Drugs Details

Drugs Info of DDAVP Nasal, DDAVP Rhinal Tube, Stimate
Drugs Details
  • Drugs Type  : FDA
  • Date : 15th Jan 2015 04:02 am
  • Brand Name : DDAVP Nasal, DDAVP Rhinal Tube, Stimate
  • Generic Name : desmopressin (nasal) (Pronunciation: DEZ mo press in)
Descriptions

Stimate® (desmopressin acetate) is a synthetic analogue of the natural pituitary hormone 8-arginine vasopressin (ADH), an antidiuretic hormone affecting renal water conservation. Stimate® Nasal Spray contains 1.5 mg/mL desmopressin acetate in an aqueous solution at a pH of approximately 5.0. Stimate® Nasal Spray's compression pump delivers 0.1 mL (150 mcg) of solution per spray. It is chemically defined as follows:

Mol. Wt. 1183.34 Empirical formula: C46H64N14O12S2 •C2H4O2•3H2O

 

Stimate® (desmopressin acetate) Structural Formula Illustration

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

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

Each mL contains:

 

Active ingredient:
  Desmopressin acetate 1.5 mg
Inactive ingredients:
  Sodium chloride 7.5 mg
  Buffer:  
     Citric acid monohydrate 1.7 mg
     Disodium phosphate dihydrate 3.0 mg
  Preservative:  
     Benzalkonium chloride 0.1 mg
     Purified water To 1 mL

What are the possible side effects of desmopressin nasal (DDAVP Nasal, DDAVP Rhinal Tube, Stimate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using desmopressin nasal and call your doctor at once if you have any of these serious side effects:

  • nausea, vomiting, weakness, loss of appetite, headache, feeling restless or irritable, confusion, hallucinations, muscle pain or weakness, and/or seizure;
  • feeling like you might pass out;
  • swelling;
  • chest pain, fast or pounding heart...

Read All Potential Side Effects and See Pictures of Stimate »

What are the precautions when taking desmopressin acetate nasal spray (Stimate)?

Before using desmopressin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, a low level of sodium in the blood (current or past hyponatremia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart disease (such as blocked blood vessels in the heart), conditions that may increase your risk of fluid/mineral imbalance (such as cystic fibrosis, heart failure),...

Read All Potential Precautions of Stimate »


This monograph has been modified to include the generic and brand name in many instances.

Indications

Before the initial therapeutic administration of Stimate® Nasal Spray, the physician should establish that the patient shows an appropriate change in the coagulation profile following a test dose of intranasal administration of Stimate® Nasal Spray.

Desmopressin acetate is also available as a solution for injection (DDAVP® 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.

Hemophilia A

Stimate® Nasal Spray is indicated for patients with hemophilia A with Factor VIII coagulant activity levels greater than 5%.

Desmopressin acetate will also stop bleeding in patients with hemophilia A with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding.

In the outpatient setting during two clinical trials where patients recorded bleeding episodes, Stimate® Nasal Spray provided effective hemostasis 100% of the time in 2 of the 5 patients. For those patients not responding in 100% of bleeding occasions, 45% (14 of 31) of bleeding episodes were effectively controlled with Stimate® Nasal Spray. Desmopressin acetate is not indicated for the treatment of hemophilia A with Factor VIII coagulant activity levels equal to or less than 5%, or for the treatment of hemophilia B, or in patients who have Factor VIII antibodies.

von Willebrand's Disease (Type I)

Stimate® Nasal Spray is indicated for patients with mild to moderate classic von Willebrand's disease (Type I) with Factor VIII levels greater than 5%.

Desmopressin acetate will also stop bleeding in mild to moderate von Willebrand's disease patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas, mucosal bleeding or menorrhagia.

In the outpatient setting during two clinical trials where patients recorded bleeding episodes, Stimate® Nasal Spray provided effective hemostasis 100% of the time in 75% of the patients (n=16). For those patients not responding in 100% of bleeding occasions, 78% (64 of 82) of bleeding episodes were effectively controlled with Stimate® Nasal Spray.

Patients may respond in a variable fashion depending on the type of molecular defect they have. Bleeding time and Factor VIII coagulant activity, ristocetin cofactor activity, and von Willebrand factor antigen should be checked after initial administration of Stimate® Nasal Spray to ensure that adequate levels have been achieved.

