HomeNDC LookupIngredientsDesmopressin Acetate › 60505-0258-01
Desmopressin Acetate .2 mg Tablet, 100-count — NDC 60505-0258-01 package photo

Desmopressin Acetate .2 mg Tablet, 100-count

by Apotex Corp. · 100 TABLET in 1 BOTTLE (60505-0258-1)
NDC 60505-0258-01
🏷️ FDA NDC (as labeled) 60505-0258-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 60505-0258-1
Product NDC 60505-0258
11-digit billing NDC 60505025801
NCPDP billing unit EA — each (per item)
Application # ANDA077414
SPL Set ID 72aeef35-c102-b628-0219-9822651887eb
Established class (EPC) Factor VIII Activator; Vasopressin Analog
Physiologic effect Increased Coagulation Factor VIII Activity; Increased Coagulation Factor VIII Concentration
Chemical class Vasopressins
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2006-03-07
Route ORAL
Dosage form TABLET
Substance DESMOPRESSIN ACETATE
GCN Seq No 019597
GCN 26172
HICL code 002841
Ingredient (HICL) Desmopressin Acetate
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P2
Therapeutic class — intermediate (HIC2) Posterior Pituitary Hormones
HIC3 code P2B
Therapeutic class — specific (HIC3) Antidiuretic And Vasopressor Hormones
AHFS code 20:28.16.00
AHFS class Hemostatics
FDB label name DESMOPRESSIN ACETATE 0.2 MG TB
FDB brand name Desmopressin Acetate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 60505-0258-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 60505-0258-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerApotex Corp.
Application holderAPOTEX INC
FDA applicationANDA077414 (ANDA)
Labeler code60505
First marketedMar 2006
Product typeHuman Prescription Drug
Portfolio306 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name DESMOPRESSIN ACETATE 0.2 MG TB Ingredient Desmopressin Acetate
📖 What it is MedlinePlus · NLM

