Desmopressin Acetate 10 ug Spray — NDC 60505-0815-0 (Billing 60505-0815-00)
This is a package of Desmopressin Acetate 10 ug Spray from Apotex Corp., marketed since Nov 2020 and currently FDA-listed; retail pharmacies pay about $10.11 per mL (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 60505-0815-0 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 60505 labeler · 0815 product · 0 package
- Package marketed since
- Nov 30, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 6050508150 9
- Medicaid fills, this package
- 12,192 prescriptions in the last four reported quarters
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 031610
- GCN: 26173
- HICL (First Databank): 013319
- AHFS class code: 68:28.00.00
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
Desmopressin nasal (DDAVP®) is used to control the symptoms of a certain type of diabetes insipidus ('water diabetes'; condition in which the body produces an abnormally large amount of urine). Desmopressinnasal (DDAVP®) is also used to control excessive thirst and the passage of an abnormally large amount of urine that may occur after a head injury or after certain types of surgery. Desmopressin nasal (Noctiva®) is used to control frequent nighttime urination in adults who awaken at least 2 times per night to urinate. Desmopressin nasal (Stimate®) is used to stop some types of bleeding in peo...
Read the full MedlinePlus article ↗- It depends on the product. It replaces the hormone that helps your body hold on to water in central diabetes insipidus. Some forms also treat hemophilia A and von Willebrand’s dise...
- Desmopressin makes your body hold on to water. Drinking too much can dilute the sodium in your blood, which can be dangerous. Ask your prescriber exactly how much fluid is right fo...
- Why do I need to limit how much I drink?
- Headache, nausea, stomach cramps, and flushing are possible. Nasal forms can cause a stuffy or runny nose or nosebleeds. Call right away for severe headache, confusion, vomiting, q...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Desmopressin Acetate — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $10.111 | — |
| Medicaid paysCMS SDUD · 12 mo | $13.73 | — |
| Medicare drug plans payPart D · Q2 2026 | $22.67 | — |
Where does this data come from?
- CMS NADAC weekly file · file of Oct 7, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 60505-0815-00 You're viewing this Main listing | 1 BOTTLE, SPRAY in 1 CARTON / 50 SPRAY in 1 BOTTLE, SPRAY | 2020-11-30 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Desmopressin Acetate 10 ugthis 60505-0815-00 | Apotex | 1 bottle | $10.111 | AB | Availability likely | — |
| Desmopressin Acetate .1 mg/mL 24208-0342-05 | Bauch | 1 bottle | $23.917 | — | FDA listed | +137% |
| Desmopressin Acetate .1 mg/mL 68682-0342-05 | Oceanside | 1 bottle | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Oct 7, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Desmopressin inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 70WT22SF4B
A mineral salt that acts as a buffer to maintain the pH balance of the medication. It helps stabilize the drug's potency and prevents unwanted chemical changes during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Apotex Corp. labeler code 60505
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Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Desmopressin nasal spray is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in adults and pediatric patients 4 years of age and older Limitations of Use: Desmopressin nasal spray is not indicated for: Treatment of nephrogenic diabetes insipidus, Treatment of primary nocturnal enuresis [see Warnings and Precautions ( 5.1 )], Use in patients with conditions that compromise the intranasal route of administration (e.g., severe nasal congestion and blockage, nasal mucosa atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) [see Warnings and Precautions ( 5.2 )].
Use in patients with an impaired level of consciousness, Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg [see Dosage Forms and Strengths ( 3 )]. Desmopressin nasal spray is a vasopressin analog indicated as antidiuretic replacement therapy in the management of central diabetes insipidus for adults and pediatric patients 4 years of age and older ( 1 ) Limitations of Use: Desmopressin nasal spray is not indicated for: Treatment of nephrogenic diabetes insipidus ( 1 ) Treatment of primary nocturnal enuresis ( 1 , 5.1 ) Use in patients with conditions that compromise intranasal route of administration ( 1 , 5.2 ) Use in patients with an impaired level of consciousness ( 1 ) Use in patients requiring doses less than 10 mcg or doses that are not multiples of 10 mcg ( 1 , 3 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For intranasal use only ( 2.1 ) Instruct patients to prime pump prior to use ( 2.1 ) Adults : 10 mcg to 40 mcg daily (either as a single dose or divided into two or three daily doses) ( 2.2 ) Pediatrics: 10 mcg once daily into one nostril up to 30 mcg once daily (or 30 mcg divided as 20 mcg during the morning and 10 mcg at night) ( 2.2 ) See the Full Prescribing Information for recommendations for switching between desmopressin acetate formulations ( 2.3 )
2.1Important Administration Instructions Administer desmopressin nasal spray by intranasal use only. Instruct patients about appropriate fluid restriction during desmopressin nasal spray treatment [see Warnings and Precautions ( 5.1 )]. Must prime the spray pump prior to the first use.
