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Desmopressin (Systemic)


VA CLASSIFICATION
Primary: HS702
Secondary: CV900; BL116; DX900

Commonly used brand name(s): DDAVP Injection; DDAVP Nasal Spray; DDAVP Rhinal Tube; DDAVP Rhinyle Nasal Solution; DDAVP Spray; DDAVP Tablets; Octostim; Stimate Nasal Spray.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antidiuretic (central diabetes insipidus)—Desmopressin Acetate Nasal Solution; Desmopressin Acetate Tablets; Desmopressin Acetate Injection;

Antidiuretic (primary nocturnal enuresis)—Desmopressin Acetate Nasal Solution; Desmopressin Acetate Tablets;

Antihemorrhagic— Desmopressin Acetate Nasal Solution (Stimate only); Desmopressin Acetate Injection ;

Diagnostic aid—Desmopressin Acetate Injection;

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Diabetes insipidus, central (prophylaxis or treatment)—Desmopressin is indicated for the prevention or control of polydipsia, polyuria, and dehydration associated with central diabetes insipidus caused by insufficient antidiuretic hormone. {02}7 {02}6 {02}5 {02}4 {02}3 {02}2 {02}1 {02}0 {22}9 {22}8 {22}7 Its efficacy, ease of administration, long duration of action, and relative lack of side effects make desmopressin the drug of choice for central diabetes insipidus. {22}6 {22}5 {22}4 {22}3 {22}2
—Desmopressin is preferred to vasopressin injection and oral antidiuretics for use in children. {22}1 Children have been found to respond well to desmopressin therapy. {22}0
—Desmopressin is also indicated to manage temporary polydipsia and polyuria associated with trauma to, or surgery in, the pituitary region. {01}9 {01}8 {01}7 {01}6 {01}5 {01}4 {01}3 {01}2 {01}1 {01}0 {22}9
—Patients should be selected for desmopressin therapy based on the results of the water deprivation test, hypertonic saline infusion test, or response to antidiuretic hormone. {22}8 {22}7 {22}6 {22}5 {22}4 {22}3

Enuresis, primary nocturnal (treatment)—Desmopressin nasal solution, as a nasal spray and for use with a rhinal tube1 , and tablets1 are indicated in the treatment of primary nocturnal enuresis. {22}2 {22}1 {22}0 {60}9 {60}8 {60}7 {60}6 {60}5 {60}4 {60}3 {60}2 {60}1 {60}0 {01}9 {01}8

Hemophilia A (treatment) or
von Willebrand's disease (treatment)— Desmopressin injection and Stimate nasal solution are indicated for patients with mild hemophilia A or mild to moderate classic von Willebrand's disease (Type I), with factor VIII concentrations greater than 5%. {01}7 {01}6 {01}5 {01}4 {01}3 {01}2 {01}1 {01}0 {61} It is useful when administered before surgery (according to the timeframe specified by the manufacturer) to maintain hemostasis. {01} {02} {22} {25} {56} {60} {61} Desmopressin usually will stop the bleeding in these patients with episodes of spontaneous or trauma-induced hemarthroses, intramuscular hematomas, or mucosal bleeding. {01} {02} {22} {49} {56} {60} {61}

[Uremia (treatment adjunct)]—Desmopressin injection is indicated to maintain hemostasis during surgical procedures and postoperatively in patients with uremia who are at increased risk of bleeding. {63} Desmopressin should be administered to these patients prior to the procedure. {60}

[Cushing's syndrome, adrenocorticotropic hormone (ACTH)–dependent (diagnosis)]1—Desmopressin is indicated in the differential diagnosis of the cause of ACTH-dependent Cushing's syndrome. {64} {65} {68} {70} Desmopressin used in conjunction with corticotropin-releasing hormone (CRH) has a synergistic effect that allows the source of ACTH production, pituitary or ectopic, to be determined more accurately and produces results that are superior to those obtained when either peptide is used alone. {64} {70} (Evidence rating: I)

