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Desmopressin Acetate

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Overview

What is Desmopressin Acetate?

DESMOPRESSIN ACETATE Injection

Mol. Wt. 1183.34                         Empirical Formula: CHNOS•CHO•3HO 

   1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.

DESMOPRESSIN ACEATE 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).



What does Desmopressin Acetate look like?



What are the available doses of Desmopressin Acetate?

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What should I talk to my health care provider before I take Desmopressin Acetate?

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How should I use Desmopressin Acetate?

Hemophilia A:

DESMOPRESSIN ACETATE Injection

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.

Hemophilia A and von Willebrand's Disease (Type I): DESMOPRESSIN ACETATE Injection

DESMOPRESSIN ACETATE Injection

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 , , Pediatric Use and Geriatric Use.)

Diabetes Insipidus:

DESMOPRESSIN ACETATE Injection

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     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:

 

 

Directions for use of One Point Cut (OPC) Ampules for DESMOPRESSIN ACETATE Injection:


What interacts with Desmopressin Acetate?

DESMOPRESSIN ACETATE Injection


DESMOPRESSIN ACETATE Injection


DESMOPRESSIN ACETATE is 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.



What are the warnings of Desmopressin Acetate?

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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  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.


What are the precautions of Desmopressin Acetate?

General:

DESMOPRESSIN ACETATE Injection

DESMOPRESSIN ACETATE (desmopressin acetate) should be used with caution in patients with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure and renal disorders, because these patients are prone to hyponatremia.

There have been rare reports of thrombotic events following 4 mcg/mL in patients predisposed to thrombus formation. No causality has been determined, however, the drug should be used with caution in these patients.

Severe allergic reactions have been reported rarely. Anaphylaxis has been reported rarely with intravenous and intranasal DESMOPRESSIN ACETATE, including isolated cases of fatal anaphylaxis with intravenous DESMOPRESSIN ACETATE. It is not known whether antibodies to 4 mcg/mL are produced after repeated injections.

Hemophilia A:

von WIllebrand's Disease:

Diabetes Insipidus:

Drug Interactions:

DESMOPRESSIN ACETATE has been used with epsilon aminocaproic acid without adverse effects.

Carcinogenicity, Mutagenicity, Impairment of Fertility:

Pregnancy Category B:

Several publications of desmopressin acetate's use 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 therapeutic advantages against the possible risks in each case.

Nursing Mothers:

Pediatric Use:

.

DESMOPRESSIN ACETATE Injection

should not be used in infants less than three months of age

Geriatric Use:

DESMOPRESSIN ACETATE

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 , Human Pharmacokinetics, and .)

Use of DESMOPRESSIN ACETATE injection in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient. (See .)


What are the side effects of Desmopressin Acetate?

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

See for the possibility of water intoxication and hyponatremia.

Post Marketing:

DESMOPRESSIN ACETATE Injection


What should I look out for while using Desmopressin Acetate?

DESMOPRESSIN ACETATE Injection

DESMOPRESSIN ACETATE Injection

DESMOPRESSIN ACETATE is 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.

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  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.


What might happen if I take too much Desmopressin Acetate?

Signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention. (See .) 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 4 mcg/mL.

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


How should I store and handle Desmopressin Acetate?

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]Protect from light.Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.PHARMACIST:DESMOPRESSIN ACETATE InjectionStore refrigerated 2 to 8°C (36 to 46°F).Keep out of the reach of children.DESMOPRESSIN ACETATE InjectionStore refrigerated 2 to 8°C (36 to 46°F).Keep out of the reach of children.DESMOPRESSIN ACETATE InjectionStore refrigerated 2 to 8°C (36 to 46°F).Keep out of the reach of children.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

DESMOPRESSIN ACETATE Injection

DESMOPRESSIN ACETATE 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 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.

Human Pharmacokinetics

Non-Clinical Toxicology
DESMOPRESSIN ACETATE Injection

DESMOPRESSIN ACETATE Injection

DESMOPRESSIN ACETATE is 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.

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  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.

Drug Interactions

The use of MAO inhibitors or tricyclic antidepressants with hydrocodone preparations may increase the effect of either the antidepressant or hydrocodone.

General:

DESMOPRESSIN ACETATE Injection

DESMOPRESSIN ACETATE (desmopressin acetate) should be used with caution in patients with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure and renal disorders, because these patients are prone to hyponatremia.

There have been rare reports of thrombotic events following 4 mcg/mL in patients predisposed to thrombus formation. No causality has been determined, however, the drug should be used with caution in these patients.

Severe allergic reactions have been reported rarely. Anaphylaxis has been reported rarely with intravenous and intranasal DESMOPRESSIN ACETATE, including isolated cases of fatal anaphylaxis with intravenous DESMOPRESSIN ACETATE. It is not known whether antibodies to 4 mcg/mL are produced after repeated injections.

Hemophilia A:

von WIllebrand's Disease:

Diabetes Insipidus:

Drug Interactions:

DESMOPRESSIN ACETATE has been used with epsilon aminocaproic acid without adverse effects.

Carcinogenicity, Mutagenicity, Impairment of Fertility:

Pregnancy Category B:

Several publications of desmopressin acetate's use 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 therapeutic advantages against the possible risks in each case.

Nursing Mothers:

Pediatric Use:

.

DESMOPRESSIN ACETATE Injection

should not be used in infants less than three months of age

Geriatric Use:

DESMOPRESSIN ACETATE

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 , Human Pharmacokinetics, and .)

Use of DESMOPRESSIN ACETATE injection in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient. (See .)

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

See for the possibility of water intoxication and hyponatremia.

Post Marketing:

DESMOPRESSIN ACETATE Injection

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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