Anaflex Max 375 mg+20 mg

Description

Indications

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

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

Use this medication only as directed by a registered physician.

Pharmacology

Anaflex Max Tablet consists of two key components: an immediate-release layer of Esomeprazole Magnesium and an enteric-coated core of Naproxen. This formulation ensures that Esomeprazole is released first into the stomach before Naproxen dissolves in the small intestine.

• Naproxen is a non-steroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties. It works by inhibiting prostaglandin synthesis, thereby reducing pain and inflammation.
• Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specifically inhibiting the H+/K+-ATPase enzyme in the gastric parietal cells, effectively lowering stomach acidity.

Dosage and Administration

Before prescribing Anaflex Max Tablet, the benefits and risks should be carefully assessed. The lowest effective dose should be used for the shortest duration necessary. If a daily Esomeprazole dose lower than 40 mg is required, an alternative treatment should be considered.

Dosage Guidelines

For Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis:

• Adults: One tablet twice daily of either:
  • 375 mg Naproxen / 20 mg Esomeprazole
  • 500 mg Naproxen / 20 mg Esomeprazole

For Juvenile Idiopathic Arthritis (Adolescents 12 Years & Older):

• Weight >50 kg: 375 mg Naproxen / 20 mg Esomeprazole or 500 mg Naproxen / 20 mg Esomeprazole, taken twice daily
• Weight 38-50 kg: One tablet of 375 mg Naproxen / 20 mg Esomeprazole, taken twice daily

Administration Instructions:

• Do not split, crush, chew, or dissolve the tablet.
• Take at least 30 minutes before meals.

Use this medication only as directed by a registered physician.

Drug Interactions

With Other Medications:

• NSAIDs: May reduce the effectiveness of ACE inhibitors, diuretics, and beta-blockers.
• Warfarin: Co-administration may increase the risk of bleeding complications.
• Gastric pH-dependent drugs (e.g., Ketoconazole, iron salts, Digoxin): Esomeprazole may alter their absorption.

With Food:

• Taking the tablet with a high-fat meal does not affect Naproxen absorption but may prolong its peak concentration time by 10 hours and reduce peak plasma levels by about 12%.

Contraindications

Anaflex Max Tablet should not be used in patients with:

• A known allergy to any of its components or benzimidazoles
• A history of asthma, urticaria, or allergic reactions to aspirin or other NSAIDs
• Perioperative use in coronary artery bypass graft (CABG) surgery

Side Effects

While Esomeprazole in Anaflex Max Tablet reduces the risk of gastrointestinal side effects, some potential adverse effects include:

• Common: Nausea, vomiting, diarrhea, constipation, bloating, abdominal pain, and indigestion
• Gastrointestinal risks: Peptic ulcers, gastrointestinal bleeding, and perforation (especially in elderly patients)
• Cardiovascular risks: Oedema, hypertension, and a potential increase in arterial thrombotic events (e.g., heart attack, stroke)
• Other effects: Headache, dizziness, fatigue, skin rash, and allergic reactions

Use During Pregnancy & Lactation

• Pregnancy: Not recommended in women trying to conceive or in the first and second trimesters unless the benefits outweigh the risks. Contraindicated in the third trimester.
• Breastfeeding: Naproxen is excreted in small amounts in breast milk, while Esomeprazole’s excretion status is unknown. Not recommended during breastfeeding.
• Fertility: NSAIDs, including Naproxen, may impair female fertility.

Precautions & Warnings

• Gastrointestinal risks: Older patients and those with a history of ulcers or gastrointestinal bleeding should use caution. Consider using protective agents like misoprostol or proton pump inhibitors when necessary.
• Cardiovascular health: Patients with hypertension, heart failure, or cardiovascular disease should use this medication cautiously.
• Renal effects: Long-term NSAID use may lead to kidney damage, including renal papillary necrosis.
• Hepatic impairment: Patients with moderate liver impairment should be monitored closely; this medication is not recommended for severe liver impairment.

Use in Special Populations

• Elderly: Increased risk of adverse effects, especially gastrointestinal bleeding. Use the lowest effective dose.
• Patients with renal impairment: Not recommended for patients with moderate to severe renal impairment (creatinine clearance <30 ml/min).
• Patients with hepatic impairment: Not advised for severe liver impairment; dose adjustment may be necessary for mild to moderate cases.

Overdose Effects & Management

Symptoms of Naproxen Overdose:
Lethargy, dizziness, drowsiness, abdominal pain, nausea, gastrointestinal bleeding, hypertension, renal failure, and in rare cases, coma or anaphylactic reactions.

Symptoms of Esomeprazole Overdose:
Transient effects; doses over 240 mg/day have not shown severe adverse reactions.

Management:

• For Naproxen overdose: Symptomatic and supportive care is recommended. Activated charcoal may be administered within four hours of ingestion.
• For Esomeprazole overdose: There is no specific antidote. Supportive treatment should be given.

Therapeutic Class

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

Storage Conditions

• Store below 30°C, protected from light and moisture.
• Keep out of reach of children.