NDC 72843-459 Desmopressin Acetate

Desmopressin Acetate

NDC Product Code 72843-459

NDC CODE: 72843-459

Proprietary Name: Desmopressin Acetate What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Desmopressin Acetate What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Desmopressin is used to control the amount of urine your kidneys make. Normally, the amount of urine you make is controlled by a certain substance in the body called vasopressin. In people who have water diabetes (diabetes insipidus) or certain kinds of head injury or brain surgery, the body does not make enough vasopressin. Desmopressin is a man-made form of vasopressin and is used to replace a low level of vasopressin. This medication helps to control increased thirst and too much urination due to these conditions, and helps prevent dehydration. Desmopressin is also used to control bleeding caused by surgery or injuries in people with certain bleeding problems (hemophilia A, type 1 von Willebrand's disease). It works by helping the body with normal blood clotting.

NDC Code Structure

  • 72843 - Ubi Pharma Inc.

NDC 72843-459-10

Package Description: 10 AMPULE in 1 BOX > 1 mL in 1 AMPULE

NDC Product Information

Desmopressin Acetate with NDC 72843-459 is a a human prescription drug product labeled by Ubi Pharma Inc.. The generic name of Desmopressin Acetate is desmopressin acetate. The product's dosage form is injection and is administered via intravenous; subcutaneous form.

Labeler Name: Ubi Pharma Inc.

Dosage Form: Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Desmopressin Acetate Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • DESMOPRESSIN ACETATE 4 ug/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Intravenous - Administration within or into a vein or veins.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Factor VIII Activator - [EPC] (Established Pharmacologic Class)
  • Increased Coagulation Factor VIII Activity - [PE] (Physiologic Effect)
  • Increased Coagulation Factor VIII Concentration - [PE] (Physiologic Effect)
  • Vasopressin Analog - [EPC] (Established Pharmacologic Class)
  • Vasopressins - [CS]

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ubi Pharma Inc.
Labeler Code: 72843
FDA Application Number: ANDA210218 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-14-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Desmopressin Acetate Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

(desmopressin acetate)4 mcg/mLRx Only

Description

Desmopressin Acetate Injection USP (desmopressin acetate) 4 mcg/mL is a synthetic analogue of the natural pituitary hormone8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:
Mol. Wt. 1183.34 Empirical Formula: C
46H
64N
14O
12S
2•C
2H
4O
2 •3H
2 O
1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.Desmopressin Acetate Injection USP 4 mcg/mL is provided as a sterile, aqueous solution for injection.
Each mL provides: Desmopressin acetate 4 mcg Sodium chloride 9 mg Hydrochloric acid to adjust pH to 4

Clinical Pharmacology

Desmopressin Acetate Injection 4 mcg/mL contains as active substance, desmopressin acetate, a synthetic analogue of the natural hormone arginine vasopressin. One mL (4 mcg) of Desmopressin Acetate Injection(desmopressin acetate) solution has an antidiuretic activity of about 16 IU; 1 mcg of Desmopressin Acetate Injection is equivalent to 4 IU.


