Sonap 500

Indications

Sonap is intended for alleviating the signs and symptoms associated with:

• Rheumatoid arthritis
• Osteoarthritis
• Ankylosing spondylitis
• Juvenile arthritis
• Tendonitis
• Bursitis
• Acute gout

Additionally, it’s indicated for managing primary dysmenorrhea and pain.

Pharmacology

Similar to other non-selective NSAIDs, naproxen operates by inhibiting COX-1 and COX-2 enzymes, thereby reducing prostaglandin synthesis. While both enzymes contribute to prostaglandin production, they serve distinct functions. COX-1 is constitutively active and present in normal tissues like the stomach lining, whereas COX-2 is inducible and produces prostaglandins involved in pain, fever, and inflammation. Naproxen’s antipyretic, analgesic, and anti-inflammatory effects stem from its inhibition of the COX-2 enzyme, while undesirable effects like gastrointestinal upset and renal toxicities are associated with COX-1 enzyme activity.

Dosage & Administration

Naproxen oral formulations should be ingested with water, preferably after meals.

Naproxen Enteric Coated Tablet (Adult)

• For rheumatoid arthritis/osteoarthritis/ankylosing spondylitis: Initially, 500-1000 mg per day in two divided doses at 12-hour intervals. Maintenance dose: 500 mg per day in two divided doses at 12-hour intervals. Total daily dose should not exceed 1000 mg with 12-hour intervals.
• For acute gout: Initial dose of 750 mg followed by 250 mg every 8 hours until the attack subsides. Not recommended for children under 16 years.
• For dysmenorrhea: Initial dose of 500 mg followed by 250 mg every 6-8 hours for up to 5 days, if needed.
• For other indications like analgesia and acute musculoskeletal disorders: Initial dose of 500 mg followed by 250 mg every 6-8 hours, if needed.

Naproxen Suspension (Children)

• For juvenile rheumatoid arthritis: Usual dose for children over 2 years is 10 mg/kg/day in two divided doses at 12-hour intervals. Not recommended for children under 2 years. Dosage may vary based on weight.

Naproxen Gel: Apply 2-6 times daily as required; not recommended for children.

Interactions

• ACE inhibitors: May reduce antihypertensive effect.
• Antacids & Sucralfate: Delay Sonap absorption.
• Aspirin: Potentiates adverse effects.
• Diuretics: Diminish natriuretic effect.
• Methotrexate: Enhances toxicity.
• Warfarin: Increases risk of GI bleeding.
• Selective Serotonin Reuptake Inhibitors (SSRI): Increases risk of GI bleeding.

Contraindications

Naproxen is contraindicated in patients with known hypersensitivity to it. Avoid in patients with asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs. Contraindicated for perioperative pain in CABG surgery.

Side Effects

Common side effects include gastrointestinal issues, central nervous system symptoms, dermatological reactions, cardiovascular effects, visual and hearing disturbances.

Pregnancy & Lactation

Use during pregnancy and lactation requires careful consideration of benefits versus risks. Excreted in breast milk but considered safe by some authorities.

Precautions & Warnings

• Renal effects: Long-term use may lead to renal complications.
• Hepatic effects: Rare cases of jaundice reported.

Therapeutic Class

Drugs for Osteoarthritis, Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Storage Conditions

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