Naxin® Plus 375 Tablet: Each multi-layered tablet contains delayed release Naproxen BP 375 mg and immediate release Esomeprazole Magnesium Tryptide USP 22.210 mg equivalent to Esomeprazole 20 mg.
Naxin® Plus 500 Tablet: Each multi-layered tablet contains delayed release Naproxen BP 500 mg and immediate release Esomeprazole Magnesium Tryptide USP 22.210 mg equivalent to Esomeprazole 20 mg.
Indications: Naxin® Plus is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, dysmenorrhea and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers.
Naxin Plus consists of an immediate release Esomeprazole magnesium layer and an enteric coated Naproxen core. As a result Esomeprazole is released first into the stomach, prior to the dissolution of Naproxen in the small intestine.
Mode of action:
Naproxen is a NSAID with analgesic and antipyretic properties. The mechanism of action of Naproxen is to inhibit the prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibitor of the in the gastric parietal cell. By acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
Pharmacokinetics:
Naproxen is completely absorbed after oral administration with bioavailability of 95%. Approximately 95% of Naproxen is excreted by the urine. Esomeprazole is 97% bound to plasma proteins. Esomeprazole is extensively metabolized in the liver.
Naxin Plus is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis, dysmenorrhoea and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers.
Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis and dysmenorrhea.
Naxin® Plus 375.
1 Tablet.
Naxin® Plus 500.
twice daily.
Over dosage: There is no clinical data on overdose with Naxin® Plus.
Overdose of Naproxen: Signs are lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc.
Overdose of Esomeprazole: Signs are reduced motor activity, changes in respiratory frequency tremor and intermittent clonic convulsions etc.
Storage: Store in a cool (Below 25° C temperature) and dry place protected from light.
Packaging: Naxin® Plus 375 Tablets: Each carton contains 3 Alu-Alu blister of 10 tablets. Naxin® Plus 500 Tablet: Each carton contains 3 Alu-Alu blister of 10 tablets.
H⁺/K⁺-ATP- .
Side effects: In general, Naxin® Plus is well tolerated. The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea etc.
Use in pregnancy & lactation: In pregnancy, USFDA Pregnancy category C. in late pregnancy, it should be avoided because it may cause premature closure of the ductus arteriosus.
In lactation: Naxin® Plus should not be used in nursing mothers due to the naproxen component.
Precautions: Patients with known CV disease/risk factors may be at greater risk. Naxin® Plus should be used with caution in patients with fluid retention or heart failure.
In pregnancy: USFDA Pregnancy category C. in late pregnancy, it should be avoided because it may cause premature closure of the ductus arteriosus. In lactation: Naxin Plus should not be used in nursing mothers due to the naproxen component.
Patients with known CV disease/risk factors may be at greater risk. Naxin Plus should be used with caution in patients with fluid retention or heart failure.