Naprosyn Plus 500/20mg Tablet

Uses of Naprosyn Plus 500/20mg Tablet

• Pain Relief

How does Naprosyn Plus 500/20mg Tablet work?

Naprosyn Plus 500/20mg Tablet is a combination of two medicines: Naproxen is a non-steroidal anti-inflammatory drug (NSAID) that works by blocking the release of certain chemical messengers that cause fever, pain, and inflammation (redness and swelling). Esomeprazole is a proton-pump inhibitor. which reduces the amount of acid in the stomach and prevents damage to the stomach lining caused by Naproxen.

Side Effects of Naprosyn Plus 500/20mg Tablet

The common side effects of taking Naprosyn Plus 500/20mg Tablet may include:

• Heartburn and indigestion
• Nausea
• Mouth ulcers or sore mouth
• Abdominal pain
• Constipation
• Headache and dizziness
• Skin reactions such as itching, sweating, sun sensitivity, or hair loss
• Changes in eyesight and eye pain
• Hearing loss or ringing in the ears
• Fluttering feeling in the heart
• Thirst, fever, fatigue, or general malaise
• Swelling of the hands, feet, or legs
• Difficulty breathing, including shortness of breath, wheezing, or coughing

Uncommon side effects may include:

• Kidney problems
• Vomiting
• Skin rashes
• Mental confusion and hallucinations

Rare side effects may include:

• Depression
• Seizures
• Pneumonia or lung swelling
• Numbness in the hands and feet
• High levels of blood potassium, which can cause abnormal heart rhythm

If you experience any of the following serious side effects, stop taking Naprosyn Plus 500/20mg Tablet and consult your doctor immediately:

• Signs of allergic reactions, such as swelling of the throat, face, hands, or feet, difficulty breathing, chest tightness, skin rashes, blisters, or itching
• Signs of stomach or gut problems, such as bleeding from the stomach (visible as blood in vomit or black, tarry stools), ulcers or holes in the stomach or gut (resulting in stomach pain, fever, vomiting, or bloody diarrhea)
• Signs of pancreas problems, such as severe stomach pain radiating to the back
• Aggravation of symptoms in patients with ulcerative colitis or Crohn's disease, including pain, diarrhea, vomiting, and weight loss
• Severe skin rashes with blistering or peeling, accompanied by fever, headache, cough, and body aches
• Blistering of the skin when exposed to sunlight, particularly on the arms, face, and hands
• Yellowing of the skin or eyes, fatigue, loss of appetite, vomiting, and pale-colored stools
• Signs of stroke, such as muscle weakness and numbness on one side of the body
• Signs of meningitis, including sudden changes in smell, taste, hearing, vision, or confusion
• Signs of systemic lupus erythematosus, such as fever, vomiting, stiff neck, headache, sensitivity to light, and confusion

It is important to consult your doctor if you experience any of these side effects or have any concerns while taking Naprosyn Plus 500/20mg Tablet.

Quick Suggestions:

• If you have asthma, it is important to be aware that symptoms such as wheezing or breathlessness may worsen when taking Naprosyn Plus 500/20mg Tablet. If you experience any worsening of asthma symptoms, it is advisable to see your doctor promptly.
• Inform your doctor if you have a history of ulcers in your stomach or intestines, as Naprosyn Plus 500/20mg Tablet may affect these conditions.
• If you are planning to undergo any kind of surgery, even a minor procedure like tooth extraction, it is important to inform your doctor about taking Naprosyn Plus 500/20mg Tablet, as it can increase the risk of bleeding.

In addition to medication, there are lifestyle measures you can take to manage painful conditions:

• Engage in physical activities that help strengthen muscles and relieve joint stiffness, such as walking or swimming for 20-30 minutes.
• Consider practicing yoga to improve joint flexibility and pain management.
• Maintain a healthy weight through regular low-strain exercises and a balanced diet.
• Ensure you get adequate sleep, as rest can help reduce inflammation and swelling.
• Apply heat or cold therapy by using hot or cold compresses on the affected joints for 15-20 minutes at regular intervals.
• Explore alternative therapies such as acupuncture, massage, and physical therapy, which may provide additional relief.
• Incorporate foods rich in flavonoids, such as soy, berries, broccoli, grapes, and green tea, into your diet to help reduce inflammation.
• Include high-fiber foods, berries, cherries, leafy green vegetables, and black pepper in your meals as they are rich in antioxidants, calcium, and vitamin B12, which can help mitigate the long-term effects of the medication.
• Consider consuming fermented dairy products like miso, sauerkraut, and kimchi, as they contain probiotics that can help prevent excessive stomach acid production.

On the other hand, it is advisable to avoid foods or drinks that can trigger acid reflux or heartburn, such as onions, peppermint, chocolate, caffeinated beverages, citrus fruits or juices, tomatoes, and high-fat and spicy foods. Additionally, it is recommended to avoid smoking and limit alcohol consumption.

