fully 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.

mptoms 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 injection should not be used to treat patients with type iib von willebrand’s disease since platelet aggregation may be induced. 4. desmopressin acetate injection 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.

treme decrease in plasma osmolality that may result in seizures which could lead to coma.

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.

rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutinin and imipramine.

n 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.

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 . )