Desmopressin ADVZ

MIMS Revision Date: 01 May 2026

1 Name of Medicine

Desmopressin acetate.

2 Qualitative and Quantitative Composition

Desmopressin ADVZ 120 mcg. Each 120 mcg sublingual tablet, contains the active substance, desmopressin, (present as acetate), a synthetic structural analogue of the natural pituitary hormone arginine vasopressin. The difference lies in the desamination of cysteine and substitution of L-arginine by D-arginine.
Desmopressin ADVZ 240 mcg. Each 240 mcg sublingual tablet, contains the active substance, desmopressin, (present as acetate), a synthetic structural analogue of the natural pituitary hormone arginine vasopressin. The difference lies in the desamination of cysteine and substitution of L-arginine by D-arginine.
Excipients with known effect. Contains lactose.
For full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

120 mcg sublingual tablets. White or almost white, octagonal, biconvex tablet debossed with 'II' on one side and plain on other side.
240 mcg sublingual tablets. White or almost white, square, biconvex tablet debossed with 'III' on one side and plain on other side.

4 Clinical Particulars

4.1 Therapeutic Indications

Desmopressin ADVZ is indicated for the treatment of:
cranial diabetes insipidus;
primary nocturnal enuresis in patients from 6 years of age with normal ability to concentrate urine, who are refractory to an enuresis alarm or in whom an enuresis alarm is contraindicated or inappropriate.

4.2 Dose and Method of Administration

Desmopressin ADVZ is placed under the tongue where it dissolves without the need for water.
If adequate clinical effect is not achieved within 4 weeks following appropriate dose titration the medication should be discontinued.
Food intake may reduce the intensity and duration of the antidiuretic effect at low oral doses of Desmopressin ADVZ sublingual tablets (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Cranial diabetes insipidus. Dosage is individual in diabetes insipidus but the total daily sublingual dose normally lies in the range of 120 microgram to 720 microgram. A suitable starting dose in adults and children is 60 microgram three times daily, administered sublingually. This dosage regimen should then be adjusted in accordance with the patient's response. For the majority of patients, the maintenance dose is 60 microgram to 120 microgram sublingually three times daily.
60 microgram strength sublingual tablets are unavailable in this brand, however this strength is available in other brands. Where correct dosing requires this strength, refer to the specific product information for these formulations for complete dosage and administration instructions.
In the event of signs of water retention/hyponatraemia, treatment should be interrupted and the dose should be adjusted (see Section 4.4 Special Warnings and Precautions for Use).
Primary nocturnal enuresis. The recommended initial dose is 120 microgram at bedtime, administered sublingually. If this dose is not sufficiently effective, the dose may be increased up to 240 microgram sublingually. Fluid intake must be limited to a minimum from 1 hour before until 8 hours after administration.
In the event of signs or symptoms of water retention and/or hyponatraemia (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions) treatment should be interrupted until the patient has fully recovered. When restarting treatment strict fluid restriction should be enforced (see Section 4.4 Special Warnings and Precautions for Use).
Desmopressin ADVZ is intended for treatment periods of up to 3 months. The need for continued treatment should be reassessed by means of a period of at least one week without Desmopressin ADVZ.

4.3 Contraindications

Desmopressin ADVZ is contraindicated in:
Habitual or psychogenic polydipsia (resulting in a urine production exceeding 40 mL/kg/24 hours);
A history of known or suspected cardiac insufficiency and other conditions requiring treatment with diuretics;
Moderate and severe renal insufficiency (creatinine clearance below 50 mL/min);
Known hyponatraemia;
Syndrome of inappropriate anti-diuretic hormone secretion (SIADH);
Hypersensitivity to desmopressin or to any of the excipients of Desmopressin ADVZ.

