Sergel Mups 20

Indications of Sergel Mups 20 mg Tablet

Esomeprazole is prescribed to treat chronic heartburn and other GERD symptoms.

• In order to treat erosive esophagitis,
• For the maintenance of erosive esophagitis healing
• In patients with duodenal ulcer illness, in conjunction with amoxicillin and clarithromycin, for the elimination of Helicobacter pylori infection.
• Syndrome of Zollinger-Ellison
• Duodenal and gastric ulcers due to acid dyspepsia

 

Pharmaceutical Name of Sergel Mups 20

Healthcare Pharmaceuticals Ltd.

 

Pharmacology

Esomeprazole is a proton pump inhibitor that inhibits the H+/K+-ATPase in the gastric parietal cell, suppressing gastric acid output. The first single optical isomer of a proton pump inhibitor, esomeprazole (S-isomer of omeprazole), provides superior acid control than racemic proton pump inhibitors.

Esomeprazole capsules contain an enteric-coated pellet version of esomeprazole magnesium for improved absorption. Peak plasma levels (Cmax) occur roughly 1.5 hours after oral dosing (Tmax). When the dose is increased, the Cmax increases correspondingly, and the area under the plasma concentration-time curve (AUC) increases thrice from 20 to 40 mg. The systemic bioavailability with repeated once-daily doses is around 90%, compared to 64% after a single dose. When compared to fasting conditions, the AUC following a single dosage of esomeprazole is reduced by 33-53 percent after food ingestion. At least one hour before meals, esomeprazole should be consumed.

Esomeprazole binds to plasma proteins 97 percent of the time. Over a concentration range of 2 20 mmol/L, plasma protein binding remains constant. In healthy volunteers, the apparent volume of distribution at steady state is around 16 L.

Esomeprazole is extensively processed by the cytochrome P450 (CYP) enzyme system in the liver. Esomeprazole's metabolites have no anti-secretory properties. The CYP2C19 isoenzyme, which creates the hydroxy and desmethyl metabolites, is responsible for the majority of esomeprazole metabolism. The sulphone metabolite is formed by CYP3A4, which is responsible for the remaining proportion.

 

Dosage & Administration

Erosive esophagitis-

• Adult (≥18 years): 40 mg once daily for 4 weeks.
• Children & adolescents (12-18 years): 40 mg once daily for 4 weeks.

Maintenance of healing of erosive esophagitis-

• Adult (≥18 years): 20 mg once daily.
• Children & adolescents (12-18 years): 20 mg once daily.

Risk reduction in NSAID associated gastric ulcer-

• Adult (≥18 years): 20 mg once daily for 4-8 weeks.

H. pylori eradication (Esomeprazole MUPS tablet with 1000 mg Amoxicillin and 500 mg Clarithromycin)-

• Adult (≥18 years): 20 mg twice daily for 7 days.
• Children & adolescents (12-18 years): 20 mg twice daily for 7 days.

Zollinger-Ellison syndrome and idiopathic hypersecretion-

• Adult (≥18 years): 40-80 mg twice daily.

Children 1-11 years:

• Erosive esophagitis: Weight <20 kg: 10 mg once daily for 8 weeks. Weight ≥20 kg: 10 mg or 20 mg once daily for 8 weeks
• Maintenance of healing of erosive esophagitis: 10 mg once daily

Children below the age of 1 year: Esomeprazole MUPS tablet is not approved for use in children younger than 1 year.

 

Interaction of Sergel Mups 20

CYP2C19 and CYP3A4 substantially metabolize esomeprazole in the liver. Esomeprazole does not appear to inhibit CYPs 1A2, 2A6, 2C9, 2D6, 2E1, or 3A4 in vitro or in vivo investigations. There should be no clinically significant interactions with medicines processed by these CYP enzymes. Esomeprazole has no clinically significant interactions with phenytoin, warfarin, quinidine, clarithromycin, or amoxicillin, according to drug interaction studies.

Esomeprazole may possibly meddled with CYP2C19, the major Esomeprazole metabolizing protein. Co-administration of Esomeprazole 30 mg and diazepam, a CYP2C19 substrate has brought about in a 45% diminish in clearance of diazepam. Expanded plasma levels of diazepam have been watched 12 hours after dosing and onwards. Esomeprazole represses gastric corrosive emission. Subsequently, Esomeprazole may meddled with the retention of drugs where gastric pH is an vital determinant of bioavailability (e.g., ketoconazole, press salts and digoxin).

Oral contraceptives, diazepam, phenytoin, or quinidine appear to have no effect on Esomeprazole's pharmacokinetic profile.

Clarithromycin in Combination Therapy: When esomeprazole, clarithromycin, and amoxicillin are given together, the plasma levels of esomeprazole and 14-hydroxyclarithromycin rise.

 

Contraindications

In patients who have a history of hypersensitivity to any of the formulations, esomeprazole is not recommended.

 

Side Effects of Sergel Mups 20

Headache, diarrhoea, nausea, flatulence, abdominal pain, constipation, and dry mouth are the most common side effects reported with Esomeprazole. When compared to short-term treatment, there is no difference in the categories of linked adverse events noticed with maintenance treatment up to 12 months.

 

Pregnancy & Lactation

In pregnant women, there are no sufficient and well-controlled trials. No teratogenic effects have been found in animal investigations. Esomeprazole excretion in milk has not been studied. If the use of esomeprazole is thought necessary, breastfeeding should be terminated.

 

Precautions & Warnings

General: A symptomatic response to esomeprazole medication does not rule out the possibility of gastric cancer.

Esomeprazole pills should be taken at least one hour before meals, according to the manufacturer's instructions. One tablespoon of applesauce can be put to an empty bowl for patients who have trouble swallowing capsules, and the Esomeprazole capsules can be opened and the pellets carefully spilled into the applesauce. The pellets should be combined with applesauce and quickly eaten. The applesauce should not be too hot, and it should be mushy enough to consume without chewing. Chewing or crushing the pellets is not recommended. 

 

Therapeutic Class

Proton Pump Inhibitor

 

Storage Conditions

Store in a dry area at a temperature of not more than 30°C. Light and dampness should be avoided. Keep out of children's reach.

 

Generic of Sergel Mups 20

Esomeprazole Magnesium Trihydrate