Remember to follow your doctor's advice and instructions regarding the use of Naprosyn Plus 500/20mg Tablet and any lifestyle modifications. If you have any concerns or experience adverse effects, consult your doctor for further guidance.

Indication

Naprosyn Plus 500/20mg Tablet is indicated for the relief of -

• Signs & symptoms of Osteoarthritis
• Rheumatoid Arthritis
• Ankylosing spondylitis
• Decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

Pharmacology

Naprosyn Plus 500/20mg Tablet is a combination medication that consists of an enteric-coated Naproxen core and an instant-release Esomeprazole Magnesium coating. This unique formulation allows for the sequential release of the two active ingredients.

Naproxen is classified as a nonsteroidal anti-inflammatory drug (NSAID) and possesses analgesic (pain-relieving) and antipyretic (fever-reducing) properties. It works by inhibiting the production of prostaglandins, which are substances involved in pain, inflammation, and fever.

Esomeprazole, on the other hand, belongs to a class of medications called proton pump inhibitors (PPIs). It selectively inhibits the H+/K+-ATPase, an enzyme responsible for acid secretion in the gastric parietal cells of the stomach. By specifically targeting the proton pump, Esomeprazole effectively reduces the production of stomach acid, resulting in a decrease in gastric acidity.

The sequential release of Esomeprazole followed by Naproxen allows Esomeprazole to exert its acid-reducing effects in the stomach first, protecting the stomach lining from potential irritation by Naproxen. Naproxen, then released in the small intestine, can exert its anti-inflammatory and pain-relieving effects.

This combination of Naproxen and Esomeprazole provides the dual benefit of relieving pain and inflammation while reducing the risk of stomach irritation and ulcers associated with Naproxen use alone.

Dosage & Administration of Naprosyn Plus 500/20mg Tablet

Before using Naprosyn-Plus® (containing Naproxen and Esomeprazole), it is important to carefully consider the potential benefits and risks associated with the medication. It is recommended to discuss with your healthcare provider or doctor the available treatment options and determine if Naprosyn-Plus® is the most suitable choice for your individual treatment goals.

When using Naprosyn-Plus®, it is advised to use the lowest effective dose for the shortest duration necessary to achieve the desired therapeutic outcomes. If a lower dose of Esomeprazole (less than a total daily dose of 40 mg) is more appropriate for your condition, alternative treatment options should be considered.

For elderly patients, studies have shown that while the total plasma concentration of naproxen remains unchanged, the unbound plasma fraction of naproxen increases in the elderly population. Caution should be exercised when higher doses are required, and dosage adjustments may be necessary in elderly patients. Similar to other medications used in the elderly, the lowest effective dose should be used.

Patients with moderate to severe or severe renal impairment (creatinine clearance less than 30 ml/min) should not use Naproxen-containing products. These medications are not recommended for individuals with significant renal impairment.

In patients with mild to moderate hepatic impairment, close monitoring is necessary, and a possible dose reduction may be considered based on the Naproxen component of Naprosyn-Plus®. However, Naprosyn-Plus® is not recommended for individuals with severe hepatic impairment, as the Esomeprazole dosage should not exceed 20 mg daily in such cases.

The use of Naprosyn-Plus® has not been established for children under 18 years of age, and therefore, the dosage for this age group has not been determined. It is important to follow the specific dosage instructions provided by your physician or healthcare provider. Swallow the Naprosyn Plus 500/20mg Tablet with a glass of water and do not crush or chew the medication. The correct dose and duration of treatment will be determined by your doctor based on factors such as your age, body weight, and the specific condition being treated.

Interaction

Naprosyn Plus 500/20mg Tablet can potentially interact with various medications and medical conditions. It is important to be aware of these interactions and consult with your doctor before taking Naprosyn Plus 500/20mg Tablet:

Drug-Drug Interactions: Naprosyn Plus 500/20mg Tablet may interact with anti-inflammatory medicines (such as aspirin, ibuprofen), blood thinners (like warfarin, rivaroxaban), steroids (such as prednisolone), diuretic medicines (like furosemide), medicines used to treat heart problems and high blood pressure (such as propranolol, enalapril, losartan, candesartan), antidepressants (like citalopram), and medicines used to treat rheumatoid arthritis (such as methotrexate). These interactions can affect the effectiveness or increase the risk of side effects of either Naprosyn Plus 500/20mg Tablet or other medications. It is important to inform your doctor about all the medications you are taking to avoid potential interactions.

Drug-Food Interactions: Naprosyn Plus 500/20mg Tablet may interact with alcohol. It is recommended to avoid alcohol intake while taking Naprosyn Plus 500/20mg Tablet as it can increase the risk of stomach bleeding, as well as enhance drowsiness and dizziness associated with the medication.