Instruct patients to: Prime pump by pressing down on pump four times (if the spray pump is not used for one week, re-prime the pump by pressing down on the pump once). Discard desmopressin nasal spray after 50 sprays since the amount delivered thereafter may be substantially less than the recommended dosage.
2.2Recommended Dosage The use of desmopressin nasal spray is not indicated for patients who require less than 10 mcg doses or doses that are not multiples of 10 mcg because the spray pump can only deliver doses of 10 mcg [see Indications and Usage ( 1 )] . If other doses are required, use another desmopressin acetate product. Individualize the dosage of desmopressin nasal spray for each patient with particular attention in pediatric and elderly patients and adjust according to the diurnal pattern of response to limit nocturia and to ensure fluid intake with respect to urine output is not excessive [see Warnings and Precautions ( 5.1 )] .
Monitor continued response to desmopressin nasal spray by urine volume and osmolality to ensure adequate diuresis to limit the risk of hyponatremia, and include measurements of serum sodium and plasma osmolality as needed. Adults The recommended dosage in adults is 10 mcg once daily into one nostril up to 40 mcg once daily (or 40 mcg divided into two or three daily doses). If administered more than once a day, adjust for an adequate diurnal rhythm of urine output.
Pediatric Patients For pediatric patients requiring doses less than 10 mcg, desmopressin nasal spray is not indicated. For pediatric patients 4 years of age and older, the recommended starting dosage of desmopressin nasal spray is 10 mcg once daily into one nostril. The dose can be titrated up to 30 mcg once daily (or 30 mcg divided into two daily doses, typically with 20 mcg given in the morning and 10 mcg given at nighttime).
If administered more than once a day, adjust for an adequate diurnal rhythm of urine output. Because administration of desmopressin acetate can be associated with decreased responsiveness with prolonged use, consider increasing the dosage of desmopressin nasal spray if patients demonstrate decreased response over a long period of time.
2.3Switching Between Desmopressin Acetate Formulations When switching from the desmopressin acetate injection to desmopressin nasal spray, administer 10 times the amount of desmopressin acetate, rounding down to the nearest 10 mcg. When switching from the desmopressin acetate tablets to desmopressin nasal spray individual dose titration is required because intranasal desmopressin is approximately 10 to 40 fold more potent than oral (tablet) desmopressin.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Desmopressin nasal spray pump delivers 10 mcg (0.1 mL) of desmopressin acetate per spray. Desmopressin nasal spray is available as a 5 mL bottle with spray pump delivering 50 sprays. Nasal Spray: 10 mcg per 0.1 mL spray, available in a 5 mL bottle with spray pump delivering 50 sprays ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Desmopressin nasal spray is contraindicated in patients with: Known hypersensitivity to desmopressin acetate or to any of the components of desmopressin nasal spray. Severe allergic reactions and anaphylaxis have been reported [see Adverse Reactions ( 6 )] . Renal impairment defined as estimated creatinine clearance (CLcr) by Cockcroft-Gault equation less than 50 mL/min [see Use in Specific Populations ( 8.6 ) and Clinical Pharmacology ( 12.3 )].
Hyponatremia or a history of hyponatremia [see Warnings and Precautions ( 5.1 )]. Known hypersensitivity to desmopressin acetate or to any of the components of desmopressin nasal spray ( 4 , 6 ) Patients with renal impairment (creatinine clearance below 50 mL/min) ( 4 , 8.6 , 12.3 ) Hyponatremia or a history of hyponatremia ( 4 , 5.1 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hyponatremia: Instruct patients about proper fluid restriction and monitor serum sodium as needed ( 2.1 , 5.1 ) Altered Absorption in Patients with Nasal Mucosa Abnormalities: May occur with chronic administration, and require use of other formulations instead ( 5.2 )
5.1Hyponatremia Excessive fluid intake when urine output is limited by the antidiuretic effect of desmopressin may lead to water intoxication with hyponatremia. Cases of hyponatremia have been reported from postmarketing experience in patients treated with desmopressin acetate. Unless properly diagnosed and treated, hyponatremia can be fatal.