Desmopressin is used to treat diabetes insipidus ('water diabetes'; condition in which the body produces an abnormally large amount of urine) excessive thirst and urination that may occur after a head injury or after pituitary (a small gland in the brain) surgery, and bedwetting Desmopressin is in a class of medications called hormones. It works by replacing vasopressin, a hormone that is normally produced in the body to help balance the amount of water and salt.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Your body normally makes a hormone that tells your kidneys to hold onto water so you don't lose too much in your urine. With central diabetes insipidus, your body isn't making enou...
  • What exactly is this medication doing for me — why do I need it?
  • This one matters more than you might think. A high-fat meal can cut the amount of desmopressin your body absorbs by a significant amount. Your prescriber will advise you on the bes...
  • Should I take it with food or on an empty stomach?
📖 Read our full Desmopressin guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeRound
ImprintAPO;DES;02
Size8 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMedingredient 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.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.370 $37.01 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.5076 $50.76 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.6671 $66.71 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.483 $0.357
▼ Down 16% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Desmopressin Acetate .2 mg 10702-0170-01 KVK-TECH, 100 tablets $0.370 AB Availability likely
Desmopressin Acetate .2 mg 23155-0490-01 Heritage 100 tablets $0.370 AB Availability likely
Desmopressin Acetate .2 mg 59651-0250-01 Aurobindo 100 tablets $0.370 AB Availability likely
Desmopressin Acetate .2 mgthis 60505-0258-01 Apotex 100 tablets $0.370 AB Availability likely
Desmopressin Acetate .2 mg 60687-0732-21 American 30 tablets $0.370 AB Availability likely
Desmopressin Acetate .2 mg 68001-0575-00 BluePoint 100 tablets $0.370 AB Availability likely
Desmopressin Acetate .2 mg 69918-0201-01 Nordic 100 tablets $0.370 AB Availability likely
Desmopressin Acetate .2 mg 68462-0276-01 Glenmark 100 tablets $0.434 FDA listed +17%
Desmopressin Acetate .2 mg 51655-0461-52 Northwind 30 tablets AB FDA listed
Ddavp .2 mg 55566-2700-00 Ferring 100 tablets AB FDA listed
Desmopressin Acetate .2 mg 63629-3257-01 Bryant 90 tablets AB FDA listed
Desmopressin Acetate .2 mg 71335-2342-01 Bryant 90 tablets AB FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2006
On the market since
Mar 2006
📍
2026
Currently FDA-listed
20 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 60505-0258-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
43.2K
Units reimbursed last 4 qtrs
3M
Gross reimbursed last 4 qtrs
$1.54M
Avg / prescription
$35.64
Avg / unit
$0.5076
Latest quarter Q4 2025
9.8KRx
Medicaid pays / ea
$0.5076
gross reimbursed
vs
NADAC / ea
$0.3701
acquisition cost
=
Spread
+$0.1375
+37% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
35% FFS 65% MCO
Fee-for-service · 15,103 Rx Managed care · 28,146 Rx
State Medicaid map
Alaska: no data reported AK Maine: 32,721 units · 2,346 per 100k residents ME Washington: 12,204 units · 156 per 100k residents WA Idaho: 6,759 units · 344 per 100k residents ID Montana: 5,090 units · 450 per 100k residents MT North Dakota: 13,324 units · 1,702 per 100k residents ND Minnesota: 26,550 units · 463 per 100k residents MN Wisconsin: 57,194 units · 968 per 100k residents WI Michigan: 147,971 units · 1,474 per 100k residents MI New York: 319,151 units · 1,631 per 100k residents NY Vermont: 18,309 units · 2,830 per 100k residents VT New Hampshire: 16,689 units · 1,190 per 100k residents NH Oregon: 6,101 units · 144 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: 2,164 units · 235 per 100k residents SD Iowa: 22,664 units · 707 per 100k residents IA Illinois: 75,409 units · 601 per 100k residents IL Indiana: 201,851 units · 2,942 per 100k residents IN Ohio: 196,276 units · 1,665 per 100k residents OH Pennsylvania: 296,656 units · 2,289 per 100k residents PA New Jersey: 88,347 units · 951 per 100k residents NJ Massachusetts: 184,147 units · 2,630 per 100k residents MA California: 93,108 units · 239 per 100k residents CA Utah: 9,928 units · 291 per 100k residents UT Colorado: 12,560 units · 214 per 100k residents CO Nebraska: 11,804 units · 597 per 100k residents NE Missouri: 76,501 units · 1,235 per 100k residents MO Kentucky: 60,300 units · 1,332 per 100k residents KY West Virginia: 31,887 units · 1,802 per 100k residents WV Virginia: 131,897 units · 1,513 per 100k residents VA Maryland: 77,973 units · 1,262 per 100k residents MD Connecticut: 88,231 units · 2,439 per 100k residents CT Rhode Island: 27,536 units · 2,515 per 100k residents RI Arizona: 14,538 units · 196 per 100k residents AZ New Mexico: 2,532 units · 120 per 100k residents NM Kansas: 18,977 units · 645 per 100k residents KS Arkansas: 18,217 units · 594 per 100k residents AR Tennessee: 59,943 units · 841 per 100k residents TN North Carolina: 187,245 units · 1,728 per 100k residents NC South Carolina: 79,927 units · 1,488 per 100k residents SC Delaware: 5,925 units · 575 per 100k residents DE Oklahoma: 21,173 units · 522 per 100k residents OK Louisiana: 17,613 units · 385 per 100k residents LA Mississippi: 9,683 units · 329 per 100k residents MS Alabama: 31,196 units · 611 per 100k residents AL Georgia: 136,869 units · 1,241 per 100k residents GA D.C.: 4,303 units · 634 per 100k residents DC Hawaii: no data reported HI Texas: 46,106 units · 151 per 100k residents TX Florida: 28,319 units · 125 per 100k residents FL
Units reimbursed · per 100k residents
1202,942
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Indiana 2,942 /100k
2 Vermont 2,830 /100k
3 Massachusetts 2,630 /100k
4 Rhode Island 2,515 /100k
5 Connecticut 2,439 /100k
6 Maine 2,346 /100k
7 Pennsylvania 2,289 /100k
8 West Virginia 1,802 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Desmopressin Acetate — the program that covers self-administered drugs. 12 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Desmopressin Acetate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.68M
Claims incl. refills
49.8K
Beneficiaries
27.1K
Spend / beneficiary
$135.80
Spend / claim
$73.95
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Desmopressin Acetate — the ingredient across all brands.

