Anaflex Max 500 mg+20 mg

Description

Indications
Anaflex Max Tablet is used for the relief of symptoms associated with:

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis
• Reducing the risk of gastric ulcers in patients prone to NSAID-related gastric ulcers

Pharmacology
Anaflex Max contains an immediate-release Esomeprazole Magnesium layer and an enteric-coated Naproxen core. This formulation ensures that Esomeprazole is released first in the stomach, followed by the dissolution of Naproxen in the small intestine.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties, functioning by inhibiting prostaglandin synthesis. Esomeprazole, a proton pump inhibitor, reduces gastric acid secretion by specifically blocking the H+/K+ ATPase enzyme in gastric parietal cells, thereby lowering stomach acidity.

Dosage and Administration
Before initiating treatment, consider the potential benefits and risks. Use the lowest effective dose for the shortest necessary duration. If a lower total daily dose of Esomeprazole (less than 40 mg) is needed, an alternative treatment should be considered.

For Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis:

• Adults: One tablet twice daily, either 375 mg Naproxen/20 mg Esomeprazole or 500 mg Naproxen/20 mg Esomeprazole.

For Juvenile Idiopathic Arthritis (Ages 12 and Older):

• Weight > 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 < 50 kg: One tablet twice daily of 375 mg Naproxen/20 mg Esomeprazole.

Tablets should be taken at least 30 minutes before meals. Do not split, chew, crush, or dissolve them.

Drug Interactions

• Concurrent use of NSAIDs may reduce the antihypertensive effects of ACE inhibitors, diuretics, and beta-blockers.
• Combining this tablet with warfarin may increase the risk of bleeding complications.
• Esomeprazole inhibits gastric acid secretion, potentially affecting the absorption of drugs dependent on gastric pH (e.g., Ketoconazole, iron salts, Digoxin).
• Taking Naproxen and Esomeprazole with high-fat foods does not impact Naproxen absorption but may delay its peak plasma concentration.

Contraindications

• Hypersensitivity to any component of the tablet or substituted benzimidazoles.
• History of asthma, urticaria, or allergic reactions triggered by aspirin or other NSAIDs.
• Use during the peri-operative period of coronary artery bypass graft (CABG) surgery.

Side Effects

• Esomeprazole reduces gastrointestinal side effects caused by Naproxen.
• Naproxen may slightly increase the risk of arterial thrombotic events, such as heart attacks or strokes, particularly with long-term use.
• Common gastrointestinal side effects include nausea, vomiting, diarrhea, constipation, abdominal pain, and indigestion.
• Rare but serious side effects include peptic ulcers, gastrointestinal bleeding, and perforation, especially in older adults.

Pregnancy and Lactation

• During the first and second trimesters, this medication should only be used if the benefits outweigh the risks. It is contraindicated in the third trimester.
• Naproxen is excreted in small amounts in breast milk, while the excretion of Esomeprazole is unknown. Therefore, this tablet should be avoided during breastfeeding.
• NSAIDs like Naproxen may impair female fertility and are not recommended for women trying to conceive.

Precautions and Warnings

• Combining Naproxen and Esomeprazole with other NSAIDs, including COX-2 inhibitors, should be avoided.
• Use the lowest effective dose for the shortest duration to minimize risks.
• Older adults are at a higher risk of gastrointestinal bleeding and cardiovascular events.
• Patients with pre-existing gastrointestinal diseases (e.g., colitis, Crohn’s disease) should use caution.
• Esomeprazole may reduce vitamin B12 absorption with long-term use.
• Caution is advised in patients with cardiovascular risk factors such as hypertension, diabetes, and hyperlipidemia.
• Long-term NSAID use may cause renal impairment; therefore, kidney function should be monitored.

Use in Special Populations

• Elderly: Increased free Naproxen levels may require dosage adjustments. Use the lowest effective dose.
• Renal Impairment: Not recommended for patients with moderate to severe renal impairment (creatinine clearance <30 ml/min).
• Hepatic Impairment: Close monitoring is required in mild to moderate cases. This tablet is not recommended for severe hepatic impairment.

Overdose Management

• Naproxen Overdose Symptoms: Lethargy, dizziness, nausea, gastrointestinal bleeding, renal dysfunction, and metabolic acidosis. Severe cases may cause hypertension, respiratory depression, or coma.
• Esomeprazole Overdose Symptoms: Generally mild, with transient symptoms reported at high doses.
• Treatment: Supportive care and symptom management are recommended. Hemodialysis is not effective for Naproxen overdose. Activated charcoal and gastric decontamination may be considered if ingestion occurred within four hours.

Therapeutic Class

• Osteoarthritis and rheumatoid arthritis treatment
• Non-steroidal anti-inflammatory drugs (NSAIDs)

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