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DDAVP MELT is a brand name for Desmopressin, supplied as a tablet (orally disintegrating). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Hypersensitivity to desmopressin or any of the tablet constituents. Patients with type IIB or platelet-type (pseudo) Willerbrand disease, because of the risk of platelet aggregation and thrombocytopenia Any condition associated with impaired water excretion, such as: Hyponatremia Severe liver disease Nephrosis Cardiac insufficiency Chronic renal insufficiency Congestive heart failure Habitual or psychogenic polydypsia Any medical conditions which lead to sodium losing states such as: Vomiting Diarrhoea Bulimia Anorexia nervosa Adrenocortical insufficiency Salt losing nephropathies WARNINGS AND PRECAUTIONS General In general, by adequate treatment with DDAVP MELT, thirst is automatically reduced.
However, there is potential risk of water intoxication if, during treatment, excessive liquid is consumed. Fluid intake should be adjusted to reduce the possibility of water intoxication and hyponatremia especially in the very young and elderly patients (See DOSAGE AND ADMINISTRATION).
Particular attention should be paid to the risk of extreme decrease in plasma osmolality and resulting seizures in young children. Treatment with desmopressin should be interrupted during acute inter-current illnesses characterised by fluid and/or electrolyte imbalance (such as systemic infections, fever, and gastroenteritis).
In patients with Syndrome of Inappropriate Antidiuretic Hormone secretion (SIADH) or with high intra-cranial pressure, it is necessary that extra care be exercised with liquid intake. Desmopressin should not be administered to dehydrated patients until water balance has been adequately restored.
DDAVP® MELT TABLETS (60μg, 120μg, 240μg) Page 5 of 34 Template Date:
January 2010 Desmopressin is not effective in controlling polyuria caused by renal disease, nephrogenic diabetes insipidus, psychogenic diabetes insipidus, hypokalemia or hypercalcemia. Cardiovascular Desmopressin acetate can occasionally produce a slight elevation of blood pressure, which disappears with a reduction in dosage.
The drug should be used with caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease because of possible tachycardia and changes in blood pressure. Genitourinary Severe bladder dysfunction and outlet obstruction should be considered before starting treatment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Respiratory Desmopressin should be used with caution in patients with cystic fibrosis because these patients are prone to hyponatremia.
Special Populations Pregnant Women:
No controlled studies in pregnant women have been carried out. The physician should weigh possible therapeutic advantages against potential risks in each case. Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus indicate no adverse effects of desmopressin on pregnancy or on the health of the fetus or newborn child.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development.
Nursing Women:
There have been no controlled studies in nursing mothers. Results from analysis of milk from nursing mothers receiving high doses of desmopressin (300 μg intranasal), indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis.
Paediatrics:
Use of desmopressin in infants and children will require careful fluid intake restriction to prevent possible hyponatremia and water retention due to over ingestion of fluids.
Geriatric:
Geriatric patients should be closely observed for possible hyponatremia and water retention due to over ingestion of fluids.
DDAVP® MELT TABLETS (60μg, 120μg, 240μg) Page 6 of 34 Template Date:
January 2010 Monitoring and Laboratory Tests Central Diabetes Insipidus Continued response to desmopressin acetate is monitored by urine volume and osmolality. ADVERSE REACTIONS Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Five pharmacokinetic and pharmacodynamic (PK/PD) studies were conducted. Four studies enrolled healthy volunteers and one study was conducted in children with primary nocturnal enuresis (PNE).
Comparison of the methodologies of the five studies is presented in Table 1.
Table 1:
Study Design of the Pharmacokinetic and Pharmacodynamic Studies Study No. Type of Study Formulation & Dosage Number, Age & Sex of Patients Study 1 Single-center, open-label, randomized, balanced, 4-way cross-over study DDAVP MELT 200, 400, 800 μg sublingually Desmopressin 2 μg IV 24 healthy male volunteers (18-55 years) Study 2 Open-label, randomized, 2- period cross-over study DDAVP MELT 240 μg sublingually DDAVP Tablets 2x 200 μg orally 14 male and 14 female healthy volunteers (18–55 years) Study 3 Single-center, open- label, randomized, balanced, 6- sequence, 3-period cross-over study DDAVP MELT 60, 120, 240 μg sublingually 15 male and 10 female healthy volunteers (18–55 years) Study 4 Single-center, open-label, replicated, randomized, 2- sequence, 4-period, , cross- over study DDAVP MELT 240 μg sublingually DDAVP tablets 2x 200 μg orally 32 male and 33 female healthy volunteers (18- 55 years) Study 5 Double-blind, randomized, placebo-controlled, parallel group study DDAVP MELT 30, 60, 120, 240, 360, 480 μg sublingually Placebo sublingually 64 males and 20 females with PNE (6-12 years) 72 DDAVP MELT 12 Placebo DDAVP® MELT TABLETS (60μg, 120μg, 240μg) Page 7 of 34 Template Date: January 2010 A total of 214 subjects were treated with DDAVP MELT in the PK/PD studies.
Of these, 172 were also administered DDAVP tablets: 28 in Study 2, 65 in Study 4 and […]