Is it safe to administer lansoprazole (Proton Pump Inhibitor) 30mg twice daily (BD) to a 60kg female patient with normal renal function for a duration of 2 weeks?

From the Guidelines

Lansoprazole 30mg twice daily is not a recommended dose, as the equivalent dose to omeprazole 20 mg once daily is lansoprazole 30 mg once daily, according to the most recent evidence 1.

Key Considerations

• The patient's weight and kidney function are not the primary concerns for lansoprazole dosing, as it is primarily metabolized by the liver.
• The standard therapeutic dose of lansoprazole is 30 mg once daily, which is equivalent to omeprazole 20 mg once daily, as shown in Table 5 of the study 1.
• A 2-week course of lansoprazole is generally considered safe, but the patient should be monitored for common side effects such as headache, nausea, diarrhea, or abdominal pain.

Dosage and Administration

• The recommended dose of lansoprazole for a 60kg female with healthy kidneys is 30 mg once daily, not twice daily.
• The patient should take the medication approximately 30 minutes before meals for optimal effect.

Safety and Efficacy

• Lansoprazole works by reducing stomach acid production by blocking the proton pump in gastric parietal cells, which helps heal damaged esophageal or gastric tissue and relieve symptoms like heartburn or acid reflux.
• Long-term use (beyond 8 weeks) would require reassessment, but a 2-week course is considered safe and appropriate, as long as the recommended dose is followed.

From the FDA Drug Label

In children aged one to 11 years, lansoprazole was dosed 15 mg daily for subjects weighing ≤ 30 kg and 30 mg daily for subjects weighing greater than 30 kg The pharmacokinetics of lansoprazole were not clinically different in patients with mild, moderate or severe renal impairment compared to healthy subjects with normal renal function Male and Female Patients: In a study comparing 12 male and six female human subjects who received lansoprazole, no sex-related differences were found in pharmacokinetics and intragastric pH results.

The dose of 30mg BD (twice daily) is higher than the recommended dose for a 60kg female. The recommended dose is 30mg daily for subjects weighing greater than 30kg. Since the patient has healthy kidneys, the pharmacokinetics of lansoprazole are not expected to be clinically different. However, the dose is higher than recommended, and there is no information about the safety of this dose for a duration of 2 weeks. Therefore, it is not possible to conclude that it is safe to give lansoprazole 30mg BD to a 60kg female with healthy kidneys for 2 weeks 2.

From the Research

Safety of Lansoprazole 30mg BD for a 60kg Female with Healthy Kidneys

• The usual dosages of lansoprazole are 15 to 60 mg/day 3, which indicates that a dose of 30mg BD (60mg/day) is within the recommended range.
• Studies have shown that lansoprazole is well tolerated in clinical trials, with headache, diarrhoea, dizziness, and nausea being the most common adverse effects 3, 4, 5, 6.
• The incidence of adverse events associated with lansoprazole is generally < 5% in short-term trials and < 10% in long-term trials 4.
• Lansoprazole has been shown to be effective in the treatment of various acid-related disorders, including peptic ulcer disease, gastro-oesophageal reflux disease, and Zollinger-Ellison syndrome 3, 4, 7, 5, 6.
• There is no indication that the dose of 30mg BD would be unsafe for a 60kg female with healthy kidneys for a period of 2 weeks, as the dosages used in clinical trials were similar or higher 3, 4, 7, 5, 6.

Pharmacokinetics and Pharmacodynamics

• Lansoprazole inhibits gastric acid secretion by selectively inhibiting the membrane enzyme H+/K+ ATPase in gastric parietal cells 7.
• The mechanism of action of lansoprazole is similar to that of other proton pump inhibitors, such as omeprazole 3, 7, 5.
• Lansoprazole has been shown to be effective in reducing basal acid output in patients with Zollinger-Ellison syndrome 3, 5.

Clinical Efficacy

• Lansoprazole has been shown to be effective in the treatment of various acid-related disorders, including peptic ulcer disease, gastro-oesophageal reflux disease, and Zollinger-Ellison syndrome 3, 4, 7, 5, 6.
• Lansoprazole has been shown to be superior to ranitidine in the treatment of gastro-oesophageal reflux disease and peptic ulcer disease 3, 4, 5, 6.
• Lansoprazole has been shown to be similar in efficacy to omeprazole in the treatment of peptic ulcer disease and gastro-oesophageal reflux disease 3, 4, 7, 5.