Each actuation press of the nozzle delivers 10 micrograms of desmopressin acetate ddavp. Minirin nasal spray contains desmopressin, a structural analogue of the natural pituitary hormone arginine vasopressin, also known as antidiuretic hormone adh. Ddavp nasal spray fda prescribing information, side. Early treatment of central diabetes insipidus used a more or less purified extract from bovine or porcine posterior pituitaries.
Children requiring an intranasal dose of less than 10 micrograms should be given ddavp intranasal solution. If doses other than these are required, the rhinal tube delivery system may be used. Desmopressin ddavp for the treatment and prevention of. Ddavp nasal spray is contraindicated in patients with. Instruct patients about appropriate fluid restriction during desmopressin acetate nasal spray treatment see warnings and precautions 5. It contains a clear, colourless solution of desmopressin acetate 0. Ddavp nasal spray desmopressin acetate dose, indications. It does not replace the advice from your doctor or pharmacist. Desmopressin nasal spray, solution drug information, side. Pr desmopressin spray 10 gspray desmopressin acetate nasal.
Consumer information about the medication desmopressin 1. Ddavp nasal spray ddavp nasal spray delivers doses in 0. Desmopressin solution nasal ddavp side effects, medical. Nov 15, 2019 desmopressin acetate nasal spray is not an indicated formulation for the treatment of primary nocturnal enuresis due to a higher risk of hyponatremia and hyponatremic convulsions with the use of the nasal spray formulation compared to desmopressin tablets seen in postmarketing reports see indications and usage 1.
When stimate nasal spray is administered, in particular in pediatric and geriatric patients, fluid 3 intake should be adjusted downward in order to decrease the potential occurrence of water. Desmopressin acetate nasal spray for adults with nocturia. Noctivatm desmopressin acetate nasal spray, dans, serenity pharmaceuticals, llc is a novel formulation of desmopressin approved by the food and drug administration for the treatment of. Desmopressin nasal and oral will be covered with prior authorization when the following criteria are met. When stimate nasal spray is administered, in particular in pediatric and geriatric patients, fluid. Desmopressin nasal solution fda prescribing information. Oral, intranasal, intravenous, subcutaneous and intramuscular doses are expressed as desmopressin acetate. Desmopressin spray should be used in children who only require a single dose of 10.
There is no evidence that this effect is due to the development of binding antibodies, but may be due to a local inactivation of the peptide. Desmopressin nasal solution belongs to 2 classes of medications. Desmopressin nasal comes as a liquid that is administered into the nose through a rhinal tube thin plastic tube that is placed in the nose to administer medication, and as a nasal spray. The composition may additionally contain an osmoticpressure controlling agent, such as sodium chloride, a preservative, such as chlorobutanol or benzalkonium chloride, and a buffer. Desmopressin nasal spray for the treatment of nocturia. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Ddavp spray and rhinyle page 1 of 23 product monograph pr ddavp spray desmopressin acetate nasal spray 10 gspray pr ddavp rhinyle desmopressin acetate nasal solution 0. An aqueous composition for spray nasal administration of a synthetic analog of vasopressin desmopressin. Fda briefing document bone, reproductive and urologic drugs. Desmopressin acetate is also available as ddavp rhinal tube, a refrigerated product with 2. In this study, efficacy and side effects of oral desmopressin was. The other way desmopressin is given is by a nasal spray spraying it in the nose. Jul 25, 2012 the spray pack comprises of a 10ml amber glass injection vial fitted with a snapon tamperproof precompression pump spray device, to which a 20mm nasal adaptor is attached. The hormone works on the kidneys to control frequent urination.
Ddavp nasal spray fda prescribing information, side effects. Appropriate studies performed to date have not demonstrated pediatricspecific problems that would limit the usefulness of desmopressin nasal spray to treat central diabetes insipidus in children 3 months of age and older for desmopressin acetate or in children 4 years of age and older for ddavp. Desmopressin acetate nasal spray solution, 10 mcg0. Ddavp nasal spray is available as a 5 ml bottle with spray pump delivering 50 sprays. Stimate nasal spray is provided as an aqueous solution for intranasal use. In some patients, better control of polyuria is attained with smaller doses given at 6 to 8 hour intervals. Read more about the prescription drug desmopressin 1. Minirin nasal spray is provided as an aqueous solution for intranasal use. Desmopressin acetate has been shown to be more potent than arginine vasopressin in increasing.
