Indications

PainCare is a combination tablet containing Naproxen and Esomeprazole. It is indicated for the relief of signs and symptoms of:

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis It is also used to decrease the risk of developing gastric ulcers in patients who are at risk due to NSAID use.

Pharmacology

PainCare combines a non-selective NSAID (Naproxen) with a proton pump inhibitor (Esomeprazole).

• Naproxen: Inhibits prostaglandin synthesis by blocking both COX-1 and COX-2 enzymes, providing analgesic and anti-inflammatory effects.
• Esomeprazole: Suppresses gastric acid secretion by specifically inhibiting the H+/K+-ATPase (proton pump) in the gastric parietal cells. The tablet is formulated so that the Esomeprazole is released first, before the Naproxen, to protect the stomach.

Dosage & Administration

• Adults (Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis): One tablet twice daily. Doses are available as 375 mg Naproxen/20 mg Esomeprazole or 500 mg Naproxen/20 mg Esomeprazole.
• Adolescents (12 years and older):
  • Weight > 50 kg: One tablet twice daily of either 375 mg/20 mg or 500 mg/20 mg.
  • Weight 38-50 kg: One tablet twice daily of 375 mg/20 mg.
• Administration: Do not split, chew, crush, or dissolve the tablet. It should be taken at least 30 minutes before meals.

Interaction

• NSAIDs & other drugs: Concomitant use with other NSAIDs (including COX-2 inhibitors) and corticosteroids should be avoided.
• Antihypertensives: May reduce the effect of ACE inhibitors, diuretics, and beta-blockers.
• Anticoagulants (e.g., Warfarin): May increase the risk of bleeding.
• Drugs affected by gastric pH: Esomeprazole may interfere with the absorption of drugs like ketoconazole, iron salts, and digoxin.
• High-fat food: May prolong the time to peak concentration (tmax) and decrease the peak concentration (Cmax) of Naproxen.

Contraindications

PainCare is contraindicated in patients with a history of hypersensitivity to its components, or a history of asthma, urticaria, or allergic reactions to aspirin or other NSAIDs. It is also contraindicated for peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Side Effects

The Esomeprazole component is included to reduce the incidence of gastrointestinal side effects from Naproxen. However, common side effects include gastrointestinal issues such as nausea, vomiting, diarrhea, flatulence, abdominal pain, and dyspepsia. Serious GI events like bleeding or perforation, though rare, can be fatal. Other potential side effects include fluid retention, edema, hypertension, and a small increased risk of arterial thrombotic events.

Pregnancy & Lactation

This tablet is contraindicated in the third trimester of pregnancy due to risks to the fetus. In the first and second trimesters, it should only be used if the benefits outweigh the risks. Naproxen is excreted in breast milk, and it is unknown if Esomeprazole is. Therefore, it is not recommended for use during breastfeeding. NSAID use may impair female fertility.

Precautions & Warnings

• Use the lowest effective dose for the shortest duration.
• Avoid use with other NSAIDs.
• Caution is advised for older people and those with a history of GI bleeding, ulcers, or other gastrointestinal diseases.
• Patients with cardiovascular, renal, or hepatic impairment should be carefully monitored.
• Long-term use may reduce vitamin B12 absorption.

Therapeutic Class

PainCare is a combination product used for Osteoarthritis, Rheumatoid Arthritis, and is classified as a Non-steroidal Anti-inflammatory Drug (NSAID).

Storage Conditions

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