- Generic Name: desmopressin acetate tablets
- Brand Name: DDAVP
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(desmopressin acetate) Tablets
DDAVP® Tablets (desmopressin acetate) are 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•
1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.
DDAVP Tablets contain either 0.1 or 0.2 mg desmopressin acetate. Inactive
ingredients include: lactose, potato starch, magnesium stearate and povidone.
Central Diabetes Insipidus: DDAVP (desmopressin acetate tablets) Tablets are indicated as antidiuretic
replacement therapy in the management of central diabetes insipidus and for
the management of the temporary polyuria and polydipsia following head trauma
or surgery in the pituitary region. DDAVP (desmopressin acetate tablets) 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 DDAVP (desmopressin acetate tablets) can be monitored by measuring urine volume and osmolality.
Primary Nocturnal Enuresis: DDAVP (desmopressin acetate tablets) Tablets are indicated for the management
of primary nocturnal enuresis . DDAVP (desmopressin acetate tablets) may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention.
DOSAGE AND ADMINISTRATION
Central Diabetes Insipidus: The dosage of DDAVP (desmopressin acetate tablets) 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 DDAVP (desmopressin acetate tablets) 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 DDAVP (desmopressin acetate tablets) Tablet therapy to assure adequate antidiuretic response. Modifications
in dosage regimen should be implemented as necessary to assure adequate water
turnover. Fluid restriction should be observed. (See WARNINGS ,
PRECAUTIONS , Pediatric Use and Geriatric
Adults and Children: It is recommended that patients be started
on doses of 0.05 mg (1/2 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 antidiuresis. See Pediatric Use subsection for special
considerations when administering desmopressin acetate to pediatric diabetes
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.)
Primary Nocturnal Enuresis: The dosage of DDAVP (desmopressin acetate tablets) Tablets must
be determined for each individual patient and adjusted according to response.
Patients previously on intranasal DDAVP (desmopressin acetate tablets) therapy can begin tablet therapy the
night following (24 hours after) the last intranasal dose. The recommended initial
dose for patients 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 administration, until the next morning, or at least 8 hours after
administration. (See WARNINGS , PRECAUTIONS ,
Pediatric Use and Geriatric Use.)
|0.1 mg||Bottle of 100||0016-00||White|
|0.2 mg||Bottle of 100||0026-00||White|
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.
Manufactured for: sanofi-aventis U.S. LLC, Bridgewater, NJ 08807
USA. Rev. July 2007. FDA Rev date: 10/26/2007
Infrequently, large doses of the intranasal formulations of DDAVP (desmopressin acetate tablets) and DDAVP (desmopressin acetate tablets) 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 DDAVP (desmopressin acetate tablets)
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 DDAVP (desmopressin acetate tablets) Tablets.
Primary Nocturnal Enuresis: The only adverse event occurring in ≥ 3%
of patients in controlled clinical trials with DDAVP (desmopressin acetate tablets) Tablets that was
probably, possibly, or remotely related to study drug was headache (4% DDAVP (desmopressin acetate tablets) ,
Other: The following adverse events have been reported; however their
relationship to DDAVP (desmopressin acetate tablets) 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
Although the pressor activity of DDAVP (desmopressin acetate tablets) is very low compared to its antidiuretic
activity, large doses of DDAVP (desmopressin acetate tablets) Tablets should be used with other pressor
agents only with careful patient monitoring. The concomitant administration
of drugs that may increase the risk of water intoxication with hyponatremia,
(e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine,
opiate analgesics, NSAIDs, lamotrigine and carbamazepine) should be performed
- Very rare cases of hyponatremia have been reported from world-wide postmarketing
experience in patients treated with DDAVP (desmopressin acetate). DDAVP (desmopressin acetate tablets) 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.
- When DDAVP (desmopressin acetate tablets) Tablets are administered, 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 Geriatric Use.) All patients receiving DDAVP (desmopressin acetate tablets) therapy should be
observed for the following signs of 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.
- DDAVP (desmopressin acetate tablets) 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.
General: Intranasal formulations of DDAVP (desmopressin acetate tablets) at high doses and DDAVP (desmopressin acetate tablets) Injection
have infrequently produced a slight elevation of blood pressure which disappears
with a reduction of dosage. Although this effect has not been observed when
single oral doses up to 0.6 mg have been administered, the drug should be used
with caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease, because of a possible rise in blood pressure.
DDAVP (desmopressin acetate tablets) 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.
