Maxima 20 mg

Description

Indications

Maxima is indicated for the following conditions:

• Chronic Heartburn and GERD Symptoms: To alleviate symptoms associated with gastroesophageal reflux disease (GERD).

• Erosive Esophagitis: To promote the healing of esophagitis caused by acid reflux.

• Maintenance of Erosive Esophagitis Healing: To maintain the healing of erosive esophagitis.

• Helicobacter pylori Eradication: In combination with amoxicillin and clarithromycin, to eradicate Helicobacter pylori infection in patients with duodenal ulcers.

• Zollinger-Ellison Syndrome: A condition where the stomach produces too much acid.

• Acid-Related Dyspepsia: To treat symptoms of indigestion.

• Duodenal and Gastric Ulcers: To treat and manage ulcers in the duodenum and stomach.

Note: Always use this medication as directed by a registered healthcare provider.

Pharmacology

Esomeprazole, the active ingredient in Maxima, is a proton pump inhibitor (PPI) that works by reducing gastric acid secretion. It achieves this by specifically inhibiting the H+/K+-ATPase enzyme in the gastric parietal cells.

Esomeprazole is the S-isomer of omeprazole, which is the first single optical isomer of proton pump inhibitors. It provides better control over stomach acid compared to racemic forms of omeprazole.

Absorption: Esomeprazole capsules contain enteric-coated pellets, which release the active substance after ingestion. The peak plasma concentration occurs approximately 1.5 hours after administration. Increasing the dose leads to a proportional increase in plasma levels. The area under the plasma concentration-time curve (AUC) increases threefold with higher doses.

Dosage

Oral Dosage:

• Healing of Erosive Esophagitis: 20 mg or 40 mg once daily for 4-8 weeks. If symptoms persist after 4-8 weeks, further treatment may be considered.

• Maintenance of Erosive Esophagitis Healing: 20 mg once daily (Clinical studies have not extended beyond 6 months).

• Symptomatic GERD: 20 mg once daily for 4 weeks. If symptoms do not fully resolve, another 4 weeks of treatment may be considered.

• Helicobacter Pylori Eradication (Triple Therapy): 40 mg of esomeprazole once daily, 1000 mg of amoxicillin twice daily, and 500 mg of clarithromycin twice daily for 10 days.

• Zollinger-Ellison Syndrome: 20-80 mg once daily. Adjust the dosage according to the patient’s clinical needs.

• Acid-Related Dyspepsia: 20-40 mg once daily for 2-4 weeks, depending on the patient’s response.

• Duodenal Ulcer: 20 mg once daily for 2-4 weeks.

• Gastric Ulcer: 20-40 mg once daily for 4-8 weeks.

IV Injection or Infusion:

• GERD with Erosive Esophagitis (Adults ≥18 years): 20 mg or 40 mg once daily. IV Injection: 3 minutes, IV Infusion: 10-30 minutes.

• Pediatric Patients (1 to 17 years): For patients under 55 kg, administer 10 mg once daily. For patients 55 kg or above, administer 20 mg once daily.

• Risk Reduction of Rebleeding from Gastric or Duodenal Ulcers (Adults ≥18 years): 80 mg via IV infusion over 30 minutes, followed by continuous infusion of 8 mg/h for a total duration of 72 hours.

Note: Always follow the advice of a registered healthcare provider when using this medication.

Administration

• Tablets or Capsules: Take one hour before meals, swallowing the tablet or capsule whole.

• Oral Suspension: Dissolve the entire contents of the packet in 15 ml of water. Stir and let it thicken for 2-3 minutes. Stir again and drink within 30 minutes. If using a nasogastric or gastric tube, prepare and administer as described, ensuring no remaining suspension in the tube.

• IV Injection: Reconstitute the solution with 5 ml of 0.9% Sodium Chloride for intravenous injection. Administer over at least 3 minutes. Use within 12 hours of preparation.

Interactions

Maxima is metabolized in the liver by the CYP2C19 and CYP3A4 enzymes. It does not significantly interact with drugs metabolized by other enzymes like CYP1A2, CYP2A6, and others.

However, it can interact with certain medications:

• Co-administration with diazepam results in a 45% decrease in diazepam clearance.

• Maxima may interfere with the absorption of drugs that rely on gastric pH (e.g., ketoconazole, iron salts, and digoxin).

• When used in combination with clarithromycin and amoxicillin, Maxima’s plasma levels may increase.

Contraindications

Esomeprazole is contraindicated in patients with known hypersensitivity to any of its components.

Side Effects

The most common side effects of Maxima include:

• Headache

• Diarrhea

• Nausea

• Flatulence

• Abdominal pain

• Constipation

• Dry mouth

These side effects tend to remain consistent whether the medication is used short-term or long-term.

Pregnancy & Lactation

Maxima has not been adequately studied in pregnant women. Animal studies show no teratogenic effects, but the safety of Maxima during pregnancy is not established. If breastfeeding, consider discontinuing the drug as esomeprazole’s excretion in breast milk has not been studied.

Precautions & Warnings

• Symptomatic relief does not exclude the possibility of gastric malignancy.

• Capsules should be taken at least one hour before meals. For patients who have difficulty swallowing capsules, the contents can be mixed with applesauce and swallowed immediately.

• Antacids may be used during treatment.

Use in Special Populations

• Paediatric Use: Safety and effectiveness in children have not been established.

• Geriatric Use: No significant differences in safety and efficacy between older and younger patients, though older patients may show increased sensitivity.

• Hepatic Insufficiency: No dosage adjustment is needed for mild to moderate liver impairment. In severe hepatic insufficiency, limit the dose to 20 mg once daily.

• Renal Insufficiency: No dose adjustment is necessary for patients with renal impairment.

Overdose Effects

Maxima has shown lethality in rats at doses approximately 103 times the human dose. Symptoms of overdose include reduced motor activity, changes in breathing rate, tremors, ataxia, and convulsions. In case of overdose, provide supportive treatment as Maxima is highly protein-bound and cannot be removed by dialysis.

Storage Conditions

Store at room temperature (not exceeding 30°C) in a dry place. Keep out of reach of children, and protect from light and moisture.

Chemical Structure

• Molecular Formula: C17H19N3O3S

• Chemical Structure: Refer to the structure of Esomeprazole.

Common Questions about Maxima 20 mg Tablet

What is Maxima 20 mg Tablet? Maxima 20 mg Tablet is a proton pump inhibitor that reduces stomach acid production. It is used to treat conditions like GERD, ulcers, and other acid-related issues.

What is it used for? It helps to relieve heartburn, heal erosive esophagitis, and prevent its recurrence, as well as treat ulcers and GERD.

What are the side effects? Side effects may include headaches, diarrhea, nausea, and abdominal discomfort. These are usually consistent whether used short-term or long-term.

Can I take it during pregnancy or breastfeeding? Consult your doctor before using Maxima if you are pregnant or breastfeeding.

How quickly does it work? Maxima typically starts to work within a few hours of ingestion.

Quick Tips

• Maxima is well-tolerated and provides long-lasting relief.

• Avoid eating late at night to minimize acid reflux symptoms.

• Report any persistent stomach pain, watery diarrhea, or fever to your doctor.

• Long-term use may affect bone density and magnesium levels, so take adequate calcium and magnesium if prescribed.

Remember: Always consult a registered healthcare provider for personalized advice.