From the Guidelines
The implication of taking 2 milligrams (mg) twice is likely ineffective for treating leishmaniasis, as the conventional target dose is approximately 2.5 mg of miltefosine/kg of body weight per day, and some data suggest that doses <2 mg/kg are associated with lower response rates 1.
Dosage Considerations
- The FDA-approved dosage regimen for persons who weigh 30–44 kg is one 50-mg capsule twice a day (total, 100 mg/day) for 28 consecutive days 1.
- The maximum daily dose of 150 mg (in 3 divided doses) applies to all persons who weigh ≥45 kg 1.
Clinical Evidence
- Clinical trials of miltefosine for VL in South Asia have shown that young children (from 2 to 11 or 14 years of age) had lower cure rates and lower plasma drug exposures compared to adults 1.
- A dosing algorithm with nonlinear, allometric scaling based on fat-free mass has been proposed to address the apparent difference in drug exposure between young children and adults, but clinical evaluations of this regimen are pending 1.
Key Points
- The dosage of 2 mg twice daily is below the recommended dose for most patients, and may result in lower response rates 1.
- The effectiveness of this dosage has not been established in clinical trials, and caution should be exercised when using this dosage in real-life clinical practice.
From the Research
Implication of Taking 2 Milligrams Twice
- The implication of taking 2 milligrams twice is not directly addressed in the provided studies, as they focus on different medications and dosing strategies.
- However, a study on hydromorphone 2 found that a single dose of 2 mg i.v. hydromorphone administered to emergency department patients in acute severe pain provided efficacious and rapid pain relief, but was associated with oxygen desaturation below 95 percent in about one third of patients.
- Another study on amlodipine 3 found that administering the medication in 2 divided doses was not associated with increased trough plasma amlodipine concentrations, reduced arterial stiffness, or improved BP control over a 24-hour period in patients with essential hypertension.
- A study on oxycodone and oxymorphone 4 found that patients taking oxymorphone ER consumed 0.6 fewer tablets per day than those taking oxycodone CR, but did not directly address the implication of taking 2 milligrams twice.
- A study on donepezil 5 derived plasma concentration profiles for higher dose immediate-release formulations and found that 10 mg twice daily, 20 mg once daily, and 23 mg SR once daily had similar steady-state concentration profiles.
- A study on glimepiride 6 found that the medication was equally effective whether administered once or twice daily, but did not directly address the implication of taking 2 milligrams twice.