Novas E Tablet (Delayed Release)

Introduction

Novas E Tablet (Delayed Release) 500 mg+20 mg is a combination medication used to treat pain and inflammation associated with conditions such as arthritis, while protecting the stomach from damage caused by nonsteroidal anti-inflammatory drugs (NSAIDs). Naproxen is a potent NSAID that relieves pain, while Esomeprazole is a proton pump inhibitor (PPI) that reduces stomach acid production, minimizing the risk of ulcers.

Uses

This combination is primarily used to treat:

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis
• Acute pain relief
• Prevention of NSAID-associated gastric ulcers

Mechanism of Action

Naproxen works by inhibiting cyclooxygenase (COX-1 and COX-2) enzymes, reducing the production of prostaglandins, which are responsible for pain, fever, and inflammation. Esomeprazole inhibits the H+/K+ ATPase pump in gastric parietal cells, reducing stomach acid production. Together, they relieve pain and inflammation while protecting the gastrointestinal tract from damage.

How Long Does It Take to Work?

Naproxen begins to relieve pain and inflammation within 30 minutes to an hour after administration. Esomeprazole takes a few hours to reduce stomach acid production, with full acid suppression occurring after several days of continuous use.

Absorption

Naproxen is rapidly absorbed from the gastrointestinal tract after oral administration, reaching peak plasma concentrations within 2-4 hours. Esomeprazole is also absorbed from the gastrointestinal tract but requires activation in acidic conditions. It reaches peak plasma concentration in about 1.5 hours.

Route of Elimination

Naproxen is primarily eliminated through the kidneys, with a small amount excreted in the bile. Esomeprazole is metabolized in the liver by cytochrome P450 enzymes (CYP2C19 and CYP3A4) and eliminated mainly through urine as metabolites.

Dosage

• Adults: One tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole

• Weight greater than 50 kg: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
• Weight 38 kg to less than 50 kg: One tablet twice daily of 375 mg naproxen/20 mg of esomeprazole.

The typical dosage for Novas E Tablet (Delayed Release) 500 mg+20 mg combination is one tablet twice daily:

• Naproxen Sodium: 500 mg per tablet
• Esomeprazole Magnesium: 20 mg per tablet

Administration

This combination is taken orally, with each tablet swallowed whole with water. It should be taken at least 30 minutes before meals to optimize the efficacy of Esomeprazole in reducing stomach acid.

Side Effects

Common side effects include:

• Nausea
• Diarrhea or constipation
• Headache
• Abdominal pain
• Dizziness

• Gastrointestinal bleeding or ulceration
• Kidney dysfunction
• Elevated liver enzymes
• Severe allergic reactions

Toxicity

Overdose of Naproxen can result in severe gastrointestinal bleeding, renal failure, and central nervous system effects such as drowsiness, dizziness, or seizures. Overdose of Esomeprazole may cause confusion, drowsiness, blurred vision, or increased heart rate. Supportive treatment and symptomatic care are required in case of overdose.

Precautions

• Patients with a history of ulcers or gastrointestinal bleeding should use this combination cautiously.
• Regular monitoring of renal and hepatic function is recommended during prolonged use.
• Patients with cardiovascular risk factors, such as hypertension or heart disease, should be monitored closely, as NSAIDs may increase the risk of cardiovascular events.

Interaction

• Anticoagulants (e.g., Warfarin): Increased risk of bleeding when used concurrently with Naproxen.
• Antacids: May reduce the absorption of Esomeprazole.
• Diuretics: Concomitant use with Naproxen may increase the risk of renal impairment.

Disease Interaction

• Patients with a history of peptic ulcers or gastrointestinal bleeding should use this combination with caution due to the increased risk of GI complications.
• Patients with kidney or liver disease may require dose adjustments and regular monitoring.
• Use cautiously in patients with cardiovascular diseases, as NSAIDs may increase the risk of heart attack or stroke.

Drug Interaction

Novas E Tablet (Delayed Release) 500 mg+20 mg can interact with:

• Warfarin: Increased bleeding risk
• Aspirin: Increased gastrointestinal side effects
• Cyclosporine: May increase the risk of nephrotoxicity
• SSRIs: Increased risk of gastrointestinal bleeding

Food Interactions

Food may reduce the absorption of Esomeprazole, so it is recommended to take the combination on an empty stomach. No significant food interactions are noted with Naproxen.

Pregnancy Use

Naproxen falls under pregnancy category C, meaning it should be avoided during the third trimester due to the risk of fetal harm, including premature closure of the ductus arteriosus. Esomeprazole is classified as category B, indicating no proven risk to humans, but caution is still advised.