Desmopressin Acetate Injection has been shown to be more potent than arginine vasopressin in increasing plasma levels of factor VIII activity in patients with hemophilia and von Willebrand’s disease Type I.Dose-response studies were performed in healthy persons, using doses of 0.1 to 0.4 mcg/kg body weight, infused over a 10-minute period. Maximal dose response occurred at 0.3 to 0.4 mcg/kg. The response to Desmopressin Acetate Injection of factor VIII activity and plasminogen activator is dose-related, with maximal plasma levels of 300 to 400 percent of initial concentrations obtained after infusion of 0.4 mcg/kg body weight. The increase is rapid and evident within 30 minutes, reaching a maximum at a point ranging from 90 minutes to two hours. The factor VIII related antigen and ristocetin cofactor activity were also increased to a smaller degree, but still are dose-dependent.1. The biphasic half-lives of Desmopressin Acetate Injection were 7.8 and 75.5 minutes for the fast and slow phases, respectively, compared with 2.5 and 14.5 minutes for lysine vasopressin, another form of the hormone. As a result, Desmopressin Acetate Injection provides a prompt onset of antidiuretic action with a long duration after each administration.2. The change in structure of arginine vasopressin to Desmopressin Acetate Injection has 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 are usually below threshold levels for effects on vascular or visceral smooth muscle.3. When administered by injection, Desmopressin Acetate Injection has an antidiuretic effect about ten times that of an equivalent dose administered intranasally.4. The bioavailability of the subcutaneous route of administration was determined qualitatively using urine output data. The exact fraction of drug absorbed by that route of administration has not been quantitatively determined.5. The percentage increase of factor VIII levels in patients with mild hemophilia A and von Willebrand’s disease was not significantly different from that observed in normal healthy individuals when treated with 0.3 mcg/kg of Desmopressin Acetate Injection infused over 10 minutes.6. Plasminogen activator activity increases rapidly after Desmopressin Acetate Injection infusion, but there has been no clinically significant fibrinolysis in patients treated with Desmopressin Acetate Injection.7. The effect of repeated Desmopressin Acetate Injection administration when doses were given every 12 to 24 hours has generally shown a gradual diminution of the factor VIII activity increase noted with a single dose. The initial response is reproducible in any particular patient if there are 2 or 3 days between administrations.Human Pharmacokinetics: Desmopressin Acetate Injection is mainly excreted in the urine. A pharmacokinetic study conducted in healthy volunteers and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects in each group) receiving single dose desmopressin acetate (2 mcg) injection demonstrated a difference in Desmopressin Acetate Injection terminal half-life. Terminal half-life significantly increased from 3 hours in normal healthy patients to 9 hours in patients with severe renal impairment. (See


CONTRAINDICATIONS.)

Indications And Usage

Hemophilia A: Desmopressin Acetate Injection 4 mcg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%.


Desmopressin Acetate Injection will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure.Desmopressin Acetate Injection will also stop bleeding in hemophilia A patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.Desmopressin Acetate Injection is not indicated for the treatment of hemophilia A with factor VIII coagulant activity levels equal to or less than 5%, or for the treatment of hemophilia B, or in patients who have factor VIII antibodies.In certain clinical situations, it may be justified to try Desmopressin Acetate Injection in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.von Willebrands Disease (Type I): Desmopressin Acetate Injection 4 mcg/mL is indicated for patients with mild to moderate classic von Willebrands disease (Type I) with factor VIII levels greater than 5%. Desmopressin Acetate Injection will often maintain hemostasis in patients with mild to moderate von Willebrands disease during surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure.


Desmopressin Acetate Injection will usually stop bleeding in mild to moderate von Willebrands patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.Those von Willebrands disease patients who are least likely to respond are those with severe homozygous von Willebrands disease with factor VIII coagulant activity and factor VIII von Willebrand factor antigen levels less than 1%. Other patients may respond in a variable fashion depending on the type of molecular defect they have. Bleeding time and factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand factor antigen should be checked during administration of Desmopressin Acetate Injection to ensure that adequate levels are being achieved.Desmopressin Acetate Injection is not indicated for the treatment of severe classic von Willebrands disease (Type I) and when there is evidence of an abnormal molecular form of factor VIII antigen. (See


WARNINGS.)


Diabetes Insipidus: Desmopressin Acetate Injection 4 mcg/mL is indicated as antidiuretic replacement therapy in the management of central (cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. Desmopressin Acetate Injection is ineffective for the treatment of nephrogenic diabetes insipidus.


Desmopressin Acetate Injection is also available as an intranasal preparation. However, this means of delivery can be compromised by a variety of factors that can make nasal insufflation ineffective or inappropriate. These include poor intranasal absorption, nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may be inappropriate where there is an impaired level of consciousness. In addition, cranial surgical procedures, such as transsphenoidal hypophysectomy, create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.