Rare severe allergic reactions have been reported with DDAVP (desmopressin acetate tablets) . Anaphylaxis has
been reported rarely with intravenous and intranasal administration of DDAVP (desmopressin acetate tablets)
but not with DDAVP (desmopressin acetate tablets) Tablets.
Laboratory Tests: Central Diabetes Insipidus: Laboratory tests
for monitoring the patient with central diabetes insipidus or post-surgical
or head trauma-related polyuria and polydipsia include urine volume and osmolality.
In some cases, measurements of plasma osmolality may be useful.
Carcinogenicity, Mutagenicity, Impairment of Fertility: Studies with
DDAVP (desmopressin acetate tablets) have not been performed to evaluate carcinogenic potential, mutagenic
potential or effects on fertility.
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 DDAVP (desmopressin acetate). There are, however,
no adequate and well-controlled studies in pregnant women. Because animal studies
are not always predictive of human response, this drug should be used during
pregnancy only if clearly needed.
Several publications where desmopressin acetate was used 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 possible therapeutic advantages against the possible risks in each case.
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 DDAVP (desmopressin acetate tablets) in breast milk following an intranasal
dose of 0.01 mg.
It is not known whether the drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when DDAVP (desmopressin acetate tablets) is administered to nursing mothers.
Pediatric Use: Central Diabetes Insipidus: DDAVP Tablets
(desmopressin acetate) have been used safely in pediatric patients, age 4 years
and older, with diabetes insipidus for periods up to 44 months. In younger pediatric
patients the dose must be individually adjusted in order to prevent an excessive
decrease in plasma osmolality leading to hyponatremia and possible convulsions;
dosing should start at 0.05 mg (1/2 of the 0.1 mg tablet). Use of DDAVP (desmopressin acetate tablets) Tablets
in pediatric patients requires careful fluid intake restrictions to prevent
possible hyponatremia and water intoxication. Fluid restriction should be discussed
with the patient and/or guardian. (See WARNINGS)
Primary Nocturnal Enuresis: DDAVP (desmopressin acetate tablets) Tablets have been safely used
in pediatric patients age 6 years and older with primary nocturnal enuresis
for up to 6 months. Some patients respond to a dose of 0.2 mg; however, increasing
responses are seen at doses of 0.4 mg and 0.6 mg. No increase in the frequency
or severity of adverse reactions or decrease in efficacy was seen with an increased
dose or duration. The dose should be individually adjusted to achieve the best
results. Treatment with desmopressin for primary nocturnal enuresis should be
interrupted during acute intercurrent illness characterized by fluid and/or
electrolyte imbalance (e.g., systemic infections, fever , recurrent vomiting
or diarrhea) or under conditions of extremely hot weather, vigorous exercise
or other conditions associated with increased water intake.
Geriatric Use: Clinical studies of DDAVP (desmopressin acetate tablets) Tablets 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 for an elderly patient 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
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. DDAVP (desmopressin acetate tablets) is contraindicated in patients with moderate to severe renal
impairment (defined as a creatinine clearance below 50ml/min). (See CLINICAL
PHARMACOLOGY , Human Pharmacokinetics and CONTRAINDICATIONS
Use of DDAVP (desmopressin acetate tablets) Tablets in geriatric patients requires careful fluid intake restrictions
to prevent possible hyponatremia and water intoxication. Fluid restriction should
be discussed with the patient. (See WARNINGS.)
Signs of overdose may include confusion, drowsiness, continuing headache, problems
with passing urine and rapid weight gain due to fluid retention. (See WARNINGS .)
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 DDAVP (desmopressin acetate tablets) . The patient should be observed
and treated with appropriate symptomatic therapy.
An oral LD50 has 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.
DDAVP (desmopressin acetate tablets) Tablets are contraindicated in individuals with known hypersensitivity
to desmopressin acetate or to any of the components of DDAVP (desmopressin acetate tablets) Tablets.
DDAVP (desmopressin acetate tablets) is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min).
DDAVP (desmopressin acetate tablets) is contraindicated in patients with hyponatremia or a history of hyponatremia.
DDAVP (desmopressin acetate tablets) Tablets contain as active substance , desmopressin acetate , a synthetic analogue of the natural hormone arginine vasopressin .
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 DDAVP (desmopressin acetate).
The plasma half-life of DDAVP (desmopressin acetate tablets) followed a monoexponential time course with t1/2
values of 1.5 to 2.5 hours which was independent of dose.