Stimate® Nasal Spray is not indicated for the treatment of severe classic von Willebrand's disease (Type I) and when there is evidence of an abnormal molecular form of Factor VIII antigen. See WARNINGS.

Dosage Administration

Hemophilia A and von Willebrand's Disease (Type I)

Stimate® Nasal Spray is administered by nasal insufflation, one spray per nostril, to provide a total dose of 300 mcg. In patients weighing less than 50 kg, 150 mcg administered as a single spray provided the expected effect on Factor VIII coagulant activity, Factor VIII ristocetin cofactor activity and skin bleeding time. If Stimate® Nasal Spray is used preoperatively, it should be administered 2 hours prior to the scheduled procedure.3,4

The necessity for repeat administration of Stimate® Nasal Spray or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient. Fluid restriction should be observed, and fluid intake should be limited to a minimum, from 1 hour before desmopressin administration, until at least 24 hours after administration. The tendency toward tachyphylaxis (lessening of response) with repeated administration given more frequently than once every 48 hours should be considered in treating each patient.

The nasal spray pump can only deliver doses of 0.1 mL (150 mcg) or multiples of 0.1 mL. If doses other than these are required, DDAVP® Injection may be used.

The spray pump must be primed prior to the first use. To prime pump, press down 4 times. The bottle should be discarded after 25 doses since the amount delivered thereafter per spray may be substantially less than 150 mcg of drug.

How Supplied

A 2.5 mL bottle with spray pump capable of delivering 25 doses of 150 mcg (NDC 0053-6871-00).

Store at room temperature not to exceed 25°C (77°F) for the period indicated by the expiration date on the label. Discard six months after being opened. Store bottle in upright position.

REFERENCES

3. Chistolini A, Dragoni F, Ferrari A, La Verde G, Arcieri R, Mohamud AE and Mazzucconi MG: Intranasal DDAVP: Biological and clinical evaluation in mild Factor VIII deficiency. Haemostasis, 21:273-277, 1991.

4. Rose EH and Aledort LM: Nasal spray desmopressin (DDAVP) for mild hemophilia A and von Willebrand's disease. Ann. Int. Med., 114:563-568, 1991.

Manufactured for: By: CSL Behring LLC Ferring GmbH, King of Prussia, PA 19406-0901 Kiel, Germany, US License No. 1767. Revised November 2012 IN-8155-08


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

Infrequently, DDAVP® Injection has produced transient headache, nausea, mild abdominal cramps and vulval pain. These symptoms disappeared with reduction in dosage. Occasional facial flushing has been reported with the administration of DDAVP® Injection. Infrequently, high doses of intranasal DDAVP® have produced transient headache and nausea. Nasal congestion, rhinitis and flushing have also been reported occasionally along with mild abdominal cramps. These symptoms disappeared with reduction in dosage. Nosebleed, sore throat, cough and upper respiratory infections have also been reported.

In addition to those listed above, the following have also been reported in clinical trials with Stimate® Nasal Spray: Somnolence, dizziness, itchy or light-sensitive eyes, insomnia, chills, warm feeling, pain, chest pain, palpitations, tachycardia, dyspepsia, edema, vomiting, agitation and balanitis.

DDAVP® Injection (desmopressin acetate) has infrequently produced changes in blood pressure causing either a slight elevation or a transient fall with a compensatory increase in heart rate. Severe allergic reactions including anaphylaxis have been reported rarely with DDAVP® Injection.

Post Marketing

There have been rare reports of convulsions from hyponatremia associated with concomitant use of desmopressin and the following medications: oxybutynin and imipramine. See WARNINGS for the possibility of water intoxication, hyponatremia and coma.

To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring Pharmacovigilance at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www. fda.gov/medwatch.

Read the Stimate (desmopressin acetate nasal spray) Side Effects Center for a complete guide to possible side effects

Interactions

Although the pressor activity of desmopressin acetate is very low, its use with other pressor agents should be done only with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia (e.g., tricyclic antidepressants, serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDS, lamotrigine and carbamazepine) should be performed with caution.

DDAVP® Injection has been used with epsilon aminocaproic acid without adverse effects.


This monograph has been modified to include the generic and brand name in many instances.

Warnings

For intranasal use only.

Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with Stimate (desmopressin acetate). Stimate is a potent antidiuretic which, when administered, may lead to water intoxication and/ or hyponatremia. Unless properly diagnosed and treated hyponatremia can be fatal. Therefore, fluid restriction is recommended and should be discussed with the patient and/ or guardian. Careful medical supervision is required.

