Desmopressin Acetate Solution
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Questions & Answers
Side Effects & Adverse Reactions
1. Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with DESMOPRESSIN ACETATE (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.
2. When DESMOPRESSIN ACETATE Injection is administered to patients who do not have need of antidiuretic hormone for its antidiuretic effect, 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 Generic Use.) All patients receiving DESMOPRESSIN ACETATE therapy 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 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.
3. DESMOPRESSIN ACETATE should not be used to treat patients with Type IIB von Willebrand's disease since platelet aggregation may be induced.
4. DESMOPRESSIN ACETATE 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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 will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure.
DESMOPRESSIN ACETATE 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 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 in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.
von Willebrand's Disease (Type I): DESMOPRESSIN ACETATE Injection 4 mcg/mL is indicated for patients with mild to moderate classic von Willebrand's disease (Type I) with factor VIII levels greater than 5%. DESMOPRESSIN ACETATE will often maintain hemostasis in patients with mild to moderate von Willebrand's disease during surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure.
DESMOPRESSIN ACETATE will usually stop bleeding in mild to moderate von Willebrand's patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.
Those von Willebrand's disease patients who are least likely to respond are those with severe homozygous von Willebrand's 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 to ensure that adequate levels are being achieved.
DESMOPRESSIN ACETATE is not indicated for the treatment of severe classic von Willebrand's 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 is ineffective for the treatment of nephrogenic diabetes insipidus.
DESMOPRESSIN ACETATE 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.
History
There is currently no drug history available for this drug.
Other Information
DESMOPRESSIN ACETATE Injection (desmopressin acetate) 4 mcg/mL is 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. 1183.34 Empirical Formula: C46H64N14O12S2•C2H4O2•3H2O
1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.
DESMOPRESSIN ACEATE Injection 4 mcg/mL is provided as a sterile, aqueous solution for injection.
Each mL provides:
Desmopressin acetate 4.0 mcg
Sodium chloride 9.0 mg
Hydrochloric acid to adjust pH to 4
The 10 mL vial contains chlorobutanol as a preservative (5.0 mg/mL).
Sources
Desmopressin Acetate Solution Manufacturers
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Ferring Pharmaceuticals Inc.
![Desmopressin Acetate Solution [Ferring Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Desmopressin Acetate Solution | Ferring Pharmaceuticals Inc.
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/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 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 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 Pharmcokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)
Directions for use of One Point Cut (OPC) Ampules for DESMOPRESSIN ACETATE Injection:
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. 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. 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. -
Physicians Total Care, Inc.
Desmopressin Acetate Solution | Physicians Total Care, Inc.
Central Cranial Diabetes Insipidus:Desmopressin acetate dosage 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 with nasal congestion and blockage have often responded well to intranasal desmopressin acetate. The usual dosage range in adults is 0.1 to 0.4 mL daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL daily in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For children aged 3 months to 12 years, the usual dosage range is 0.05 to 0.3 mL daily, either as a single dose or divided into two doses. About 1/4 to 1/3 of patients can be controlled by a single daily dose of desmopressin acetate administered intranasally. Fluid restriction should be observed. (See WARNINGS:, PRECAUTIONS:, Pediatric Use: and Geriatric Use:.)
The nasal spray pump can only deliver doses of 0.1 mL (10 μg) or multiples of 0.1 mL. If doses other than these are required, the rhinal tube delivery system may be used. The spray pump must be primed prior to the first use. To prime pump, press down five (5) times. The bottle will now deliver 10 μg of drug per spray. Discard desmopressin acetate nasal solution after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 μg of drug.
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, CONTRAINDICATION:, and PRECAUTIONS:, Geriatric Use:.)
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Bauch & Lomb Incorporated
Desmopressin Acetate Solution | Bauch & Lomb Incorporated
Central Cranial Diabetes Insipidus:Desmopressin acetate dosage 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 with nasal congestion and blockage have often responded well to intranasal desmopressin acetate. The usual dosage range in adults is 10 mcg to 40 mcg (1spray to 4 sprays) intranasally daily, either as a single dose or divided into two or three doses. Most adults require 20 mcg daily in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For children aged 3 months to 12 years, the usual dosage range is 5 mcg to 30 mcg intranasally daily, either as a single dose or divided into two doses. About 1/4 to 1/3 of patients can be controlled by a single daily dose of desmopressin acetate administered intranasally. Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)
The nasal spray pump can only deliver doses in multiples of 10 mcg (1 spray). Doses of 10 mcg (1 spray) to 30 mcg (3 sprays) can be delivered with the nasal spray pump. If doses other than these are required, the rhinal tube delivery system may be used. The spray pump must be primed prior to the first use. To prime pump, press down five (5) times. The bottle will now deliver 10 mcg of drug per spray. Discard desmopressin acetate nasal spray solution after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 mcg of drug.
