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MINIRIN NASAL SPRAY (DESMOPRESSIN ACETATE): USE IN SPECIAL POPULATIONS

Pregnancy

Pregnancy Category B (No evidence of risk in humans)

Fertility studies have not been done. Teratology studies in rats and rabbits at doses from 0.05 to 10 ėg/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 (Minirin) 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 of Minirin (Desmopressin) spray nasal 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 ėg. 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

Minirin (Desmopressin Acetate) Nasal Spray has been used in childhood nocturnal enuresis. Short-term (4-8 weeks) Minirin nasal spray 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 Minirin in 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

Minirin (Desmopressin) nasal spray has been used in children with diabetes insipidus. Use in infants and children 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.

Since the spray cannot deliver less than 0.1 mL (10 ėg), smaller doses should be administered using the rhinal tube delivery system. Do not use the nasal spray in pediatric patients requiring less than 0.1 mL (10 ėg) per dose.

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.

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