Top reported reactions

Hyponatraemia357
Headache268
Nausea204
Fatigue173
Vomiting155
Dizziness138
Diarrhoea117

Age at onset

Neonate5
Infant6
Child46
Adolescent61
Adult175
Elderly84

Reporter sex

3,776 reports
Male · 44%
Female · 56%
Unknown · 0%

Serious outcomes

Hospitalization1,368
Life-threatening233
Disabling74
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 256 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
60505-0258-01 You're viewing this 100 TABLET in 1 BOTTLE (60505-0258-1) 2006-03-07 Active

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 124 words

INDICATIONS AND USAGE Central Diabetes Insipidus Desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin acetate is ineffective for the treatment of nephrogenic diabetes insipidus. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone.

Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality. Primary Nocturnal Enuresis Desmopressin acetate tablets are indicated for the management of primary nocturnal enuresis. Desmopressin acetate may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention.

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION Central Diabetes Insipidus The dosage of desmopressin acetate tablets must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients previously on intranasal desmopressin acetate therapy should begin tablet therapy twelve hours after the last intranasal dose.

During the initial dose titration period, patients should be observed closely and appropriate safety parameters measured to assure adequate response. Patients should be monitored at regular intervals during the course of desmopressin acetate tablet therapy to assure adequate antidiuretic response. Modifications in dosage regimen should be implemented as necessary to assure adequate water turnover.

Fluid restriction should be observed. (See WARNINGS , PRECAUTIONS , Pediatric Use and Geriatric Use .) Adults and Children It is recommended that patients be started on doses of 0.05 mg (1/2 of the 0.1 mg tablet) two times a day and individually adjusted to their optimum therapeutic dose. Most patients in clinical trials found that the optimal dosage range is 0.1 mg to 0.8 mg daily, administered in divided doses.

Each dose should be separately adjusted for an adequate diurnal rhythm of water turnover. Total daily dosage should be increased or decreased in the range of 0.1 mg to 1.2 mg divided into two or three daily doses as needed to obtain adequate antidiuresis. See Pediatric Use subsection for special considerations when administering desmopressin acetate to pediatric diabetes insipidus patients.

Geriatric Use This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINCAL PHARMACOLOGY , Human Pharmacokinetics , CONTRAINDICATIONS , and PRECAUTIONS , Geriatric Use .) Primary Nocturnal Enuresis The dosage of desmopressin acetate tablets must be determined for each individual patient and adjusted according to response.

Patients previously on intranasal desmopressin acetate therapy can begin tablet therapy the night following (24 hours after) the last intranasal dose. The recommended initial dose for patients age 6 years and older is 0.2 mg at bedtime. The dose may be titrated up to 0.6 mg to achieve the desired response.

Fluid restriction should be observed, and fluid intake should be limited to a minimum from 1 hour before desmopressin administration, until the next morning, or at least 8 hours after administration. (See WARNINGS , PRECAUTIONS , Pediatric Use and Geriatric Use .)

Contraindications 57 words

CONTRAINDICATIONS Desmopressin acetate tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate tablets. Desmopressin acetate tablets are contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50mL/min). Desmopressin acetate is contraindicated in patients with hyponatremia or a history of hyponatremia.

⚠️ Warnings ~1 min read

WARNINGS Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated 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 tablets are administered, 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 tablets 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 tablets 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.

🤒 Adverse Reactions 184 words

ADVERSE REACTIONS Infrequently, large doses of the intranasal formulations of desmopressin acetate tablets and injection have produced transient headache, nausea, flushing and mild abdominal cramps. These symptoms have disappeared with reduction in dosage. Central Diabetes Insipidus In long-term clinical studies in which patients with diabetes insipidus were followed for periods up to 44 months of desmopressin acetate tablet therapy, transient increases in AST (SGOT) no higher than 1.5 times the upper limit of normal were occasionally observed.

Elevated AST (SGOT) returned to the normal range despite continued use of desmopressin acetate tablets. Primary Nocturnal Enuresis The only adverse event occurring in ≥3% of patients in controlled clinical trials with desmopressin acetate tablets that was probably, possibly, or remotely related to study drug was headache (4% desmopressin acetate, 3% placebo). Other The following adverse events have been reported; however their relationship to desmopressin acetate has not been established: abnormal thinking, diarrhea, and edema-weight gain.

See WARNINGS for the possibility of water intoxication and hyponatremia. Post Marketing There have been rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutinin and imipramine.