All patients receiving desmopressin nasal spray should be observed for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness, and confusion. Severe symptoms due to an extreme decrease in serum sodium and plasma osmolality may include one or a combination of the following: seizure, coma, and/or respiratory arrest.
In order to decrease the risk of water intoxication with hyponatremia, fluid restriction is recommended. Careful fluid intake restriction is particularly important in pediatric and geriatric patients because these patients are at greater risk of developing hyponatremia [see Use in Specific Populations ( 8.4 , 8.5 )] . More frequent monitoring of serum sodium levels is recommended in the following patients: those with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure, renal disorders, habitual or psychogenic polydipsia or those taking concomitant drugs that may cause hyponatremia [see Drug Interactions ( 7.1 )].
Desmopressin nasal spray is not an indicated formulation for the treatment of primary nocturnal enuresis due to a higher risk of hyponatremia and hyponatremic convulsions with the use of the nasal spray formulation compared to desmopressin tablets seen in postmarketing reports [see Indications and Usage ( 1 )].
5.2Altered Absorption in Patients With Nasal Mucosa Abnormalities Chronic administration of desmopressin nasal spray may result in changes to nasal mucosa. Nasal mucosa abnormalities (such as scarring and edema) due to chronic administration, or due to other causes (nasal blockage, nasal mucosal atrophy, severe atrophic rhinitis, recent nasal surgery such as transsphenoidal hypophysectomy) may cause erratic, unreliable absorption. Avoid use of desmopressin nasal spray in such patients [see Indications and Usage ( 1 )] and consider use of other formulations of desmopressin acetate given by other routes of administration.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious reactions are described below and elsewhere in the labeling: Hyponatremia [see Warnings and Precautions ( 5.1 )]. Altered Absorption in Patients with Changes in Nasal Mucosa [see Warnings and Precautions ( 5.2 )]. The following adverse reactions have been identified during post-approval use of desmopressin acetate.
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: 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 of the following medications: oxybutinin and imipramine [see Drug Interactions ( 7.1 )] .
Severe allergic reactions and anaphylaxis [see Contraindications ( 4 )] Adverse reactions that have been identified in patients administered desmopressin nasal spray are headache, nasal congestion, rhinitis, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and mild abdominal cramps ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Drugs that Increase Risk of Hyponatremia: Requires more frequent monitoring of serum sodium ( 7.1 ) Other Vasoconstrictors: Concomitant use may elevate blood pressure and require a reduction in desmopressin nasal spray dosage ( 7.2 )
7.1Other Drugs that may Increase Risk of Hyponatremia The concomitant administration of desmopressin nasal spray with other drugs that may increase the risk of water intoxication with hyponatremia, (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine, oxybutynin and carbamazepine) requires more frequent serum sodium monitoring [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6 )].
7.2Other Vasoconstrictors Desmopressin acetate can elevate blood pressure. Use of large doses of desmopressin nasal spray with other vasoconstrictors may require a reduction of the desmopressin dosage [see Adverse Reactions ( 6 )].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatric Use: Use requires careful fluid intake restriction to prevent hyponatremia with water intoxication ( 5.1 , 8.4 ) Geriatric Use: Carefully monitor renal function; restrict fluid intake to prevent hyponatremia with water intoxication ( 5.1 , 8.5 )
8.1Pregnancy 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. In addition, in vitro studies with human placenta demonstrate poor placental transfer of desmopressin. No adverse developmental outcomes were observed in animal reproduction studies with administration of desmopressin during organogenesis to pregnant rats and rabbits at doses approximately <1 and 38 times, respectively, the maximum recommended human dose based on body surface area (mg/m 2 ) (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Desmopressin acetate at up to 50 ng/kg/day was given by subcutaneous injection to pregnant rats, from gestation day 1 to 20 during the period of early embryonic development and organogenesis without teratogenic effects.