When Stimate Nasal Spray is administered, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward in order to decrease the potential occurrence of water intoxication and hyponatremia (See PRECAUTIONS, Pediatric Use and Geriatric Use.) All patients receiving Stimate therapy should be observed for the following signs or symptoms associated with hyponatremia: headache, nausea/vomiting, decreased serum sodium, weight gain, restlessness, fatigue, lethargy, disorientation, depressed reflexes, loss of appetite, irritability, muscle weakness, muscle spasms or cramps and abnormal mental status such as hallucinations, decreased consciousness and confusion. Severe symptoms may include one or a combination of the following: seizure, coma and/or respiratory arrest. Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures that could lead to coma.

Stimate should be used with caution in patients with habitual or psychogenic polydipsia, who may be more likely to drink excessive amounts of fluids, putting them at greater risk of hyponatremia.

Stimate® Nasal Spray should not be used to treat patients with Type IIB von Willebrand's disease since platelet aggregation may be induced.

Precautions

General

Desmopressin acetate has infrequently produced changes in blood pressure causing either a slight elevation 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 artery insufficiency and/or hypertensive cardiovascular disease.

Stimate® Nasal Spray should be used with caution in patients with conditions associated with fluid and electrolyte imbalance, such as cystic fibrosis, heart failure and renal disorders because these patients are prone to hyponatremia.

There have been rare reports of thrombotic events (thrombosis, acute cerebrovascular thrombosis, acute myocardial infarction) following desmopressin acetate injection in patients predisposed to thrombus formation. No causality has been determined; however, the drug should be used with caution in these patients.

Severe allergic reactions have been reported rarely. Fatal anaphylaxis has been reported in one patient who received intravenous DDAVP® (desmopressin acetate). It is not known whether antibodies to desmopressin acetate are produced after repeated administration. Since Stimate® Nasal Spray is used intranasally, changes in the nasal mucosa such as scarring, edema, or other disease may cause erratic, unreliable absorption in which case Stimate® Nasal Spray should be discontinued until the nasal problems resolve. For such situations, DDAVP® Injection should be considered.

Information for Patients

Patients should be informed that the bottle accurately delivers 25 doses of 150 mcg each. Any solution remaining after 25 doses should be discarded since the amount delivered thereafter may be substantially less than 150 mcg of drug. No attempt should be made to transfer remaining solution to another bottle. Patients should be instructed to read accompanying directions on use of the spray pump carefully before use.

Patients should also be advised that if bleeding is not controlled, the physician should be contacted.

Hemophilia A

Laboratory tests for assessing patient status include levels of Factor VIII coagulant, Factor VIII antigen and Factor VIII ristocetin cofactor (von Willebrand factor) as well as activated partial thromboplastin time. Factor VIII coagulant activity should be determined before giving Stimate® Nasal Spray for hemostasis. If Factor VIII coagulant activity is present at less than 5% of normal, Stimate® Nasal Spray should not be relied on.

von Willebrand's Disease

Laboratory tests for assessing patient status include levels of Factor VIII coagulant activity, VWF:RCo and VWF:Ag.

Carcinogenicity, Mutagenicity, Impairment of Fertility

There have been no long-term studies in animals to assess the carcinogenic, mutagenic or impairment of fertility potential of Stimate® Nasal Spray.

Pregnancy Category B

Reproduction studies performed in rats and rabbits by the subcutaneous route at doses up to 10 mcg/kg/day have revealed no evidence of harm to the fetus due to desmopressin acetate. This dose is equivalent to 10 times (for Factor VIII stimulation) or 38 times (for diabetes insipidus) the systemic human dose based on a mg/M2 surface area.

There are no adequate and well-controlled studies in pregnant women. 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 has been established. A 15-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. 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 in nursing mothers. A single study in postpartum women demonstrated a marked change in plasma, but little if any change in assayable DDAVP® in breast milk following an intranasal dose of 10 mcg. 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 Stimate® Nasal Spray is administered to a nursing woman.

Pediatric Use

Use in infants and children will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. Stimate® Nasal Spray should not be used in infants younger than 11 months in the treatment of hemophilia A or von Willebrand's disease; safety and effectiveness in children between 11 months and 12 years of age has been demonstrated.

