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Rofecoxib

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Generic Name of Rofecoxib - Learn More

Rofecoxib

Rofecoxib Precaution - What You Need to Know

Before initiating Rofecoxib, patients must consult with their healthcare provider, especially if they have the following conditions or risk factors:

- Cardiovascular Disease: Rofecoxib is a COX-2 inhibitor and has been associated with an increased risk of cardiovascular events, such as heart attack, stroke, and hypertension. Patients with a history of cardiovascular disease (such as heart failure, angina, or prior heart attack) should be carefully monitored or consider alternative treatments.
- Gastrointestinal Disorders: Although COX-2 inhibitors like Rofecoxib generally have a lower risk of causing gastrointestinal bleeding and ulcers compared to traditional NSAIDs, patients with a history of gastric ulcers, GI bleeding, or inflammatory bowel disease should still be cautious.
- Renal Impairment: Patients with renal dysfunction (kidney disease) should use Rofecoxib with caution, as it can affect kidney function, especially with long-term use or high doses. Dosage adjustments may be required for individuals with renal impairment.
- Liver Disease: Individuals with severe liver impairment should avoid Rofecoxib, as the drug is metabolized by the liver. Regular liver function tests are recommended for those using Rofecoxib for prolonged periods.
- Hypertension: Rofecoxib can cause or worsen high blood pressure. Blood pressure should be monitored regularly while on this medication.
- Pregnancy and Breastfeeding: Rofecoxib should generally be avoided during pregnancy, particularly in the third trimester, as it can cause premature closure of the ductus arteriosus, a vital vessel in fetal circulation. It is also not recommended during breastfeeding, as it is excreted in breast milk.
- Allergic Reactions: Patients who have had an allergic reaction to Rofecoxib, other COX-2 inhibitors, or NSAIDs should not take this medication.

Rofecoxib Indication - Uses and Benefits

Rofecoxib was primarily used for:

- Osteoarthritis and Rheumatoid Arthritis: Rofecoxib was commonly prescribed to reduce inflammation, pain, and stiffness in patients with osteoarthritis and rheumatoid arthritis.
- Acute Pain: It was used for the short-term relief of acute pain (such as dental pain, post-operative pain, or menstrual pain).
- Dysmenorrhea: Rofecoxib was also used to relieve pain associated with menstrual cramps (dysmenorrhea).
- Ankylosing Spondylitis: Rofecoxib was used to treat the pain and inflammation associated with ankylosing spondylitis, a type of arthritis affecting the spine.
- Post-operative Pain: It was prescribed for pain relief after surgical procedures.

However, Rofecoxib was withdrawn from the market in 2004 due to concerns about its association with increased cardiovascular risks. Therefore, it is no longer commonly prescribed.

Rofecoxib Contraindications - Important Warnings

Rofecoxib is contraindicated in the following situations:

- Active or History of Cardiovascular Disease: Individuals with a history of heart attack, stroke, or uncontrolled hypertension should avoid Rofecoxib due to the increased risk of cardiovascular events.
- Gastrointestinal Ulcers or Bleeding: Those with a history of peptic ulcers, GI bleeding, or other gastrointestinal conditions should not take Rofecoxib, as it can exacerbate these conditions.
- Severe Liver Disease: Rofecoxib is contraindicated in patients with severe liver dysfunction, as it is metabolized by the liver and may cause further liver damage.
- Allergic Reactions to NSAIDs or COX-2 Inhibitors: Patients with known allergies to Rofecoxib, other NSAIDs, or COX-2 inhibitors (like Celecoxib) should avoid this medication.
- Pregnancy (Third Trimester): Rofecoxib should not be used during the third trimester of pregnancy due to the risk of fetal complications such as premature closure of the ductus arteriosus.
- Severe Renal Impairment: Patients with significant renal impairment should avoid Rofecoxib, as it can further affect kidney function.

Rofecoxib Side Effects - What to Expect

Common and serious side effects of Rofecoxib include:

- Common Side Effects:
- Headache and dizziness.
- Nausea and stomach upset.
- Diarrhea or constipation.
- Edema (swelling, especially in the legs and ankles).