Lactation Use

Naproxen is excreted in breast milk in small amounts and may cause harm to the infant. Esomeprazole is also excreted in breast milk, but its effects on the nursing infant are unknown. Therefore, breastfeeding is not recommended while using this combination.

Acute Overdose

Symptoms of overdose include severe nausea, vomiting, abdominal pain, dizziness, drowsiness, and possibly gastrointestinal bleeding. In severe cases, kidney failure, liver damage, or seizures may occur. Treatment includes gastric lavage, activated charcoal, and supportive measures.

Contraindication

This combination is contraindicated in patients with:

• Known hypersensitivity to Naproxen, Esomeprazole, or other NSAIDs
• Active peptic ulcer disease or gastrointestinal bleeding
• Severe renal or hepatic impairment
• Third trimester of pregnancy

Use Direction

Take one tablet twice daily, at least 30 minutes before meals. Do not crush or chew the tablet. Complete the full course of therapy as directed by your healthcare provider. Avoid alcohol and smoking while on this medication, as they may increase the risk of gastrointestinal bleeding.

Storage Conditions

Store at room temperature (20°C to 25°C or 68°F to 77°F). Keep the medication in its original packaging and away from moisture and light. Keep out of reach of children.

Volume of Distribution

Naproxen has a moderate volume of distribution of approximately 0.16 L/kg, indicating good tissue penetration. Esomeprazole has a volume of distribution of about 16 L, which reflects its distribution into various tissues.

Half Life

Naproxen has a half-life of approximately 12-17 hours, allowing for twice-daily dosing. Esomeprazole has a shorter half-life of around 1-1.5 hours, but its effects on acid suppression persist longer due to irreversible binding to the proton pump.

Clearance

Naproxen is primarily cleared by the kidneys, with a clearance rate of around 0.13 mL/min/kg. Esomeprazole is metabolized in the liver and excreted through both urine and feces, with a clearance rate dependent on CYP2C19 activity.

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Some Frequently Asked Questions About Novas E Tablet (Delayed Release) 500 mg+20 mg

1. What is naproxen sodium + esomeprazole magnesium?

It is a combination medication in a single tablet containing naproxen sodium, a nonsteroidal anti-inflammatory drug (NSAID), and esomeprazole magnesium, a proton pump inhibitor (PPI), used to relieve pain and protect the stomach.

2. What is naproxen sodium + esomeprazole magnesium used for?

It is used to:

3. How does naproxen sodium + esomeprazole magnesium work?

Naproxen sodium reduces pain and inflammation by inhibiting prostaglandin production, while esomeprazole magnesium decreases stomach acid to prevent ulcers caused by naproxen.

4. Is naproxen sodium + esomeprazole magnesium a prescription drug?

Yes, it is available only with a doctor’s prescription.

5. Who can take naproxen sodium + esomeprazole magnesium?

It’s suitable for adults and children over 12 weighing at least 38 kg who need NSAID treatment and have a risk of stomach ulcers, but not for those with severe liver disease or NSAID allergies.

6. How is naproxen sodium + esomeprazole magnesium taken?

It is taken orally as a tablet, typically twice daily, at least 30 minutes before a meal.

7. What is the typical dosage of naproxen sodium + esomeprazole magnesium?

Dosage depends on condition and weight:

8. How long does naproxen sodium + esomeprazole magnesium take to work?

Pain relief may begin within hours, while acid reduction starts within 1-2 hours, with full benefits in a few days.

9. Can naproxen sodium + esomeprazole magnesium be taken long-term?

Yes, for chronic conditions, but long-term use requires monitoring due to risks like kidney issues or nutrient deficiencies.

10. Does naproxen sodium + esomeprazole magnesium treat infections?

No, it treats pain and inflammation, not infections.

11. What are the common side effects of naproxen sodium + esomeprazole magnesium?

Common side effects include:

12. Can naproxen sodium + esomeprazole magnesium cause stomach bleeding?

Yes, though esomeprazole reduces the risk, naproxen may still cause bleeding or ulcers, especially with prolonged use.

13. Does naproxen sodium + esomeprazole magnesium affect the heart?

Naproxen may increase the risk of heart attack or stroke, especially in high doses or long-term use.

14. Can naproxen sodium + esomeprazole magnesium be taken with food?

It should be taken 30 minutes before a meal for best results; food may delay absorption.

15. What happens if I miss a dose of naproxen sodium + esomeprazole magnesium?

Take it as soon as you remember unless it’s near the next dose; then skip it. Don’t double up.

16. Can I overdose on naproxen sodium + esomeprazole magnesium?

Yes, overdose may cause drowsiness, stomach pain, or irregular heartbeat. Seek emergency help if suspected.

17. Is naproxen sodium + esomeprazole magnesium safe during pregnancy?

It’s not recommended, especially in the third trimester, due to naproxen’s risks to the fetus.