The bioavailability of DDAVP (desmopressin acetate tablets) oral tablets is about 5% compared to intranasal
DDAVP (desmopressin acetate tablets) , and about 0.16% compared to intravenous DDAVP (desmopressin acetate tablets) . The time to reach maximum
plasma DDAVP (desmopressin acetate tablets) levels ranged from 0.9 to 1.5 hours following oral or intranasal
administration, respectively. Following administration of DDAVP (desmopressin acetate tablets) 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 DDAVP (desmopressin acetate tablets) 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 DDAVP (desmopressin acetate tablets) (DDAVP (desmopressin acetate tablets) Nasal Spray and DDAVP (desmopressin acetate tablets) 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, but may be due
to a local inactivation of the peptide. No lessening of effect was observed
in the 46 patients who were treated with DDAVP (desmopressin acetate tablets) 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 DDAVP (desmopressin acetate tablets) Tablets,
no increases in blood pressure in 46 patients receiving DDAVP (desmopressin acetate tablets) Tablets
for periods of 12 to 44 months were reported.
In one study, the pharmacodynamic characteristics of DDAVP (desmopressin acetate tablets) 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:
Mean Changes from Baseline (SE) in Pharmacodynamic Parameters
in Normal Healthy Adult Volunteers
|Treatment|| Total Urine Volume |
|Maximum Urine Osmolality in mOsm/kg|
|0.1 mg PO q8h||-3689.3 (149.6)||514.8 (21.9)|
|0.2 mg PO q8h||-4429.9 (149.6)||686.3 (21.9)|
|0.4 mg PO q8h||-4998.8 (149.6)||769.3 (21.9)|
|0.01 mg IN q8h||-4844.9 (149.6)||754.1 (21.9)|
|(SE) = Standard error of the mean|
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 DDAVP (desmopressin acetate tablets) 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.
Mean Peak Pharmacodynamic Parameters (SD) in Pediatric and
Adolescent Diabetes Insipidus Patients
|Treatment||Urine Volume in mL/min||Maximum Urine Osmolality in mOsm/kg|
|0.01 mg IN||0.3 (0.15)||717.0 (224.63)|
|0.02 mg IN||0.3 (0.25)||761.8 (298.82)|
|0.2 mg PO||0.3 (0.12)||678.3 (147.91)|
|0.4 mg PO||0.2 (0.15)||787.2 (73.34)|
|(SD) = Standard Deviation|
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
DDAVP (desmopressin acetate tablets) intranasal spray, after one week of self-titration from spray to tablets,
patients’ diuresis was controlled with 0.1 mg DDAVP (desmopressin acetate tablets) Tablets three times
Primary Nocturnal Enuresis: 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 DDAVP (desmopressin acetate tablets) or placebo. The pooled results after
two weeks are shown in the following table:
Response to DDAVP (desmopressin acetate tablets) and Placebo at Two Weeks of Treatment Mean
(SE) Number of Wet Nights/2 Weeks
| Placebo |
(n = 85)
| 0.2 mg/day|
(n = 79)
| 0.4 mg/day|
(n = 82)
| 0.6 mg/day|
(n = 83)
|Baseline||10 (0.3)||11 (0.3)||10 (0.3)||10 (0.3)|
|Reduction from Baseline||1 (0.3)||3 (0.4)||3 (0.4)||4 (0.4)|
|Percent Reduction from Baseline||10%||27%||30%||40%|
|p-value vs placebo||—-||<0.05||<0.05||<0.05|
Patients treated with DDAVP (desmopressin acetate tablets) 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 DDAVP (desmopressin acetate tablets) , 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.
Human Pharmacokinetics: DDAVP (desmopressin acetate tablets) 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 (2mcg) injection demonstrated a difference in DDAVP (desmopressin acetate tablets) 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 .)
No information provided. Please refer to the WARNINGS
and PRECAUTIONS sections.
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DDAVP Drug Imprint
oval, white, imprinted with 0 1, 36 AV
round, white, imprinted with AV 37, 0.2
oval, white, imprinted with WPI, 22 25
oval, white, imprinted with WPI, 22/26
round, white, imprinted with APO, DES 0.1
oval, white, imprinted with 232 0.1, barr
oblong, white, imprinted with 9 3, 7316
round, white, imprinted with APO, DES 0.2
oval, white, imprinted with 232 0.2, barr
round, white, imprinted with 9 3, 7317
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