Geriatric Use

Clinical studies of Stimate® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects. However, other post-marketing experience has indicated the occurrence of hyponatremia with the use of desmopressin acetate and fluid overload.

Therefore, in elderly patients fluid intake should be adjusted downward in an effort to decrease the potential occurrence of water intoxication and hyponatremia. Particular attention should be paid to the possibility of the rare occurrence of an extreme decrease in plasma osmolality that may result in seizures, and that could lead to coma. Patients who do not have need of antidiuretic hormone for its antidiuretic effect should be cautioned to ingest only enough fluid to satisfy thirst, in an effort to decrease the potential occurrence of water intoxication and hyponatremia.

As for all patients, dosing for geriatric patients should be appropriate to their clinical condition.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

Signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention. (See WARNINGS.) In cases of overdosage, the dosage 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 Stimate® Nasal Spray. An oral LD50 has not been established. An intravenous dose of 2 mg/kg in mice demonstrated no effect.

ContrainDications

None.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Stimate® Nasal Spray contains as active substance, desmopressin acetate, which is a synthetic analogue of the natural hormone arginine vasopressin. One spray or 0.1 mL (150 mcg) of Stimate® Nasal Spray solution has an antidiuretic activity of about 600 IU. Desmopressin acetate has been shown to be more potent than arginine vasopressin in increasing plasma levels of Factor VIII activity in patients with hemophilia and von Willebrand's disease Type I.

Dose-response studies were performed in healthy persons using doses of 150 to 450 mcg, administered as one to three sprays. The response to Stimate® Nasal Spray is dose-related, with maximal plasma levels of 150 to 250 percent of initial concentrations achieved for both Factor VIII and von Willebrand factor. The increase is rapid and evident within 30 minutes, reaching a maximum at about 1.5 hours.

The percentage increase of Factor VIII and von Willebrand factor levels in patients with mild hemophilia A and von Willebrand's disease was not notably different from that observed in normal healthy individuals when treated with 300 mcg of Stimate® Nasal Spray. In patients with von Willebrand's disease, levels of Factor VIII coagulant activity and von Willebrand factor antigen remained greater than 30 U/dL for 8 hours after a 300 mcg dose of Stimate® Nasal Spray.1 After 300 mcg of Stimate® Nasal Spray, the percentage increase of Factor VIII and von Willebrand factor levels in patients with mild hemophilia A and von Willebrand's disease was less than observed after 0.3 mcg/kg of intravenous desmopressin acetate.

Plasminogen activator activity increases rapidly after intravenous desmopressin acetate infusion, but there has been no clinically significant fibrinolysis in patients treated with desmopressin acetate.

The effect of repeated intravenous desmopressin acetate administration when doses were given every 12 to 24 hours has generally shown a diminution of the Factor VIII activity increase noted after a single dose. It is possible to reproduce the initial response in some patients after an interval of one week, but other patients may require as long as 6 weeks.2

The half-life of Stimate® Nasal Spray was between 3.3 and 3.5 hours, over the range of intranasal doses, 150 to 450 mcg. Plasma concentrations of Stimate® Nasal Spray were maximal approximately 40 to 45 minutes after dosing.

The bioavailability of Stimate® Nasal Spray when administered by the intranasal route as a 1.5 mg/mL solution is between 3.3 and 4.1 percent.

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 antidiuretic activity, so that clinically effective antidiuretic doses are usually below threshold levels for effects on vascular or visceral smooth muscle.

REFERENCES

1. Lethagen S, Harris AS and Nilsson IM: Intranasal desmopressin (DDAVP) by spray in mild hemophilia A and von Willebrand's disease type I. Blut, 60:187-191, 1990.

2. Lethagen S, Harris AS, Sjörin E and Nilsson IM: Intranasal and intravenous administration of desmopressin: Effect on FVIII/vWF, pharmacokinetics and reproducibility. Thromb. Haemost., 58:1033-1036, 1987.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Stimate® Nasal Spray
(Pronounced Stim-ate)
(desmopressin acetate)

Read this patient information leaflet before you start taking Stimate® Nasal Spray and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Stimate® Nasal Spray?

All patients using Stimate® Nasal Spray are at risk for water intoxication, fluid overload and low sodium levels in the blood. You must follow your healthcare provider's instructions on limiting the amount of fluid you can drink when taking Stimate® Nasal Spray.

