Desmopressin Nasal Spray

Desmopressin is used to control the amount of urine your kidneys make. Normally, the amount of urine you make is controlled by a certain substance in the body called vasopressin. In people who have "water diabetes" (diabetes insipidus) or certain kinds of head injury or brain surgery, the body does not make enough vasopressin. Desmopressin is a man-made form of vasopressin and is used to replace a low level of vasopressin. This medication helps to control increased thirst and too much urination due to these conditions, and helps prevent dehydration.Desmopressin products applied in the nose are no longer indicated to control nighttime bedwetting in children because of the increased risk of developing a serious side effect (a low level of sodium in the blood).

Read the patient instruction sheet that comes with this product before you start using desmopressin and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Follow the instructions on how to properly prime the bottle if you are using it for the first time or if you have not used it for a week or more. Spray this medication in the nose, usually 1 to 3 times a day as directed by your doctor. If the dose is more than 1 spray, spray half the dose in each nostril. For example, if the dose is 2 sprays, give 1 spray in each nostril.Keep track of the number of sprays used from each container. Discard the container after you have used the number of sprays specified on the package.If a child is using this medication, a parent or other responsible adult should supervise and help the child use this medication properly.Limit drinking of water and other fluids while using this medication, especially in children and older adults. Consult your doctor for details. If you find that you are drinking more fluids than directed, tell your doctor immediately. Your treatment will need to be adjusted. (See also Side Effects and Precautions sections.)Dosage is based on your medical condition and response to treatment. Do not use more desmopressin or use it more often than prescribed.Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.Tell your doctor if your condition does not improve or if this medication stops working well.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Other medications besides desmopressin may also affect the balance of water and sodium in your body. Therefore, tell your doctor or pharmacist about all the products you take, including: narcotic pain relievers (such as morphine), nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, naproxen), psychiatric medicines (such as chlorpromazine), drugs to treat seizures (such as carbamazepine), SSRI antidepressants (such as sertraline), tolvaptan, tricyclic antidepressants (such as amitriptyline), "water pills" (diuretics such as furosemide).

Desmopressin acetate contains as active substance 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin, which is a synthetic analogue of the natural hormone arginine vasopressin. One mL (0.1 mg) of intranasal desmopressin acetate has an antidiuretic activity of about 400 International Units (IU); 10 mcg of desmopressin acetate is equivalent to 40 IU. The change in structure of arginine vasopressin to desmopressin acetate has resulted in a decreased vasopressor action and decreased actions on visceral smooth muscle relative to the enhanced antiduretic activity, so that clinically effective antiduretic doses are usually below threshold levels for effects on vascular or visceral smooth muscle.

Desmopressin acetate administered intranasally has an antiduretic effect about one-tenth that of an equivalent dose administered by injection.

Pharmacokinetics

Intranasal Desmopressin Acetate is absorbed from the nasal mucosa. Desmopressin Acetate exhibits a biphasic elimination profile, with half-lives of 7.8 and 75.5 minutes for the initial and terminal phases, respectively, in contrast to lysine vasopressin, which has initial and terminal phase half-lives of 2.5 and 14.5 minutes, respectively. Desmopressin Acetate is mainly excreted in the urine. A pharmacokinetic study conducted in healthy volunteers and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects each group) receiving single dose Desmopressin Acetate (2 mcg) injection demonstrated a difference in Desmopressin Acetate half-life. Terminal half-life significantly increased from 3 hours in normal healthy patients to 9 hours in patients with severe renal impairment [see CONTRAINDICATIONS].

Central Cranial Diabetes Insipidus

Desmopressin Acetate 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 Desmopressin Acetate 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 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 desmopressin acetate can be monitored by urine volume and osmolality.

Desmopressin Acetate 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.

Signs of overdosage may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention [see WARNINGS]. In case of overdosage, the dose should be reduced, frequency of administration decreased, or the drug withdrawn according to the severity of the condition. There is no known specific antidote for desmopressin acetate or Desmopressin Acetate Nasal Spray.

An oral LD50 has not been established. An intravenous dose of 2 mg/kg in mice demonstrated no effect.

Desmopressin Acetate Nasal Spray is available as a 5 mL bottle with spray pump delivering 50 sprays of 10 mcg (NDC 69918-501-05).

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.
U.S. Pat. Nos. 5,500,413, 5,596,078, and 5,674,850

Toll free number for providers and patients to call with questions:
1-844-Amring1 (1-844-267-4641)

Manufactured for:
Amring Pharmaceuticals Inc.
Berwyn, PA 19312

Origin Germany

XXXXXXXXXXX

NDC 69918-501-05

Desmopressin
Acetate

Nasal Spray

10 mcg per 0.1 mL

Rx Only

5 mL
(50 sprays)

Attention Pharmacist-
detach patient's
instructions from
package insert and
dispense with spray pump.

AMRING
PHARMACEUTICALS

DESMOPRESSIN ACETATE  desmopressin acetate spray

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69918-501 Route of Administration NASAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Desmopressin Acetate (desmopressin) Desmopressin Acetate 10 ug  in 0.1 mL

Inactive Ingredients Ingredient Name Strength Sodium Chloride   Citric Acid Monohydrate   Sodium Phosphate, Dibasic Dihydrate   Benzalkonium Chloride

Packaging # Item Code Package Description 1 NDC:69918-501-05 1 BOTTLE, SPRAY in 1 CARTON 1 5 mL in 1 BOTTLE, SPRAY

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA AUTHORIZED GENERIC NDA017922 03/01/2016

Labeler - Amring Pharmaceuticals, Inc. (079843051)

Registrant - Ferring International Center S.A. (481210362)

Establishment
Name	Address	ID/FEI	Operations
Ferring International Center S.A.		481210362	MANUFACTURE(69918-501)

Revised: 02/2016   Amring Pharmaceuticals, Inc.