Desmopressin - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Desmopressin. This is the same information dispensing pharmacists read.
\u26a0\ufe0f Boxed Warning (Highest FDA Alert)
WARNING: HYPONATREMIA Desmopressin Acetate Injection can cause hyponatremia. Severe hyponatremia can be life-threatening, leading to seizures, coma, respiratory arrest, or death [see Warnings and Precautions ] . Desmopressin Acetate Injection 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 and Warnings and Precautions ] . Ensure the serum sodium concentration is normal before starting or resuming Desmopressin Acetate Injection. 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 and Warnings and Precautions ] . If hyponatremia occurs, Desmopressin Acetate Injection may need to be temporarily or permanently discontinued [see Warnings and Precautions ] . WARNING: HYPONATREMIA See full prescribing information for complete boxed warning. Desmopressin Acetate Injection can cause hyponatremia, which may be life-threatening if severe. Desmopressin Acetate Injection 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, a
5 WARNINGS AND PRECAUTIONS Hypotension and Hypertension : May cause hypotension with compensatory increase in heart rate or hypertension.
Monitor blood pressure during Desmopressin Acetate Injection administration, especially in patients with heart disease.
Increased Risk of Thrombosis in Patients with von Willebrand’s Disease Type IIB : Use of Desmopressin Acetate Injection in patients with Type IIB von Willebrand’s disease may cause thrombosis due to platelet aggregation.
Hypersensitivity Reactions : Severe reactions have occurred.
Monitor for reactions during administration and interrupt if reaction occurs.
Fluid Retention : Fluid retention can worsen underlying conditions that are susceptible to volume status.
Not recommended in patients at risk for increased intracranial pressure or with a history of urinary retention.
5.1 Hyponatremia Desmopressin Acetate Injection 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 [see Boxed Warning ] .
Desmopressin Acetate Injection is contraindicated in patients with hyponatremia (or a history of hyponatremia), with excessive fluid intake (e.g., polydipsia), using loop diuretics or systemic or inhaled glucocorticoids, with known or suspected SIADH, and/or illnesses that can cause fluid or electrolyte imbalances [see Contraindications , Drug Interactions ] .
Avoid concomitant treatments that also cause hyponatremia.
Prior to starting or resuming Desmopressin Acetate Injection, ensure that the serum sodium concentration is normal.
Limit fluid intake to a minimum from 1 hour before administration until 8 hours after administration.
Use of Desmopressin Acetate Injection without concomitant reduction of fluid intake may lead to fluid retention and hyponatremia.
Monitor the serum sodium concentration within 1 week and approximately 1 month of initiating Desmopressin Acetate Injection, and periodically thereafter [see Dosage and Administration ] .
Base the frequency of serum sodium monitoring on the patient’s risk of hyponatremia.
Patients with conditions associated with fluid and electrolyte imbalance (i.e., cystic fibrosis, heart failure, and renal disorders), geriatric and pediatric patients, patients receiving concomitant treatments that also cause hyponatremia (i.e., tricyclic antidepressants, selective serotonin reuptake inhibitors, nonsteroidal anti-inflammatory drugs, chlorpromazine, opiate analgesics, carbamazepine, lamotrigine, thiazide diuretics and chlorpropamide), and patients with habitual or psychogenic polydipsia who may drink excessive amounts of water, may be at increased risk of hyponatremia [see Contraindications ] .
If hyponatremia occurs, Desmopressin Acetate Injection 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.
5.2 Hypotension and Hypertension Desmopressin acetate may cause hypotension (with compensatory increase in heart rate) or hypertension.
Monitor blood pressure during Desmopressin Acetate Injection administration, particularly in patients with a history of coronary artery insufficiency and/or hypertensive cardiovascular disease [see Adverse Reactions , Drug Interactions ] 5.3 Increased Risk of Thrombosis in Patients with von Willebrand’s Disease Type IIB Use of desmopressin acetate in patients with Type IIB von Willebrand’s disease may result in platelet aggregation, thrombocytopenia, and possibly thrombosis.
5.4 Hypersensitivity Reactions Hypersensitivity reactions including anaphylaxis have been reported with intravenous and intranasal desmopressin acetate, including cases of fatal anaphylaxis with intravenous desmopressin acetate.
Desmopressin Acetate Injection is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of Desmopressin Acetate Injection [see Contraindications ] .
It is not known whether antibodies to Desmopressin Acetate Injection are produced after repeated injections.
Monitor patients for signs or symptoms of hypersensitivity reactions during administration, interrupt treatment should a reaction occur, and manage medically.
Permanently discontinue for serious hypersensitivity reaction [see Adverse Reactions ].
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