Xenole 500 mg+20 mg

Description

Indications Xenole Tablet is prescribed for the relief of symptoms associated with:

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis Additionally, it is used to lower the risk of developing gastric ulcers in patients who are susceptible to NSAID-induced gastric ulcers.

(Take this medication as per the advice of a registered physician.)

Pharmacology Xenole Tablet is formulated with an immediate-release layer of Esomeprazole Magnesium and an enteric-coated core of Naproxen. This unique formulation ensures that Esomeprazole is released first in the stomach before Naproxen dissolves in the small intestine.

Naproxen is a non-steroidal anti-inflammatory drug (NSAID) known for its analgesic and antipyretic effects. It functions by inhibiting prostaglandin synthesis, thereby reducing inflammation and pain. Esomeprazole, a proton pump inhibitor (PPI), suppresses gastric acid secretion by inhibiting the H+/K+ -ATPase enzyme in the gastric parietal cells, reducing acidity in the stomach.

Dosage Before initiating treatment with Xenole Tablet, the potential benefits and risks should be carefully assessed. It is advisable to use the lowest effective dose for the shortest possible duration.

• For Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis:
  • Adults: One tablet twice daily of either 375 mg Naproxen/20 mg Esomeprazole or 500 mg Naproxen/20 mg Esomeprazole.
• For Juvenile Idiopathic Arthritis (Adolescents 12 years and older):
  • Weight over 50 kg: One tablet twice daily of either 375 mg Naproxen/20 mg Esomeprazole or 500 mg Naproxen/20 mg Esomeprazole.
  • Weight 38 kg to less than 50 kg: One tablet twice daily of 375 mg Naproxen/20 mg Esomeprazole.

(Take this medication as per the advice of a registered physician.)

Administration

• Swallow the tablet whole; do not split, chew, crush, or dissolve it.
• Take the tablet at least 30 minutes before meals.

(Take this medication as per the advice of a registered physician.)

Drug Interactions

• Concomitant use of NSAIDs may reduce the antihypertensive effects of ACE inhibitors, diuretics, and beta-blockers.
• Co-administration with warfarin may increase the risk of bleeding.
• Esomeprazole may interfere with the absorption of medications that require gastric acid for bioavailability (e.g., ketoconazole, iron salts, digoxin).
• Taking Naproxen and Esomeprazole with high-fat food may delay Naproxen absorption, lowering peak plasma concentration by about 12%.

Contraindications Xenole Tablet should not be used in individuals who:

• Have a known hypersensitivity to any of its components or substituted benzimidazoles.
• Have a history of asthma, urticaria, or allergic reactions triggered by aspirin or other NSAIDs.
• Are undergoing coronary artery bypass graft (CABG) surgery.

Side Effects Xenole Tablet is designed to reduce gastrointestinal side effects compared to Naproxen alone. However, some adverse effects may still occur, including:

• Common effects: Nausea, vomiting, diarrhea, constipation, flatulence, dyspepsia, abdominal pain.
• Serious but rare effects: Peptic ulcers, gastrointestinal bleeding, cardiovascular events (such as myocardial infarction or stroke), hypertension, and fluid retention.

Use During Pregnancy and Lactation

• Pregnancy: Avoid use during the third trimester. In the first and second trimesters, Xenole Tablet should only be used if the benefits outweigh the potential risks to the fetus.
• Breastfeeding: Naproxen is excreted in small amounts in breast milk. The presence of Esomeprazole in breast milk is unknown. It is recommended to avoid use during breastfeeding.
• Fertility: Naproxen may impair female fertility and is not recommended for women attempting to conceive.

Precautions and Warnings

• Avoid concomitant use with other NSAIDs, including selective COX-2 inhibitors.
• Use the lowest effective dose for the shortest duration to reduce the risk of gastrointestinal complications.
• Patients at high risk of NSAID-induced ulcers (elderly individuals, those on corticosteroids or anticoagulants) should be monitored closely.
• Esomeprazole may lead to decreased vitamin B12 absorption with long-term use.

Special Populations

• Elderly patients: Due to increased risks of gastrointestinal bleeding and other adverse effects, lower doses should be considered where possible.
• Renal impairment: Not recommended for patients with moderate to severe renal impairment (creatinine clearance <30 ml/min).
• Hepatic impairment: Patients with mild to moderate hepatic impairment should be closely monitored. Not recommended for severe hepatic impairment.

Overdose Effects

• Naproxen overdose symptoms: Drowsiness, nausea, abdominal pain, gastrointestinal bleeding, hypertension, renal dysfunction, metabolic acidosis.
• Esomeprazole overdose symptoms: Typically transient; includes mild gastrointestinal symptoms.
• Management: Treatment is supportive and symptomatic. Activated charcoal may be considered in case of early ingestion. Naproxen is highly protein-bound and not removed effectively by hemodialysis.

Therapeutic Class

• Drugs for Osteoarthritis
• Drugs used for Rheumatoid Arthritis
• Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Storage Conditions Store at temperatures below 30°C, away from light and moisture. Keep out of reach of children.