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(desmopressin acetate) Spray, for Nasal Administration
- NOCTIVA can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest or death (WARNINGS AND PRECAUTIONS, ADVERSE REACTIONS).
- NOCTIVA is contraindicated in patients at increased risk of severe hyponatremia, such as patients with excessive fluid intake, illnesses that can cause fluid or electrolyte imbalances, and in those using loop diuretics or systemic or inhaled glucocorticoids (CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS).
- Ensure serum sodium concentrations are normal before starting or resuming NOCTIVA. Measure serum sodium within seven days and approximately one month after initiating therapy or increasing the dose, and periodically during treatment. More frequently monitor serum sodium in patients 65 years of age and older and in patients at increased risk of hyponatremia (DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS).
- If hyponatremia occurs, NOCTIVA may need to be temporarily or permanently discontinued (WARNINGS AND PRECAUTIONS).
Desmopressin acetate is a synthetic analogue of 8-arginine vasopressin, an endogenous pituitary hormone also known as antidiuretic hormone (ADH). Its chemical name is 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate, and its molecular weight is 1183.31. Its molecular formula is C48H68N14O14S2·3H2O. Its chemical structure is:
Desmopressin acetate is a white powder that is freely soluble in water. It is also soluble in alcohol and glacial acetic acid. NOCTIVA (desmopressin acetate) nasal spray is formulated for intranasal use as a milky white emulsion without preservatives at pH 5.5.
NOCTIVA is available as an oil-in-water emulsion at two dose strengths, 0.83 mcg and 1.66 mcg of desmopressin acetate per spray, for nasal administration. Each spray is 0.1 mL. The dose strengths are expressed as desmopressin acetate and are equivalent to 0.75 mcg and 1.5 mcg of desmopressin free base per spray, respectively. Both formulations also contain the following inactive ingredients: cyclopentadecanolide; cottonseed oil; sorbitan monolaurate; polysorbate 20; citric acid, anhydrous; sodium citrate dihydrate; and water for injection.
After initial priming, each actuation of NOCTIVA 0.83 mcg/0.1 mL or 1.66 mcg/0.1 mL delivers a dose of 0.83 mcg or 1.66 mcg of desmopressin acetate, respectively.
Last reviewed on RxList: 3/8/2017
This monograph has been modified to include the generic and brand name in many instances.
Additional Noctiva Information
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