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Noctiva

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Overview

What is Noctiva?

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 CHNOS·3HO. 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 2 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.



What does Noctiva look like?



What are the available doses of Noctiva?

Preservative-free nasal spray delivering 0.83 mcg of desmopressin acetate (equivalent to 0.75 mcg desmopressin) or 1.66 mcg of desmopressin acetate (equivalent to 1.5 mcg desmopressin) in each spray (0.1 mL). ()

What should I talk to my health care provider before I take Noctiva?

How should I use Noctiva?

NOCTIVA is indicated for the treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void.

Nocturnal polyuria was defined in the NOCTIVA clinical trials as nighttime urine production exceeding one-third of the 24-hour urine production.

Before starting NOCTIVA:

Limitation of Use

NOCTIVA has not been studied in patients less than 50 years of age.

Prime with 5 actuations before initial use. Re-prime with 2 actuations if not used for more than 3 days. ()

For patients <65 years of age who are not at increased risk for hyponatremia: Use 1 spray of 1.66 mcg in either nostril nightly approximately 30 minutes before going to bed. ()

For patients ≥65 years of age or younger patients at risk for hyponatremia: Use 0.83 mcg nightly, which can be increased to 1 spray of 1.66 mcg after at least 7 days, if needed, provided the serum sodium has remained normal. ()


What interacts with Noctiva?

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What are the warnings of Noctiva?

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What are the precautions of Noctiva?

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What are the side effects of Noctiva?

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What should I look out for while using Noctiva?

NOCTIVA is contraindicated in patients with the following conditions due to an increased risk of severe hyponatremia:

NOCTIVA is contraindicated in patients with the following conditions because fluid retention increases the risk of worsening the underlying condition:


What might happen if I take too much Noctiva?

Signs of overdose may include effects from hyponatremia such as seizure, altered mental status, cardiac arrhythmias, and worsening edema. Other signs of overdose may include oliguria and rapid weight gain due to fluid retention . In case of overdosage, NOCTIVA should be discontinued immediately, serum sodium should be assessed, and appropriate medical treatment initiated.


How should I store and handle Noctiva?

Dexamethasone Sodium Phosphate Injection, USP is available in the following package:10 mg/mLOverbagged with 5 x 1 mL vials per bag, NDC 55154-5118-5Overbagged with 1 x 1 mL vial per bag, NDC 55154-5118-8Dexamethasone Sodium Phosphate Injection, USP is available in the following package:10 mg/mLOverbagged with 5 x 1 mL vials per bag, NDC 55154-5118-5Overbagged with 1 x 1 mL vial per bag, NDC 55154-5118-8Dexamethasone Sodium Phosphate Injection, USP is available in the following package:10 mg/mLOverbagged with 5 x 1 mL vials per bag, NDC 55154-5118-5Overbagged with 1 x 1 mL vial per bag, NDC 55154-5118-8Dexamethasone Sodium Phosphate Injection, USP is available in the following package:10 mg/mLOverbagged with 5 x 1 mL vials per bag, NDC 55154-5118-5Overbagged with 1 x 1 mL vial per bag, NDC 55154-5118-8


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Desmopressin is a synthetic analog of vasopressin. Desmopressin is a selective agonist at V2 receptors on renal cells in the collecting ducts, increasing water reabsorption in the kidneys, and reducing urine production.

Non-Clinical Toxicology
NOCTIVA is contraindicated in patients with the following conditions due to an increased risk of severe hyponatremia:

NOCTIVA is contraindicated in patients with the following conditions because fluid retention increases the risk of worsening the underlying condition:

NOCTIVA can cause hyponatremia Severe hyponatremia can be life-threatening if it is not promptly diagnosed and treated, leading to seizures, coma, respiratory arrest, or death.

NOCTIVA is contraindicated 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, and in those using loop diuretics or systemic or inhaled glucocorticoids

Before starting or resuming NOCTIVA, ensure that the serum sodium concentration is normal. Consider the 0.83 mcg dose as the starting dose for patients who may be at risk for hyponatremia

When NOCTIVA is administered, fluid intake in the evening and nighttime hours should be moderated to decrease the risk of hyponatremia. Monitor the serum sodium concentration within 7 days and approximately 1 month of initiating NOCTIVA or increasing the dose, and periodically thereafter. The frequency of serum sodium monitoring should be based on the patient’s risk for hyponatremia. 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 tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), chlorpromazine, carbamazepine, and thiazide diuretics

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

The following adverse reaction is described elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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