4.4 Special Warnings and Precautions for Use

When used for primary nocturnal enuresis, the fluid intake must be limited to a minimum from 1 hour before administration, until the next morning (at least 8 hours) after administration. Treatment without concomitant reduction of fluid intake may lead to water retention and/or hyponatraemia with or without accompanying warning signs and symptoms (headache, nausea/vomiting, weight gain, and, in severe cases, convulsions). In the event of signs or symptoms of water retention and/or hyponatraemia, treatment should be interrupted until the patient has fully recovered. When restarting treatment, strict fluid restriction should be enforced. All patients and, when applicable, their guardians, should be carefully instructed to adhere to the fluid restrictions.
In the event of signs or symptoms of water retention/hyponatraemia in cranial diabetes insipidus patients, treatment should be interrupted and the dose should be adjusted.
Severe bladder dysfunction and outlet obstruction should be considered before starting treatment.
Caution should be exercised in patients with other causes of urinary frequency (e.g. multiple sclerosis or urge incontinence), and in diabetes mellitus and renal impairment, since the use of desmopressin has not been well studied in these populations.
Elderly patients and patients with low serum sodium levels may have an increased risk of hyponatraemia (see Section 4.4 Special Warnings and Precautions for Use, Use in the elderly).
Precautions to avoid hyponatraemia must be taken in:
conditions characterised by fluid and/or electrolyte imbalances (such as systemic infections, fever, gastroenteritis and syndrome of inappropriate ADH secretion (SIADH)) (see Section 4.3 Contraindications);
conditions requiring concomitant treatment with diuretic agents;
concomitant treatment with drugs known to induce SIADH (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions) including careful attention to fluid restrictions and more frequent monitoring of serum sodium;
concomitant treatment with NSAIDs (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Treatment with desmopressin should be interrupted during acute intercurrent illnesses characterised by fluid and/or electrolyte imbalance (such as systemic infections, fever, gastroenteritis).
Precautions must be taken in patients at risk of increased intracranial pressure.
For each approved indication the lowest effective dose should be used. Patient dosage should be reassessed periodically.
Desmopressin ADVZ should not be administered to dehydrated or overhydrated patients until water balance has been adequately restored.
Desmopressin ADVZ should be used with caution in patients with cystic fibrosis because of impaired water handling and increased risk of hyponatraemia.
Use in the elderly. The initiation of treatment in patients over 65 years of age is not recommended. Should physicians decide to initiate desmopressin treatment in these patients then serum sodium should be measured before beginning the treatment and 3 days after initiation or dosage increase, and at other times during treatment as deemed necessary by the treating physician.
Paediatric use. Dose recommendations are the same as in adults. Children should be closely observed to avoid over ingestion of fluid and to ensure that only the recommended dose of Desmopressin ADVZ is taken.
Effects on laboratory tests. No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

NSAIDs may induce water retention/hyponatraemia (see Section 4.4 Special Warnings and Precautions for Use).
Substances which are known to induce SIADH, e.g. tricyclic antidepressants, selective serotonin reuptake inhibitors, chlorpromazine and carbamazepine as well as some antidiabetics of the sulfonylurea group particularly chlorpropamide, may cause an additive antidiuretic effect leading to an increased risk of water retention/hyponatraemia.
Concomitant treatment with loperamide may result in a 3-fold increase of desmopressin plasma concentrations, which may lead to an increased risk of water retention/hyponatraemia. Although not investigated, other drugs slowing intestinal transport might have the same effect.
It is unlikely that desmopressin will interact with drugs affecting hepatic metabolism, since desmopressin has been shown not to undergo significant liver metabolism in in vitro studies with human microsomes. However, formal in vivo interaction studies have not been performed.
A standardised 27% fat meal significantly decreased absorption (rate and extent) of desmopressin sublingual tablets. No significant effect was observed with respect to pharmacodynamics (urine production or osmolality). Food intake may reduce the intensity and duration of the antidiuretic effect at low oral doses of desmopressin sublingual tablets.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. Fertility studies have not been done. In vitro analysis of human cotyledon models have shown that there is no transplacental transport of desmopressin when administered at therapeutic concentration corresponding to recommended dose.
Use in pregnancy. (Category B2)
Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus as well as data on a limited number (n=54) of exposed pregnancies in women with von Willebrand disease indicate no adverse effects of desmopressin on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available.
However, these findings are based on case report data and should be interpreted with caution. No reproduction study has been conducted in animals using oral administration. Studies performed in rats and rabbits with cutaneous doses up to 50 nanogram/kg/day and 10 microgram/kg/day, respectively, revealed no evidence for a harmful effect on the foetus.
Caution should be exercised when prescribing to pregnant women.
Use in lactation. No study has been conducted in animals to examine the effects of desmopressin on postnatal development.
There have been no controlled studies in nursing mothers. In a single dose study in 6 lactating women administered 300 microgram desmopressin intranasally, the concentration of desmopressin was less in breast milk than in plasma. However, until further evidence is available for its safe use during lactation, desmopressin should not be used in breast feeding mothers.

4.7 Effects on Ability to Drive and Use Machines

Desmopressin ADVZ has no or negligible influence on the ability to drive and use machines.