🔄 Drug Interactions 69 words

Drug Interactions Although the pressor activity of desmopressin acetate is very low compared to its antidiuretic activity, large doses of desmopressin acetate tablets should be used with other pressor agents only with careful patient monitoring. The concomitant administration of 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 and carbamazepine) should be performed with caution.

🤰 Pregnancy 212 words

Pregnancy Category B Fertility studies have not been done. Teratology studies in rats and rabbits at doses from 0.05 to 10 mcg/kg/day (approximately 0.1 times the maximum systemic human exposure in rats and up to 38 times the maximum systemic human exposure in rabbits based on surface area, mg/m2) revealed no harm to the fetus due to desmopressin acetate. There are, however, no adequate and well-controlled studies in pregnant women.

Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Several publications where desmopressin acetate was used in the management of diabetes insipidus during pregnancy are available; these include a few anecdotal reports of congenital anomalies and low birth weight babies. However, no causal connection between these events and desmopressin acetate has been established.

A fifteen year Swedish epidemiologic study of the use of desmopressin acetate in pregnant women with diabetes insipidus found the rate of birth defects to be no greater than that in the general population; however, the statistical power of this study is low. As opposed to preparations containing natural hormones, desmopressin acetate in antidiuretic doses has no uterotonic action and the physician will have to weigh the possible therapeutic advantages against the possible risks in each case.

🧒 Pediatric Use ~1 min read

Pediatric Use Central Diabetes Insipidus Desmopressin acetate tablets have been used safely in pediatric patients, age 4 years and older, with diabetes insipidus for periods up to 44 months. In younger pediatric patients the dose must be individually adjusted in order to prevent an excessive decrease in plasma osmolality leading to hyponatremia and possible convulsions; dosing should start at 0.05 mg (1/2 of the 0.1 mg tablet). Use of desmopressin acetate tablets in pediatric patients requires careful fluid intake restrictions to prevent possible hyponatremia and water intoxication.

Fluid restriction should be discussed with the patient and/or guardian. (See WARNINGS .) Primary Nocturnal Enuresis Desmopressin acetate tablets have been safely used in pediatric patients age 6 years and older with primary nocturnal enuresis for up to 6 months. Some patients respond to a dose of 0.2 mg; however, increasing responses are seen at doses of 0.4 mg and 0.6 mg.

No increase in the frequency or severity of adverse reactions or decrease in efficacy was seen with an increased dose or duration. The dose should be individually adjusted to achieve the best results. Treatment with desmopressin for primary nocturnal enuresis should be interrupted during acute intercurrent illness characterized by fluid and/or electrolyte imbalance (e.g., systemic infections, fever, recurrent vomiting or diarrhea) or under conditions of extremely hot weather, vigorous exercise or other conditions associated with increased water intake.

🧓 Geriatric Use 199 words

Geriatric Use Clinical studies of desmopressin acetate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually 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.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. Desmopressin acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min).

(See CLINICAL PHARMACOLOGY , Human Pharmacokinetics and CONTRAINDICATIONS .) Use of desmopressin acetate tablets in geriatric patients requires careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient. (See WARNINGS .)

🆘 Overdosage 109 words

OVERDOSAGE Signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention. (See WARNINGS .) In case of overdose, the dose should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition. There is no known specific antidote for desmopressin acetate.

The patient should be observed and treated with appropriate symptomatic therapy. An oral LD50 has not been established. Oral doses up to 0.2 mg/kg/day have been administered to dogs and rats for 6 months without any significant drug-related toxicities reported.

An intravenous dose of 2 mg/kg in mice demonstrated no effect.

🧬 Clinical Pharmacology ~3 min read

CLINICAL PHARMACOLOGY Desmopressin acetate tablets contain as active substance, desmopressin acetate, a synthetic analogue of the natural hormone arginine vasopressin. Central Diabetes Insipidus Dose response studies in patients with diabetes insipidus have demonstrated that oral doses of 0.025 mg to 0.4 mg produced clinically significant antidiuretic effects. In most patients, doses of 0.1 mg to 0.2 mg produced optimal antidiuretic effects lasting up to eight hours.

With doses of 0.4 mg, antidiuretic effects were observed for up to 12 hours; measurements beyond 12 hours were not recorded. Increasing oral doses produced dose dependent increases in the plasma levels of desmopressin acetate. The plasma half-life of desmopressin acetate followed a monoexponential time course with t1/2 values of 1.5 to 2.5 hours which was independent of dose.