Desmopressin acetate at up to 10 mcg/kg/day was given to pregnant rabbits by subcutaneous injection from gestation day 6 to 18 during fetal organogenesis without teratogenic effects. These doses of desmopressin acetate represent approximately <1 times (rat) and 38 times (rabbit) the maximum recommended human dose based on body surface area (mg/m 2 ).
8.2Lactation Risk Summary Breastfeeding is not expected to result in clinically relevant exposure of the infant to desmopressin following maternal intranasal administration. Desmopressin is poorly transferred into human breastmilk at negligible amounts (see Data). There is no information on the effects of desmopressin on the breastfed infant or on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for desmopressin nasal spray and any potential adverse effects on the breastfed infant from desmopressin nasal spray or from the underlying maternal condition. Data A trial was conducted in six healthy lactating women, at greater than 4 months postpartum, to evaluate intranasal administration of 300 mcg single dose of another desmopressin product (7.5 times the recommended adult dose of desmopressin nasal spray).
Samples of maternal plasma and breastmilk were obtained at 0, 30, 60, 120, 240, 360 and 480 min after the drug administration. At 8 hours after dose intake, the levels in the milk ranged between 4.16 and 101 pg/ml, and the plasma levels ranged between 40 and 242 pg/ml. The total amount of desmopressin present in the milk over the 8 hours ranged between 491 pg and 16 ng, which corresponds to 0.0001 to 0.005% of the administered dose to the breastfeeding mother.
8.4Pediatric Use Desmopressin nasal spray is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in pediatric patients 4 years of age and older. Desmopressin nasal spray is not indicated in pediatric patients less than 4 years of age. Use of desmopressin nasal spray in pediatric patients 4 years of age and older is supported by evidence from adults and pediatric patients with central diabetes insipidus.
Use in pediatric patients requires careful fluid intake restriction to prevent possible water intoxication with hyponatremia [see Warnings and Precautions ( 5.1 )].
8.5Geriatric Use Clinical studies of desmopressin nasal spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently fr… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy 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. In addition, in vitro studies with human placenta demonstrate poor placental transfer of desmopressin. No adverse developmental outcomes were observed in animal reproduction studies with administration of desmopressin during organogenesis to pregnant rats and rabbits at doses approximately <1 and 38 times, respectively, the maximum recommended human dose based on body surface area (mg/m 2 ) (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Desmopressin acetate at up to 50 ng/kg/day was given by subcutaneous injection to pregnant rats, from gestation day 1 to 20 during the period of early embryonic development and organogenesis without teratogenic effects.
Desmopressin acetate at up to 10 mcg/kg/day was given to pregnant rabbits by subcutaneous injection from gestation day 6 to 18 during fetal organogenesis without teratogenic effects. These doses of desmopressin acetate represent approximately <1 times (rat) and 38 times (rabbit) the maximum recommended human dose based on body surface area (mg/m 2 ).
🧒 Pediatric Use ▾
8.4Pediatric Use Desmopressin nasal spray is indicated as antidiuretic replacement therapy in the management of central diabetes insipidus in pediatric patients 4 years of age and older. Desmopressin nasal spray is not indicated in pediatric patients less than 4 years of age. Use of desmopressin nasal spray in pediatric patients 4 years of age and older is supported by evidence from adults and pediatric patients with central diabetes insipidus.
Use in pediatric patients requires careful fluid intake restriction to prevent possible water intoxication with hyponatremia [see Warnings and Precautions ( 5.1 )].
🧓 Geriatric Use ▾
8.5Geriatric Use Clinical studies of desmopressin nasal spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at a low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy. Because elderly patients are more likely to have renal impairment, care should be taken in dose selection, and monitoring renal function is recommended [see Contraindications ( 4 ), Use in Specific Populations ( 8.6 )].
Use of desmopressin nasal spray in geriatric patients requires careful fluid intake restriction to prevent possible water intoxication with hyponatremia [see Warnings and Precautions ( 5.1 )].
🆘 Overdosage ▾
10 OVERDOSAGE Signs of desmopressin acetate overdosage may include confusion, drowsiness, continuing headache, problems with passing urine, and rapid weight gain due to fluid retention [see Warnings and Precautions ( 5.1 )]. In case of overdosage, reduce the dosage, decrease the frequency of administration, or discontinue desmopressin nasal spray. There is no known specific antidote for desmopressin acetate.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The antidiuretic effects of desmopressin are mediated by stimulation of vasopressin 2 (V2) receptors, thereby increasing water re-absorption in the kidney, and hence reducing urine production. Desmopressin 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 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.
