Neusangel 40 mg – Full Product Description

Neusangel 40 mg is a proton pump inhibitor (PPI) medication that contains Esomeprazole Magnesium Trihydrate, designed to reduce excessive stomach acid production. Manufactured by Pristine Pharmaceuticals Ltd., this formulation is commonly prescribed for the treatment and prevention of various acid-related gastrointestinal disorders.

Therapeutic Class:

Proton Pump Inhibitor (PPI)

Indications:

Neusangel 40 mg is used for the management of:

• Gastroesophageal Reflux Disease (GERD)

• Erosive Esophagitis (EE)

• Peptic Ulcer Disease

• Zollinger-Ellison Syndrome

• Prevention of gastric ulcers caused by NSAIDs

• Part of triple therapy for H. pylori eradication (as per physician's advice)

Pharmacology:

Esomeprazole is the S-isomer of omeprazole and works by selectively inhibiting the H⁺/K⁺ ATPase enzyme system (the gastric proton pump) in the parietal cells of the stomach. This action blocks the final step of acid production, leading to decreased gastric acidity and improved symptom control.

• Bioavailability: Increases with repeated use (up to 90%)

• Peak Plasma Concentration: Reached within 1.5 hours

• Half-Life: 1 to 1.5 hours

• Protein Binding: ~97%

• Metabolism: Primarily in the liver via CYP2C19 and CYP3A4

• Excretion: Mostly in urine and feces as inactive metabolites

Dosage and Administration:

• Usual adult dose: One capsule (40 mg) once daily, preferably 1 hour before a meal

• Duration: Typically 4–8 weeks, depending on diagnosis

• Children & elderly: Use under medical supervision

• Note: Dosage may be adjusted for patients with liver impairment or specific treatment needs (e.g., high-dose therapy for Zollinger-Ellison Syndrome)

Side Effects:

Most side effects are mild and self-limiting. These may include:

• Headache

• Nausea or vomiting

• Abdominal pain

• Flatulence

• Diarrhea or constipation

• Dizziness

• Dry mouth

Serious but rare effects:

• Hypomagnesemia (with long-term use)

• Bone fracture risk (long-term/high-dose)

• Vitamin B12 deficiency

Precautions and Warnings:

• Use with caution in severe liver disease

• Long-term use may require monitoring of magnesium, calcium, and B12 levels

• Consult a physician before use during pregnancy or lactation

• May mask symptoms of gastric malignancy – diagnostic evaluation recommended before long-term use

Drug Interactions:

• May reduce absorption of drugs requiring gastric pH (e.g., ketoconazole, atazanavir)

• Interacts with diazepam, phenytoin, and warfarin (monitor levels)

• Clopidogrel: Esomeprazole may reduce its antiplatelet effect; use with caution

Storage Instructions:

• Store below 25°C

• Keep in a dry place, away from direct sunlight

• Keep out of reach of children

Presentation:

• Form: Enteric-coated capsule

• Strength: 40 mg of Esomeprazole

• Packaging: Usually available in strips of 10 capsules