  • Do not drink more than you need to satisfy your thirst.
  • You can have serious side effects such as seizures, coma, and death from drinking too much fluid.
  • Children and elderly patients are at higher risk for these conditions and must follow their healthcare provider's restrictions on drinking fluids.

Call your healthcare provider right away if you have any of the following symptoms while using Stimate® Nasal Spray. They may mean that your blood sodium level is low:

  • Headache
  • Loss of appetite
  • Nausea
  • Irritability
  • Vomiting
  • Muscle weakness
  • Weight gain
  • Muscle spasms or cramps
  • Restlessness
  • Hallucinations
  • Tiredness
  • Confusion

Using Stimate® Nasal Spray the wrong way may cause it not to work to control bleeding.

Call your healthcare provider right away if you have any uncontrolled bleeding.

What is Stimate® Nasal Spray?

Stimate® Nasal Spray is a prescription medicine used to stop some types of bleeding in people with mild hemophilia A or mild to moderate von Willebrand's disease Type 1. Stimate® Nasal Spray should not be used in children under 11 months of age.

What should I tell my healthcare provider before I use Stimate® Nasal Spray?

Before taking Stimate® Nasal Spray, tell your healthcare provider about all of your medical conditions, including if you:

  • Have any nasal problems such as a stuffy nose, have ever had surgery on your nose, or have trouble breathing through your nose. You may need to use another form of this medicine.
  • Have or have had any heart, blood circulation, or blood pressure problems.
  • Have a condition that causes fluid or water imbalance problems such as:
    • Cystic fibrosis
    • Heart failure
    • Kidney problems
  • Have or have had a condition that causes you to be very thirsty.
  • Are pregnant or plan to become pregnant. It is not known if Stimate® Nasal Spray will harm your unborn baby.
  • Are breast-feeding or plan to breast-feed. It is not known if Stimate® Nasal Spray passes into your breast milk. You and your healthcare provider should decide if you will take Stimate® Nasal Spray.

Tell your healthcare provider and pharmacist about all the medicines you take, including prescription and non-prescription medicines, such as over-the-counter medicines, vitamins, supplements and herbal remedies.

Using Stimate® Nasal Spray with certain other medicines can affect the way Stimate® Nasal Spray works.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

It is especially important to tell your healthcare provider if you take:

  • Blood pressure or heart medicines
  • Antidepressants
  • Anti-anxiety medicines
  • Antihistamines
  • Pain relievers such as narcotics or non-steroidal anti-inflammatory medicines (NSAIDs)
  • Seizure medicines
  • Medicines for over-active urinary bladder

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one of these.

How should I use Stimate® Nasal Spray?

  • Use Stimate® Nasal Spray exactly as your healthcare provider told you. Do not use more Stimate® Nasal Spray or take it more often than your healthcare provider told you.
  • The Stimate® Nasal Spray pump provides the correct dose of your medicine. For detailed instructions on how to use the nasal spray pump, see the Patient Instructions for Use at the end of this leaflet.
  • The nasal spray pump delivers 25 doses of Stimate® Nasal Spray and each spray contains a measured amount of medicine. Any medicine left in the spray pump after 25 sprays should be thrown away because, at that time, the amount of medicine in each spray may be a lot less than the correct amount. Do not put any leftover medicine into another bottle.
  • If your symptoms do not improve, or if they become worse, contact your healthcare provider. Do not stop taking Stimate® Nasal Spray without talking to your healthcare provider.
  • If you use too much Stimate® Nasal Spray, call your healthcare provider or go to the nearest hospital emergency department right away.

What are the possible side effects of Stimate® Nasal Spray?

Stimate® Nasal Spray may cause serious side effects, that come from having too much water in the body. See “What is the most important information I should know about Stimate® Nasal Spray?”.

Common side effects of Stimate Nasal Spray include:

  • Occasional facial flushing
  • Nasal congestion
  • Runny nose
  • Nosebleed
  • Sore throat
  • Cough
  • Upper respiratory infections.

Tell your healthcare provider about any side effect that bothers you or does not go away.

These are not all the possible side effects of Stimate® Nasal Spray. If you have questions, talk to your healthcare provider.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Stimate® Nasal Spray?

  • Store at room temperature, but not higher than 77°F (25°C).
  • Throw away Stimate® Nasal Spray six months after it is opened, or when the expiration date has passed, if this date is before the six months is up.
  • Store Stimate® Nasal Spray standing upright.