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, CONTRAINDICATION, and PRECAUTIONS, Geriatric Use)
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Sun Pharmaceutical Industries Limited
Desmopressin Acetate Solution | Sun Pharmaceutical Industries Limited
Central Cranial Diabetes Insipidus:
Desmopressin nasal spray solution 0.01% dosage 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 with nasal congestion and blockage have often responded well to intranasal desmopressin acetate. The usual dosage range in adults is 0.1 mL to 0.4 mL daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL daily in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For children aged 3 months to 12 years, the usual dosage range is 0.05 mL to 0.3 mL daily, either as a single dose or divided into two doses. About 1/4 to 1/3 of patients can be controlled by a single daily dose of desmopressin acetate administered intranasally. Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)
The nasal spray pump can only deliver doses of 0.1 mL (10 mcg) or multiples of 0.1 mL. If doses other than these are required, the rhinal tube delivery system may be used.
The spray pump must be primed prior to the first use. To prime pump, press down five (5) times. The bottle will now deliver 10 mcg of drug per spray. Discard desmopressin nasal spray solution 0.01% after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 mcg of drug. 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.) -
Ferring Pharmaceuticals Inc.
Desmopressin Acetate Solution | Ferring Pharmaceuticals Inc.
Central Cranial Diabetes Insipidus: This drug is administered into the nose through a soft, flexible plastic rhinal tube which has four graduation marks on it that measure 0.2, 0.15, 0.1 and 0.05 mL. DESMOPRESSIN ACETATE Rhinal Tube dosage 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 with nasal congestion and blockage have often responded well to intranasal DESMOPRESSIN ACETATE. The usual dosage range in adults is 0.1 to 0.4 mL daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL daily in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For children aged 3 months to 12 years, the usual dosage range is 0.05 to 0.3 mL daily, either as a single dose or divided into two doses. About 1/4 to 1/3 of patients can be controlled by a single daily dose of DESMOPRESSIN ACETATE administered intranasally. Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)
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.)
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Sun Pharma Global Fze
Desmopressin Acetate Solution | Sun Pharma Global Fze
Central Cranial Diabetes Insipidus: Desmopressin Acetate Nasal Solution 0.01% (Nasal Spray) dosage 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 with nasal congestion and blockage have often responded well to intranasal desmopressin acetate. The usual dosage range in adults is 0.1 mL to 0.4 mL daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL daily in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For children aged 3 months to 12 years, the usual dosage range is 0.05 mL to 0.3 mL daily, either as a single dose or divided into two doses. About 1/4 to 1/3 of patients can be controlled by a single daily dose of desmopressin acetate administered intranasally. Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Useand Geriatric Use.)
The nasal spray pump can only deliver doses of 0.1 mL (10 mcg) or multiples of 0.1 mL. If doses other than these are required, the rhinal tube delivery system may be used.
The spray pump must be primed prior to the first use. To prime pump, press down four times. The bottle will now deliver 10 mcg of drug per spray. Discard Desmopressin Acetate Nasal Solution 0.01% (Nasal Spray) after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 mcg of drug.
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.)
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Amring Pharmaceuticals Inc.
Desmopressin Acetate Solution | Amring Pharmaceuticals Inc.
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/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 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 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 Pharmcokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)
Directions for use of One Point Cut (OPC) Ampules for DESMOPRESSIN ACETATE Injection:
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. 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. 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.
![Desmopressin Acetate Solution [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b3b68b3a-aa82-4464-8146-51d27861023d&name=5602.jpg)
![Desmopressin Acetate Solution [Bauch & Lomb Incorporated]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8ca799f1-7029-4527-9ab4-7512504bb8e2&name=Desmopressincarton.jpg)
![Desmopressin Acetate Solution [Sun Pharmaceutical Industries Limited ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ceee4883-6c49-4538-a747-354d0743b221&name=label.jpg)
![Desmopressin Acetate Solution [Sun Pharma Global Fze]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b47d691e-28a9-4e10-92b8-310aecc2f953&name=label1.jpg)
![Desmopressin Acetate Solution [Amring Pharmaceuticals Inc.]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
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