Unaccepted
Desmopressin is not indicated in the treatment of nephrogenic diabetes insipidus {03} {08} {11} {18} {22} {51} {69} or polyuria associated with psychogenic diabetes insipidus, renal disease, hypokalemia, hypercalcemia, {10} or the administration of demeclocycline or lithium. {18} {51}

Desmopressin is not indicated for patients with factor VIII concentrations of 5% or less (except in certain clinical situations with careful monitoring), or in patients who have factor VIII antibodies. {02} {22} {56} {61} Desmopressin is not indicated for treatment of severe classic von Willebrand's disease (Type I) or when there is evidence of an abnormal molecular form of von Willebrand antigen. {01} {02} {22} {54} {56} {60} {61} In patients with Type IIB von Willebrand's disease, desmopressin may induce platelet aggregation {02} {10} {20} {22} {56} {61} and thrombocytopenia {01} {10} {18} {60}, and its use is not recommended.

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Source—
    Synthetic polypeptide structurally related to the posterior pituitary hormone arginine vasopressin (antidiuretic hormone). {01} {02} {03} {08} {10} {11} {18} {22} {56} {60} {61}
Molecular weight—
    Desmopressin acetate: 1183.34 {02} {03} {08} {22} {59}

Mechanism of action/Effect:

Antidiuretic—Increases water reabsorption in the kidney by increasing the cellular permeability of the collecting ducts {10} {18} and distal tubules {10} {18}, resulting in an increase in urine osmolality with a concurrent decrease in urine output. {18}

Antihemorrhagic—Increases plasma concentrations of clotting factor VIII (antihemophilic factor) and von Willebrand's factor activity along with a possible direct effect on the blood vessel wall, {54} causing increased platelet spreading and adhesion at sites of injury. {01} {60}

Diagnostic aid—Desmopressin and corticotropin-releasing hormone (CRH) stimulate release of adrenocorticotropic hormone (ACTH) {64} {66} and cortisol {64} {66} {67} in patients with Cushing's disease, but rarely in patients with occult ectopic ACTH syndrome {64} {67} or in normal individuals. {66} {67} The mechanism by which desmopressin stimulates ACTH release is not completely understood. {66} However, desmopressin is thought to function via G protein–coupled V 1b vasopressin receptors. {65} The receptors are expressed in high concentrations in corticotroph adenoma and some ACTH-secreting bronchial carcinoid cells {64} and appear to show a high level of sensitivity to desmopressin, {65} perhaps as a result of up-regulation of the V 1b receptor in neuroendocrine tissue. {64} It is believed that the lack of response seen in normal individuals is due to an insufficient number of V 1b receptors in normal pituitary corticotrophs. {66} The CRH receptor also is present in corticotroph adenomas but far less commonly in bronchial carcinoid tumors. {64} The synergistic effect demonstrated with the use of both desmopressin and CRH is thought to relate to a greater increase in the co-overexpression of CRH and V 1b receptors in corticotroph adenomas than in ACTH-secreting ectopic tumors. {64}


Other actions/effects:

Much less pressor activity than vasopressin and less action on visceral smooth muscle. {02} {03} {08} {11} {22} {56}

Absorption:

10 to 20% from nasal mucosa. {09} {18} An intravenous dose of desmopressin possesses antidiuretic activity approximately 10 times that of the same nasal desmopressin dose. {01} {02} {08} {11} {18} {22} {51} {56}

Biotransformation:

Renal.

Half-life:


Intranasal or intravenous:

Fast phase: 7.8 minutes. {02} {08} {11} {22} {56}

Slow phase: 75.5 minutes. {02} {08} {11} {22} {56}



Oral:

1.5 to 2.5 hours. {03}


Onset of action:

Antidiuretic—Intranasal or oral: Within 1 hour. {03} {10} {18}

Antihemorrhagic—Increased factor VIII activity and von Willebrand factor concentrations: Intravenous—15 to 30 minutes. {02} {22} {54} {56}

Time to peak plasma concentration

Intranasal— 1.5 hours. {03}

Oral—0.9 hour. {03}

Time to peak effect:


Antidiuretic:

Intranasal: 1 to 5 hours. {18}

Oral: 4 to 7 hours. {03}



Antihemorrhagic:

