Flurbiprofen 100mg Tablets

Flurbiprofen 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 the inhibition of prostaglandin synthesis, primarily by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes. This reduces the formation of prostaglandin precursors from arachidonic acid.

Serious 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 uncontrolled bleeding.
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.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Chest pain or pressure.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, drooping on one side of the face, or blurred vision.
Ringing in the ears.
Depression or other mood changes.
Shakiness.
Changes in vision.
Memory problems or loss.
Flu-like symptoms.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or persist:

Headache.
Constipation, diarrhea, stomach pain, upset stomach, or vomiting.
Heartburn.
Gas.
Dizziness, drowsiness, tiredness, or weakness.
Weight gain or loss.
Sleep disturbances.

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 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.
Certain health conditions, including:
+ Gastrointestinal (GI) bleeding or kidney problems.
+ Heart failure (weak heart) or a recent heart attack.
Current medications, including:
+ Other NSAIDs.
+ Salicylate drugs, such as aspirin.
+ Pemetrexed.
Fertility issues, if you are trying to conceive or undergoing fertility evaluation.
* Pregnancy, planned pregnancy, or suspected 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.

To ensure your safety, it is crucial to disclose all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, as well as any health problems. Your doctor and pharmacist will assess potential interactions and determine the safety of taking this medication with your other treatments. Never start, stop, or adjust the dose of any medication without consulting your doctor.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition. Be sure to discuss any concerns or questions with your doctor.

Drugs like this one can increase blood pressure. Follow your doctor's instructions for checking your blood pressure regularly.

Before consuming alcohol, consult with your doctor to discuss any potential risks or interactions.

If you smoke, talk to your doctor about the potential risks and how to minimize them.

Dosage and Administration

Do not exceed the dosage prescribed by your doctor, as taking more than recommended may increase the risk of severe side effects. Additionally, do not take this medication for longer than your doctor has instructed.

Special Precautions

If you have asthma, consult with your doctor, as you may be more sensitive to this medication.

This drug may increase the risk of bleeding. To minimize this risk, be careful to avoid injury, use a soft toothbrush, and consider using an electric razor.

Cardiovascular Risks

The use of drugs like this one may increase the risk of heart failure. If you already have heart failure, your risk of heart attack, hospitalization for heart failure, and death may be higher. Discuss these risks with your doctor.

In people who have had a recent heart attack, the use of drugs like this one may increase the risk of another heart attack and heart-related death. Additionally, people taking this type of medication after a first heart attack may be more likely to die within the year following the heart attack compared to those not taking this medication. Talk to your doctor about these risks.

If you are taking aspirin to help prevent a heart attack, consult with your doctor to discuss any potential interactions.

Liver and Skin Risks

Drugs like this one can cause liver problems, which can be severe and even life-threatening. If you experience any signs of liver problems, such as dark urine, tiredness, decreased appetite, stomach pain, light-colored stools, vomiting, or yellow skin or eyes, contact your doctor immediately.

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, can occur with this medication. These reactions can be life-threatening and may also affect other organs. If you experience any signs of a severe skin reaction, such as red, swollen, blistered, or peeling skin, red or irritated eyes, sores in your mouth, throat, nose, eyes, genitals, or any areas of skin, fever, chills, body aches, shortness of breath, or swollen glands, seek medical help immediately.

Age and Pregnancy Considerations

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.

NSAIDs like this drug may affect ovulation, which can impact fertility. However, this effect is typically reversible when the medication is stopped. Discuss any concerns with your doctor.

If you are breast-feeding, consult with your doctor to discuss any potential risks to your baby.

• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)
• Severe renal impairment
• Severe hepatic impairment
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

• Anticoagulants (e.g., Warfarin, Heparin): Increased risk of bleeding.
• Antiplatelet agents (e.g., Aspirin, Clopidogrel): Increased risk of bleeding.
• Corticosteroids: Increased risk of GI ulceration/bleeding.
• SSRIs/SNRIs: Increased risk of GI bleeding.
• Diuretics (e.g., Furosemide, Hydrochlorothiazide): Reduced natriuretic effect, increased risk of renal impairment.
• ACE Inhibitors/ARBs: Reduced antihypertensive effect, increased risk of renal impairment.
• Lithium: Increased lithium plasma concentrations and toxicity.
• Methotrexate: Increased methotrexate plasma concentrations and toxicity.
• Cyclosporine: Increased nephrotoxicity.
• Digoxin: Increased digoxin plasma concentrations.
• Pemetrexed: Increased pemetrexed toxicity (avoid in patients with renal impairment).

• Beta-blockers: Reduced antihypertensive effect.
• Hydantoins (e.g., Phenytoin): Increased phenytoin levels.
• Sulfonylureas: Increased hypoglycemic effect.
• Quinolone antibiotics: Increased risk of CNS stimulation and convulsions.
• Alcohol: Increased risk of GI irritation/bleeding.

• Antacids: May delay absorption but not extent.

• Abdominal pain
• Indigestion (dyspepsia)
• Heartburn
• Nausea
• Vomiting
• Black, tarry stools (melena)
• Vomit that looks like coffee grounds (hematemesis)
• Unusual bruising or bleeding
• Swelling of ankles, feet, or hands (edema)
• Unexplained weight gain
• Shortness of breath
• Chest pain
• Weakness or numbness on one side of the body
• Slurred speech
• Skin rash or itching
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Flu-like symptoms (fever, fatigue, rash) - rare, but indicative of severe reactions

Avoid use during the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus and potential for renal dysfunction in the fetus. Use during the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus, and at the lowest effective dose for the shortest possible duration.

Flurbiprofen is excreted into breast milk in small amounts. Due to the potential for serious adverse reactions in breastfed infants (e.g., cardiovascular, renal effects), it is generally recommended to avoid use during breastfeeding or to use with caution and monitor the infant for adverse effects. Consider alternative agents with better safety profiles during lactation.

Safety and effectiveness in pediatric patients (under 18 years of age) have not been established for systemic use. Not generally recommended.

Elderly patients are at increased risk for serious adverse reactions to NSAIDs, including gastrointestinal bleeding, ulceration, and perforation, as well as renal impairment and cardiovascular events. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects, especially renal function and GI symptoms.

• Flurbiprofen is a potent NSAID; consider its use when other NSAIDs may not be sufficient, but be mindful of its side effect profile.
• Always advise patients to take flurbiprofen with food or milk to minimize GI upset.
• Educate patients on the signs and symptoms of GI bleeding and cardiovascular events, and to seek immediate medical attention if they occur.
• Regular monitoring of renal function, liver function, and blood pressure is crucial, especially in elderly patients or those with comorbidities.
• Avoid concomitant use with other NSAIDs, including low-dose aspirin for cardioprotection, unless specifically directed by a physician and with careful monitoring due to increased risk of adverse effects.

• Other NSAIDs (e.g., Ibuprofen, Naproxen, Diclofenac, Celecoxib)
• Acetaminophen (for pain and fever, no anti-inflammatory effect)
• Opioid analgesics (for severe pain, different mechanism of action, higher risk of dependence)
• Topical NSAIDs (e.g., Diclofenac gel, for localized pain with less systemic exposure)
• Corticosteroids (for severe inflammation, different mechanism, more systemic side effects)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.

This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. It is vital to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

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 consumed, and the time it occurred.