Us5498598a composition for nasal administration of. Nasal spray desmopressin ddavp for mild hemophilia a and. Read more about the prescription drug desmopressin solution nasal. Desmopressin spray 10 microgramsdose nasal spray solution. Ddavp nasal spray, solution drug information, side effects. Desmopressin is not made from blood and carries no risk of viruses. This condition causes frequent urination and thirst. It can be used to treat central diabetes insipidus, a condition where the kidneys are unable to conserve water due to a lack of antidiuretic hormone adh. Minirin nasal spray should be used with caution in patients with cystic fibrosis because of impaired water handling and increased risk of hyponatraemia. Prime with 1 spray after the first use if the vial has not been used in 7 days.
Ddavp, ddavp rhinal tube, ddavp rhinyle drops, stimate. Division of bone, reproductive and urologic products. Desmoperssin is the drug of choice for treatment of central diabetes insipidus and most commonly it is used as intranasal spray. Desmospray, desmopressin nasal spray summary of product. Consumer information about the medication desmopressin solution nasal ddavp, includes side effects, drug interactions, recommended dosages, and storage information. It is also used to treat temporary increased thirst and urination that.
This change may be due to decreased responsiveness, or to shortened duration of effect. A hyponatremia or a history of uncorrected hyponatremia, b. Usually, the change occurred over a period of time greater than six months. Discard desmopressin acetate nasal spray solution after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 mcg of drug. Nasal desmopressin is also used to control excessive thirst and the passage of an abnormally large amount of urine that may occur after a head injury or after certain types of surgery.
Desmopressin acetate is contraindicated in patients with moderate to severe renal impairment defined as a creatinine clearance below 50 mlmin. This leaflet is intended to answer questions you may have about minirin spray. Find medication information including related drug classes, side effects, patient statistics and answers to frequently asked questions. Xxxx ddavp nasal spray desmopressin acetate rx only. Jun 27, 2017 ddavp nasal spray desmopressin acetate nasal spray is available in a 5ml bottle with spray pump delivering 50 sprays of 10 mcg ndc 0075245201.
Known hypersensitivity to desmopressin acetate or to any of the components of ddavp nasal spray. Desmopressin acetate nasal spray stimate is a synthetic analogue of the natural pituitary hormone 8arginine vasopressin adh, an antidiuretic hormone affecting renal water conservation. Oct 01, 2018 discard desmopressin acetate nasal spray solution after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 mcg of drug. Ddavp nasal spray is provided as an aqueous solution for intranasal use. Fda briefing document bone, reproductive and urologic.
The name of your medicine is desmopressin spray, 10 microgramsdose, nasal spray, solution referred to as desmopressin spray throughout this leaflet. Minirin nasal spray 1 minirinr nasal spray desmopressin acetate consumer medicine information important please read this leaflet carefully before using minirin spray. Csl behring stimate desmopressin acetate nasal spray, 1. Product strength pack size ndc brand reference details. One spray 10 mcg has an antidiuretic activity of about 40 international units. The spray pack comprises of a 10ml amber glass injection vial fitted with a snapon tamperproof precompression pump spray device, to which a 20mm nasal adaptor is attached.
Nasal spray desmopressin acetate rx only description ddavp nasal spray desmopressin acetate is a synthetic analogue of the natural pituitary hormone 8arginine vasopressin adh, an antidiuretic hormone affecting renal water conservation. If you contact our customer support by one of the methods below, we will be able to assist you in locating the product you are looking for. Ddavp nasal spray desmopressin acetate nasal spray. The drug should be used with caution in patients with coronary. Drug name availability desmopressin sublingual tablet nocdurna sublingual tablets. Ddavp nasal spray desmopressin acetate nasal spray is available in a 5ml bottle with spray pump delivering 50 sprays of 10 mcg ndc 0075245201. The applicant is seeking approval of desmopressin nasal spray for the treatment of nocturia in adults.
Click here to read more about desmopressin, which is also available under the brand names minirin nasal and stimate nasal. Ddavp injection desmopressin acetate 4 mcgml has infrequently produced changes in blood pressure causing either a slight elev ation in blood pressure or a transient fall in blood pressure and a compensatory increase in heart rate. One brand of desmopressin nasal spray stimate is used to stop bleeding in people who have certain bleeding disorders. Desmopressin acetate nasal spray is provided as an aqueous solution for intranasal use.
219 381 567 1566 840 1396 1448 1023 1502 249 1222 302 614 1253 1043 292 742 1091 81 755 1510 514 646 1583 853 999 367 959 1516 640 191 33 1166 1193 127 1332 1362 231 1438 979 1194 997 1242 1093 1226 436 274 117 314 961