Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/823
| Subject | Predicate | Object | Context |
|---|---|---|---|
| dailymed-drugs:823 | rdf:type | http://www4.wiwiss.fu-berli... | lld:dailymed |
| dailymed-drugs:823 | rdf:type | dailymed-instance:drugs | lld:dailymed |
| dailymed-drugs:823 | rdfs:label | Desmopressin Acetate (Tablet) | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:dosage | Central Diabetes Insipidus: The dosage of desmopressin acetate tablets 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 previously on intranasal desmopressin acetate therapy should begin tablet therapy twelve hours after the last intranasal dose. During the initial dose titration period, patients should be observed closely and appropriate safety parameters measured to assure adequate response. Patients should be monitored at regular intervals during the course of desmopressin acetate tablet therapy to assure adequate antidiuretic response. Modification in dosage regimen should be implemented as necessary to assure adequate water turnover. Adults and Children: It is recommended that patients be started on doses of 0.05 mg (��of the 0.1 mg tablet) two times a day and individually adjusted to their optimum therapeutic dose. Most patients in clinical trials found that the optimal dosage range is 0.1 mg to 0.8 mg daily, administered in divided doses. Each dose should be separately adjusted for an adequate diurnal rhythm of water turnover. Total daily dosage should be increased or decreased in the range of 0.1 mg to 1.2 mg divided into two or three daily doses as needed to obtain adequate antidiuretic. See Pediatric Usesubsection for special considerations when administering desmopressin acetate to pediatric diabetes insipidus patients. 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. . Primary Nocturnal Enuresis: The dosage of desmopressin acetate tablets must be determined for each individual patient and adjusted according to response. Patients previously on intranasal desmopressin acetate therapy can begin tablet therapy the night following (24 hours after) the last intranasal dose. The recommended initial dose for patients (adults up to 45 years of age and children age 6 years and older) is 0.2 mg at bedtime. The dose may be titrated up to 0.6 mg to achieve the desired response. Fluid restriction should be observed, and fluid intake should be limited to a minimum from 1 hour before desmopressin acetate administration, until the next morning, or at least 8 hours after administration. . Renal Concentration Capacity Test in Pediatrics: Desmopressin acetate tablets 0.6 mg (3 x 0.2 mg), for children between 3 and 18 years of age, should be taken at bedtime after bladder emptying. Urine osmolality should be measured in the first voided volume occurring>1 hour after administration. | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:descripti... | Desmopressin acetate tablets contain desmopressin acetate, 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: CHNOS���CHO���3HO 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate. Desmopressin acetate tablets contain either 0.1 or 0.2 mg desmopressin acetate. Inactive ingredients include: lactose, potato starch, magnesium stearate and povidone. | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:clinicalP... | Desmopressin acetate tablets contain as active substance, desmopressin acetate, a synthetic analogue of the natural hormone arginine vasopressin.<br/>Pharmacokinetics: The mean time to reach maximum plasma desmopressin levels (t) was 1.1 hours following desmopressin acetate tablet administration. The plasma half-life of desmopressin after desmopressin acetate tablet administration followed a monoexponential time course with mean t��value of 2.0 hours. Geometric means of maximum plasma concentrations and area under the plasma concentration-time curves were 32.7 pg/mL and 85.2 pg*hr/mL, respectively, for desmopressin after 3 x 0.2mg desmopressin acetate tablet administration in healthy adult volunteers. The bioavailability of desmopressin acetate oral tablets is about 5% compared to intranasal formulation, and about 0.16% compared to intravenous formulation. Desmopressin 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 terminal half-life. Terminal half life significantly increased from 3 hours in normal healthy patients to 9 hours in patients with severe renal impairment. . Central Diabetes Insipidus: Dose response studies in patients with diabetes insipidus have demonstrated that oral doses of 0.025 mg to 0.4 mg produced clinically significant antidiuretic effects. In most patients, doses of 0.1 mg to 0.2 mg produced optimal antidiuretic effects lasting up to eight hours. With doses of 0.4 mg, antidiuretic effects were observed for up to 12 hours; measurements beyond 12 hours were not recorded. Increasing oral doses produced dose dependent increases in the plasma levels of desmopressin. Following administration of desmopressin acetate tablets, the onset of antidiuretic effect occurs at around 1 hour, and it reaches a maximum at about 4 to 7 hours based on the measurement of increased urine osmolality. The use of desmopressin acetate tablets in patients with an established diagnosis will result in a reduction in urinary output with an accompanying increase in urine osmolality. These effects usually will allow resumption of a more normal life style, with a decrease in urinary frequency and nocturia. There are reports of an occasional change in response to the intranasal formulations of desmopressin acetate (desmopressin acetate nasal spray and desmopressin acetate rhinal tube). Usually, the change occurred over a period of time greater than six months. This change may be due to decreased responsiveness, or to shortened duration of effect. There is no evidence that this effect is due to the development of binding antibodies. No lessening of effect was observed in the 46 patients who were treated with desmopressin acetate tablets for 12 to 44 months and no serum antibodies to desmopressin were detected. The change in structure of arginine vasopressin to desmopressin acetate resulted in less vasopressor activity and decreased action on visceral smooth muscle relative to enhanced antidiuretic activity. Consequently, clinically effective antidiuretic doses are usually below the threshold for effects on vascular or visceral smooth muscle. In the four long-term studies of desmopressin acetate tablets, no increases in blood pressure in 46 patients receiving desmopressin acetate tablets for periods of 12 to 44 months were reported. In one study, the pharmacodynamic characteristics of desmopressin acetate tablets and intranasal formulation were compared during an 8-hour dosing interval at steady state. The doses administered to 36 hydrated (water loaded) healthy male adult volunteers every 8 hours were 0.1, 0.2, 0.4 mg orally and 0.01 mg intranasally by rhinal tube. The results are shown in the following table: With respect to the mean values of total urine volume decrease and maximum urine osmolality increase from baseline, the 90% confidence limits estimated that the 0.4 mg and 0.2 mg oral dose produced between 95% and 110% and 84% to 99% of pharmacodynamic activity, respectively, when compared to the 0.01 mg intranasal dose. While both the 0.2 mg and 0.4 mg oral doses are considered pharmacodynamically similar to the 0.01 mg intranasal dose, the pharmacodynamic data on an inter-subject basis was highly variable and, therefore, individual dosing is recommended. In another study in diabetes insipidus patients, the pharmacodynamic characteristics of desmopressin acetate tablets and intranasal formulations were compared over a 12-hour period. Ten fluid-controlled patients under age 18 were administered tablet doses of 0.2 mg and 0.4 mg, and intranasal doses of 0.01 mg and 0.02 mg. All four dose formulations (0.01 mg IN, 0.02 mg IN, 0.2 mg PO and 0.4 mg PO) have a similar, pronounced pharmacodynamic effect on urine volume and urine osmolality. At two hours after study drug administration, mean urine volume was 4 mL/min and urine osmolality was>500 mOsm/kg. Mean plasma osmolality remained relatively constant over the time course recorded (0 to 12 hours). A statistical separation from baseline did not occur at any dose or time point. In these patients, the 0.2 mg tablets and the 0.01 mg intranasal spray exhibited similar pharmacodynamic profiles as did the 0.4 mg tablets and the 0.02 mg intranasal spray formulation. In another study of adult diabetes insipidus patients previously controlled on desmopressin acetate intranasal spray, after one week of self-titration from spray to tablets, patients'diuresis was controlled with 0.1 mg desmopressin acetate tablets three times a day. Primary Nocturnal Enuresis in Pediatrics: Two double-blind, randomized, placebo-controlled studies were conducted in 340 patients with primary nocturnal enuresis. Patients were 5-17 years old, and 72% were males. A total of 329 patients were evaluated for efficacy. Patients were evaluated over a two-week baseline period in which the average number of wet nights was 10 (range 4-14). Patients were then randomized to receive 0.2, 0.4, or 0.6 mg of desmopressin acetate or placebo. The pooled results after two weeks are shown in the following table: Patients treated with desmopressin acetate tablets showed a statistically significant reduction in the number of wet nights compared to placebo-treated patients. A greater response was observed with increasing doses up to 0.6 mg. In a six month, open-label extension study, patients completing the placebo-controlled studies were started on 0.2 mg/day desmopressin acetate, and the dose was progressively increased until the optimal response was achieved (maximum dose 0.6 mg/day). A total of 230 patients were evaluated for efficacy; the average number of wet nights/2 weeks during the untreated baseline period was 10 (range 4-14), and the average duration (SD) of treatment was 4.2 (1.8) months. Twenty-five (25) patients (11%) achieved a complete or near complete response (���2 wet nights/2 weeks) and did not require titration to the 0.6 mg/day dose. The majority of patients (198 of 230, 86%) were titrated to the highest dose. When all dose groups were combined, 128 (56%) showed at least a 50% reduction from baseline in the number of wet nights/2 weeks, while 87 (38%) patients achieved a complete or near complete response. The study showed a similar mean reduction from baseline to end of treatment: 3.2 wet nights/week (95% CI 2.4-4.1, p<0.01) on the 0.2 mg dose and 3.4 wet nights/week (95% CI 2.7-4.1, p<0.01) on the 0.4 mg dose. Primary Nocturnal Enuresis in Adolescents and Adults: A double-blind, randomized, parallel-group study was conducted in 66 patients with primary nocturnal enuresis who were determined to be responders to therapy with desmopressin acetate nasal spray (e.g.,>50% reduction in the number of wet nights/week) and continued to have at least one wet night per week during the washout period. The median age of the subjects was 17 with a range of 12 to 45 years, 56% were males, and