Drug-Disease Interactions: Individuals with certain medical conditions should consult their doctor before taking Naprosyn Plus 500/20mg Tablet. These conditions include diabetes, stomach ulcer, gastrointestinal bleeding, asthma, kidney or liver problems, heart problems, and autoimmune conditions such as systemic lupus erythematosus (characterized by joint pain, fever, and skin rashes), colitis, or Crohn's disease (conditions causing swelling of the bowel, diarrhea, bowel pain, vomiting, and weight loss). Your doctor will assess the risks and benefits of using Naprosyn Plus 500/20mg Tablet in these situations and may adjust the dosage or recommend alternative treatments if necessary.

It is important to have open communication with your healthcare provider or doctor regarding your medical history, current medications, and any potential interactions or concerns before starting or changing any medication regimen, including Naprosyn Plus 500/20mg Tablet.

Contraindications

Known hypersensitivity: If you have a known hypersensitivity or allergic reaction to any component of Naprosyn-Plus® or substituted benzimidazoles, it is important to avoid using this medication.

History of asthma or allergic reactions: If you have a history of asthma, urticaria (hives), or other allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs), Naprosyn-Plus® should be avoided as it may trigger similar reactions.

The peri-operative period in CABG surgery: Naprosyn-Plus® should not be used during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. This is because it may increase the risk of cardiovascular events and impair the healing process.

Late pregnancy: Naprosyn-Plus® should not be used in the late stages of pregnancy. It is generally recommended to avoid NSAIDs, including Naprosyn-Plus®, in the third trimester of pregnancy due to the potential risks to the fetus and the potential to delay labor.

Pregnancy & Lactation

Naprosyn-Plus® is classified as Pregnancy Category C. It means that there may be potential risks to the fetus, and its use should be avoided in late pregnancy. Naproxen, one of the components of Naprosyn-Plus®, has been associated with the premature closure of the ductus arteriosus in the fetus.

Regarding lactation, Naprosyn-Plus® should not be used by nursing mothers due to the Naproxen component. It is possible for Naproxen to pass into breast milk and may have adverse effects on the nursing infant.

It is important to discuss any concerns or questions about medication use during pregnancy or lactation with your healthcare provider. They can provide personalized advice and suggest alternative treatment options that are safer for you and your baby.

Precautions & Warnings

• Allergy: Do not take Naprosyn Plus 500/20mg Tablet if you are allergic to it.
• Long-term use and risks: Prolonged use of nonsteroidal anti-inflammatory drugs (NSAIDs), including naproxen in Naprosyn Plus 500/20mg Tablet, may increase the risk of heart attack, stroke, and stomach ulcers. This risk is higher in individuals with a history of ulcers, bleeding disorders, advanced age, alcoholism, or multiple diseases.
• Elderly patients: Elderly patients are at a higher risk of gastrointestinal bleeding problems, so their dosage may need to be limited. Close monitoring and caution are advised.
• Monitoring of vitamin B-12: Regular monitoring of vitamin B-12 levels is advised when taking Naprosyn Plus 500/20mg Tablet for a long time. Although rare, there is a risk of vitamin B-12 deficiency with long-term use, especially if taken daily for an extended period.
• Osteoporosis-related fractures: Individuals at risk for osteoporosis-related fractures should ensure they receive adequate calcium and vitamin D intake. This is important for maintaining bone health while taking Naprosyn Plus 500/20mg Tablet.
• Recent heart bypass surgery: Naprosyn Plus 500/20mg Tablet is not recommended for patients who have recently undergone heart bypass surgery or are scheduled to have it.
• Pregnancy and breast-feeding: Naprosyn Plus 500/20mg Tablet is not recommended for pregnant women, particularly in the third trimester, as it may harm the baby. Pregnant or breastfeeding women should consult a doctor before taking Naprosyn Plus 500/20mg Tablet.
• Children: Naprosyn Plus 500/20mg Tablet should not be given to children unless prescribed by a doctor.
• NSAIDs and pain relief: Avoid taking other NSAIDs for pain relief in combination with Naprosyn Plus 500/20mg Tablet unless specifically prescribed.
• Proton pump inhibitors and bone health: Prolonged use of proton pump inhibitors like esomeprazole (found in Naprosyn Plus 500/20mg Tablet) may increase the risk of brittle bones. Your doctor may recommend taking Vitamin D and calcium supplements while using Naprosyn Plus 500/20mg Tablet.
• Alcohol consumption: Avoid consuming alcohol while taking Naprosyn Plus 500/20mg Tablet, as it may increase the risk of stomach bleeding or ulcers.
• Cardiovascular disease: Patients with known cardiovascular disease or risk factors may be at greater risk when using Naprosyn Plus 500/20mg Tablet. Use with caution, particularly in patients with fluid retention or heart failure.
• Interference with laboratory tests: Esomeprazole in Naprosyn Plus 500/20mg Tablet may interfere with specific laboratory tests, such as urine tests for tetrahydrocannabinol (THC) or blood tests to detect certain tumors. It is important to inform laboratory personnel and all your doctors that you are using Naprosyn Plus 500/20mg Tablet to avoid false test results.

Storage Conditions

Store in a cool & dry place, and protect from light. Keep out of reach of children.