Solivo® consists of Naproxen (enteric-coated, delayed-release core) and Esomeprazole (as Esomeprazole Magnesium Trihydrate, immediate-release layer surrounding the core). As a result, Esomeprazole is released first into the stomach, before the dissolution of Naproxen in the small intestine. The enteric coating prevents Naproxen release at pH levels below 5.5.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of Naproxen is to inhibit prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specifically inhibiting the H⁺/K⁺-ATPase in the gastric parietal cells. By acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.

Solivo® is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. It also helps reduce the risk of developing gastric ulcers in patients at risk of NSAID-associated gastric ulcers. Solivo® is not recommended for the initial treatment of acute pain, as the absorption of Naproxen is delayed compared to other Naproxen-containing products.

Carefully consider the potential benefits and risks of Solivo® and other treatment options before deciding to use Solivo®. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Solivo® does not allow for the administration of a lower daily dose of Esomeprazole. If a daily dose lower than 40 mg of Esomeprazole is required, an alternative treatment should be considered.

Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis:

Solivo® 375 Tablet: 1 tablet twice daily
Solivo® 500 Tablet: 1 tablet twice daily

The tablets should be swallowed whole with liquid. Do not split, chew, crush, or dissolve the tablet. Solivo® should be taken at least 30 minutes before meals.

Studies indicate that although the total plasma concentration of Naproxen is unchanged, the unbound plasma fraction of Naproxen increases in elderly patients. Use caution when high doses are required, and dosage adjustments may be necessary. As with other drugs in elderly patients, the lowest effective dose should be used.

Naproxen-containing products are not recommended for use in patients with moderate to severe renal impairment (creatinine clearance <30 mL/min).

Monitor patients with mild to moderate hepatic impairment closely and consider a possible dose reduction based on the Naproxen component of Solivo®. Solivo® is not recommended in patients with severe hepatic impairment, as Esomeprazole doses should not exceed 20 mg daily in these patients.

The safety and efficacy of Solivo® in children younger than 18 years have not been established. Solivo® is therefore not recommended for use in children

Solivo® is contraindicated in:Patients with known hypersensitivity to Naproxen, Esomeprazole Magnesium, substituted benzimidazoles, or any of the excipients.

Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.

Treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

The most common adverse reactions observed in clinical trials (>5%) include:

Erosive gastritis
Dyspepsia
Gastritis
Diarrhea
Gastric ulcer
Upper abdominal pain
Nausea

Cardiovascular Risks: Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. Patients with known CV disease or risk factors may be at greater risk.

Gastrointestinal Risks: Serious gastrointestinal (GI) adverse events, which can be fatal. The risk is greater in patients with a prior history of ulcer disease, GI bleeding, or high-risk factors (especially the elderly). Solivo® should be used with caution in these patients.

Bleeding Risk: Treatment should be discontinued if active and clinically significant bleeding occurs.

Liver Function: Elevated liver enzymes and, rarely, severe hepatic reactions. Discontinue use immediately if abnormal liver enzymes persist or worsen.

Hypertension: New onset or worsening of pre-existing hypertension. Blood pressure should be monitored closely during treatment with Solivo®.

Congestive Heart Failure and Edema: Solivo® should be used with caution in patients with fluid retention or heart failure.

Renal Risks: Long-term use may cause renal papillary necrosis and other renal injuries. Use Solivo® with caution in the elderly, those with impaired renal function, hypovolemia, salt depletion, heart failure, liver dysfunction, or those taking diuretics or ACE inhibitors. Solivo® is not recommended for patients with moderate or severe renal impairment.

Hypersensitivity Reactions: Anaphylactoid reactions may occur. Do not use Solivo® in patients with the aspirin triad. Discontinue use immediately at the first sign of skin rash or any other sign of hypersensitivity.

Pregnancy Category C. In late pregnancy, Solivo® should be avoided as it may cause premature closure of the ductus arteriosus. Solivo® should not be used by nursing mothers.

NSAIDs may reduce the antihypertensive effects of ACE inhibitors, diuretics, and beta-blockers.
NSAIDs may increase plasma lithium levels.
Methotrexate toxicity may increase when used concomitantly with Solivo®.
Increased bleeding risk when used with warfarin; monitor INR and prothrombin time.

Esomeprazole inhibits gastric acid secretion, which may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts, and digoxin).

Store at a temperature not exceeding 30°C in a dry place. Protect from light. Keep out of reach of children.