12.2Pharmacodynamics The use of desmopressin nasal spray in patients with central diabetes insipidus reduces urinary output, increases urine osmolality, and decreases plasma osmolality.
12.3Pharmacokinetics Absorption: Desmopressin acetate is absorbed through the nasal mucosa. Elimination: Desmopressin acetate exhibits a biphasic elimination profile, with half-lives of 7.8 and 75.5 minutes for the initial and terminal phases, respectively. Specific Populations Renal Impairment: Desmopressin acetate is mainly excreted in the urine.
A pharmacokinetic study was conducted in subjects with normal renal function and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects each group) with a single 2 mcg dose of desmopressin acetate injection (this results in approximately 20 times the exposure of 10 mcg of desmopressin nasal spray). The terminal half-life was 2.8 hours in subjects with normal renal function, 4.0 hours in mild renal impairment, 6.6 hours in moderate renal impairment and 8.7 hours in severe renal impairment. In patients with mild, moderate and severe renal impairment, mean desmopressin exposure was 1.5 fold, 2.4 fold and 3.6 fold higher, respectively compared to that of subjects with normal renal function [see Contraindications ( 4 ), Use in Specific Populations ( 8.6 )].
🧬 Mechanism of Action ▾
12.1Mechanism of Action The antidiuretic effects of desmopressin are mediated by stimulation of vasopressin 2 (V2) receptors, thereby increasing water re-absorption in the kidney, and hence reducing urine production. Desmopressin 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 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Desmopressin nasal spray, USP is available in a 5 mL bottle with a nasal spray pump dispenser with dust cover and patient instruction sheet delivering 50 sprays of 10 mcg (NDC 60505-0815-0).
16.2Storage and Handling Store at 25°C (77°F) [see USP Controlled Room Temperature]; excursions permitted from 15°C to 30°C (59°F to 86°F). AFTER ASSEMBLY, STORE UPRIGHT. Keep out of the reach of children.
📋 Description ▾
11 DESCRIPTION Desmopressin nasal spray, USP is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. The structural formula for the active ingredient is: Mol. wt . 1183.34 g/mol Molecular formula: C 46 H 64 N 14 O 12 S 2 • C 2 H 4 O 2 • 3H 2 O Chemical name: 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.
Desmopressin nasal spray, USP is provided as an aqueous solution for intranasal use. Each mL contains: Desmopressin acetate 0.1 mg Inactive: Benzalkonium chloride solution (50% w/v) 0.2 mg Citric acid monohydrate 1.7 mg Sodium chloride 7.5 mg Sodium phosphate dibasic heptahydrate 4.52 mg Purified water to 1 mL The desmopressin nasal spray, USP compression pump delivers 0.1 mL (10 mcg) of desmopressin acetate per spray.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use) Administration Inform caregivers for pediatric patients that administration should be supervised to ensure the patient receives the prescribed dose. Inform patients that the pump must be primed prior to first use and again if not used for greater than one week. Inform patients that the desmopressin nasal spray bottle delivers 50 sprays of 10 mcg each following the initial 4 priming pumps.
Inform patients to discard any solution remaining after 50 sprays since the amount delivered thereafter may be substantially less than 10 mcg of drug. Monitoring Educate patients about the signs and symptoms of hyponatremia and advise them to contact a healthcare provider if such symptoms occur. Discuss downward adjustment of fluid intake and monitoring of urine output with patients.
APOTEX INC. Desmopressin Nasal Spray, USP 10 mcg/ 0.1 mL Manufactured by Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for Apotex Corp.
Weston, Florida 33326 September 2022
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption: Desmopressin acetate is absorbed through the nasal mucosa. Elimination: Desmopressin acetate exhibits a biphasic elimination profile, with half-lives of 7.8 and 75.5 minutes for the initial and terminal phases, respectively. Specific Populations Renal Impairment: Desmopressin acetate is mainly excreted in the urine.
