Naspro Plus 500 mg+20 mg (Tablet (Delayed Release))

Title

• Naproxen & Esomeprazole

Categories

• Pain Relief
• Gastrointestinal Health
• Anti-inflammatory

Description

• Naproxen & Esomeprazole is indicated for the relief of signs & symptoms of Osteoarthritis, Rheumatoid arthritis, Ankylosing spondylitis & to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

Color Options

• White
• Blue

Dosage

• Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

Dosage Recommendations

• Adults: One tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
• Adolescent Patients 12 Years of Age & Older: Varies based on weight

Administration

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

Interaction with Medicine

• Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers
• Concomitant use of this tablet and warfarin may result in an increased risk of a bleeding complication.
• Inhibits gastric acid secretion & may interfere with the absorption of certain drugs.

Interaction with Food

• Administration with high-fat food does not affect the extent of absorption of naproxen but significantly prolongs tmax by 10 hours and decreases peak plasma concentration (Cmax) by about 12%

Contraindications

• Known hypersensitivity to any component of this tablet or substituted benzimidazoles.
• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
• Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery.

Side Effects

• May decrease the incidence of gastrointestinal side effects from Naproxen.
• Gastric ulcers and NSAID associated upper gastrointestinal adverse events.
• Elevated risk of arterial thrombotic events (e.g. myocardial infarction or stroke).

Pregnancy & Lactation

• Contraindicated during the third trimester of pregnancy.
• Not recommended during breastfeeding.
• May impair female fertility.

Precautions & Warnings

• Avoid combining with other NSAIDs including cyclooxygenase-2 selective inhibitors.
• Minimize undesirable effects by using the lowest effective dose for the shortest duration necessary to control symptoms.

Use in Special Populations

• Use caution when high doses are required in elderly patients.
• Not recommended for use in patients with moderate to severe renal impairment.
• Monitor patients with mild to moderate hepatic impairment closely.

Overdose Effects

• Symptoms include lethargy, dizziness, drowsiness, epigastric pain, and may lead to hypertension, acute renal failure, and coma.
• No specific antidote is known, treatment should be symptomatic and general supportive measures should be utilized.

Therapeutic Class

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

Storage Conditions

• Store below 30°C, protect from light & moisture.

Dimensions

• 5mm x 10mm

Technical Specifications

• Consists of an immediate release Esomeprazole Magnesium layer & an enteric-coated Naproxen core.

Materials

• Naproxen
• Esomeprazole

Design Elements

• Enteric-coated

Usability Features

• Relief of signs & symptoms of Osteoarthritis, Rheumatoid arthritis, Ankylosing spondylitis.

Risk Factors

• High age, concomitant use of anticoagulants, corticosteroids, other NSAIDs.
• Debilitating cardiovascular disease, Helicobacter pylori infection, and a history of gastric and/or duodenal ulcers.

Age Group

• Adolescents 12 years and older
• Elderly patients

Renal Impairment

• Not recommended for use in patients with moderate to severe or severe renal impairment.

Hepatic Impairment

• Consider a possible dose reduction based on the Naproxen component.

Overdose Management

• No specific antidote, treatment should be symptomatic and general supportive measures should be utilized.

Storage Precautions

• Keep out of reach of children.

Benefit-Risk Ratio

• Rigorous benefit-risk ratio should be considered in conditions such as Inducible porphyries, Systemic lupus erythematosis, and mixed connective tissue disease.

Cardiovascular Monitoring

• Appropriate monitoring and advice required for patients with a history of hypertension and/or mild to moderate congestive heart failure.

Renal Side Effects

• Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.

Peak Plasma Concentration

• Decreased by about 12% when administered with high-fat food.

Elevated Risk Factors

• Patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidemia, diabetes mellitus, smoking).

Additional Drug Class

• Proton Pump Inhibitors (PPIs)

Co-administration Precautions

• Caution advised in patients receiving NSAIDs with concomitant medications which could increase the risk of ulceration or bleeding.

Food Absorption

• High-fat food does not affect the extent of absorption of naproxen but significantly prolongs tmax by 10 hours.

Medication Absorption Interference

• May interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability.

Storage Temperature

• Below 30°C

Light & Moisture Protection

• Store at temperature of below 30°C, protect from light & moisture.

Protein Binding

• Extensively plasma protein bound and is therefore not readily dialyzable.

Dose Adjustment

• Some adjustment of dosage may be required in elderly patients.

Medication Excretion

• Naproxen is excreted in low quantities in human milk.

Dose Recommendation Variations

• Varies based on weight for adolescents 12 years and older.

NSAID Interaction Effects

• May reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers.

Adverse Reactions in Older People

• Increased frequency of adverse reactions especially gastrointestinal bleeding, and perforation.

Potential Drug Interference

• May interfere with the absorption of drugs like Ketoconazole, iron salts, and digoxin.

Drug Combination Risks

• Cumulative risks of inducing serious NSAID-related adverse events.

NSAID-specific Risks

• Gastrointestinal bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at anytime during treatment.

GI Conditions Caution

• Caution should be advised in patients receiving NSAIDs with concomitant medications which could increase the risk of ulceration or bleeding.

Esomeprazole Specific Effects

• As all acid-blocking medicines, might reduce the absorption of vitamin B12.

Pregnancy Use Caution

• In women attempting to conceive or during the first and second trimester, the tablet should not be given unless the potential benefit to the patient outweighs the potential risk to the foetus.

Elderly Dose Caution

• Use caution when high doses are required & some adjustment of dosage may be required in elderly patients.

NSAID-induced GI Effects

• Risk of GI bleeding, ulceration or perforation with NSAIDs is higher with increasing NSAID doses.

Esomperazole Overdose Symptoms

• Transient symptoms described in connection with deliberate overdose.

Life-threatening Dose

• Not known what dose of the drug would be life-threatening.

Related Brands

• Ultranax Plus 500 mg+20 mg (Tablet (Delayed Release)) - ad-din-pharmaceuticals-ltd
• Anaflex Max 375 mg+20 mg (Tablet (Delayed Release)) - aci-limited
• Anaflex Max 500 mg+20 mg (Tablet (Delayed Release)) - aci-limited
• Demovo 375 mg+20 mg (Tablet (Delayed Release)) - delta-pharma-ltd
• Demovo 500 mg+20 mg (Tablet (Delayed Release)) - delta-pharma-ltd