- Serious Side Effects:
- Cardiovascular Events: Rofecoxib has been associated with an increased risk of heart attack, stroke, and thromboembolic events (blood clots). These risks increase with long-term use or higher doses.
- Gastrointestinal Bleeding: Though less common than with traditional NSAIDs, Rofecoxib may still cause gastric ulcers, GI bleeding, or perforation, especially in high-risk individuals.
- Kidney Damage: Prolonged use of Rofecoxib can lead to kidney problems, including acute renal failure.
- Liver Toxicity: Liver enzyme abnormalities or liver damage (hepatotoxicity) may occur, requiring regular monitoring of liver function.
- Severe Allergic Reactions: Symptoms like swelling, hives, or difficulty breathing may indicate an allergic reaction.

Rofecoxib Pregnancy Category ID - Safety Information

3

Rofecoxib Mode of Action - How It Works

Rofecoxib is a selective COX-2 inhibitor (cyclooxygenase-2 inhibitor). Its mode of action involves selectively inhibiting the COX-2 enzyme, which is involved in the synthesis of prostaglandins—chemicals that mediate inflammation, pain, and fever in the body. By reducing the levels of these pro-inflammatory prostaglandins, Rofecoxib helps to alleviate pain and inflammation associated with conditions like arthritis and acute pain. Unlike traditional NSAIDs, which inhibit both COX-1 and COX-2, Rofecoxib targets only COX-2, theoretically reducing the risk of gastrointestinal side effects like ulcers and bleeding.

However, COX-2 inhibitors may increase the risk of cardiovascular events because COX-2 plays a role in vascular health.

Rofecoxib Drug Interactions - What to Avoid

Rofecoxib may interact with other medications, potentially altering its effects or increasing the risk of side effects:

- Antihypertensives: Rofecoxib can reduce the effectiveness of ACE inhibitors, angiotensin receptor blockers (ARBs), and diuretics. It may also increase blood pressure, counteracting the effects of antihypertensive drugs.
- Anticoagulants: Rofecoxib can interact with warfarin and other blood-thinning medications, increasing the risk of bleeding. Regular monitoring of INR (International Normalized Ratio) is recommended for patients on warfarin.
- Lithium: Rofecoxib can increase the levels of lithium in the blood, potentially leading to lithium toxicity. Close monitoring of lithium levels is necessary.
- Diuretics: Rofecoxib can reduce the effect of diuretics like furosemide and increase the risk of kidney dysfunction, especially in individuals with pre-existing kidney issues.
- Methotrexate: Combining Rofecoxib with methotrexate may increase the risk of toxicity, especially in high doses of methotrexate.

Rofecoxib Pregnancy Category Note - Key Information

Pregnancy Category C, D (in 3rd trimester or near delivery)

Rofecoxib Adult Dose - Recommended Dosage

The usual dose of Rofecoxib for osteoarthritis and rheumatoid arthritis was 12.5 mg to 25 mg once daily. For acute pain or dysmenorrhea, a 50 mg dose was typically used for a short duration.

Note: Rofecoxib was withdrawn from the market in 2004, so it is no longer recommended or available for use.

Rofecoxib Child Dose - Dosage for Children

Rofecoxib was not typically recommended for use in children, particularly in individuals under 18 years old, as safety and efficacy have not been well established for pediatric populations. Always consult a healthcare provider before using this medication in children.

Rofecoxib Renal Dose - Dosage for Kidney Conditions

In patients with renal impairment, Rofecoxib should be used with caution. The drug is primarily eliminated via the kidneys, so in individuals with severe renal dysfunction (creatinine clearance <30 mL/min), the use of Rofecoxib may need to be avoided or closely monitored.

  • Non-steroidal Anti-inflammatory Drugs (NSAIDs) -
  • Drugs used for Rheumatoid Arthritis -
  • Drugs for Osteoarthritis -
  • Non-steroidal Anti-inflammatory Drugs (NSAIDs) -
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