Keep Stimate® Nasal Spray and all medicines out of the reach of children.

General information about Stimate® Nasal Spray

Medicines are sometimes prescribed for conditions that are not mentioned in the patient leaflet. Do not use Stimate® Nasal Spray for a condition for which it was not prescribed. Do not give Stimate® Nasal Spray to other people, even if they have the same symptoms you have. It may harm them.

This patient information leaflet summarizes the most important information about Stimate® Nasal Spray. If you would like more information about Stimate® Nasal Spray, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Stimate® Nasal Spray that is written for health professionals. For more information, go to www.stimate.com or call CSL Behring Medical Affairs at 1-800-504-5434.

What are the ingredients in Stimate® Nasal Spray?

Active ingredients: desmopressin acetate

Inactive ingredients: sodium chloride, citric acid monohydrate, disodium phosphate dihydrate, benzalkonium chloride, purified water.

Patient Instructions for Use

Read these instructions carefully before you use your Stimate® Nasal Spray pump. The following instructions tell you how to prepare, or prime, your Stimate® Nasal Spray pump so that it is ready to use.

Using your Stimate® Nasal Spray Pump

1. Remove the protective cap.

2. When using Stimate® Nasal Spray for the first time, the spray pump must be primed by pressing down on the ring at the top of the pump 4 times. Hold the spray tip away from your face and eyes. See Figure A.

Figure A

 
Spray pump must be primed -  Illustration

3. When primed, the Stimate® Nasal Spray pump delivers one dose of medicine each time it is pressed. For the right dose, tilt your Stimate® Nasal Spray pump so that the tube inside the spray pump draws the medicine up from the deepest part of the medicine inside the container. See Figures A and B.

Figure B

Stimate® (desmopressin acetate) Figure BIncorrect way of holding the pump - Illustration

4. Put the spray nozzle tip into your nostril and press the spray pump one time for one dose (150-micrograms). If two doses are prescribed, spray each nostril one time (for a dose of 300-micrograms).

5. When you finish using your Stimate® Nasal Spray, put the cap over the tip of the pump.

6. If Stimate® Nasal Spray has not been used for one week, you will need to prime the pump again by pressing one time, or until you see a fine mist.

Use this check-off chart to help you keep track of the number of sprays used. This will help make sure that you receive 25 doses with each bottle of Stimate® Nasal Spray. There is extra medicine in the bottle to allow for priming. When using the chart to check off sprays, do not count the priming sprays.

Stimate® Nasal Spray

Check-off chart - Illustration

25 Spray Check-off Chart

1. Keep this chart with your Stimate® Nasal Spray or put it someplace where you can easily get it.

2. Check off number 1 on the chart with your first dose of Stimate® Nasal Spray. Check off the numbers after each use of Stimate® Nasal Spray. If your healthcare provider prescribed a 2-spray dose (300-micrograms), then two numbers should be checked off.

3. Throw away the Stimate® Nasal Spray after 25 doses.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

DESMOPRESSIN 1.5 MG/ML SPRAY - NASAL

 

(dess-mow-PRESS-in)

 

COMMON BRAND NAME(S): Stimate

 

USES: Desmopressin is used in people with certain bleeding problems (hemophilia A, type 1 von Willebrand's disease) to control bleeding caused by surgery, injuries, or heavy menstrual periods. This medication is a man-made form of a certain substance in the body called vasopressin that helps with normal blood clotting.

 

HOW TO USE: Read the patient instructions that come 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.

Before using, follow the instructions on how to properly prime the bottle. Spray this medication in the nose 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 the container. Discard the container after you have used the number of sprays specified on the package.

If this medication is used by a child, 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. You may need to use another dose if your doctor directs you to do so. This medication is not used on a regular schedule. Do not use more desmopressin or use it more often or for longer than prescribed.

If using before surgery, give the dose 2 hours before the procedure as directed.

Tell your doctor if your bleeding is not controlled.