Contraindications

Desmopressin Acetate Injection 4 mcg/mL is contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of


Desmopressin Acetate Injection 4 mcg/mL.


Desmopressin Acetate Injection is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min).Desmopressin Acetate Injection is contraindicated in patients with hyponatremia or a history of hyponatremia.

Adverse Reactions

Infrequently, Desmopressin Acetate Injection has produced transient headache, nausea, mild abdominal cramps and vulval pain. These symptoms disappeared with reduction in dosage. Occasionally, injection of Desmopressin Acetate Injection has produced local erythema, swelling or burning pain. Occasional facial flushing has been reported with the administration of Desmopressin Acetate Injection.


Desmopressin Acetate Injection has infrequently produced changes in blood pressure causing either a slight elevation or a transient fall and a compensatory increase in heart rate. Severe allergic reactions including anaphylaxis have been reported rarely with


Desmopressin Acetate Injection.


See


WARNINGS for the possibility of water intoxication and hyponatremia.

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 overdosage, the dosage 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 or


Desmopressin Acetate Injection 4 mcg/mL.


An oral LD


50 has not been established. An intravenous dose of 2 mg/kg in mice demonstrated no effect.

Dosage And Administration

Hemophilia A and von Willebrand’s Disease (Type I): Desmopressin Acetate Injection 4 mcg/mL is administered as an intravenous infusion at a dose of 0.3 mcg Desmopressin Acetate Injection/kg body weight diluted in sterile physiological saline and infused slowly over 15 to 30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended. Blood pressure and pulse should be monitored during infusion. If


Desmopressin Acetate Injection 4 mcg/mL is used preoperatively, it should be administered 30 minutes prior to the scheduled procedure.


The necessity for repeat administration of Desmopressin Acetate Injection or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient. The tendency toward tachyphylaxis (lessening of response) with repeated administration given more frequently than every 48 hours should be considered in treating each patient.Fluid restriction should be observed. (See


WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)


Diabetes Insipidus: This formulation is administered subcutaneously or by direct intravenous injection.


Desmopressin Acetate Injection 4 mcg/mL dosage must be determined for each patient and adjusted according to the pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover.


The usual dosage range in adults is 0.5 mL (2.0 mcg) to 1 mL (4.0 mcg) daily, administered intravenously or subcutaneously, usually in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For patients who have been controlled on intranasal Desmopressin Acetate Injection and who must be switched to the injection form, either because of poor intranasal absorption or because of the need for surgery, the comparable antidiuretic dose of the injection is about one-tenth the intranasal dose.Fluid restriction should be observed. (See


WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)


Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.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


CLINICAL PHARMACOLOGY, Human Pharmacokinetics,


CONTRAINDICATIONS, and


PRECAUTIONS, Geriatric Use.)

Directions For Use Of One Point Cut (Opc) Ampules For Desmopressin Acetate Injection:

1. Use aseptic technique to clean ampule. Gently tap the top of the ampule to assist the flow of the solution from the upper portion of the ampule to the lower portion.


2. Locate the blue dot on the upper portion of the ampule.


Below this dot is a small score on the neck of the ampule. Hold the ampule with the blue dot


facing away from you.


3. Cover the vial with an appropriate wipe. Apply pressure to the top and bottom portions of the ampule to snap the ampule open away from you.

How Supplied

Desmopressin Acetate Injection USP 4 mcg/mL is available as a sterile solution in cartons of ten 1 mL single-dose ampules (NDC 72843-459-10) containing 4 mcg Desmopressin Acetate per mL.

Store refrigerated 2 to 8°C (36 to 46°F).
Keep out of the reach of children.Manufactured for:

United Biomedical Inc.

25 Davids Drive

Hauppauge, NY 11788

Manufactured in Taiwan

* Please review the disclaimer below.