Overview
DESCRIPTION Desmopressin Acetate Tablets 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. 1129.27 Empirical Formula: C 46 H 64 N 14 O 12 S 2 • C 2 H 4 O 2 where 1
Mechanism of Action
CLINICAL PHARMACOLOGY Desmopressin acetate 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 desmopressin acetate.
Indications
- INDICATIONS AND USAGE Central Diabetes Insipidus Desmopressin acetate 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. Desmopressin acetate 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.
Common Doses
- 0.05 mg
- 0.1 mg
- 0.8 mg
- 1.2 mg
Dosage
DOSAGE AND ADMINISTRATION Central Diabetes Insipidus The dosage of desmopressin acetate 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 desmopressin acetate therapy should begin tablet therapy twelve hours after the last intranasal dose.
Contraindications
- CONTRAINDICATIONS Desmopressin acetate tablets are contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin acetate tablets. Desmopressin acetate tablets are contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50mL/min). Desmopressin acetate is contraindicated in patients with hyponatremia or a history of hyponatremia.
Side Effects
- ADVERSE REACTIONS Infrequently, large doses of the intranasal formulations of desmopressin acetate tablets and 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 desmopressin acetate tablet therapy, transient increases in AST (SGOT) no higher than 1.5 times the upper limit of normal were occasionally observed.
Interactions
- Drug Interactions Although the pressor activity of desmopressin acetate is very low compared to its antidiuretic activity, large doses of desmopressin acetate 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.