For example, more frequent monitoring is recommended for patients 65 years of age or older or those on concomitant medications that can increase the risk of hyponatremia, such as If hyponatremia occurs, NOCTIVA may need to be temporarily or permanently discontinued, and treatment for the hyponatremia instituted, depending on the clinical circumstances, including the duration and severity of the hyponatremia [see NOCTIVA can cause fluid retention, which can worsen underlying conditions that are susceptible to volume status. STORE BOTTLE IN UPRIGHT POSITION.Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use) This Patient Information has been approved by the Food and Drug AdministrationRead these instructions before using desmopressin acetate nasal solution 0.01% (nasal spray), and each time you get a refill.
0.83 mcg, 4.4% with NOCTIVA 1.66 mcg, and 2.3% with placebo. If your dose is different, do not change it unless your doctor tells you to do so. Nasal mucosa abnormalities (such as scarring and edema) due to chronic administration, or due to other causes (nasal blockage, nasal mucosal atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) may cause erratic, unreliable absorption. Page, in Side Effects of Drugs Annual, 2009. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.Do not drink large amounts of fluids close to bedtime during treatment with NOCTIVA.These are not all the possible side effects of NOCTIVA. Hold the spray tip away from your face and eyes (see Figure C).• After your desmopressin acetate nasal solution 0.01% (nasal spray) pump is primed, it will spray 10 micrograms (1 dose) of medicine each time it is pressed.Step 3. No adverse developmental outcomes were observed in animal reproduction studies with administration of desmopressin during organogenesis to pregnant rats and rabbits at doses approximately <1 and 31 times, respectively, the maximum recommended human dose based on nasal surface area (see Data).In the U.S. general population, the estimated background rate of major birth defects and Desmopressin acetate did not cause fetal harm in teratology studies in rats and rabbits at doses from 0.05 to 10 mcg/kg/day, which is approximately <1 times (rat) and 31 times (rabbit) the maximum recommended human dose based on nasal surface area.Desmopressin is present in small amounts in human milk and is poorly absorbed orally by an infant.
their health care provider about new medications, and to stop NOCTIVA during illnesses that can cause fluid or electrolyte imbalance.
Severe symptoms due to an extreme decrease in serum sodium and plasma osmolality may include one or a combination of the following: seizure, coma, and/or respiratory arrest.In order to decrease the risk of water intoxication with hyponatremia, fluid restriction is recommended. The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for NOCTIVA and any potential adverse effects on the breastfed infant from NOCTIVA or from the underlying maternal condition.NOCTIVA is contraindicated for the treatment of primary Patients 65 years and older treated with NOCTIVA had a higher incidence of hyponatremia compared to patients less than 65 years old treated with NOCTIVA [see Desmopressin is mainly excreted in the urine. It is an anticholinergic agent chemically described as 8-azoniabicyclo [3.2.1] octane, 3-(3-hydroxy-1-oxo-2 … In general, dose selection for an elderly patient should be cautious, usually starting at a low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy. In both trials, there was consistent separation between the NOCTIVA 1.66 mcg and placebo curves.The results for selected secondary efficacy endpoints among patients with nocturia due to nocturnal polyuria are shown in Table 6.Call your doctor if you have any of the following symptoms of low salt levels in your blood:Low salt levels in the blood happen more often in people who are treated with NOCTIVA and are 65 years old or older than in people treated with NOCTIVA who are younger than 65 years old.Your doctor should check the salt levels in your blood before you start taking NOCTIVA, during treatment with NOCTIVA, before increasing your dose, and before you restart taking NOCTIVA if your treatment with NOCTIVA was stopped for a period of time.To help decrease your risk of developing low levels of sodium in your blood:Your doctor may stop your treatment with NOCTIVA for a period of time or stop your treatment completely if you have low levels of salt in your blood during treatment with NOCTIVA.NOCTIVA is a prescription medicine used in adults who wake up two or more times during the night to urinate due to a condition called nocturnal polyuria. Four of these patients were taking a concomitant systemic or inhaled The incidence of hyponatremia with NOCTIVA was similar in men and women.Patients 65 years of age and older treated with NOCTIVA had a higher incidence of hyponatremia compared to those younger than 65 years of age (see Table 4).No specific pharmacokinetic studies were conducted to evaluate potential drug-drug interactions between NOCTIVA and other medications.Monitor serum sodium more frequently in patients taking NOCTIVA concomitantly with medications that may cause The drug interaction potential between NOCTIVA and other intranasally administered drugs has not been studied. Desmopressin is a synthetic analog of vasopressin. Call your doctor for medical advice about side effects.