Increased factor VIII activity and von Willebrand factor concentrations: Intravenous—30 to 60 minutes. {54}


Duration of action:


Antidiuretic:


Intranasal—

Variable, {15} {18} {20} 8 to 20 hours; {01} {18} {50} long duration of action is due to the medication's rate of absorption from nasal mucosa, persistence in plasma, and effect on renal tubules. {18} Effect ends abruptly, over a period of 60 to 90 minutes. {18}



Oral—

Following a 0.1- to 0.2-mg dose—Up to 8 hours. {03}

Following a 0.4-mg dose—Up to 12 hours. {03}




Antihemorrhagic:

Mild hemophilia A: Intravenous—4 to 24 hours.

von Willebrand's disease: Intravenous—Approximately 3 hours.



Precautions to Consider

Carcinogenicity/Mutagenicity

Studies have not been done in either animals or humans. {02} {03} {08} {22} {61}

Pregnancy/Reproduction

Pregnancy—
Controlled studies have not been done in humans. {01} {02} {08} {10} {11} {18} {22} {56} {60} {61}

Clinical use of desmopressin in pregnant women has been reported, with no adverse effects in the fetus. {01} {10} {18} {25} {26} {27} {51} {52} {60} Desmopressin does not appear to have uterotonic activity. {01} {02} {03} {08} {09} {10} {11} {18} {22} {56} {60} {61}

Studies in rats and rabbits at doses of 0.05 to 10 mcg per kg of body weight (mcg/kg) (approximately 0.1 time and up to 38 times, respectively, the maximum human systemic exposure, based on mg per square meter of body surface area [mg/m 2]) per day {02} {03} {08} {22} have not shown that desmopressin causes adverse effects in the fetus. {02} {03} {08} {10} {11} {18} {22} {60} {61}

FDA Pregnancy Category B. {02} {03} {08} {11} {22} {56} {61}

Breast-feeding

In one study conducted in postpartum women, desmopressin was distributed into breast milk in minimal amounts, following a 10-mcg intranasal dose. {02} {03} {08} {10} {11} {18} {22} {60} However, problems in humans have not been documented. {52}

Pediatrics

Use of desmopressin as an antihemorrhagic in infants younger than 11 months of age {61} and in all indications in infants younger than 3 months of age is not recommended {02} {10} {13} {22} {56} because of an increased tendency to fluid balance problems in neonates. {13} However, desmopressin may be the drug of choice for use as an antidiuretic agent in older children because of its low incidence of side effects. {50}

Caution and careful restriction of fluid intake are recommended with use of desmopressin in infants because of the increased risk of hyponatremia and water intoxication. {01} {02} {03} {08} {09} {10} {11} {12} {13} {14} {16} {17} {18} {22} {56} {60} {61} Rarely, an extreme decrease in plasma osmolality may cause seizures that lead to coma. {02} {03} {08} {10} {11} {18} {22} {56} {61}


Geriatrics


Although appropriate studies have not been performed in the geriatric population, caution and careful restriction of fluid intake are recommended with use of desmopressin in the elderly because of the increased risk of hyponatremia and water intoxication. {01} {02} {03} {08} {10} {11} {18} {22} {56} {60} {61} Rarely, an extreme decrease in plasma osmolality may cause seizures that lead to coma. {02} {03} {08} {11} {22} {56} {61}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Carbamazepine{10}{18}{60} or
Chlorpropamide{10}{18}{60} or
Clofibrate{09}{10}{18}{60}    (may potentiate the antidiuretic effect of desmopressin when used concurrently {10} {18} {60})


Demeclocycline{10}{18}{60} or
Lithium{10}{18}{60} or
Norepinephrine{10}{18}{60}    (may decrease the antidiuretic effect of desmopressin when used concurrently {10} {18} {60})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
Coronary artery disease{01}{02}{03}{08}{10}{11}{18}{22}{45}{56}{60}{61} or
Headache, vascular, predisposition to{01}{60} or
Hypertensive cardiovascular disease{01}{02}{03}{08}{10}{11}{17}{18}{22}{45}{56}{60}{61}    (desmopressin may produce a slight increase in blood pressure {03} {08} {10} {11} {22} {61} or a transient decrease in blood pressure with a compensatory increase in heart rate {02} {22} {61})


