Drugs Details

Drugs Info of DDAVP
Drugs Details
  • Drugs Type  : Multum
  • Date : 13th Jan 2015 11:10 pm
  • Brand Name : DDAVP
  • Generic Name : desmopressin (oral) (Pronunciation: DEZ mo press in)
Descriptions

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• 3H2O

DDAVP (desmopressin acetate) strcutural formula illustration

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.

What are the possible side effects of desmopressin (DDAVP)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking desmopressin and call your doctor at once if you have any of these serious side effects:

  • nausea, vomiting, weakness, loss of appetite, headache, feeling restless or irritable, confusion, hallucinations, muscle pain or weakness, and/or seizure;
  • feeling like you might pass out;
  • swelling, weight gain; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing...

Read All Potential Side Effects and See Pictures of DDAVP »

What are the precautions when taking desmopressin acetate tablets (DDAVP)?

Before taking desmopressin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, a low level of sodium in the blood (current or past hyponatremia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart disease (such as blocked blood vessels in the heart), conditions that may increase your risk of fluid/mineral imbalance (such as cystic fibrosis, heart...

Read All Potential Precautions of DDAVP »


This monograph has been modified to include the generic and brand name in many instances.

Indications

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 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 Use.)

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 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. (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.)

How Supplied

Strength Size NDC 0075- Color Markings
0.1 mg Bottle of 100 0016-00 White Markings - illustration 1
0.2 mg Bottle of 100 0026-00 White Markings - illustration 2

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


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

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) , 3% placebo).

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 imipramine.

Read the DDAVP (desmopressin acetate tablets) Side Effects Center for a complete guide to possible side effects

Interactions

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 with caution.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

  1. 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.
  2. 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.
  3. 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.

Precautions

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 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. 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.)


This monograph has been modified to include the generic and brand name in many instances.

OverDose

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.

ContrainDications

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.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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
in mL
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 a day.

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.)


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

DESMOPRESSIN - ORAL

 

(DES-moe-PRES-in)

 

COMMON BRAND NAME(S): DDAVP

 

USES: Desmopressin is used to control the amount of urine your kidneys make. Normally, the amount of urine you make is controlled by a certain substance in the body called vasopressin. In people who have "water diabetes" (diabetes insipidus) or certain kinds of head injury or brain surgery, the body does not make enough vasopressin. Desmopressin is a man-made form of vasopressin and is used to replace a low level of vasopressin. This medication helps to control increased thirst and too much urination due to these conditions, and helps prevent dehydration.

Desmopressin is also used to control nighttime bedwetting in children. It reduces how often your child urinates and decreases the number of bedwetting episodes.

 

HOW TO USE: For the treatment of diabetes insipidus, take this medication by mouth, usually 2 to 3 times a day or as directed by your doctor.

For the treatment of bedwetting, take this medication by mouth, usually once a day at bedtime. Children should limit the fluids they drink after dinner, especially 1 hour before the desmopressin dose until the next morning, or at least 8 hours after the dose. If your child wakes up during the night, limit the amount that he or she drinks.

All patients taking desmopressin, especially children and older adults, must limit drinking of water and other fluids. Consult your doctor for details. If you find that you are drinking more fluids than directed, tell your doctor immediately. Your treatment will need to be adjusted. (See also Side Effects and Precautions sections.)

Dosage is based on your medical condition and response to treatment. Do not take more desmopressin or take it more often than prescribed.

Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.

Tell your doctor if your condition does not improve or if this medication stops working well.

Consumer Overview Side Effect

SIDE EFFECTS: Headache, nausea, upset stomach, or flushing of the face may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Desmopressin can infrequently cause a low level of sodium in the blood, which can be serious and possibly life-threatening. Drinking too much water or other fluids increases the risk of having a low level of sodium in the blood. Therefore, follow your doctor's directions for limiting fluids. Seek immediate medical attention if you have any of these unlikely but serious symptoms of a low level of sodium in the blood: loss of appetite, severe nausea, vomiting, severe headache, muscle weakness/spasms/cramps, sudden weight gain, unusual tiredness, unusual severe drowsiness, mental/mood changes (such as confusion, hallucinations, irritability), loss of consciousness, seizures, slow/shallow breathing.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the DDAVP (desmopressin acetate tablets) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking desmopressin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, a low level of sodium in the blood (current or past hyponatremia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart disease (such as blocked blood vessels in the heart), conditions that may increase your risk of fluid/mineral imbalance (such as cystic fibrosis, heart failure), the urge to drink too much water without being thirsty, bleeding/clotting problems.

If you have lost too much body water (become dehydrated), your doctor will correct that condition first before starting treatment with desmopressin.

Limit alcohol because it can interfere with how well desmopressin works.

Tell the doctor immediately if you develop any illness that can cause water/mineral imbalance (including fever, diarrhea, vomiting, infections such as the flu) or if you experience conditions that require drinking more fluids (for example, exposure to very hot weather, strenuous exercise, persistent sweating). The doctor may need to stop or adjust desmopressin treatment, especially in children and older adults.

Children may be more sensitive to the side effects of this drug, especially water/mineral imbalance and a low level of sodium in the blood.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be at greater risk for water/mineral imbalance and a low level of sodium in the blood while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Other medications besides desmopressin may also affect the balance of water and sodium in your body. Therefore, tell your doctor or pharmacist about all the products you take, including: narcotic pain relievers (such as morphine), nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, naproxen), psychiatric medicines (such as chlorpromazine), drugs to treat seizures (such as carbamazepine), SSRI antidepressants (such as sertraline), tolvaptan, tricyclic antidepressants (such as amitriptyline), "water pills" (diuretics such as furosemide).

