Desmopressin Acetate (12 brand names, 4 dosage forms, 4 routes)
Available dosage forms: INJECTABLE, TABLET, SPRAY, METERED, SOLUTION.
Routes of administration: INJECTION, ORAL, NASAL, SUBLINGUAL.
Brand Names
- CONCENTRAID
- DDAVP
- DDAVP (NEEDS NO REFRIGERATION)
- DESMODA
- DESMOPRESSIN ACETATE
- DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
- DESMOPRESSIN ACETATE PRESERVATIVE FREE
- MINIRIN
- NOCDURNA
- NOCTIVA
- STIMATE
- STIMATE (NEEDS NO REFRIGERATION)
Boxed Warning
Desmopressin acetate can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death [see Warnings and Precautions (5.1)]. Desmopressin acetate 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 [see Contraindications (4) and Warnings and Precautions (5.1)]. Ensure the serum sodium concentration is normal before starting or resuming desmopressin acetate. Measure serum sodium within 7 days and approximately 1 month after initiating therapy, 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 [see Dosage and Administration (2.1) and Warnings and Precautions (5.1)]. If hyponatremia occurs, desmopressin acetate may need to be temporarily or permanently discontinued [see Warnings and Precautions (5.1)].
Contraindications
Desmopressin acetate injection is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of Desmopressin acetate injection [see Warnings and Precautions (5.4), Adverse Reactions (6), Description (11)]. Desmopressin acetate injection is contraindicated in patients with the following conditions due to an increased risk of hyponatremia: Moderate to severe renal impairment defined as a creatinine clearance below 50 mL/min [see Use in Specific Populations (8.5, 8.6) and Clinical Pharmacology (12.3)]. Hyponatremia or a history of hyponatremia [see Warnings and Precautions (5.1), Drug Interactions (7.1)], Use in Specific Populations (8.4, 8.5)]. Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion [see Warnings and Precautions (5.1)]. Polydipsia [see Warnings and Precautions (5.1)]. Concomitant use with loop diuretics [see Boxed Warning]. Concomitant use with systemic or inhaled glucocorticoids [see Boxed Warning]. During illnesses that can cause fluid or electrolyte imbalance, such as gastroenteritis, salt-wasting nephropathies, or systemic infection [see Boxed Warning]. Desmopressin acetate injection is contraindicated in patients with the following conditions because fluid retention increases the risk of worsening the underlying condition: Heart failure Uncontrolled hypertension
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: Hyponatremia [see Contraindications, Warnings and Precautions (5.1)] Hypotension and Hypertension [see Warnings and Precautions (5.2)] Increased risk of thrombosis in patients with von Willebrand’s Disease Type IIB [see Warnings and Precautions (5.3)] Hypersensitivity reactions [see Warnings and Precautions (5.4)] Fluid retention [see Warnings and Precautions (5.5)] The following adverse reactions have been identified during post-approval use of desmopressin acetate injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: Hypertension, hypotension, tachycardia, thrombotic events, fluid retentionDigestive: Nausea, abdominal crampsImmune: Hypersensitivity reactionsIntegumentary: Erythema, swelling, burning pain, facial flushingLaboratory: HyponatremiaNervous: Headache, hyponatremic seizures
Mechanism of Action
Desmopressin acetate increases plasma levels of factor VIII activity in patients with hemophilia and von Willebrand’s disease Type I. The antidiuretic effects of desmopressin acetate are mediated by stimulation of vasopressin 2 (V2) receptors, thereby increasing water re-absorption in the kidney, and hence reducing urine production. Desmopressin acetate is a replacement hormone for antidiuretic hormone in the treatment of central diabetes insipidus. The change in structure of arginine vasopressin to desmopressin acetate resulted in increased duration of action and a decreased vasopressor action and decreased actions on visceral smooth muscle relative to the enhanced antidiuretic activity, so that clinically effective antidiuretic doses were usually below threshold levels for effects on vascular or visceral smooth muscle.
Overdosage
Overdosage of desmopressin acetate injection leads to prolonged duration of action with an increased risk of water retention and hyponatremia. Signs of overdose may include headaches, abdominal cramps, nausea, facial flushing, confusion, drowsiness, problems with passing urine and rapid weight gain due to fluid retention [see Warnings and Precautions (5.1)]. In case of overdosage, the dosage should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition, serum sodium assessed, and hyponatremia treated appropriately. There is no known specific antidote for desmopressin acetate or desmopressin acetate injection 4 mcg/mL.