Cystic fibrosis{02}{03}{08}{11}{15}{18}{22}{53}{56}{60}{61} or
Dehydration{01}{18}{53}{60}    (risk of hyponatremia may be increased {02} {03} {11} {15} {18} {22} {53} {56} {60} {61})


Sensitivity to desmopressin{01}{02}{03}{08}{10}{11}{18}{22}{56}{60}
Thrombosis, predisposition to{02}{22}{28}{29}{30}{31}{32}{33}{34}{35}{36}{37}{49}{53}{56}{61}    (rarely, myocardial infarction and strokes have been reported to occur following the use of desmopressin in patients predisposed to thrombus formation; although it is not known whether these events were related to the use of desmopressin, caution is recommended in the use of desmopressin in this patient population {02} {22} {28} {29} {30} {31} {32} {33} {34} {35} {36} {37} {49} {53} {56} {61})


For intranasal dosage form only (in addition to those listed above):
Allergic rhinitis{18}{22}{47}{61} or
Nasal congestion or edema{08}{11}{15}{18}{22}{47} {56}{61} or
Upper respiratory infection{47}    (nasal absorption of desmopressin may be erratic {08} {11} {18} {22} {47} {56} {61})


Impaired consciousness{08}{11}{61} or
Nasal packing{08}{11} or
Postoperative state{08}{11} or
Surgery, cranial{08}{11}    (intranasal delivery may be inappropriate {08} {11} {61})



Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):


For use as an antidiuretic
Electrolytes{08}{11}    (measurement of serum concentrations is recommended if therapy for primary nocturnal enuresis is continued beyond 7 days {08} {11} {55} or as determined by physician {55})


Urine osmolality{01}{03}{08}{10}{11}{18}{22}{56} and/or
Urine volume{01}{03}{08}{10}{11}{18}{22}{56}    (determinations recommended at appropriate intervals to monitor response and aid in dosage adjustment; {18} in some cases, plasma osmolality determinations may be necessary {01} {03} {08} {10} {11} {18} {22})


For use in hemophilia A or von Willebrand's disease
Activated partial thromboplastin time (APTT){01}{02}{61} and
Bleeding time{01}{02}{22}{56}{60}{61} and
Coagulation factor assay{01}{02}{22}{56}{60}{61} and
von Willebrand factor antigen (factor VIII–related antigen){01}{02}{22}{56}{60}{61} and
von Willebrand factor assay (ristocetin cofactor){01}{02}{22}{56}{60}{61}    (determinations recommended after initial administration {61} and at appropriate intervals to monitor response {22})

    (if factor VIII coagulant activity, as determined prior to administration of desmopressin, is present at less than 5% of normal, the efficacy of desmopressin may be uncertain {02} {22} {56})


For injection dosage form
Blood pressure{02}{22}{56}{60} and
Pulse rate{02}{22}{56}{60}    (recommended during intravenous infusion {02} {22} {60})


Fluid intake{60} and
Fluid output{60}    (close monitoring recommended to prevent water intoxication and hyponatremia {60})




Side/Adverse Effects

Note: Rarely, thrombotic events (myocardial infarction and strokes) have been reported to occur following the use of desmopressin in patients predisposed to thrombus formation. {02} {22} {28} {29} {30} {31} {32} {33} {34} {35} {36} {49} {53} {56} {61} Although it is not known whether these events were related to the use of desmopressin, caution is recommended in the use of desmopressin in this patient population. {02} {22} {28} {29} {30} {31} {32} {33} {34} {35} {36} {37} {49} {53} {56} {61}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
—dose-related    
Hypertension, slight {02}{03}{08}{10}{11}{18}{22}{38}{39}{40}{49}{56}{61}
    
hyponatremia{01}{02}{08}{09}{12}{13}{14}{15}{16}{17}{22}{41}{49}{51} or water intoxication{01}{02}{08}{09}{15}{22}{42} {09}{12}{13}{14}{15}{16}{17}{41}{42}{49}(coma; confusion; continuing headache; decreased urination; drowsiness; rapid weight gain; seizures)
    
hypotension, transient {01}{02}{54}{56}{60}{61}
    
tachycardia (fast heartbeat){01}{02}{56}{60}{61}

Incidence rare
    
Allergic reaction, severe (chills; fever; shortness of breath, tightness in chest, trouble in breathing, or wheezing; skin rash, hives, or itching){02}{03}{08}{22}{56}{61}



Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent or rare
—dose-related{02}{09}{22}    
Abdominal or stomach cramps {01}{02}{03}{08}{09}{10}{11}{18}{22}{45}{51}{56}{60}{61}
    
flushing or redness of skin {01}{02}{03}{08}{09}{10}{11}{18}{22}{49}{56}{60}{61}
    
pain in vulva {01}{02}{09}{22}{56}{60}{61}

With high doses
    
Headache {01}{02}{03}{08}{09}{10}{11}{15}{17}{18}{22}{45}{49}{51}{56}{60}{61}
    
nausea {01}{02}{03}{08}{09}{10}{11}{15}{18}{22}{45}{51}{56}{60}{61}

With intranasal use
    
Epistaxis (nosebleed){08}{11}{18}{61}
    
runny or stuffy nose {08}{11}{18}{45}{51}{61}
    
upper respiratory infection (cough; fever; runny or stuffy nose; sneezing; sore throat){08}{11}{61}

With intravenous use
    
Pain, redness, or swelling at site of injection {01}{02}{22}{56}{60}





Overdose
For specific information on the agent used in the management of desmopressin overdose, see Furosemide in Diuretics, Loop (Systemic) monograph.

For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Treatment of overdose
Treatment of overdose consists of reduction of dosage {01} {02} {03} {08} {10} {11} {18} {22} {60} {61} or withdrawal of the medication. {01} {02} {03} {08} {10} {11} {22} {56} {60} {61} Fluid intake should be restricted to less than urine output {62} to allow plasma sodium concentration to return to normal gradually. This usually occurs within a few days. {21} If fluid overload is severe, furosemide, {01} {03} {10} {18} {21} {60} along with intravenous hypertonic saline {62} or oral salt, {21} should be administered.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Desmopressin (Systemic) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Sensitivity to desmopressin





Breast-feeding—Distributed into breast milk in minimal amounts





Use in children—Not recommended for use as an antihemorrhagic in infants younger than 11 months of age or for use for any indication in infants younger than 3 months of age; increased risk of hyponatremia and water intoxication






Use in the elderly—Increased risk of hyponatremia and water intoxication

Proper use of this medication
» Importance of not using more medication than the amount prescribed

For intranasal use only
Reading patient instructions carefully before using

» Not using the nasal spray beyond the labeled number of sprays, because accuracy of dose delivered cannot be assured

» Proper dosing
Missed dose: If dosing schedule is—

• Once a day: Using as soon as possible if remembered same day; if not remembered until next day, not using at all and not doubling dose, but going back to regular schedule {57}


• More than once a day: Using as soon as possible; not using at all if almost time for next dose; not doubling doses {57}


» Proper storage


Side/adverse effects
Signs of potential side effects, especially slight hypertension, hyponatremia or water intoxication, transient hypotension, tachycardia, and severe allergic reaction


General Dosing Information
Fluid intake should be adjusted to decrease the potential for water intoxication and hyponatremia, especially in very young or geriatric patients. {01} {03} {08} {10} {11} {12} {13} {14} {16} {17} {18} {22} {56} {60} {61} Rarely, an extreme decrease in plasma osmolality may cause seizures that lead to coma. {02} {03} {08} {10} {11} {18} {22} {56} {61}

Tolerance may develop with long-term (longer than 6 months) intranasal use or tachyphylaxis may occur when intravenous doses are administered more frequently than every 24 to 48 hours. {01} {02} {03} {08} {10} {11} {18} {22} {56} {60} This effect appears to be caused by the local inactivation of the peptide rather than by the development of binding antibodies. {03} {10} {11}