The bioavailability of desmopressin acetate oral tablets is about 5% compared to intranasal desmopressin acetate, and about 0.16% compared to intravenous desmopressin acetate. The time to reach maximum plasma desmopressin acetate levels ranged from 0.9 to 1.5 hours following oral or intranasal administration, respectively. Following administration of desmopressin acetate tablets, the onset of antidiuretic effect occurs at around 1 hour, and it reaches a maximum at about 4 to 7 hours based on the measurement of increased urine osmolality.

The use of desmopressin acetate tablets in patients with an established diagnosis will result in a reduction in urinary output with an accompanying increase in urine osmolality. These effects usually will allow resumption of a more normal life style, with a decrease in urinary frequency and nocturia. There are reports of an occasional change in response to the intranasal formulations of desmopressin acetate.

Usually, the change occurred over a period of time greater than six months. This change may be due to decreased responsiveness, or to shortened duration of effect. There is no evidence that this effect is due to the development of binding antibodies, but may be due to a local inactivation of the peptide.

No lessening of effect was observed in the 46 patients who were treated with desmopressin acetate tablets for 12 to 44 months and no serum antibodies to desmopressin were detected. The change in structure of arginine vasopressin to desmopressin acetate resulted in less vasopressor activity and decreased action on visceral smooth muscle relative to enhanced antidiuretic activity. Consequently, clinically effective antidiuretic doses are usually below the threshold for effects on vascular or visceral smooth muscle.

In the four long-term studies of desmopressin acetate tablets, no increases in blood pressure in 46 patients receiving desmopressin acetate tablets for periods of 12 to 44 months were reported. In one study, the pharmacodynamic characteristics of desmopressin acetate tablets and intranasal formulation were compared during an 8-hour dosing interval at steady state. The doses administered to 36 hydrated (water loaded) healthy male adult volunteers every 8 hours were 0.1, 0.2, 0.4 mg orally and 0.01 mg intranasally by rhinal tube.

The results are shown in the following table: Mean Changes from Baseline (SE) in Pharmacodynamic Parameters in Normal Healthy Adult Volunteers Treatment Total Urine Volume in mL Maximum Urine Osmolality in mOsm/kg (SE) = Standard error of the mean 0.1 mg PO q8h -3689.3 (149.6) 514.8 (21.9) 0.2 mg PO q8h -4429.9 (149.6) 686.3 (21.9) 0.4 mg PO q8h -4998.8 (149.6) 769.3 (21.9) 0.01 mg IN q8h -4844.9 (149.6) 754.1 (21.9) With respect to the mean values of total urine volume decrease and maximum urine osmolality increase from baseline, the 90% confidence limits estimated that the 0.4 mg and 0.2 mg oral dose produced between 95% and 110% and 84% to 99% of pharmacodynamic activity, respectively, when compared to the 0.01 mg intranasal dose.

While both the 0.2 mg and 0.4 mg oral doses are considered pharmacodynamically similar to…

📦 How Supplied / Storage and Handling 131 words

HOW SUPPLIED Desmopressin Acetate Tablets 0.1 mg are available for oral administration as white to off-white, round shaped, scored tablets, imprinted “APO” on one side and “DES” bisect “0.1” on the other side. They are supplied as follows: Bottles of 30 (NDC 60505-0257-3) Bottles of 100 (NDC 60505-0257-1) Bottles of 1000 (NDC 60505-0257-8) Desmopressin Acetate Tablets 0.2 mg are available for oral administration as white to off-white, round shaped, scored tablets, imprinted “APO” on one side and “DES” bisect “0.2” on the other side.

They are supplied as follows: Bottles of 30 (NDC 60505-0258-3) Bottles of 100 (NDC 60505-0258-1) Bottles of 1000 (NDC 60505-0258-8) Store 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP]. Keep out of the reach of children.

📋 Description 75 words

DESCRIPTION Desmopressin Acetate Tablets are a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows: Mol. Wt.

1129.27 Empirical Formula: C46H64N14O12S2 • C2H4O2 where 1<x<1.5 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt). Desmopressin acetate tablets, for oral administration, contain either 0.1 or 0.2 mg desmopressin acetate. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, corn starch, and magnesium stearate. desmo-image01

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.