Children requiring an intranasal dose of less than 10 micrograms should be given ddavp intranasal solution. Stimate nasal spray is provided as an aqueous solution for intranasal use. 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. 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. Ddavp nasal spray desmopressin acetate nasal spray is available in a 5ml bottle with spray pump delivering 50 sprays of 10 mcg ndc 0075245201. It does not replace the advice from your doctor or pharmacist. Usually, the change occurred over a period of time greater than six months. The name of your medicine is desmopressin spray, 10 microgramsdose, nasal spray, solution referred to as desmopressin spray throughout this leaflet. Ddavp nasal spray fda prescribing information, side. 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. Administer desmopressin acetate nasal spray by intranasal use only. Ddavp nasal spray is contraindicated in patients with. Desmopressin spray should be used in children who only require a single dose of 10. In this study, efficacy and side effects of oral desmopressin was.
Consumer information about the medication desmopressin 1. Ddavp nasal spray, solution drug information, side effects. If doses other than these are required, the rhinal tube delivery system may be used. Us5498598a composition for nasal administration of. Desmopressin acetate 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. Desmospray, desmopressin nasal spray summary of product.
Ddavp nasal spray fda prescribing information, side effects. Consumer information about the medication desmopressin solution nasal ddavp, includes side effects, drug interactions, recommended dosages, and storage information. Minirin nasal spray contains desmopressin, a structural analogue of the natural pituitary hormone arginine vasopressin, also known as antidiuretic hormone adh. This change may be due to decreased responsiveness, or to shortened duration of effect. 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. The drug should be used with caution in patients with coronary. Oral, intranasal, intravenous, subcutaneous and intramuscular doses are expressed as desmopressin acetate. 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. Desmopressin solution nasal ddavp side effects, medical.
Each actuation press of the nozzle delivers 10 micrograms of desmopressin acetate ddavp. The other way desmopressin is given is by a nasal spray spraying it in the nose. Xxxx ddavp nasal spray desmopressin acetate rx only. Known hypersensitivity to desmopressin acetate or to any of the components of ddavp nasal spray. 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. This leaflet is intended to answer questions you may have about minirin spray. Ddavp nasal spray is available as a 5 ml bottle with spray pump delivering 50 sprays. Click here to read more about desmopressin, which is also available under the brand names minirin nasal and stimate nasal. 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. The composition may additionally contain an osmoticpressure controlling agent, such as sodium chloride, a preservative, such as chlorobutanol or benzalkonium chloride, and a buffer stabilizing the ph between about 4 and 6. Product strength pack size ndc brand reference details. 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. 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. A hyponatremia or a history of uncorrected hyponatremia, b. Ddavp nasal spray is provided as an aqueous solution for intranasal use. It is also used to treat temporary increased thirst and urination that. Desmoperssin is the drug of choice for treatment of central diabetes insipidus and most commonly it is used as intranasal spray. 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. 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. An aqueous composition for spray nasal administration of a synthetic analog of vasopressin desmopressin. Fda briefing document bone, reproductive and urologic drugs. 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 nasal and oral will be covered with prior authorization when the following criteria are met. Ddavp nasal spray, solution drug information, side effects, faqs. Csl behring stimate desmopressin acetate nasal spray, 1. Desmopressin spray 10 microgramsdose nasal spray solution. Ddavp, ddavp rhinal tube, ddavp rhinyle drops, stimate. Division of bone, reproductive and urologic products. Desmopressin acetate nasal spray for adults with nocturia. Prime with 1 spray after the first use if the vial has not been used in 7 days. Instruct patients about appropriate fluid restriction during desmopressin acetate nasal spray treatment see warnings and precautions 5. Minirin nasal spray is provided as an aqueous solution for intranasal use. Desmopressin nasal solution belongs to 2 classes of medications. Minirin nasal spray 1 minirinr nasal spray desmopressin acetate consumer medicine information important please read this leaflet carefully before using minirin spray. Desmopressin nasal spray, solution drug information, side. 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.
Desmopressin ddavp for the treatment and prevention of. 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. 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. 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. Desmopressin acetate is contraindicated in patients with moderate to severe renal impairment defined as a creatinine clearance below 50 mlmin. Ddavp nasal spray ddavp nasal spray delivers doses in 0. 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.
Desmopressin acetate nasal spray solution, 10 mcg0. Desmopressin is not made from blood and carries no risk of viruses. Nasal spray desmopressin ddavp for mild hemophilia a and. 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.
Read more about the prescription drug desmopressin solution nasal. Desmopressin acetate is also available as ddavp rhinal tube, a refrigerated product with 2. Find medication information including related drug classes, side effects, patient statistics and answers to frequently asked questions. Early treatment of central diabetes insipidus used a more or less purified extract from bovine or porcine posterior pituitaries. It contains a clear, colourless solution of desmopressin acetate 0. This condition causes frequent urination and thirst.
When stimate nasal spray is administered, in particular in pediatric and geriatric patients, fluid. The applicant is seeking approval of desmopressin nasal spray for the treatment of nocturia in adults. Minirin nasal spray should be used with caution in patients with cystic fibrosis because of impaired water handling and increased risk of hyponatraemia. Ddavp nasal spray desmopressin acetate nasal spray. Pr desmopressin spray 10 gspray desmopressin acetate nasal. Read more about the prescription drug desmopressin 1. The hormone works on the kidneys to control frequent urination. Desmopressin nasal solution fda prescribing information. Drug name availability desmopressin sublingual tablet nocdurna sublingual tablets. One brand of desmopressin nasal spray stimate is used to stop bleeding in people who have certain bleeding disorders.
Desmopressin nasal spray for the treatment of nocturia. Desmopressin acetate nasal spray stimate is a synthetic analogue of the natural pituitary hormone 8arginine vasopressin adh, an antidiuretic hormone affecting renal water conservation. Ddavp nasal spray desmopressin acetate dose, indications. One spray 10 mcg has an antidiuretic activity of about 40 international units.