For use in central diabetes insipidus
Initially, therapy should be directed to control nocturia. {18} {51}

The dosage of desmopressin should be adjusted according to the diurnal pattern of response, with the morning and evening doses being adjusted separately. {03} {08} {11} {18} {22} {51} {56} {69}

Response to therapy can be measured by the volume and frequency of urination and an adequate duration of sleep. {03} {08} {10} {11} {18} {22} {51} {56} {69}

For use in primary nocturnal enuresis
Fluid intake should be restricted a few hours before administration of desmopressin. {18}

For intranasal dosage forms
Desmopressin is administered intranasally as a spray or through a flexible, calibrated catheter known as a rhinal (or rhinyle) tube. {11} {18}

Because the nasal spray delivery unit cannot deliver less than 10 mcg, patients requiring smaller doses must use the rhinal tube delivery system. {08}

The nasal spray delivery unit should not be used beyond the labeled number of sprays; {08} {61} if it is, the accuracy of the dose delivered cannot be assured. {08} {61}


Nasal Dosage Forms

Note: The antidiuretic activity of 10 mcg of desmopressin acetate nasal solution is equivalent to 40 International Units (IU). {08} {11} {61}


DESMOPRESSIN ACETATE NASAL SOLUTION

Usual adult and adolescent dose
Central diabetes insipidus
Initial: Intranasal, 10 mcg at bedtime; {51} this dose may be increased nightly in increments of 2.5 mcg until a satisfactory sleep response is obtained. {51} If urine volume is still large, a 10-mcg morning dose may be added and adjusted to obtain the desired response.

Maintenance: Intranasal, 10 to 40 mcg per day, as a single dose or in two or three divided doses per day. {08} {09} {11} {18} {20} {51} {69}

Note: In one quarter to one third of patients, adequate control is maintained with a single daily dose; {18} however, in some patients, three doses per day are necessary.


Primary nocturnal enuresis
Initial: Intranasal, 10 mcg into each nostril at bedtime (total dose per day of 20 mcg). {04} {08} {09} {11} {17} {18} {20} {44} {45} {46} {47} {48} {69}

Maintenance: Dosage is adjusted according to patient response; total dose per day may range from 10 to 40 mcg. {04} {08} {09} {18} {19} {20} {43} {44} {45} {46} {47} {48} {69}

Antihemorrhagic ( Stimate only)
Intranasal, 150 mcg into each nostril. The dose may be repeated based upon laboratory test parameters and the condition of the patient. {61}

Note: Patients who weigh less than 50 kg may require only a single 150-mcg dose. {61}



Usual pediatric dose
Central diabetes insipidus


Children up to 3 months of age:
Dosage has not been established. {18}



Children 3 months to 12 years of age:
Intranasal, 0.25 mcg per kg of body weight one or two times per day. {62}


Primary nocturnal enuresis


Children up to 6 years of age:
Dosage has not been established.



Children 6 years of age or older:
See Usual adult and adolescent dose .


Note: Because the nasal spray delivery unit cannot deliver less than 10 mcg, patients requiring smaller doses must use the rhinal tube delivery system. {08} {18}



Strength(s) usually available
U.S.—


10 mcg per 0.1 mL metered spray (0.01%) (Rx) [DDAVP Nasal Spray{08}][Generic]{69}


100 mcg per mL (0.01%) (Rx) [DDAVP Rhinal Tube][Generic]{11}


150 mcg per 0.1 mL metered spray (0.15%) (Rx) [Stimate Nasal Spray{61}]

Canada—


10 mcg per 0.1 mL metered spray (0.01%) (Rx) [DDAVP Spray]{18}


100 mcg per mL (0.01%) (Rx) [DDAVP Rhinyle Nasal Solution]{18}

Packaging and storage:
Store Stimate Nasal Spray {61} and the nasal solution for use with a rhinal tube at a temperature between 2 and 8 °C (36 and 46 °F). {18} DDAVP Nasal Spray should be stored at room temperature between 15 and 30 °C (59 and 86 °F) {08} {18} in an upright position. {08} Protect all products from freezing. {18}

Note: Include patient instructions when dispensing.