Consumer Overview Side Effect

SIDE EFFECTS: Headache, runny/stuffy nose, nausea, upset stomach, or flushing of the face may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Desmopressin reduces the amount of urine your kidneys make. It may affect the balance of water and minerals in your body. Desmopressin can infrequently cause a low level of sodium in the blood, which can be serious and possibly life-threatening. Drinking too much water or other fluids increases the risk of having a low level of sodium in the blood. Therefore, follow your doctor's directions for limiting fluids. Seek immediate medical attention if you have any of these unlikely but serious symptoms of a low level of sodium in the blood: loss of appetite, severe nausea, vomiting, severe headache, muscle weakness/spasms/cramps, sudden weight gain, unusual tiredness, unusual severe drowsiness, mental/mood changes (such as confusion, hallucinations, irritability), loss of consciousness, seizures, slow/shallow breathing.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Stimate (desmopressin acetate nasal spray) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using desmopressin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, a low level of sodium in the blood (current or past hyponatremia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart disease (such as blocked blood vessels in the heart), conditions that may increase your risk of fluid/mineral imbalance (such as cystic fibrosis, heart failure), the urge to drink too much water without being thirsty.

If you have lost too much body water (become dehydrated), your doctor will correct that condition first before starting treatment with desmopressin.

Limit alcohol because it can interfere with how well desmopressin works.

Changes inside the nose (such as scarring, swelling, congestion, or blockage) may affect how well desmopressin nasal spray is absorbed. Tell your doctor if you have any of these changes inside the nose because he or she may need to adjust your treatment.

Tell the doctor immediately if you develop any illness that can cause water/mineral imbalance (including fever, diarrhea, vomiting, infections such as the flu) or if you experience conditions that require drinking more fluids (for example, exposure to very hot weather, strenuous exercise, persistent sweating). The doctor may need to stop or adjust desmopressin treatment, especially in children and older adults.

Children may be more sensitive to the side effects of this drug, especially water/mineral imbalance and a low level of sodium in the blood.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be at greater risk for water/mineral imbalance and a low level of sodium in the blood while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: 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).

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, drowsiness, persistent/severe headache, sudden weight gain.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as blood tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: This medication is used as needed for bleeding episodes as directed by your doctor. It is not for regular (scheduled) use.

 

STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist.

Keep the bottle upright. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: DDAVP Nasal, DDAVP Rhinal Tube, Stimate

Generic Name: desmopressin (nasal) (Pronunciation: DEZ mo press in)

  • What is desmopressin nasal (Stimate)?
  • What are the possible side effects of desmopressin nasal (Stimate)?
  • What is the most important information I should know about desmopressin nasal (Stimate)?
  • What should I discuss with my healthcare provider before using desmopressin nasal (Stimate)?
  • How should I use desmopressin nasal (Stimate)?
  • What happens if I miss a dose (Stimate)?
  • What happens if I overdose (Stimate)?
  • What should I avoid while using desmopressin nasal (Stimate)?
  • What other drugs will affect desmopressin nasal (Stimate)?
  • Where can I get more information?

What is desmopressin nasal (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.

What are the possible side effects of desmopressin nasal (Stimate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using desmopressin nasal and call your doctor at once if you have any of these serious side effects:

  • nausea, vomiting, weakness, loss of appetite, headache, feeling restless or irritable, confusion, hallucinations, muscle pain or weakness, and/or seizure;
  • feeling like you might pass out;
  • swelling;
  • chest pain, fast or pounding heart rate;
  • vaginal pain;
  • nosebleed; or
  • dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

  • runny or stuffy nose;
  • sore throat, cough, or other cold symptoms;
  • eye redness or watering;
  • eye itching or increased sensitivity to light;
  • headache, weakness;
  • feeling dizzy or agitated;
  • nausea, vomiting, stomach pain;
  • hot or cold feeling; or
  • warmth, redness, or tingly feeling in your face.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Stimate (desmopressin acetate nasal spray) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about desmopressin nasal (Stimate)?

It is very important to reduce your intake of water and other fluids while you are using desmopressin. Drinking too much water can cause your body to lose sodium, which may lead to a serious, life-threatening electrolyte imbalance.

Fluid restriction is especially important in children and older adults using desmopressin nasal. Follow your doctor's instructions about the type and amount of liquids you should drink.

You should not use this medication if you have severe kidney disease or if you have ever had hyponatremia (low sodium levels in your body).

Before using desmopressin nasal, tell your doctor if you have heart disease, coronary artery disease, congestive heart failure, kidney disease, cystic fibrosis, high or low blood pressure, an electrolyte imbalance, or a psychological disorder that causes extreme or unusual thirst.

Desmopressin nasal may be less effective if you have any swelling or scarring inside your nose, or any nasal or sinus problems (such as deviated septum).

