Cambia 50mg Powder

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 the inhibition of prostaglandin synthesis, primarily through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes. For migraine, it is thought to act by inhibiting prostaglandin synthesis in the central and peripheral nervous systems, reducing inflammation and pain perception.

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 immediately or seek emergency medical attention:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
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.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
High Potassium Levels: Abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, numbness or tingling, or shortness of breath.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Respiratory Issues: Shortness of breath, sudden weight gain, or swelling in the arms or legs.
Cardiovascular Problems: Chest pain or pressure, rapid heartbeat, or weakness on one side of the body.
Neurological Symptoms: Trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Extreme Fatigue: Feeling very tired or weak.
Urinary Problems: Pain while urinating or blood in the urine.
Liver Damage: Dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes. (Note: Liver problems can be fatal, so seek medical attention immediately if you experience these symptoms.)
Severe Skin Reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or other serious reactions, which can be life-threatening. Seek medical help right away if you experience red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

Most medications can cause side effects, but many people experience none or only mild symptoms. If you encounter any of the following side effects or any other symptoms that concern you or persist, contact your doctor or seek medical attention:

Constipation, diarrhea, stomach pain, upset stomach, or vomiting
Heartburn
Gas
Dizziness or drowsiness
Headache
Excessive sweating
* Common cold symptoms

This is not an exhaustive list of potential 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 crucial to inform your doctor about the following:

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.
If you are allergic to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen.
If you have ever experienced asthma triggered by a salicylate drug, such as aspirin, or an NSAID.
If you have a history of gastrointestinal (GI) bleeding or kidney problems.
If you have heart failure (a weak heart) or have recently had a heart attack.
If you are currently taking another NSAID, a salicylate drug like aspirin, or pemetrexed.
If you are having difficulty getting pregnant or are undergoing fertility testing.
If you are pregnant, planning to become pregnant, or become pregnant while taking this medication. It is essential to note that this drug may harm an unborn baby if taken at 20 weeks or later in pregnancy.
- If you are between 20 and 30 weeks pregnant, only take this medication if your doctor advises you to do so.
- Do not take this medication if you are more than 30 weeks pregnant.

To ensure your safety, it is vital to provide your doctor and pharmacist with a comprehensive list of all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help determine if it is safe for you to take this medication with your other drugs and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

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 this with your doctor.

There is a risk of developing high blood pressure with medications like this one. 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 effects on your health while taking this medication.

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

Adhere to the prescribed dosage and do not exceed the recommended amount, as taking more than directed may increase the risk of severe side effects. Additionally, do not take this medication for longer than your doctor has prescribed.

Be cautious, as this medication may increase your risk of bleeding easily. To minimize this risk, use a soft toothbrush and an electric razor, and avoid injuries.

The use of medications 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 this with your doctor.

In people who have recently experienced a heart attack, the risk of another heart attack and heart-related death may be increased when taking medications like this one. Furthermore, individuals taking this type of medication after a first heart attack may have a higher likelihood of death within the following year compared to those not taking this medication. Consult with your doctor to discuss these risks.

If you are taking aspirin to prevent a heart attack, inform your doctor, as this may affect your treatment plan.

If you have phenylketonuria (PKU), consult with your doctor, as some products contain phenylalanine.

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

Medications like this one, which are classified as NSAIDs, may affect ovulation, potentially impacting fertility. However, this effect is reversible when the medication is stopped. Discuss this with your doctor if you have concerns.

If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.

• Aspirin (concomitant use increases risk of GI adverse events)
• Other NSAIDs (concomitant use increases risk of GI adverse events)
• Coronary Artery Bypass Graft (CABG) surgery (peri-operative pain)

• Anticoagulants (e.g., Warfarin, Dabigatran, Apixaban, Rivaroxaban) - increased risk of bleeding
• Antiplatelet agents (e.g., Clopidogrel) - increased risk of bleeding
• SSRIs/SNRIs - increased risk of GI bleeding
• Lithium - increased lithium levels and toxicity
• Methotrexate - increased methotrexate levels and toxicity
• Diuretics (e.g., Furosemide, Hydrochlorothiazide) - reduced diuretic and antihypertensive effects, increased risk of renal impairment
• ACE Inhibitors/ARBs - reduced antihypertensive effects, increased risk of renal impairment
• Cyclosporine - increased risk of nephrotoxicity
• Tacrolimus - increased risk of nephrotoxicity
• Pemetrexed - increased pemetrexed levels and toxicity (avoid in patients with renal impairment)

• Corticosteroids - increased risk of GI ulceration and bleeding
• Digoxin - increased digoxin levels
• Phenytoin - increased phenytoin levels
• Sulfonylureas - potential for altered blood glucose levels
• Cholestyramine/Colestipol - reduced diclofenac absorption (separate administration by several hours)
• CYP2C9 inhibitors (e.g., Fluconazole, Voriconazole) - increased diclofenac exposure
• CYP2C9 inducers (e.g., Rifampin) - decreased diclofenac exposure

• Not specifically categorized as minor for clinically significant interactions, but general caution with other hepatotoxic or nephrotoxic agents.

• Signs of gastrointestinal bleeding (e.g., black, tarry stools; coffee-ground vomit; severe abdominal pain)
• Symptoms of cardiovascular events (e.g., chest pain, shortness of breath, weakness on one side of the body, slurred speech)
• Signs of renal impairment (e.g., decreased urine output, swelling in ankles/feet, unusual fatigue)
• Symptoms of liver injury (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, flu-like symptoms)
• Signs of allergic reaction (e.g., rash, hives, itching, difficulty breathing, swelling of face/lips/tongue/throat)
• Symptoms of fluid retention/edema
• Changes in vision or hearing (rare, but reported with NSAIDs)

Avoid use in the third trimester of pregnancy due to the risk of premature closure of the fetal ductus arteriosus. Use in the first and second trimesters should only be if the potential benefit justifies the potential risk to the fetus.

Diclofenac is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, 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.

Safety and effectiveness in pediatric patients have not been established for the treatment of acute migraine. Not recommended for use in children.

Elderly patients are at greater risk for serious cardiovascular, gastrointestinal, and renal adverse events. Use the lowest effective dose for the shortest duration possible. Monitor closely for adverse effects, especially GI bleeding and renal impairment.

• Cambia is specifically formulated for rapid absorption to treat acute migraine, with a Tmax of 0.5 hours.
• It must be taken on an empty stomach (1 hour before or 2 hours after food) for optimal efficacy.
• Unlike some other NSAIDs, Cambia is not indicated for chronic pain or prophylactic migraine treatment.
• Patients should be advised about the black box warnings for cardiovascular and gastrointestinal risks, even with short-term use for acute conditions.
• Ensure patients understand that this is a single-dose treatment for an acute attack and not for daily use.

• Other NSAIDs (e.g., ibuprofen, naproxen, celecoxib)
• Triptans (e.g., sumatriptan, zolmitriptan, rizatriptan)
• CGRP receptor antagonists (e.g., ubrogepant, rimegepant)
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine)
• Acetaminophen
• Opioid analgesics (generally not recommended for migraine due to abuse potential and risk of medication overuse headache)

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, which provides crucial information 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, consult 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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.