Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1453
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Desmopressin Acetate (Injection, Solution)
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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. 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 mcg) to
1 mL (4 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. 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.
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Desmopressin Acetate Injection 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 Molecular Formula: CHNOS���CHO���3HO 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate
(salt) trihydrate. Desmopressin Acetate Injection
4 mcg/mL is provided as a sterile, aqueous solution for intravenous
or subcutaneous use. Each mL contains desmopressin acetate, 4 mcg
and sodium chloride, 9 mg. May contain hydrochloric acid for pH adjustment.
pH is 4.0 (3.5 to 5.0).
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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 solution has an antidiuretic activity of about 16 IU; 1 mcg
of desmopressin acetate is equivalent to 4 IU. 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: Desmopressin acetate 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 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.
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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 is contraindicated in patients with
moderate to severe renal impairment (defined as a creatinine clearance
below 50 mL/min).
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Desmopressin Acetate Injection 4 mcg/mL is available
as a clear colorless sterile solution as follows: KEEP REFRIGERATED AT 2��to 8��C (36��to 46��F). Keep out of the reach of children. Revised: February, 2007
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General:: For injection use only. Desmopressin
Acetate Injection 4 mcg/mL has infrequently produced changes in blood
pressure causing either a slight elevation in blood pressure or a
transient fall in blood pressure and a compensatory increase in heart
rate. The drug should be used with caution in patients with coronary
artery insufficiency and/or hypertensive cardiovascular disease. Desmopressin Acetate Injection should be used with caution
in patients with conditions associated with fluid and electrolyte
imbalance, such as cystic fibrosis, because these patients are prone
to hyponatremia. There have been rare reports
of thrombotic events following Desmopressin Acetate Injection 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 Desmopressin Acetate Injection 4 mcg/mL are
produced after repeated injections. Hemophilia A: Laboratory tests for assessing
patient status include levels of factor VIII coagulant, factor VIII
antigen and factor VIII ristocetin cofactor (von Willebrand factor)
as well as activated partial thromboplastin time. Factor VIII coagulant
activity should be determined before giving desmopressin acetate for
hemostasis. If factor VIII coagulant activity is present at less than
5% of normal, desmopressin acetate should not be relied on. von Willebrand's Disease: Laboratory tests for assessing patient status include levels of
factor VIII coagulant activity, factor VIII ristocetin cofactor activity,
and factor VIII von Willebrand factor antigen. The skin bleeding time
may be helpful in following these patients. Diabetes Insipidus: Laboratory
tests for monitoring the patient include urine volume and osmolality.
In some cases, plasma osmolality may be required.<br/>Drug Interactions:: Although the pressor activity of desmopressin acetate
is very low compared with the antidiuretic activity, use of doses
as large as 0.3 mcg/kg of desmopressin acetate with other pressor
agents should be done only with careful patient monitoring. Desmopressin acetate has been used with epsilon aminocaproic
acid without adverse effects.<br/>Carcinogenicity, Mutagenicity,
Impairment of Fertility:: Studies with desmopressin acetate have not been performed
to evaluate carcinogenic potential, mutagenic potential, or effects
on fertility.<br/>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/m) revealed no harm to the fetus due to desmopressin
acetate. There are, however, no adequate and well controlled studies
in pregnant women. Because animal reproduction studies are not always
predictive of human response, this drug should be used during pregnancy
only if clearly needed. 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.<br/>Nursing Mothers:: There have been no controlled studies in nursing
mothers. A single study in postpartum women demonstrated a marked
change in plasma, but little if any change in assayable desmopressin
acetate in breast milk following an intranasal dose of 10 mcg. It
is not known whether this drug is excreted in human milk. Because
many drugs are excreted in human milk, caution should be exercised
when desmopressin acetate is administered to a nursing woman.<br/>Pediatric Use:: Use in infants and pediatric patients will require
careful fluid intake restriction to prevent possible hyponatremia
and water intoxication. Desmopressin
Acetate Injection 4 mcg/mL should not be used in infants less than
three months of age in the treatment of hemophilia A or
von Willebrand's disease; safety and effectiveness in
children under 12 years of age with diabetes insipidus have not been
established.<br/>Geriatric Use:: Clinical studies of Desmopressin Acetate Injection
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 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
withmoderate to severe renal impairment (defined as a creatinine
clearance below 50 mL/min). See CLINICAL PHARMACOLOGY: Human
Pharmacokinetics and CONTRAINDICATIONS. Use of desmopressin acetate injection in
geriatric patients will require careful fluid intake restrictions
to prevent possible hyponatremia and water intoxication. See WARNINGS.
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See ADVERSE REACTIONS. 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 LDhas
not been established. An intravenous dose of 2 mg/kg in mice demonstrated
no effect.
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Desmopressin Acetate
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Desmopressin Acetate (Injection, Solution)
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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 hasbeen reported with the administration of desmopressin
acetate. 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. There have
been rare reports of thrombotic events (acute cerebrovascular thrombosis,
acute myocardial infarction) following Desmopressin Acetate Injection
in patients predisposed to thrombus formation.
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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 with accompanying signs and symptoms
(headache, nausea/vomiting, decreased serum sodium and weight gain).
See PRECAUTIONS: Geriatric Use. 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
should not be used to treat patients with Type IIB von Willebrand's
disease since platelet aggregation may be induced.
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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. 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.
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Desmopressin Acetate
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