Ddavp
.1 mg · Tablet
- Prescription only
- Factor VIII Activator
- Active substance
- Desmopressin Acetate
- Made by
- Ferring Pharmaceuticals Inc.
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2021-02-03
Factor VIII Activator
- Central Diabetes Insipidus DDAVP Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia…
Adults and Children It is recommended that patients be started on doses of 0.05 mg (½ of the 0.1 mg tablet) two times a day and individually adjusted to their optimum therapeutic dose.
Full directions ↓DDAVP Tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of DDAVP Tablets.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- Central Diabetes Insipidus DDAVP 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 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 can be monitored by measuring urine volume and osmolality.
- Primary Nocturnal Enuresis DDAVP Tablets are indicated for the management of primary nocturnal enuresis.
- DDAVP may be used alone or as an adjunct to behavioral conditioning or other non-pharmacologic intervention.
From the official label · 2021-02-03 · DailyMed
How it works
From this product’s own US prescribing label.
DDAVP 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.
Human Pharmacokinetics DDAVP is mainly excreted in the urine.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2021-02-03
Do not take it if
- DDAVP Tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of DDAVP Tablets.
- DDAVP is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min).
- DDAVP is contraindicated in patients with hyponatremia or a history of hyponatremia.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
- Central Diabetes Insipidus The dosage of DDAVP 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 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 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 (½ 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 Tablets must be determined for each individual patient and adjusted according to response.
- Patients previously on intranasal DDAVP 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 acetate administration, until the next morning, or at least 8 hours after administration.
- (See WARNINGS , PRECAUTIONS, Pediatric Use and Geriatric Use .)
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- 1.
- Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with DDAVP (desmopressin acetate).
- DDAVP 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 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 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 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 at high doses and DDAVP 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 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.
- Anaphylaxis has been reported rarely with intravenous and intranasal administration of DDAVP but not with DDAVP 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.
- Drug Interactions Although the pressor activity of DDAVP is very low compared to its antidiuretic activity, large doses of DDAVP Tablets should be used with other pressor agents only with careful patient monitoring.
- Carcinogenicity, Mutagenicity, Impairment of Fertility Studies with DDAVP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
- Pregnancy Category B Fertility studies have not been done.
- Nursing Mothers There have been no controlled studies in 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.
- Geriatric Use Clinical studies of DDAVP Tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
- (See WARNINGS .)
- General Intranasal formulations of DDAVP at high doses and DDAVP 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 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.
- Anaphylaxis has been reported rarely with intravenous and intranasal administration of DDAVP but not with DDAVP Tablets.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- 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 2 ) 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.
- 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 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 is administered to nursing mothers.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
Other medicines
- Although the pressor activity of DDAVP is very low compared to its antidiuretic activity, large doses of DDAVP 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.
Quoted from the official label, section “Drug Interactions”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
- 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.
- The patient should be observed and treated with appropriate symptomatic therapy.
- An oral LD 50 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.
Quoted from the official label, section “Overdosage”.
Use in children
- 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 (½ of the 0.1 mg tablet).
- Use of DDAVP 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 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.
Quoted from the official label, section “Pediatric Use”.
Use in older people
- Clinical studies of DDAVP 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 is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min).
- (See CLINICAL PHARMACOLOGY, Human Pharmacokinetics and CONTRAINDICATIONS .) Use of DDAVP 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 .)
Quoted from the official label, section “Geriatric Use”.
Side effects
- Infrequently, large doses of the intranasal formulations of DDAVP and DDAVP 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 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 Tablets .
- Primary Nocturnal Enuresis The only adverse event occurring in ≥3% of patients in controlled clinical trials with DDAVP Tablets that was probably, possibly, or remotely related to study drug was headache (4% DDAVP, 3% placebo).
- Other The following adverse events have been reported; however their relationship to DDAVP 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.
Quoted from the official label, section “Adverse Reactions”.
What it looks like and how it is packed
- Strength Size NDC Code Color Markings 0.1 mg Bottle of 100 55566-2600-0 White 0.2 mg Bottle of 100 55566-2700-0 White Figure Figure
- 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.
Quoted from the official label, section “How Supplied”.
How to store it
- 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.
Quoted from the official label, section “Storage and Handling”.
What is in it
- 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:
- C 46 H 64 N 14 O 12 S 2 ∙C 2 H 4 O 2 ∙3H 2 O 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.
- Chemical Structure
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
- Lactose
: lactose
Milk sugar: matters with lactose intolerance or a milk allergy.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (10)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 10 of 10
- DdavpThis onePrescription onlyFerring Pharmaceuticals Inc.Lactose
- Desmopressin AcetatePrescription onlyAmerican Health PackagingLactose
- Desmopressin AcetatePrescription onlyApotex Corp.No ingredient list on the stored label
- Desmopressin AcetatePrescription onlyAurobindo Pharma LimitedLactose
- Desmopressin AcetatePrescription onlyBluePoint LaboratoriesLactose
- Desmopressin AcetatePrescription onlyGlenmark Pharmaceuticals Inc.,USALactose
- Desmopressin AcetatePrescription onlyHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.Lactose
- Desmopressin AcetatePrescription onlyKVK-TECH, INC.Lactose
- Desmopressin AcetatePrescription onlyNordic Pharma, Inc.Lactose
- Desmopressin AcetatePrescription onlyREMEDYREPACK INC.Lactose
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
Details
| Made by | Ferring Pharmaceuticals Inc. |
|---|---|
| Active substance | Desmopressin Acetate |
| Used in | Hormones, such as thyroid and steroids |
| Strength | .1 mg |
| Form | Tablet |
| Route | Oral |
| Packs | 1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE |
| NDC | 55566-2600 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
3 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.