Lansoprazole / Naproxen

Pronunciation: (lan-SOE-pra-zole/na-PROX-en)
Class: Non-narcotic analgesic combination

Trade Names:
Prevacid NapraPAC 500
- Tablets 15 mg lansoprazole/500 mg naproxen

Pharmacology

Lansoprazole

Suppresses gastric acid secretion by blocking acid (proton) pump within gastric parietal cells.

Naproxen

Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.

Indications and Usage

For reducing the risk of NSAID-associated gastric ulcers in patients with a history of documented gastric ulcers who need an NSAID for treatment of signs and symptoms of rheumatoid arthritis, osteoarthritis, and/or ankylosing spondylitis.

Contraindications

Treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery; aspirin- or NSAID-related asthma, urticaria, or allergic-type reactions; hypersensitivity to any component of the product.

Dosage and Administration

Adults

PO Lansoprazole 15 mg once daily and naproxen 500 mg twice daily. The naproxen dose and frequency may be adjusted to meet the patient's needs.

General Advice

• In the morning before eating, administer lansoprazole 15 mg and one naproxen 500 mg tablet. In the evening, administer the second naproxen 500 mg tablet.
• Swallow lansoprazole capsules whole; do not crush or chew.

Storage/Stability

Store at 59° to 86°F. Protect from light and moisture.

Drug Interactions

ACE inhibitors, beta-blockers

Antihypertensive effect may be decreased by naproxen.

Aspirin

Risk of serious GI complications, including bleeding, may be increased.

Diuretics (eg, loop diuretics [eg, furosemide], thiazide diuretics [eg, hydrochlorothiazide])

Diuretic effect may be reduced.

Drugs in which gastric pH is an important determinant of bioavailability (eg, ampicillin esters, digoxin, iron salts, ketoconazole)

Absorption may be altered by lansoprazole (eg, absorption of digoxin increased and ketoconazole decreased).

Lithium

Lithium levels may be elevated, increasing the risk of toxicity.

Probenecid

Naproxen plasma levels may be elevated and the t _½ may be prolonged.

Sucralfate

Take lansoprazole at least 30 min prior to sucralfate.

Theophylline

Cl may be increased slightly.

Laboratory Test Interactions

Naproxen may falsely increase urinary 17-ketosteroid values; may interfere with urinary assays for 5-hydroxy-indolacetic acid, decrease platelet aggregation, and prolong bleeding times.

Adverse Reactions

CNS

Dizziness, drowsiness, headache, light-headedness, vertigo (1% to 10%); abnormal dreams, aseptic meningitis, cognitive dysfunction, depression, insomnia, malaise, speech disorder (postmarketing).

Cardiovascular

Edema, palpitations (1% to 10%); CHF, vasculitis (postmarketing).

Dermatologic

Ecchymosis, pruritus, purpura, skin eruptions, sweating (1% to 10%); alopecia, erythema multiforme, photosensitivity (including cases resembling porphyria cutanea tarda), skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria (postmarketing).

EENT

Hearing disturbances, tinnitus, visual disturbances (1% to 10%); hearing impairment (postmarketing).

GI

Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, GI ulcers, gross bleeding/perforation, heartburn, nausea, stomatitis, vomiting (1% to 10%); colitis, hematemesis, nonpeptic ulceration, pancreatitis, ulcerative stomatitis (postmarketing).

Genitourinary

Glomerular nephritis, hematuria, interstitial nephritis, menstrual disorder, nephrotic syndrome, renal disease, renal failure, renal papillary necrosis, urinary retention (postmarketing).

Hematologic-Lymphatic

Agranulocytosis, aplastic anemia, eosinophilia, granulocytopenia, hemolytic anemia, leukopenia, melena, neutropenia, pancytopenia, thrombocytopenia, thrombotic thrombocytopenic purpura (postmarketing).

Hepatic

Abnormal LFTs, hepatotoxicity, jaundice (postmarketing).

Metabolic-Nutritional

Hyperglycemia, hyperkalemia, hypoglycemia (postmarketing).

Musculoskeletal

Muscle weakness, myalgia, myositis (postmarketing).

Respiratory

Dyspnea (1% to 10%); eosinophilic pneumonitis (postmarketing).

Miscellaneous

Thirst (1% to 10%); anaphylactic reactions, angioneurotic edema, pyrexia (postmarketing).

Precautions

Warnings NSAIDs may cause an increased risk of serious CV thrombotic events, MI, and stroke, which can be fatal. This risk may increase with length of therapy. Patients with CV disease or risk factors for CV disease may be at greater risk. Naproxen is contraindicated for the treatment of perioperative pain in the setting of CABG surgery. NSAIDs cause an increased risk of serious GI adverse reactions, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These reactions can occur any time during use and without warning symptoms. Elderly patients are at greater risk of serious GI reactions.

Monitor Determine hemoglobin values periodically in patients with an initial hemoglobin value of 10 g or less who receiving long-term therapy.

Pregnancy

Category C . Avoid use in late pregnancy; may cause premature ductus arteriosus closure.

Lactation

Naproxen

Excreted in breast milk.

Lansoprazole

Undetermined.

Children

Safety and efficacy not established.

Renal Function

Naproxen-containing products are not recommended in patients with moderate to severe and severe renal function impairment (Ccr less than 30 mL/min).

Hepatic Function

Consider dosage adjustments for the naproxen component in elderly patients and patients with liver disease.

Special Risk Patients

Use with caution in elderly patients or patients with fluid retention, hypertension, heart failure, or history of GI bleeding or ulcer disease.

Bleeding

Bleeding time may be prolonged as a result of inhibition of platelet aggregation.

Concomitant therapy

Do not use naproxen sodium with other naproxen-containing drugs because they all will circulate as naproxen anion.

Hypertension

Onset of new hypertension or worsening of preexisting hypertension may occur, increasing the risk of CV events.

Inflammatory conditions

Because fever and inflammation may be reduced by naproxen, signs used in diagnosing complications of presumed noninfectious, noninflammatory painful conditions may be diminished.

Renal effects

Long-term administration may result in renal injury, including renal papillary necrosis.

Overdosage

Symptoms

Abdominal discomfort, acute renal failure, alterations in liver function, anaphylactoid reactions, apnea, coma, disorientation, dizziness, drowsiness, epigastric pain, GI bleeding, heartburn, hypertension, hypoprothrombinemia, indigestion, lethargy, metabolic acidosis, nausea, renal function impairment, respiratory depression, seizures, vomiting.

Patient Information

• Advise patient to read the Medication Guide before starting therapy and with each refill.
• Instruct patient to take lansoprazole 15 mg and one naproxen 500 mg tablet in the morning before eating and to take the second naproxen 500 mg tablet in the evening.
• Instruct patient to promptly report signs or symptoms of unexplained weight gain or edema to health care provider.
• Instruct patient of the warning signs and symptoms of hepatotoxicity and to stop therapy and seek immediate medical attention if they occur.
• Instruct patients to seek immediate medical assistance if they experience difficulty breathing and/or swelling of the face or throat.
• Caution patient to avoid taking this medication in late pregnancy because of risk of premature closure of the ductus arteriosus.
• Advise patients to use caution when engaging in activities requiring alertness if they experience drowsiness, dizziness, vertigo, or depression during therapy.

Copyright © 2009 Wolters Kluwer Health.