Celecoxib (Celbex 400) 400mg Capsule 20's

Here is the detailed information for Celecoxib (Celbex 400) 400mg Capsule 20's:

Product Description:

Celecoxib (Celbex 400) is a nonsteroidal anti-inflammatory drug (NSAID) that specifically inhibits the COX-2 enzyme, which plays a key role in producing prostaglandins that cause inflammation and pain. By selectively inhibiting COX-2, Celecoxib provides effective pain and inflammation relief while reducing the risk of gastrointestinal side effects commonly associated with traditional NSAIDs.

Each capsule contains 400mg of Celecoxib, and the packaging includes 20 capsules. Celecoxib is often used for managing conditions like arthritis and acute pain.

Indications:

Celecoxib (Celbex 400) is indicated for the treatment of the following conditions:

1. Osteoarthritis:

   • To reduce pain and inflammation associated with osteoarthritis (degenerative joint disease).

2. Rheumatoid Arthritis:

   • To manage the pain, swelling, and stiffness associated with rheumatoid arthritis (an autoimmune inflammatory joint disease).

3. Acute Pain:

   • For the short-term relief of acute pain, including pain from injuries or surgeries.

4. Dysmenorrhea:

   • To treat primary dysmenorrhea, which is painful menstruation caused by prostaglandin release.

5. Ankylosing Spondylitis:

   • Celecoxib can be used to treat pain and inflammation caused by ankylosing spondylitis, a type of arthritis that primarily affects the spine.

6. Postoperative Pain:

   • Used to manage moderate to severe pain after surgery.

Dosages:

The dosage of Celecoxib (Celbex 400) depends on the condition being treated and the individual patient's response to treatment. The following dosages are general guidelines:

For Osteoarthritis:

• Initial dose: 200mg per day, typically in the form of a single dose or divided into two doses.

• Maintenance dose: 200mg to 400mg per day. This may be adjusted depending on the patient’s condition.

For Rheumatoid Arthritis:

• Initial dose: 200mg to 400mg per day.

• Maintenance dose: 200mg to 400mg per day, depending on the response and individual tolerance.

For Acute Pain and Dysmenorrhea:

• Initial dose: 400mg, followed by 200mg after 12 hours if necessary. A maximum dose of 400mg per day is typically not exceeded.

For Ankylosing Spondylitis:

• Initial dose: 200mg per day, in one or two doses.

• Maintenance dose: 200mg to 400mg per day, depending on individual response.

For Postoperative Pain:

• Initial dose: 400mg, followed by 200mg after 12 hours, if necessary.

Adjustments for Renal Impairment:

• Dose reduction may be required for individuals with renal impairment. Consult a doctor for specific dosage adjustments.

Side Effects:

Although Celecoxib (Celbex 400) is generally well-tolerated, it can cause side effects. The following are common and serious side effects:

Common Side Effects:

1. Gastrointestinal Issues:

   • Nausea, indigestion, gastritis, diarrhea, or abdominal pain.

2. Headache:

   • Some patients may experience mild headaches.

3. Dizziness:

   • Feeling lightheaded or dizzy, particularly when standing up quickly.

4. Swelling (Edema):

   • Swelling in the feet, ankles, or hands, especially with long-term use.

5. Fatigue:

   • Some users may feel more tired than usual.

Serious Side Effects (Less Common but Serious):

1. Cardiovascular Events:

   • Celecoxib may increase the risk of heart attack, stroke, or high blood pressure, especially with long-term use or in patients with preexisting heart conditions.

2. Gastrointestinal Bleeding:

   • Although Celecoxib is a selective COX-2 inhibitor, it can still cause serious stomach ulcers or bleeding, especially in older adults or those with a history of ulcers or gastrointestinal bleeding.

3. Liver Toxicity:

   • Elevated liver enzymes, hepatitis, or liver failure. Symptoms include jaundice, dark urine, and persistent stomach pain.

4. Kidney Problems:

   • Renal failure, or fluid retention, leading to swelling in the body.

5. Allergic Reactions:

   • Severe allergic reactions including anaphylaxis, swelling of the face, lips, tongue, or throat, which can cause difficulty breathing.

6. Severe Skin Reactions:

   • Rash, blisters, or peeling skin, indicating a potentially serious condition such as Stevens-Johnson syndrome.

Contraindications:

Celecoxib (Celbex 400) should not be used in the following situations:

1. Hypersensitivity:

   • If you are allergic to celecoxib or any of the ingredients in the formulation.

   • Known allergy to sulfonamides (Celecoxib is a sulfonamide-based drug).

2. Active Gastrointestinal Bleeding or Ulcers:

   • Celecoxib is contraindicated in patients with a history of active gastrointestinal bleeding, ulcers, or gastritis.

3. Severe Liver Disease:

   • Contraindicated in patients with severe liver impairment or active liver disease.

4. Severe Renal Impairment:

   • Contraindicated in patients with severe renal impairment or end-stage renal disease who are not on dialysis.

5. Third Trimester of Pregnancy:

   • Celecoxib should not be used during the third trimester of pregnancy as it can harm the fetus (Category D).

6. Post-Heart Bypass Surgery:

   • Celecoxib should not be used in patients who have recently undergone coronary artery bypass graft (CABG) surgery.

7. Children:

   • The use of Celecoxib in children has not been adequately studied, and its safety has not been established in the pediatric population.

Precautions:

1. Cardiovascular Risk:

   • Celecoxib should be used with caution in individuals with existing heart disease, high blood pressure, or risk factors for cardiovascular events, as it may increase the risk of heart attacks or stroke.

2. Gastrointestinal Caution:

   • Use with caution in individuals with a history of ulcers, gastrointestinal bleeding, or inflammatory bowel disease.

3. Kidney and Liver Monitoring:

   • Regular monitoring of liver and kidney function may be necessary, especially during prolonged use.

4. Elderly Patients:

   • Older adults may be at higher risk of gastrointestinal bleeding, kidney problems, and cardiovascular events.

5. Pregnancy and Lactation:

   • Celecoxib should not be used during the third trimester of pregnancy, and its safety during the first and second trimesters should be carefully considered. It is unknown whether it passes into breast milk, so caution is advised during breastfeeding.

6. Drug Interactions:

   • Celecoxib may interact with other medications such as anticoagulants (e.g., warfarin), other NSAIDs, blood pressure medications, and diuretics. Close monitoring may be needed if these drugs are used together.

Summary:

Celecoxib (Celbex 400) 400mg is a COX-2 selective NSAID used to treat conditions like osteoarthritis, rheumatoid arthritis, acute pain, dysmenorrhea, ankylosing spondylitis, and postoperative pain. The typical dosage ranges from 200mg to 400mg daily, depending on the condition. Common side effects include gastrointestinal discomfort, headache, and edema, while serious side effects can include cardiovascular events, liver toxicity, and gastrointestinal bleeding.

Celecoxib is contraindicated in patients with a history of gastrointestinal bleeding, severe liver disease, or renal impairment, and it should not be used during the third trimester of pregnancy.