FDA Okays Drug for Frequent Nocturia
By medpagetoday.com
For the first time the FDA approved a treatment for frequent nighttime urination due to overproduction of urine.
The drug, desmopressin acetate (Noctiva), is delivered as a nasal spray and is approved for use only in adults who awaken two or more times nightly to urinate due to nocturnal polyuria. Used daily "approximately 30 minutes before going to bed, it works by increasing the absorption of water through the kidneys, which leads to less urine production," the agency said.
In a statement, Hylton V. Joffe, MD, MMSc, of the FDA's Center for Drug Evaluation and Research, said, "It is important to know that Noctiva is not approved for all causes of nighttime urination, so patients should discuss their symptoms with their healthcare provider who can determine the underlying cause of the nighttime urination and whether Noctiva is right for them."
The FDA cautioned that nocturia can be caused by a wide variety of conditions, "such as congestive heart failure, poorly controlled diabetes mellitus, medications, or diseases of the bladder or prostate. Before considering Noctiva, healthcare providers should evaluate each patient for possible causes for the nocturia, and optimize the treatment of underlying conditions that may be contributing to the nighttime urination. Because Noctiva is approved only for adults with nocturia caused by nocturnal polyuria, healthcare providers should confirm overproduction of urine at night with a 24-hour urine collection, if one has not been obtained previously."
Moreover, the FDA warned that underlying conditions, including congestive heart failure, could make use of the drug unsafe.
Noctiva is taken daily, approximately 30 minutes before going to bed. It works by increasing the absorption of water through the kidneys, which leads to less urine production.
The approval was based on two 12-week, randomized, placebo-controlled trials in 1,045 patients 50 years of age and older with nocturia due to nocturnal polyuria. Both studies demonstrated only a small benefit compared with placebo, but "more patients treated with Noctiva were able to at least halve their number of nighttime urinations, and patients treated with Noctiva had more nights with one or fewer night-time urinations."
The drug will carry a boxed warning that it can cause hyponatremia, which can be life-threatening if severe.
"Noctiva should not be used in patients at increased risk of severe hyponatremia, such as those with excessive fluid intake, those who have illnesses that can cause fluid or electrolyte imbalances, certain patients with kidney damage, and in those using certain medicines, known as loop diuretics or glucocorticoids," the FDA said. The drug should not be used in pregnant women or children.
Side effects included nasal discomfort, nasal congestion, sneezing, hypertension, nose bleeds, bronchitis, and dizziness.
Noctiva is marketed by Milford, Pennsylvania-based Renaissance Lakewood, LLC for Serenity Pharmaceuticals, LLC.
Source: http://www.medpagetoday.com/urology/urology/63578
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Thursday, May 14, 2026
Lopressor Metoprolol Treatment Decisions: Formulation Differences, Dosing, and Monitoring
Metoprolol prescribing requires an upfront decision about formulation that significantly affects dosing schedule and consistency of effect. Understanding why metoprolol tartrate and metoprolol succinate are treated as distinct medications with different clinical applications helps patients use their prescribed formulation correctly and understand why switching between them is not simply a dose rename. Metoprolol tartrate, sold as Lopressor, has a shorter duration of action that typically keeps blood levels therapeutic for eight to twelve hours. This requires twice-daily dosing for most blood pressure and cardiac rate management applications. Once-daily metoprolol tartrate produces uneven blood levels, with adequate coverage during the dosing window but a trough effect late in the twenty-four hour period that allows blood pressure and heart rate to rise before the next dose. Metoprolol succinate, sold as Toprol-XL, uses an extended-release formulation that sustains therapeutic levels over twenty-four hours with once-daily dosing. This more consistent blood level profile translates to more stable blood pressure and heart rate control throughout the day and night. For chronic outpatient management of hypertension, angina, or stable heart failure, the succinate formulation is generally preferred specifically because of this pharmacokinetic advantage. Heart failure management with metoprolol specifically uses the succinate formulation based on evidence from the MERIT-HF trial. Metoprolol tartrate is not directly interchangeable for heart failure because the clinical evidence was gathered using the succinate extended-release version. Patients with heart failure should confirm their prescription is for metoprolol succinate. Dose ranges for blood pressure management using metoprolol tartrate typically fall between 50 mg and 200 mg daily in divided doses. For metoprolol succinate, once-daily doses for hypertension range from 25 mg to 200 mg. Both formulations use weight of milligrams that are not directly dose-equivalent per milligram, so dose conversions should be managed by the prescriber. Resting heart rate monitoring guides dose titration and safety assessment. Maintaining resting rates between fifty-five and seventy beats per minute is a common clinical target. Patients whose rates drop below fifty should report this to their provider. Physical activity patterns such as competitive athletics can result in very low resting heart rates from fitness combined with beta-blocker effects, which warrants discussion. Drug interactions require consideration with metoprolol. Both formulations are metabolized through the CYP2D6 enzyme pathway. Drugs that inhibit CYP2D6, including certain antidepressants like bupropion, paroxetine, and fluoxetine, raise metoprolol blood levels and can cause excessive rate and pressure reduction. For patients reviewing their metoprolol regimen with a provider, learning about lopressor metoprolol treatment decisions helps clarify the formulation choices and what monitoring the medication requires. For comprehensive context on beta-blocker therapy and cardiovascular medication management, exploring blood pressure medication guidance and treatment resources supports informed patient engagement in long-term care.
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