Desmopressin Acetate Spray

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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Desmopressin Acetate Spray Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Desmopressin acetate 10mcg/spray; nasal spray; contains benzalkonium chloride.

    Pharmacological Class

    Vasopressin (synthetic).

    See Also

    How Supplied

    Tabs—100; Amp (1mL)—10; Multi-dose vial (10mL)—1; Nasal spray—Contact generic supplier

    Storage

    Contact generic supplier.

    Manufacturer

    Various generic manufacturers

    Desmopressin Acetate Spray Indications

    Indications

    Central diabetes insipidus.

    Limitations of Use

    Not indicated for nephrogenic diabetes insipidus, primary nocturnal enuresis, patients with conditions that compromise intranasal route of administration, or patients with an impaired level of consciousness.

    Desmopressin Acetate Spray Dosage and Administration

    Adult

    Individualize. 10–40mcg once daily into 1 nostril (or 40mcg divided into 2–3 daily doses). Use other forms for doses <10mcg or doses other than multiples of 10mcg. If switching from desmopressin acetate injection to nasal spray, use 10 times the amount of desmopressin acetate rounding down to the nearest 10mcg. If switching from desmopressin acetate tablets to nasal spray, individual dose titration is required.

    Children

    <4yrs: not recommended. Individualize. ≥4yrs: initially 10mcg once daily into 1 nostril; may increase to 30mcg once daily (or in 2 divided doses, usually 20mcg in the AM and 10mcg in the PM). Use other forms for doses <10mcg. If switching from desmopressin acetate tablets to nasal spray, individual dose titration is required.

    Elderly

    Use caution for dose selection in elderly patients, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    Desmopressin Acetate Spray Contraindications

    Contraindications

    Moderate to severe renal impairment (CrCl <50mL/min). Hyponatremia, or history of.

    Desmopressin Acetate Spray Boxed Warnings

    Not Applicable

    Desmopressin Acetate Spray Warnings/Precautions

    Warnings/Precautions

    Monitor fluid intake, urine volume and osmolality. Fluid/electrolyte imbalance (eg, cystic fibrosis). Habitual or psychogenic polydipsia. Coronary artery insufficiency. Hypertension. Inj: Predisposition to thrombosis. Nasal mucosal abnormalities (nasal forms). Young children. Elderly. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Desmopressin Acetate Nasal Spray

    • Can cause water intoxication with hyponatremia, which may be life-threatening if not promptly diagnosed and treated. 

    • Monitor all patients for signs or symptoms of hyponatremia, especially for the rare occurrence of an extreme decrease in serum sodium and plasma osmolality resulting in seizures, coma, and/or respiratory arrest.

    • Fluid restriction is recommended, and careful medical supervision is required. Careful fluid intake restriction is important especially in pediatric and geriatric patients. Monitor serum sodium levels frequently in the following patients: conditions associated with fluid and electrolyte imbalance (eg, cystic fibrosis, heart failure, renal disorders), or habitual or psychogenic polydipsia or those taking concomitant drugs that may cause hyponatremia.

    • Avoid use in patients with nasal mucosa abnormalities (eg, scarring and edema) due to chronic use, or due to other causes (eg, nasal blockages, nasal mucosal atrophy, severe atrophic rhinitis, recent nasal surgery).

    Pregnancy Considerations

    Risk Summary

    • Prolonged experience with desmopressin in pregnant women over several decades, based on the available published data and case reports, did not identify a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

    Nursing Mother Considerations

    Risk Summary

    • There is no information on the effects of desmopressin on the breastfed child or on milk production. Consider the benefits for the mother vs the potential risk to the breastfed infant.

    Pediatric Considerations

    • Desmopressin nasal spray is not indicated in patients younger than 4 years of age.

    • Use in pediatric patients requires careful fluid restrictions to prevent hyponatremia and water intoxication.

     

    Geriatric Considerations

    Clinical studies did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. May be useful to monitor renal function.

    Use in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient.

    Renal Impairment Considerations

    Desmopressin acetate is substantially excreted by the kidney. 

    DDAVP is contraindicated in patients with CrCl<50mL/min.

    Desmopressin Acetate Spray Pharmacokinetics

    Absorption

    Desmopressin acetate spray is absorbed through the nasal mucosa.

    Elimination

    Renal. Half-life: 7.8 minutes (initial), 75.5 minutes (terminal).

    Desmopressin Acetate Spray Interactions

    Interactions

    Caution with other pressor agents, drugs that may increase the risk of water intoxication with hyponatremia (eg, tricyclic antidepressants, SSRIs, chlorpromazine, opiates, NSAIDs, lamotrigine, carbamazepine). Possible convulsions with oxybutynin, imipramine.

    Desmopressin Acetate Spray Adverse Reactions

    Adverse Reactions

    Headache, nausea, flushing, abdominal cramps, vulval pain, water intoxication, hyponatremia, nasal congestion or rhinitis (nasal forms), inj site reaction; rare: changes in BP, severe allergic reactions, seizures in children from plasma hypoosmolality, thrombotic events (inj).

    Adverse Reactions

    Desmopressin Acetate Nasal Spray

    The following have been identified during post-approval use of desmopressin acetate. These reactions are reported voluntarily and it is not possible to reliably establish a causal relationship to drug exposure:

    • Increase in blood pressure, headache, nasal congestion, rhinitis, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and abdominal cramps.

    • Water intoxication with hyponatremia.

    • Hyponatremic convulsions associated with concomitant use with oxybutynin and imipramine.

    Desmopressin Acetate Spray Clinical Trials

    See Literature

    Desmopressin Acetate Spray Note

    Not Applicable

    Desmopressin Acetate Spray Patient Counseling

    Patient Counseling

    Desmopressin Acetate Nasal Spray

    Administration

    • For pediatric patients, ensure the patient received the prescribed dose.

    • Advise patients to prime the pump prior to first use and prime again if not used for >1 week.

    Monitoring

    • Inform patients about the signs and symptoms of hyponatremia and advise them to contact a healthcare provider if symptoms occur.

    • Monitor urine output and discuss decreasing fluid intake.

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