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DESCRIPTION
Desmopressin nasal spray is used to treat central cranial diabetes insipidus. This is a condition that causes the body to lose too much fluid and become dehydrated. It is also used to control frequent urination and increased thirst caused by certain types of brain injury or brain surgery. It is used to treat bleeding in patients with hemophilia A or von Willebrand disease (Type I).
It is used to treat nocturnal polyuria in adults who awaken two or more times to urinate at night. Nocturnal polyuria is a condition where your body makes too much urine at night. Your doctor will need to measure your urine and the times that you urinate for 24 hours to determine if you have nocturnal polyuria.
Desmopressin is similar to a hormone that is produced in the body. It acts on the kidneys to reduce the flow of urine. For bleeding, desmopressin increases the blood levels of factor VIII and von Willebrand factor. This results in less bleeding for patients who have low levels of these agents.
CLINICAL PHARMACOLOGY:
Desmopressin acetate is a synthetic analogue of the natural hormone arginine vasopressin. One mL (0.1 mg) of intranasal desmopressin acetate has an antidiuretic activity of about 400 IU; 10 mcg of desmopressin acetate is equivalent to 40 IU.
- The biphasic half-lives for intranasal desmopressin acetate were 7.8 and 75.5 minutes for the fast and slow phases, compared with 2.5 and 14.5 minutes for lysine vasopressin, another form of the hormone used in this condition. As a result, intranasal desmopressin acetate provides a prompt onset of antidiuretic action with a long duration after each administration.
- The change in structure of arginine vasopressin to desmopressin acetate has resulted in a decreased vasopressor action and decreased actions on visceral smooth muscle relative to the enhanced antidiuretic activity, so that clinically effective antidiuretic doses are usually below threshold levels for effects on vascular or visceral smooth muscle.
- Desmopressin acetate administered intranasally has an antidiuretic effect about one-tenth that of an equivalent dose administered by injection.
Human Pharmacokinetics: Desmopressin acetate is mainly excreted in the urine. A pharmacokinetic study conducted in healthy volunteers and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects in each group) receiving single dose desmopressin acetate (2 mcg) injection demonstrated a difference in desmopressin acetate terminal half-life. Terminal half-life significantly increased from 3 hours in normal healthy patients to 9 hours in patients with severe renal impairment.
INDICATIONS AND USAGE
Central Cranial Diabetes Insipidus: Desmopressin nasal spray solution, USP 0.01% is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. It is ineffective for the treatment of nephrogenic diabetes insipidus.
The use of desmopressin nasal spray solution, USP 0.01% in patients with an established diagnosis will result in a reduction in urinary output with increase in urine osmolality and a decrease in plasma osmolality. This will allow the resumption of a more normal life-style with a decrease in urinary frequency and nocturia.
There are reports of an occasional change in response with time, usually greater than 6 months. Some patients may show a decreased responsiveness, others a shortened duration of effect. There is no evidence this effect is due to the development of binding antibodies but may be due to a local inactivation of the peptide.
Patients are selected for therapy by establishing the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or the response to antidiuretic hormone. Continued response to intranasal desmopressin acetate can be monitored by urine volume and osmolality.
Desmopressin acetate is also available as a solution for injection when the intranasal route may be compromised. These situations include nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may also be inappropriate where there is an impaired level of consciousness. In addition, cranial surgical procedures, such as transsphenoidal hypophysectomy create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.
CONTRAINDICATIONS
Desmopressin nasal spray solution 0.01% is contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of desmopressin nasal spray solution 0.01%.
Desmopressin acetate is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min).
Desmopressin acetate is contraindicated in patients with hyponatremia or a history of hyponatremia.
Drug Interactions:
Although the pressor activity of desmopressin acetate is very low compared to the antidiuretic activity, use of large doses of intranasal desmopressin acetate with other pressor agents should only be done 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.
Storage
Store in refrigerator at 2°-8°C (36°-46°F).
When traveling, product will maintain stability for up to 3 weeks when stored at room temperature, 22°C (72°F).
STORE BOTTLE IN UPRIGHT POSITION.
Keep out of reach of children.
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