they had an average of 5 wet nights per week (range 2-7). Patients were randomized to receive 0.2 or 0.4 mg of desmopressin acetate tablets. Treatment outcome was measured as a mean reduction in the number of wet nights per week at the end of the four week treatment period relative to the baseline observation period. The results by age group are shown in the following table: Renal Concentration Capacity Test in Pediatrics: A multi-center, randomized, double-blind, double-dummy, four-period, cross-over trial was performed in 153 patients aged 3 to 18 years to compare desmopressin acetate tablets (0.6 mg), desmopressin acetate nasal spray (20 mcg) and placebo. All subjects were given medication in the evening before bedtime, with fluid restriction maintained from one hour before dosing to 8 hours after dosing. Any urine sample within one hour of drug administration was discarded. Urine osmolality was measured in the first voided specimen, at least one hour but not more than 12 hours after drug administration. The results of the test are shown in the following table: | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:activeIng... | dailymed-ingredient:Desmopr... | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:supply | Store at Controlled Room Temperature 20 to 25��C (68 to 77��F) [See USP]. Avoid exposure to excessive heat or light. This product should be dispensed in a container with a child-resistant cap. Keep out of the reach of children. U.S. Patent Nos. 5,500,413, 5,596,078, 5,674,850, 5,047,398; 5,763,407 Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054 USA May 2008 | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:activeMoi... | dailymed-ingredient:Desmopr... | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:inactiveI... | dailymed-ingredient:lactose | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:inactiveI... | dailymed-ingredient:magnesi... | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:inactiveI... | dailymed-ingredient:povidon... | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:inactiveI... | dailymed-ingredient:potato_... | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:overdosag... | Signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention. . In case of overdose, the dose 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. The patient should be observed and treated with appropriate symptomatic therapy. An oral LDhas not been established. Oral doses up to 0.2 mg/kg/day have been administered to dogs and rats for 6 months without any significant drug-related toxicities reported. An intravenous dose of 2 mg/kg in mice demonstrated no effect. | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:genericMe... | Desmopressin Acetate | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:fullName | Desmopressin Acetate (Tablet) | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:adverseRe... | Infrequently, high doses of the intranasal formulations of desmopressin acetate and desmopressin acetate injection have produced transient headache, nausea, flushing and mild abdominal cramps. These symptoms have disappeared with reduction in dosage. Central Diabetes Insipidus: In long-term clinical studies in which patients with diabetes insipidus were followed for periods up to 44 months of desmopressin acetate tablet therapy, transient increases in AST (SGOT) no higher than 1.5 times the upper limit of normal were occasionally observed. Elevated AST (SGOT) returned to the normal range despite continued use of desmopressin acetate tablets. Primary Nocturnal Enuresis: The only adverse event occurring in���3% of patients in controlled clinical trials with desmopressin acetate tablets that was probably, possibly, or remotely related to study drug was headache (4% desmopressin acetate, 3% placebo). Other: The following adverse events have been reported; however their relationship to desmopressin acetate has not been established: abnormal thinking, diarrhea, and edema-weight gain. See WARNINGS for the possibility of water intoxication and hyponatremia. Post Marketing: There have been rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutinin and imipramine. | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:indicatio... | Central Diabetes Insipidus: Desmopressin acetate tablets are indicated as antidiuretic replacement therapy in the mangement of central 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. Patients were selected for therapy based on the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or response to antidiuretic hormone. Continued response to desmopressin acetate can be monitored by measuring urine volume and osmolality. Primary Nocturnal Enuresis: Desmopressin acetate tablets are indicated for the management of primary nocturnal enuresis may be used alone or as an adjunct to behavioral conditioning or other nonpharmacologic intervention. Renal Concentration Capacity Test in Pediatrics: Desmopressin acetate tablets are used to determine the capacity of the kidney to concentrate urine in pediatric patients. Safety and efficacy for use in adults with secondary nocturia has not been established. | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:represent... | http://www4.wiwiss.fu-berli... | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:routeOfAd... | http://www4.wiwiss.fu-berli... | lld:dailymed |
| dailymed-drugs:823 | dailymed-instance:name | Desmopressin Acetate | lld:dailymed |
| http://www4.wiwiss.fu-berli... | dailymed-instance:producesD... | dailymed-drugs:823 | lld:dailymed |