurred recently.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without medical guidance, especially if you are using it for a chronic inflammatory condition.
Like all NSAIDs, Diclofenac is most frequently associated with gastrointestinal (GI) issues. More than 10% of patients may experience:
Diclofenac is a powerful medication that requires careful oversight by a healthcare professional. It is not a 'simple' pain reliever and carries significant systemic risks that must be balanced against its benefits. Patients with a history of heart disease, high blood pressure, or stomach ulcers must exercise extreme caution. It is vital to use the lowest effective dose for the shortest time possible to manage symptoms. Avoid taking multiple NSAIDs (such as ibuprofen, naproxen, or aspirin) simultaneously, as this dramatically increases the risk of toxicity without providing additional therapeutic benefit.
Cardiovascular Thrombotic Events: Clinical trials of several COX-2 selective and non-selective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and non-selective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with Diclofenac, the lowest effective dose should be used for the shortest duration possible.
Gastrointestinal Bleeding, Ulceration, and Perforation: NSAIDs, including Diclofenac, cause an increased risk of serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the stomach, small intestine, or large intestine, which can be fatal. These events can occur at any time during use and without warning symptoms. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic.
Certain medications should never be combined with Diclofenac due to the risk of severe, life-threatening interactions:
Diclofenac must NEVER be used in the following circumstances:
Diclofenac use during pregnancy is complex and depends on the gestational age.
Diclofenac is a potent inhibitor of cyclooxygenase (COX), the enzyme responsible for the synthesis of prostaglandins and thromboxanes from arachidonic acid. It is a non-selective NSAID, meaning it inhibits both the COX-1 and COX-2 isoforms. COX-1 is involved in 'housekeeping' functions like gastric mucosal protection and platelet aggregation, while COX-2 is induced during inflammation. By reducing the production of Prostaglandin E2 (PGE2), Diclofenac effectively raises the pain threshold and reduces the vasodilation and edema associated with the inflammatory response. Additionally, Diclofenac may reduce intracellular concentrations of free arachidonic acid in leukocytes, potentially by altering fatty acid transport.
The pain-relieving effects of Diclofenac typically begin within 30 to 60 minutes for immediate-release formulations, while the full anti-inflammatory effects for conditions like arthritis may take up to two weeks of consistent dosing to reach their peak. There is a clear dose-response relationship; however, increasing the dose beyond the recommended maximums does not significantly increase efficacy but does dramatically increase the risk of adverse events. Tolerance to the analgesic effects does not typically develop, but the risk of systemic toxicity increases over time.
Common questions about Diclofenac Sodium Misoprostol
Diclofenac is primarily used to relieve pain, swelling, and joint stiffness caused by various types of arthritis, including osteoarthritis and rheumatoid arthritis. It is also highly effective for managing acute pain from muscle strains, menstrual cramps, and dental procedures. Some specific formulations are used to treat acute migraine attacks or inflammatory skin conditions like actinic keratosis. Because it targets the inflammatory process directly, it is often more effective for joint pain than simple pain relievers like acetaminophen. Your healthcare provider will determine the best use case based on your specific symptoms and medical history.
The most common side effects of Diclofenac involve the digestive system, including stomach pain, nausea, heartburn, diarrhea, and constipation. Many patients also report mild headaches or dizziness when first starting the medication. Fluid retention, which can cause slight swelling in the ankles or hands, is another frequently observed side effect. While these are common, they are usually manageable and may improve if the medication is taken with food. However, any persistent or worsening symptoms should be reported to your doctor to ensure the medication is being tolerated well.
It is generally advised to avoid or strictly limit alcohol consumption while taking Diclofenac. Both alcohol and Diclofenac can irritate the protective lining of the stomach and intestines. When used together, they significantly increase the risk of developing stomach ulcers or experiencing a dangerous gastrointestinal bleed. Even small amounts of alcohol can exacerbate the gastric side effects of NSAIDs. If you have a history of heavy alcohol use, you must discuss this with your healthcare provider, as you may be at a much higher risk for liver and stomach complications.
