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Desmopressin Rhinal Tube (Desmopressin Acetate Rhinal Tube) - Warnings and Precautions

 
 



WARNINGS

  1. For intranasal use only.
  2. In very young and elderly patients in particular, fluid intake should be adjusted downward in order to decrease the potential occurrence of water intoxication and hyponatremia. Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures which could lead to coma.

PRECAUTIONS

General: Intranasal Desmopressin acetate at high dosage has infrequently produced a slight elevation of blood pressure, which disappeared 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 rise in blood pressure.

Desmopressin acetate should be used with caution in patients with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, because these patients are prone to hyponatremia.

Rare severe allergic reactions have been reported with Desmopressin acetate. Anaphylaxis has been reported with intravenous administration of Desmopressin acetate Injection, but not with Desmopressin Acetate Intranasal.

Central Cranial Diabetes Insipidus: Since Desmopressin Acetate Rhinal Tube is used intranasally, changes in the nasal mucosa such as scarring, edema, or other disease may cause erratic, unreliable absorption in which case intranasal Desmopressin acetateshould not be used. For such situations, Desmopressin Acetate Injection should be considered.

Primary Nocturnal Enuresis: If changes in the nasal mucosa have occurred, unreliable absorption may result. Desmopressin Acetate Rhinal Tube should be discontinued until the nasal problems resolve.

Laboratory Tests: Laboratory tests for following the patient with central cranial diabetes insipidus or post-surgical or head trauma-related polyuria and polydipsia include urine volume and osmolality. In some cases plasma osmolality measurements may be required. For the healthy patient with primary nocturnal enuresis, serum electrolytes should be checked at least once if therapy is continued beyond 7 days.

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.

Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with Desmopressin acetate have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy Category B: Fertility studies have not been done. Teratology studies in rats and rabbits at doses from 0.05 to 10 µg/kg/day (approximately 0.1 times the maximum systemic human exposure in rats and up to 38 times the maximum systemic human exposure in rabbits based on surface area, mg/m2) revealed no harm to the fetus due to Desmopressin acetate. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Several publications of desmopressin acetate's use in the management of diabetes insipidus during pregnancy are available; these include a few anecdotal reports of congenital anomalies and low birth weight babies. However, no causal connection between these events and desmopressin acetate has been established. A fifteen year, Swedish epidemiologic study of the use of desmopressin acetate in pregnant women with diabetes insipidus found the rate of birth defects to be no greater than that in the general population; however the statistical power of this study is low. As opposed to preparations containing natural hormones, desmopressin acetate in antidiuretic doses has no uterotonic action and the physician will have to weigh the therapeutic advantages against the possible risks in each case.

Nursing Mothers: There have been no controlled studies in nursing mothers. A single study in postpartum women demonstrated a marked change in plasma, but little if any change in assayable Desmopressin acetate in breast milk following an intranasal dose of 10 µg. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Desmopressin acetate is administered to a nursing woman.

Pediatric Use: Primary Nocturnal Enuresis: Desmopressin Acetate Rhinal Tube has been used in childhood nocturnal enuresis. Short-term (4-8 weeks) Desmopressin Acetate Rhinal Tube administration has been shown to be safe and modestly effective in pediatric patients aged 6 years or older with severe childhood nocturnal enuresis. Adequately controlled studies with intranasal Desmopressin acetatein primary nocturnal enuresis have not been conducted beyond 4-8 weeks. The dose should be individually adjusted to achieve the best results.

Central Cranial Diabetes Insipidus: Desmopressin Acetate Rhinal Tube has been used in pediatric patients with diabetes insipidus. Use in infants and pediatric patients will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. The dose must be individually adjusted to the patient with attention in the very young to the danger of an extreme decrease in plasma osmolality with resulting convulsions. Dose should start at 0.05 mL or less.

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.

Page last updated: 2006-12-12

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