Oral Dosage Forms

DESMOPRESSIN ACETATE TABLETS

Usual adult and adolescent dose
Central diabetes insipidus
Initial: Oral, 0.05 mg two times a day. {03}

Maintenance: Dosage is adjusted according to patient response; total dose may range from 0.1 to 0.8 mg per day in divided doses. {03}

Note: Patients previously on intranasal therapy may begin oral therapy twelve hours after the last intranasal dose. {03}


Primary nocturnal enuresis 1
Initial: Oral, 0.2 mg once a day at bedtime. {03}

Maintenance: Dosage is adjusted according to patient response, and total dose may be up to 0.6 mg per day. {03}

Note: Patients previously on intranasal therapy may begin oral therapy twenty-four hours after the last intranasal dose. {03}



Usual adult and adolescent prescribing limits
1.2 mg per day. {10}

Usual pediatric dose
Central diabetes insipidus
See Usual adult and adolescent dose .

Primary nocturnal enuresis
Children up to 6 years of age: Dosage has not been established.

Children 6 years of age or older: See Usual adult and adolescent dose .


Strength(s) usually available
U.S.—


0.1 mg (Rx) [DDAVP Tablets (scored) (magnesium stearate){03}]


0.2 mg (Rx) [DDAVP Tablets (scored){03}]

Canada—


0.1 mg (Rx) [DDAVP Tablets{10}]


0.2 mg (Rx) [DDAVP Tablets{10}]

Packaging and storage:
Store between 20 and 25 °C (68 and 77 °F), {03} {10} unless otherwise specified by manufacturer. Protect from excessive heat and light. {03}



Parenteral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

The antidiuretic activity of 1 mcg of desmopressin acetate injection is equivalent to 4 International Units (IU). {02} {22} {56}

DESMOPRESSIN ACETATE INJECTION

Usual adult and adolescent dose
Antidiuretic
Intramuscular, {01} intravenous (direct), or subcutaneous, 2 to 4 mcg per day or 0.025 mcg per kg of body weight, {62} usually in two divided doses in the morning and evening. {20} {22} {51} {56}

Antihemorrhagic
Intravenous infusion, 0.3 mcg per kg of body weight diluted in 50 mL of 0.9% sodium chloride injection and infused slowly over fifteen to thirty minutes. {02} {22} {49} {56} {60} The dose may be repeated based upon laboratory test parameters and the condition of the patient. {01} {02} {22} {56} {60}

[Diagnostic aid]1
Intravenous, 10 mcg. {64} {65} {66} {67} {68}

Note: Desmopressin should be administered with 100 mcg of corticotropin-releasing hormone (CRH; corticorelin). {64} {65} {68}



Usual pediatric dose
Antidiuretic
Intramuscular, intravenous (direct), or subcutaneous, 0.4 mcg {01} or 0.025 mcg per kg of body weight {62} {70} once a day.

Antihemorrhagic


Children up to 11 months of age:
Use is not recommended. {61}



Children 11 months of age or older:
For children weighing 10 kg or less—Intravenous infusion, 0.3 mcg per kg of body weight diluted in 10 mL of 0.9% sodium chloride injection and infused slowly over fifteen to thirty minutes. {01} {02} {09} {13} {20} {22} {49} {56} {60} The dose may be repeated based upon laboratory test parameters and the condition of the patient. {01} {02} {22} {56} {60}

For children weighing more than 10 kg—See Usual adult and adolescent dose . {70}


[Diagnostic aid]1
See Usual adult and adolescent dose .


Strength(s) usually available
U.S.—


4 mcg per mL (Rx) [DDAVP Injection{22}][Generic]{56}


15 mcg per mL (Rx) [DDAVP Injection{02}]

Canada—


4 mcg per mL (Rx) [DDAVP Injection{01}]


15 mcg per mL (Rx) [Octostim{60}]

Packaging and storage:
Store between 2 and 8 °C (36 and 46 °F), {02} {22} unless otherwise specified by manufacturer. Protect from freezing {01} {22} {60} and light. {01}



Revised: 06/04/1999



References
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