Diclofenac is generally not recommended during pregnancy unless specifically prescribed by a doctor who has weighed the risks. It is especially dangerous during the third trimester (after 30 weeks) because it can cause serious heart defects in the developing fetus and may complicate labor and delivery. Use in the first and second trimesters has also been linked to an increased risk of miscarriage in some studies. If you are pregnant or planning to become pregnant, you should discuss alternative pain management strategies with your obstetrician. Always notify your healthcare provider immediately if you become pregnant while taking this medication.
The time it takes for Diclofenac to work depends on the formulation and the condition being treated. For acute pain, immediate-release tablets or powder packets (like Diclofenac Potassium) typically begin providing relief within 30 to 60 minutes. However, for chronic inflammatory conditions like rheumatoid arthritis, it may take up to two weeks of regular dosing before you experience the full anti-inflammatory benefits. It is important to take the medication consistently as prescribed rather than just 'as needed' if you are treating a chronic condition. If you do not feel any improvement after two weeks, consult your healthcare provider.
Diclofenac is not an addictive medication, so you can generally stop taking it without experiencing physical withdrawal symptoms. However, if you are taking it for a chronic condition like arthritis, stopping suddenly may cause a rapid return of pain, stiffness, and inflammation. It is always best to consult your healthcare provider before discontinuing long-term therapy to ensure your symptoms remain managed. They may suggest a different treatment or a gradual transition to another medication. If you were taking it for a short-term injury, you can usually stop once the pain has resolved.
If you miss a dose of Diclofenac, take it as soon as you remember. If it is nearly time for your next scheduled dose, skip the missed dose and continue with your regular schedule. Never take two doses at the same time to 'catch up,' as this significantly increases the risk of stomach irritation and other side effects. Maintaining a consistent level of the medication in your bloodstream is important for treating inflammation, so try to take it at the same time each day. Using a pill organizer or setting a phone reminder can help you stay on track with your doses.
Diclofenac does not typically cause weight gain in the form of increased body fat. However, it can cause the body to retain excess fluid (edema), which may lead to a sudden increase in weight or swelling in the legs and feet. This fluid retention is a result of the drug's effect on the kidneys and sodium balance. If you notice a rapid weight gain of more than 3 to 5 pounds in a week, or if you have difficulty breathing, contact your doctor immediately. This could be a sign of heart failure or significant kidney stress, especially in patients with pre-existing heart conditions.
Diclofenac has many potential drug interactions, so it is crucial to inform your doctor of all medications you are currently taking. It can interact dangerously with blood thinners like warfarin, increasing the risk of bleeding. It may also reduce the effectiveness of blood pressure medications and increase the toxicity of drugs like lithium or methotrexate. You should also avoid taking it with other NSAIDs, such as ibuprofen or aspirin, as this increases the risk of stomach ulcers. Your pharmacist can provide a comprehensive check for any potential conflicts with your current medication regimen.
Yes, Diclofenac is widely available as a generic medication in many forms, including Diclofenac Sodium and Diclofenac Potassium. Generic versions are typically much more affordable than brand-name versions like Voltaren or Cataflam and are required by the FDA to have the same active ingredient, strength, and efficacy. Whether you are prescribed the brand or the generic, the clinical effects and safety profile remain the same. Most insurance plans prefer the generic version, and your pharmacist can help you determine which specific formulation is covered under your plan.
Other drugs with the same active ingredient (Diclofenac)
These effects are often transient and may diminish as your body acclimates to the drug. Taking the medication with food can often mitigate the GI-related symptoms.
Between 1% and 10% of patients may experience:
While rare, these effects require careful monitoring:
> Warning: Stop taking Diclofenac and call your doctor immediately if you experience any of these symptoms. These may indicate life-threatening complications.
Prolonged use of Diclofenac, particularly at high doses, increases the cumulative risk of several conditions:
The FDA has issued a Black Box Warning for Diclofenac, the highest level of alert, regarding two major risks:
Report any unusual symptoms to your healthcare provider immediately to ensure your treatment remains safe.
If you are prescribed Diclofenac for a chronic condition, your healthcare provider will likely require regular monitoring, including:
Diclofenac can cause dizziness, drowsiness, or visual disturbances in some patients. If you experience these side effects, you should avoid driving, operating heavy machinery, or performing tasks that require mental alertness until you know how the medication affects you.
