Desmopressinside effects

desmopressin acetate 0.004 MG/ML Injectable Solution

Adverse reactions

The following clinically significant adverse reactions are described elsewhere in the labeling: Hyponatremia Hypotension and Hypertension Increased risk of thrombosis in patients with von Willebrand's Disease Type IIB Hypersensitivity reactions Fluid retention 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 retention Digestive: Nausea, abdominal cramps Immune: Hypersensitivity reactions Integumentary: Erythema, swelling, burning pain, facial flushing Laboratory: Hyponatremia Nervous: Headache, hyponatremic seizures Common adverse reactions are abdominal cramps, burning pain, erythema, facial flushing, fluid retention, headache, hypersensitivity reactions, hypertension, hyponatremia, hyponatremic seizures, hypotension, nausea, swelling, tachycardia, and thrombotic events. To report SUSPECTED ADVERSE REACTIONS, contact XGen Pharmaceuticals DJB, Inc. at 1-866-390-4411 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective March 22, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Warnings

Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with desmopressin acetate. Desmopressin acetate is a potent antidiuretic which, when administered, may lead to water intoxication and/or hyponatremia. Unless properly diagnosed and treated hyponatremia can be fatal. Therefore, fluid restriction is recommended and should be discussed with the patient and/or guardian. Careful medical supervision is required. When desmopressin acetate injection is administered to patients who do not have need of antidiuretic hormone for its antidiuretic effect, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward to decrease the potential occurrence of water intoxication and hyponatremia. ( See PRECAUTIONS, Pediatric Use and Geriatric Use.) All patients receiving desmopressin acetate therapy should be observed for the following signs of symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion. Severe symptoms may include one or a combination of the following: seizure, coma and/or respiratory arrest. Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures which could lead to coma. Desmopressin acetate should not be used to treat patients with Type IIB von Willebrand’s disease since platelet aggregation may be induced. Desmopressin acetate should be used with caution in patients with habitual or psychogenic polydipsia who may be more likely to drink excessive amounts of water, putting them at greater risk of hyponatremia.

Contraindications

Desmopressin acetate injection is contraindicated in patients with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate injection. 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. Hyponatremia or a history of hyponatremia. Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion. Polydipsia. Concomitant use with loop diuretics. Concomitant use with systemic or inhaled glucocorticoids. During illnesses that can cause fluid or electrolyte imbalance, such as gastroenteritis, salt-wasting nephropathies, or systemic infection. 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 Known hypersensitivity to desmopressin acetate or to any of the components Moderate to severe renal impairment defined as a creatinine clearance below 50 mL/min Hyponatremia or a history of hyponatremia Known or suspected syndrome of inappropriate antidiuretic hormone (SIADH) secretion Polydipsia Concomitant use with loop diuretics or systemic or inhaled glucocorticoids During illnesses that can cause fluid or electrolyte imbalance Heart failure or uncontrolled hypertension

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