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, drowsiness, persistent/severe headache, sudden weight gain.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as urine tests, sodium blood level) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you take 1 dose daily and miss a dose, take it as soon as you remember. If you do not remember until the next day, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

If you take more than 1 dose daily and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: DDAVP

Generic Name: desmopressin (oral) (Pronunciation: DEZ mo press in)

  • What is desmopressin (DDAVP)?
  • What are the possible side effects of desmopressin (DDAVP)?
  • What is the most important information I should know about oral desmopressin (DDAVP)?
  • What should I discuss with my healthcare provider before taking oral desmopressin (DDAVP)?
  • How should I take desmopressin (DDAVP)?
  • What happens if I miss a dose (DDAVP)?
  • What happens if I overdose (DDAVP)?
  • What should I avoid while taking desmopressin (DDAVP)?
  • What other drugs will affect desmopressin (DDAVP)?
  • Where can I get more information?

What is desmopressin (DDAVP)?

Desmopressin is a man-made form of a hormone that occurs naturally in the pituitary gland. This hormone is important for many functions including blood flow, blood pressure, kidney function, and regulating how the body uses water.

Desmopressin is used to treat bed-wetting, central cranial diabetes insipidus, and increased thirst and urination caused by head surgery or head trauma.

Desmopressin may also be used for other purposes not listed in this medication guide.

DDAVP 0.1 mg

oval, white, imprinted with RPR, DDAVP 01

What are the possible side effects of desmopressin (DDAVP)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking desmopressin and call your doctor at once if you have any of these serious side effects:

  • nausea, vomiting, weakness, loss of appetite, headache, feeling restless or irritable, confusion, hallucinations, muscle pain or weakness, and/or seizure;
  • feeling like you might pass out;
  • swelling, weight gain; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • headache;
  • nausea, mild stomach pain;
  • diarrhea; or
  • warmth, redness, or tingly feeling in your face.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the DDAVP (desmopressin acetate tablets) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about oral desmopressin (DDAVP)?

It is very important to reduce your intake of water and other fluids while you are taking desmopressin. Drinking too much water can cause your body to lose sodium, which may lead to a serious, life-threatening electrolyte imbalance.

Fluid restriction is especially important in children and older adults taking desmopressin. Follow your doctor's instructions about the type and amount of liquids you should drink.

You should not use this medication if you have severe kidney disease or if you have ever had hyponatremia (low sodium levels in your body).

Before taking desmopressin, tell your doctor if you have heart disease, coronary artery disease, congestive heart failure, kidney disease, cystic fibrosis, high or low blood pressure, an electrolyte imbalance, or a psychological disorder that causes extreme or unusual thirst.

To be sure desmopressin is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with this medication. Do not miss any scheduled appointments.

Side Effects Centers
  • DDAVP

Patient Detailed How Take

What should I discuss with my healthcare provider before taking oral desmopressin (DDAVP)?

You should not take this medication if you are allergic to desmopressin, or if you have:

  • severe kidney disease; or
  • if you have ever had hyponatremia (low sodium levels in your body).

Before taking desmopressin, tell your doctor if you are allergic to any medications, or if you have:

  • heart disease, coronary artery disease;
  • congestive heart failure;
  • kidney disease;
  • cystic fibrosis;
  • high or low blood pressure;
  • an electrolyte imbalance; or
  • a psychologic disorder that causes extreme or unusual thirst.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take desmopressin.

FDA pregnancy category B. This medication is not expected to harm an unborn baby. Do not use desmopressin without telling your doctor if you are pregnant.

It is not known whether desmopressin passes into breast milk, or if it could harm a nursing baby. Do not use desmopressin without telling your doctor if you are breast-feeding a baby.

How should I take desmopressin (DDAVP)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

It is very important to reduce your intake of water and other fluids while you are taking desmopressin. Drinking too much water can cause your body to lose sodium, which may lead to a serious, life-threatening electrolyte imbalance.

Fluid restriction is especially important in children and older adults taking desmopressin. Follow your doctor's instructions about the type and amount of liquids you should drink.

If you are switching from desmopressin nasal spray to desmopressin tablets, wait at least 24 hours after your last nasal dose before you take your first tablet.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with desmopressin. Do not miss any scheduled appointments.

Store the tablets at room temperature away from moisture, light, and heat.

Side Effects Centers
  • DDAVP

Patient Detailed Avoid Taking

What happens if I miss a dose (DDAVP)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (DDAVP)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include headache, confusion, drowsiness, rapid weight gain, or urination problems.

What should I avoid while taking desmopressin (DDAVP)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are taking desmopressin.

What other drugs will affect desmopressin (DDAVP)?

Many drugs can interact with desmopressin. Below is just a partial list. Tell your doctor if you are using:

  • carbamazepine (Carbatrol, Tegretol);
  • chlorpromazine (Thorazine);
  • lamotrigine (Lamictal);
  • oxybutynin (Ditropan, Urotrol, Oxytrol);
  • vasopressin (Pitressin);
  • a narcotic pain medicine such as fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin), oxycodone (Oxycontin), and others;
  • an "SSRI" antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft);
  • a tricyclic antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), and others;
  • medicine to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);
  • drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax);
  • a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta, Ziac), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), or timolol (Blocadren); or
  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), and others.

This list is not complete and there may be other drugs that can interact with desmopressin. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about desmopressin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 1.10. Revision date: 12/15/2010.

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