4.8 Adverse Effects (Undesirable Effects)

Treatment with and without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with or without accompanying warning signs and symptoms (headache, nausea/vomiting, decreased serum sodium, weight gain, and in severe cases, convulsions). The risk appears to be dose-related and the elderly (> 60 years) are at increased risk.
The most serious adverse reaction with desmopressin is hyponatraemia, which may cause headache, abdominal pain, nausea, vomiting, weight increase, dizziness, confusion, malaise, memory impairment, vertigo, falls and in severe cases convulsions and coma. The cause of the potential hyponatraemia is the anticipated antidiuretic effect. The hyponatraemia is reversible and in children it is often seen to occur in relation to changes in daily routines affecting fluid intake and/or perspiration. In both adults and children special attention should be paid to the precautions addressed in Section 4.4 Special Warnings and Precautions for Use.
Clinical trials. Cranial diabetes insipidus. During clinical trials with desmopressin in diabetes insipidus the following adverse events have been reported more than once: headache, cold, weight gain, dizziness, sore throat, and depressed mood.
Primary nocturnal enuresis. Based on the frequency of adverse drug reactions reported in clinical trials with oral desmopressin conducted in children and adolescents for treatment of primary nocturnal enuresis (N = 1923), the following adverse events have been listed in Table 1.

Post marketing experience. Table 2 lists additional adverse drug reactions reported in the post marketing period in children, adolescents and adults treated with oral desmopressin, distributed by organ class. The frequency of adverse drug reactions occurring in the post marketing period is regarded as unknown.
Reporting suspected adverse effects. Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Overdose of desmopressin leads to a prolonged duration of action with an increased risk of water retention and hyponatraemia.
Treatment. Although the treatment of hyponatraemia should be individualised, the following general recommendations can be given: discontinue the desmopressin treatment, fluid restriction, and symptomatic treatment if needed.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Pharmacotherapeutic group: vasopressin and analogues.
Compared to vasopressin, desmopressin has a considerably longer duration of action and a complete lack of pressor effect in the dosages clinically used.
Clinical trials. Results of a bioequivalence study comparing desmopressin 240 microgram administered sublingually versus a 400 microgram dose desmopressin tablet administered orally are summarized in Table 3.

The relative bioavailability of the oral lyophilisate versus Desmopressin tablet, based on dose adjusted values, was estimated to be 1.57 for both AUC and AUC_t and 1.23 for C_max.

5.2 Pharmacokinetic Properties

Absorption. The overall mean systemic bioavailability of desmopressin administered sublingually as desmopressin at doses of 200, 400 and 800 microgram is 0.25%. The C_max was 14, 30 and 65 picogram/mL after administration of 200, 400 and 800 microgram, respectively. T_max was observed at 0.5 - 2.0 hours after dosing. The geometric mean terminal half-life is 2.8 (CV = 24%) hours.
Concomitant intake of food decreases the rate and extent of absorption by 40%.
Distribution. The distribution volume of desmopressin after intravenous administration is 33 L (0.41 L/kg). Desmopressin does not cross the blood-brain barrier. Desmopressin exhibits a moderate to high variability in bioavailability, both within and between subjects.
Metabolism. In in vitro studies in human liver microsome preparations, it has been shown that no significant amount of desmopressin is metabolised in the liver, and thus human liver metabolism in vivo is not likely to occur.
Elimination. After iv injection 45% of the amount of desmopressin could be recovered in the urine within 24 hours.

5.3 Preclinical Safety Data

Genotoxicity. The genotoxic potential of desmopressin has not been adequately investigated, although in vitro studies in bacterial and mammalian cells revealed no mutagenicity of the drug.
Carcinogenicity. The carcinogenic potential of desmopressin has not been investigated in pre-clinical studies.

6 Pharmaceutical Particulars

6.1 List of Excipients

The sublingual tablet also contain the following inactive ingredients: lactose monohydrate, maize starch, citric acid, croscarmellose sodium, magnesium stearate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Keep in original container to protect from moisture and light.

6.5 Nature and Contents of Container

Desmopressin ADVZ is available in cartons of 30 each containing 3 Aluminium/Aluminium blister trays of 10 sublingual tablets. Not all strengths/pack sizes are being distributed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Synonyms of desmopressin: DDAVP.
1-desamino-8-D-Arginine vasopressin. Desamino-cys-1-D-Arginine-8 vasopressin.
CAS number. Desmopressin base. 16679-58-6.
Desmopressin acetate. 62288-83-9.
Molecular weights: Desmopressin base - 1069.22.
Desmopressin acetate - 1183.34.

7 Medicine Schedule (Poisons Standard)

Prescription Only Medicine (S4).

Date of First Approval

25 July 2025