Consumption of alcohol while taking Diclofenac significantly increases the risk of gastrointestinal bleeding and stomach ulcers. It is generally advised to avoid or strictly limit alcohol intake during treatment. Even moderate alcohol consumption can irritate the stomach lining, which is already sensitized by the NSAID.
While Diclofenac does not have a formal 'withdrawal syndrome,' stopping the medication suddenly if you have been taking it for chronic inflammation may result in a rapid return of pain and stiffness. If you need to stop the medication, discuss a management plan with your doctor. There is no need for tapering for the purpose of preventing physiological withdrawal, but a gradual transition to another therapy may be clinically appropriate.
> Important: Discuss all your medical conditions, especially any history of heart, liver, or kidney disease, with your healthcare provider before starting Diclofenac.
Diclofenac does not typically interfere with common laboratory tests, but it can cause false-positive results in some urine drug screens for certain substances (though this is rare). It will affect tests for fecal occult blood (may cause a positive result due to minor GI bleeding).
For each major interaction, the management strategy usually involves either avoiding the combination, adjusting the dose of the interacting drug, or performing more frequent laboratory monitoring.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking to prevent dangerous interactions.
These conditions require a careful risk-benefit analysis by a healthcare provider:
There is a high degree of cross-sensitivity between Diclofenac and other NSAIDs. If you have had a severe reaction (like swelling or difficulty breathing) to ibuprofen, naproxen, celecoxib, or indomethacin, you are highly likely to react to Diclofenac as well. Always inform your healthcare provider of any previous drug allergies before starting a new medication.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Diclofenac to ensure it is safe for you.
Diclofenac is excreted into human breast milk in very small amounts. In limited studies, a dose of 150 mg daily produced milk levels that were considered too low to be harmful to a nursing infant. However, because of the potential for serious adverse reactions in nursing infants from Diclofenac, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Diclofenac is not approved for general use in children under 18 for acute pain. Its use is limited to Juvenile Rheumatoid Arthritis (JRA) in specific formulations for children aged 2 and older. Pediatric patients may be more susceptible to certain side effects, and growth monitoring is sometimes recommended during long-term therapy for JRA.
Patients aged 65 and older are at the highest risk for Diclofenac-related complications. Age-related declines in renal and hepatic function mean the drug may clear more slowly from the body. The risk of fatal GI bleeding is significantly higher in this population. Clinical guidelines recommend starting at the lowest end of the dosing range and monitoring for signs of occult GI bleeding (such as anemia or dark stools) and kidney stress.
Diclofenac is not recommended in patients with advanced renal disease. For those with mild to moderate impairment, no specific starting dose adjustment is usually required, but the glomerular filtration rate (GFR) must be monitored. Prostaglandins help maintain renal perfusion; by blocking them, Diclofenac can cause a sudden drop in kidney function, particularly in patients who are dehydrated or taking diuretics.
Since Diclofenac is primarily metabolized by the liver, patients with hepatic impairment (Child-Pugh Class A or B) should be monitored closely for worsening liver function. In patients with severe hepatic impairment (Child-Pugh Class C), the use of Diclofenac is generally avoided due to the increased risk of toxicity and bleeding.
> Important: Special populations require individualized medical assessment and frequent monitoring to ensure the safest possible outcomes.
| Parameter | Value |
|---|---|
| Bioavailability | ~50% (due to first-pass metabolism) |
| Protein Binding | >99.7% (primarily to albumin) |
| Half-life | 1.2 to 2.0 hours (plasma) |
| Tmax | 1-2 hours (Potassium); 2-3 hours (Sodium EC) |
| Metabolism | Hepatic (CYP2C9 hydroxylation) |
| Excretion | Renal 65%, Fecal 35% |
Diclofenac is classified as a nonsteroidal anti-inflammatory drug (NSAID) and specifically falls under the acetic acid derivative group. It is therapeutically related to medications such as indomethacin, etodolac, and ketorolac. Within the broader category of analgesics, it is distinct from opioids as it does not bind to mu-opioid receptors and does not carry a risk of physical dependence or respiratory depression.