ARTG Entry
DESMOMED
ARTG entry for DESMOMED (desmopressin acetate), ARTG 447745 — Product Information, dosage form, registration history. Compiled by arcimedes.
- Sponsor: Medsurge Pharma
- Active ingredient: desmopressin acetate
- Therapeutic area: Endocrinology
What it is
DESMOMED is a nasal spray solution containing desmopressin acetate 10 micrograms per actuation. It contains desmopressin, a structural analogue of the natural pituitary hormone arginine vasopressin, also known as antidiuretic hormone (ADH).
Approved indications
— Treatment of ADH-sensitive cranial diabetes insipidus, including treatment of post-hypophysectomy polydipsia and polyuria. — Symptomatic treatment of primary nocturnal enuresis in patients who have normal ability to concentrate urine. — Diagnostic testing to establish renal concentrating capacity in adults and children.
Dosing overview
Dosage must be determined for each individual patient and adjusted according to the diurnal pattern of response. The daily dose is usually given as two divided doses. DESMOMED is for intranasal administration only.
Key safety warnings
Post-marketing data indicates the occurrence of severe hyponatraemia in association with the nasal spray formulation of desmopressin when it is used in the treatment of central diabetes insipidus. Hyponatraemia in the context of desmopressin use is generally due to fluid overload, thus careful attention to fluid balance is needed. Children, patients with cognitive impairment, and patients with inadequate thirst sensation need close monitoring of fluid intake; regular monitoring of serum and urinary sodium and osmolality is recommended at the clinician's discretion. When used for the treatment of primary nocturnal enuresis, fluid intake must be limited to a minimum from 1 hour before until 8 hours after administration, and serum electrolytes should be checked at least once if therapy is continued beyond 7 days. Intranasal administration may be ineffective and unreliable absorption may result in the presence of local infection or rhinorrhoea; in patients being treated for enuresis, treatment should cease until the nasal condition resolves. Desmopressin acetate should be used with caution in patients with cardiovascular disease and the elderly. DESMOMED should be used with caution in patients with cystic fibrosis because of impaired water handling and increased risk of hyponatraemia. Due to the presence of benzalkonium chloride, DESMOMED may cause bronchospasm.
Contraindications
— Habitual and 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 acetate or any of the excipients in DESMOMED.
PBS listing
DESMOMED nasal spray (pump pack) containing desmopressin acetate 10 micrograms per actuation, 50 actuations, 5 mL is listed on the PBS with streamlined restriction at an ex-manufacturer price of A$34.41.
Regulatory history
DESMOMED (desmopressin acetate 10 microgram per actuation nasal spray) was first listed on the ARTG on 27 August 2025 under licence category RE.