18. Can breastfeeding mothers take naproxen sodium + esomeprazole magnesium?

It’s not advised; naproxen passes into breast milk, and esomeprazole’s safety is unclear.

19. Does naproxen sodium + esomeprazole magnesium interact with other medications?

Yes, it interacts with:

20. Can I drink alcohol while taking naproxen sodium + esomeprazole magnesium?

Avoid alcohol; it increases the risk of stomach bleeding with naproxen.

21. Is naproxen sodium + esomeprazole magnesium safe for kidney disease?

Use with caution; naproxen may worsen kidney function, especially in severe cases.

22. Can naproxen sodium + esomeprazole magnesium be used in liver disease?

It’s contraindicated in severe liver disease due to metabolism of both components in the liver.

23. How should naproxen sodium + esomeprazole magnesium be stored?

Store at room temperature, away from moisture, heat, and light.

24. Does naproxen sodium + esomeprazole magnesium expire?

Yes, check the expiration date; expired tablets may lose effectiveness.

25. Can naproxen sodium + esomeprazole magnesium cause drowsiness?

Yes, naproxen can cause drowsiness or dizziness in some people.

26. Is naproxen sodium + esomeprazole magnesium the same as ibuprofen?

No, naproxen is a different NSAID, and this combo includes esomeprazole for stomach protection.

27. Can naproxen sodium + esomeprazole magnesium treat migraines?

It’s not approved for migraines but may help with inflammation-related pain if prescribed off-label.

28. Does naproxen sodium + esomeprazole magnesium cause constipation?

Yes, though less common than diarrhea, it’s a possible side effect.

29. Can naproxen sodium + esomeprazole magnesium help with swelling?

Yes, naproxen reduces inflammation and swelling associated with arthritis.

30. Is naproxen sodium + esomeprazole magnesium gluten-free?

Most formulations are gluten-free, but check with the manufacturer.

31. Can naproxen sodium + esomeprazole magnesium tablets be crushed?

No, they are delayed-release; crushing disrupts the coating and effectiveness.

32. What if I’m allergic to naproxen sodium + esomeprazole magnesium?

Allergic reactions (rash, swelling) are rare but serious. Stop use and seek help.

33. Can naproxen sodium + esomeprazole magnesium cause vitamin deficiencies?

Long-term use of esomeprazole may reduce B12, magnesium, and calcium absorption.

34. Does naproxen sodium + esomeprazole magnesium affect blood pressure?

Naproxen may increase blood pressure, especially in those with hypertension.

35. Can naproxen sodium + esomeprazole magnesium treat back pain?

It’s not specifically approved for back pain but may help if inflammation-related, per doctor’s advice.

36. Is naproxen sodium + esomeprazole magnesium safe for children?

Yes, for children 12+ and over 38 kg, with dosing adjusted by a doctor.

37. Can naproxen sodium + esomeprazole magnesium cause headaches?

Yes, headaches are a common side effect of both components.

38. Does naproxen sodium + esomeprazole magnesium need refrigeration?

No, store at room temperature; protect from moisture.

39. Can naproxen sodium + esomeprazole magnesium be used for fever?

Naproxen reduces fever, but it’s not the primary use of this combination.

40. What’s the difference between naproxen sodium + esomeprazole magnesium and naproxen alone?

The combo includes esomeprazole to protect the stomach, unlike naproxen alone.

41. Can naproxen sodium + esomeprazole magnesium cause kidney damage?

Yes, naproxen may harm kidneys, especially with long-term use or in at-risk patients.

42. Is naproxen sodium + esomeprazole magnesium available as a generic?

Yes, generic versions are available alongside the brand Vimovo.

43. Can naproxen sodium + esomeprazole magnesium be taken at night?

Yes, but it’s typically taken twice daily, 30 minutes before meals.

44. Does naproxen sodium + esomeprazole magnesium affect the liver?

Rarely, it may elevate liver enzymes; report jaundice to a doctor.

45. Can naproxen sodium + esomeprazole magnesium be used for gout?

It’s not approved for gout but may help with inflammation if prescribed off-label.

46. What should I do if I experience severe stomach pain?

Stop the medication and contact your doctor immediately; it could signal bleeding or ulcers.

47. Can naproxen sodium + esomeprazole magnesium cause fatigue?

Yes, fatigue is a possible side effect, though less common.

48. Does naproxen sodium + esomeprazole magnesium interact with caffeine?

No major interaction, but caffeine may worsen acid reflux symptoms.

49. Can naproxen sodium + esomeprazole magnesium be stopped abruptly?

For short-term use, yes; for long-term, taper off to avoid rebound acid production.