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

To be sure desmopressin nasal is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with this medication. Do not miss any scheduled appointments.

Side Effects Centers
  • Stimate
  • DDAVP Nasal Spray
  • DDAVP Rhinal Tube

Patient Detailed How Take

What should I discuss with my healthcare provider before using desmopressin nasal (Stimate)?

You should not use this medication if you are allergic to desmopressin, or if you have:

  • severe kidney disease; or
  • if you have ever had hyponatremia (low sodium levels in your body).

Before using desmopressin nasal, tell your doctor if you are allergic to any medications, or if you have:

  • heart disease, coronary artery disease;
  • congestive heart failure;
  • kidney disease;
  • cystic fibrosis;
  • high or low blood pressure;
  • an electrolyte imbalance; or
  • a psychologic disorder that causes extreme or unusual thirst.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use desmopressin.

Desmopressin nasal may be less effective if you have any swelling or scarring inside your nose, or any nasal or sinus problems (such as deviated septum).

FDA pregnancy category B. This medication is not expected to harm an unborn baby. Do not use desmopressin nasal without telling your doctor if you are pregnant.

It is not known whether desmopressin nasal passes into breast milk, or if it could harm a nursing baby. Do not use desmopressin nasal without telling your doctor if you are breast-feeding a baby.

How should I use desmopressin nasal (Stimate)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

It is very important to reduce your intake of water and other fluids while you are using desmopressin. Drinking too much water can cause your body to lose sodium, which may lead to a serious, life-threatening electrolyte imbalance.

Fluid restriction is especially important in children and older adults using desmopressin nasal. Follow your doctor's instructions about the type and amount of liquids you should drink.

Before using desmopressin nasal spray for the first time, prime the spray pump by pressing down on the pump 4 times.

To be sure this medication is helping your condition, your blood will need to be tested often. This will help your doctor determine how long to treat you with desmopressin nasal. Do not miss any scheduled appointments.

Keep track of how many sprays have been used from each bottle of desmopressin nasal spray. Stimate nasal spray contains enough desmopressin for the priming spray plus 25 full sprays. DDAVP nasal spray contains enough desmopressin for the priming spray plus 50 sprays. Your patient instructions may include a check-off chart to help you keep an accurate record or sprays you use.

If you are treating hemophilia or von Willebrand's disease, call your doctor if your bleeding is not controlled during treatment with desmopressin nasal.

The desmopressin nasal spray bottle should be thrown away after the specified number of sprays have been used, even if there is medicine leftover in the bottle. Do not try to pour solution from one bottle to another.

Store DDAVP nasal spray at room temperature away from moisture and heat. Keep the bottle in an upright position when not in use.

Store Stimate nasal spray or DDAVP Rhinal Tube in the refrigerator. Do not freeze. If refrigeration is not available, you may keep the closed bottles at room temperature for up to 3 weeks.

Side Effects Centers
  • Stimate
  • DDAVP Nasal Spray
  • DDAVP Rhinal Tube

Patient Detailed Avoid Taking

What happens if I miss a dose (Stimate)?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Stimate)?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include headache, confusion, drowsiness, rapid weight gain, or urination problems.

What should I avoid while using desmopressin nasal (Stimate)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using desmopressin.

What other drugs will affect desmopressin nasal (Stimate)?

Many drugs can interact with desmopressin nasal. Below is just a partial list. Tell your doctor if you are using:

  • carbamazepine (Carbatrol, Tegretol);
  • chlorpromazine (Thorazine);
  • lamotrigine (Lamictal);
  • oxybutynin (Ditropan, Urotrol, Oxytrol);
  • vasopressin (Pitressin);
  • a narcotic pain medicine such as fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin), oxycodone (Oxycontin), and others;
  • an "SSRI" antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft);
  • a tricyclic antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), and others;
  • medicine to treat erectile dysfunction, such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra);
  • drugs to treat high blood pressure or a prostate disorder, such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), terazosin (Hytrin), tamsulosin (Flomax);
  • a beta-blocker such as atenolol (Tenormin), bisoprolol (Zebeta, Ziac), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), or timolol (Blocadren); or
  • an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), and others.

This list is not complete and there may be other drugs that can interact with desmopressin nasal. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about desmopressin nasal.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 2.09. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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  • DDAVP Rhinal Tube

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