A pharmacokinetic study was conducted in subjects with normal renal function and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects each group) with a single 2 mcg dose of desmopressin acetate injection (this results in approximately 20 times the exposure of 10 mcg of desmopressin nasal spray). The terminal half-life was 2.8 hours in subjects with normal renal function, 4.0 hours in mild renal impairment, 6.6 hours in moderate renal impairment and 8.7 hours in severe renal impairment. In patients with mild, moderate and severe renal impairment, mean desmopressin exposure was 1.5 fold, 2.4 fold and 3.6 fold higher, respectively compared to that of subjects with normal renal function [see Contraindications ( 4 ), Use in Specific Populations ( 8.6 )].
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics The use of desmopressin nasal spray in patients with central diabetes insipidus reduces urinary output, increases urine osmolality, and decreases plasma osmolality.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with desmopressin acetate have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with desmopressin acetate have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.
📄 Patient Package Insert ▾
Patient Information Desmopressin Nasal Spray, USP 10 mcg per 0.1 mL (des·mo·pres·sin) For Intranasal Use Only What is desmopressin nasal spray ? Desmopressin nasal spray is a prescription medicine called a vasopressin analog used as an antidiuretic replacement to manage central diabetes insipidus. Desmopressin nasal spray is not effective in the treatment of nephrogenic diabetes insipidus.
Desmopressin nasal spray should not be used in people with nasal problems that may keep them from using a nasal spray. Who should not use desmopressin nasal spray? Do not use desmopressin nasal spray if you: are allergic to desmopressin or any of the ingredients in desmopressin nasal spray.
Some people have had severe allergic reactions while taking desmopressin nasal spray. See the end of this Patient Information for a complete list of ingredients in desmopressin nasal spray. have kidney problems have or have had low levels of sodium in your blood (hyponatremia) What should I tell my healthcare provider before using desmopressin nasal spray? Before using desmopressin nasal spray, tell your healthcare provider about all your medical conditions including if you: have or have had nasal sores, nasal surgery, nasal injury, or have problems such as a stuffy nose or trouble breathing through your nose. have or have had any heart, blood circulation, or blood pressure problems have a condition that causes fluid or water imbalance problems such as cystic fibrosis, or heart failure. have or have had a condition that causes you to be very thirsty are pregnant or plan to become pregnant.
It is not known if desmopressin will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if desmopressin passes into your breast milk. You and your healthcare provider should decide if you will use desmopressin nasal spray.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I use desmopressin nasal spray? Read the Instructions for Use that comes with your desmopressin nasal spray.
Use desmopressin nasal spray exactly as your healthcare provider tells you to use it. Your healthcare provider may change your dose of desmopressin nasal spray if needed. What are the possible side effects of desmopressin nasal spray?
Desmopressin nasal spray may cause serious side effects including: low levels of sodium in the blood (hyponatremia). People using desmopressin nasal spray are at risk for low sodium levels in the blood, water intoxication, and fluid overload. Follow your healthcare provider’s instructions on limiting the amount of fluid you can drink when using desmopressin nasal spray.
Do not drink more than you need to satisfy your thirst. You can have serious side effects such as seizures, coma, and death from drinking too much fluid. Children and the elderly are at higher risk for these problems and should follow their healthcare provider’s limits on drinking fluids.
Call your healthcare provider right away if you have any of the following symptoms while using desmopressin nasal spray. They may mean that your blood sodium level is too low. headache nausea, vomiting weight gain restlessness tiredness sleepiness disorientation loss of appetite feeling irritable feeling weak muscle cramps hallucinations confusion nasal scarring or swelling. Some people using desmopressin nasal spray for long periods of time may have nasal problems such as scarring or swelling.
This may affect how well desmopressin nasal spray works for you. The most common side effects of desmopressin nasal spray include: headache, stuffy nose, runny nose, nosebleed, sore throat, cough, upper respiratory infections, nausea, flushing, and stomach cramps. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of desmopressin nasal spray . Medicines are sometimes prescri… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 5 mL Carton Label APOTEX CORP. NDC 60505-0815-0 Desmopressin Nasal Spray Solution USP, 0.01% Rx Only 5 mL
PRINCIPAL DISPLAY PANEL - 5 mL Bottle Label APOTEX CORP. NDC 60505-0815-0 Desmopressin Nasal Spray Solution USP, 0.01% Rx Only 5 mL