DDAVP Nasal Spray

Name: DDAVP Nasal Spray

How supplied

DDAVP Nasal Spray (desmopressin acetate nasal spray) is available in a 5-mL bottle with spray pump delivering 50 sprays of 10 mcg (NDC 0075-2452-01). Desmopressin acetate is also available as DDAVP Rhinal Tube, a refrigerated product with 2.5 mL per bottle, packaged with two rhinal tube applicators per carton (NDC 0075-2450-01).

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP]. STORE BOTTLE IN UPRIGHT POSITION.

Keep out of the reach of children.

Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807 Rev. July 2007. FDA Rev date: 10/26/2007

What is desmopressin nasal (ddavp nasal, ddavp rhinal tube, stimate)?

Desmopressin is a man-made form of a hormone that occurs naturally in the pituitary gland. This hormone is important for many functions including blood flow, blood pressure, kidney function, and regulating how the body uses water.

Desmopressin nasal is used to treat central cranial diabetes insipidus, and increased thirst and urination caused by head surgery or head trauma.

Desmopressin nasal is also used to treat hemophilia A or von Willebrand's disease Type I.

Desmopressin nasal may also be used for other purposes not listed in this medication guide.

DDAVP Nasal Spray Description

DDAVP® Nasal Spray (desmopressin acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. It is chemically defined as follows:

Mol. wt. 1183.34

Empirical formula: C46H64N14O12S2∙C2H4O2∙3H2O

1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate (salt) trihydrate.

DDAVP Nasal Spray is provided as an aqueous solution for intranasal use.

Each mL contains:
Desmopressin acetate 0.1 mg
Sodium Chloride 7.5 mg
Citric acid monohydrate 1.7 mg
Disodium phosphate dihydrate 3.0 mg
Benzalkonium chloride solution (50%) 0.2 mg

The DDAVP Nasal Spray compression pump delivers 0.1 mL (10 mcg) of DDAVP (desmopressin acetate) per spray.

Indications and Usage for DDAVP Nasal Spray

Central Cranial Diabetes Insipidus

DDAVP Nasal Spray 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 DDAVP Nasal Spray 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 DDAVP can be monitored by urine volume and osmolality.

DDAVP 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.

DDAVP Nasal Spray Dosage and Administration

Central Cranial Diabetes Insipidus

DDAVP Nasal Spray dosage must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients with nasal congestion and blockage have often responded well to intranasal DDAVP. The usual dosage range in adults is 0.1 to 0.4 mL daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL daily in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For children aged 3 months to 12 years, the usual dosage range is 0.05 to 0.3 mL daily, either as a single dose or divided into two doses. About 1/4 to 1/3 of patients can be controlled by a single daily dose of DDAVP administered intranasally. Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

The nasal spray pump can only deliver doses of 0.1 mL (10 mcg) or multiples of 0.1 mL. If doses other than these are required, the rhinal tube delivery system may be used.

The spray pump must be primed prior to the first use. To prime pump, press down four times. The bottle will now deliver 10 mcg of drug per spray. Discard DDAVP Nasal Spray after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 µg of drug.

Geriatric Use

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. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY, Human Pharmacokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)

How is DDAVP Nasal Spray Supplied

DDAVP Nasal Spray is available in a 5-mL bottle with spray pump delivering 50 sprays of 10 mcg (NDC 55566-2500-0). Desmopressin acetate is also available as DDAVP Rhinal Tube, a refrigerated product with 2.5 mL per bottle, packaged with two rhinal tube applicators per carton (NDC 55566-2400-0).

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP]. STORE BOTTLE IN UPRIGHT POSITION.

Keep out of the reach of children.

Manufactured for:
Ferring Pharmaceuticals Inc.
Parsippany, NJ 07054 USA

Origin Sweden

Rev. 04/2015

2009054172

PRINCIPAL DISPLAY PANEL - 5 mL Bottle Carton

NDC 55566-2500-0

DDAVP®
Nasal
Spray
desmopressin
acetate

10 mcg/0.1 mL

FOR INTRANASAL USE ONLY

5 mL Bottle (50 Doses)

Rx ONLY

FERRING
PHARMACEUTICALS

DDAVP 
desmopressin acetate spray
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55566-2500
Route of Administration NASAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Desmopressin Acetate (desmopressin) Desmopressin Acetate 0.1 ug  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride 7.5 mg  in 1 mL
Citric Acid Monohydrate  
Sodium Phosphate, Dibasic Dihydrate  
Benzalkonium Chloride  
Packaging
# Item Code Package Description
1 NDC:55566-2500-0 1 BOTTLE, PUMP in 1 CARTON
1 5 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017922 02/21/1978
Labeler - Ferring Pharmaceuticals Inc. (103722955)
Establishment
Name Address ID/FEI Operations
Ferring GmbH 328609615 MANUFACTURE(55566-2500), ANALYSIS(55566-2500), PACK(55566-2500)
Establishment
Name Address ID/FEI Operations
Rechon Life Science AB 775207769 MANUFACTURE(55566-2500), ANALYSIS(55566-2500), PACK(55566-2500)
Establishment
Name Address ID/FEI Operations
Ferring International Center SA 481210362 PACK(55566-2500)
Revised: 06/2016   Ferring Pharmaceuticals Inc.

For the Consumer

Applies to desmopressin: oral tablet

Other dosage forms:

  • injection solution
  • nasal solution, nasal spray

Along with its needed effects, desmopressin (the active ingredient contained in DDAVP Nasal) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking desmopressin:

Rare
  • Confusion
  • convulsions
  • decreased urine output
  • dizziness
  • fast or irregular heartbeat
  • headache
  • increased thirst
  • muscle pain or cramps
  • nausea or vomiting
  • shortness of breath
  • swelling of the face, ankles, or hands
  • unusual tiredness or weakness
Incidence not known
  • Weight gain

Some side effects of desmopressin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Delusions
  • dementia
  • diarrhea

Contraindications

DDAVP Nasal Spray is contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of DDAVP Nasal Spray .

(web3)