Stimate

Generic name: Desmopressin
Drug class: Antidiuretic hormones

Usage of Stimate

Desmopressin nasal spray is used to treat central cranial diabetes insipidus. This is a condition that causes the body to lose too much fluid and become dehydrated. It is also used to control frequent urination and increased thirst caused by certain types of brain injury or brain surgery. The Stimate® nasal spray is used to treat bleeding in patients with hemophilia A or von Willebrand disease (Type I).

Noctiva™ nasal spray is used to treat nocturnal polyuria in adults who awaken two or more times to urinate at night. Nocturnal polyuria is a condition where your body makes too much urine at night. Your doctor will need to measure your urine and the times that you urinate for 24 hours to determine if you have nocturnal polyuria.

Desmopressin is similar to a hormone that is produced in the body. It acts on the kidneys to reduce the flow of urine. For bleeding, desmopressin increases the blood levels of factor VIII and von Willebrand factor. This results in less bleeding for patients who have low levels of these agents.

This medicine is available only with your doctor's prescription.

Stimate side effects

Along with its needed effects, a medicine 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:

Rare

Chills

confusion

cough

difficulty swallowing

dizziness

drowsiness

fever

puffiness or swelling of the eyelids or around the eyes

seizures

skin rash, hives, or itching

tightness in the chest

trouble breathing

unusual tiredness or weakness

Incidence not known

Blurred vision

body aches or pain

chest pain

decreased urine output

ear congestion

fast, irregular, pounding, or racing heartbeat or pulse

headache

increased thirst

loss of consciousness

loss of voice

muscle pain or cramps

nausea

nervousness

nosebleed

pounding in the ears

runny or stuffy nose

slow or fast heartbeat

sneezing

sore throat

swelling of the face, ankles, or hands

vomiting

Some side effects 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:

Less common

Bloody nose

burning, dry, or itching eyes

diarrhea

eye discharge or excessive tearing

indigestion

loss of appetite

passing gas

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

stomach pain, fullness, or discomfort

Incidence not known

Belching

feeling of warmth

heartburn

redness of the face, neck, arms, and upper chest

sleepiness or unusual drowsiness

stomach cramps

trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Before taking Stimate

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific 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®. Safety and efficacy have been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Stimate® to treat hemophilia A and von Willebrand disease in children 11 months of age and older. However, use is not recommended in children younger than 11 months of age.

Appropriate studies have not been performed on the relationship of age to the effects of Noctiva™ in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of desmopressin nasal spray in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving desmopressin.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Noctiva™ in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood), which may require caution and an adjustment in the dose for patients receiving Noctiva™.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Alclometasone

Aldosterone

Amcinonide

Beclomethasone

Betamethasone

Budesonide

Bumetanide

Ciclesonide

Clobetasol

Clobetasone

Clocortolone

Cortisone

Deflazacort

Desonide

Desoximetasone

Dexamethasone

Diflorasone

Diflucortolone

Difluprednate

Ethacrynic Acid

Flucloronide

Fludrocortisone

Flumethasone

Flunisolide

Fluocinolone

Fluocinonide

Fluocortin

Fluocortolone

Fluorometholone

Flurandrenolide

Fluticasone

Furosemide

Halcinonide

Halobetasol

Hydrocortisone

Loteprednol

Medrysone

Methylprednisolone

Mometasone

Paramethasone

Prednicarbate

Prednisolone

Prednisone

Rimexolone

Torsemide

Triamcinolone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Aceclofenac

Acemetacin

Acetohexamide

Alfentanil

Amineptine

Amitriptyline

Amitriptylinoxide

Amoxapine

Amtolmetin Guacil

Anileridine

Aspirin

Bendroflumethiazide

Benzhydrocodone

Benzthiazide

Bromfenac

Bufexamac

Buprenorphine

Butorphanol

Carbamazepine

Celecoxib

Chlorothiazide

Chlorpromazine

Chlorpropamide

Chlorthalidone

Choline Salicylate

Citalopram

Clomipramine

Clonixin

Clopamide

Codeine

Desipramine

Dexibuprofen

Dexketoprofen

Dezocine

Diacetylmorphine

Diazoxide

Dibenzepin

Diclofenac

Difenoxin

Diflunisal

Dihydrocodeine

Diphenoxylate

Dipyrone

Doxepin

Droxicam

Escitalopram

Ethylmorphine

Etodolac

Etofenamate

Etoricoxib

Felbinac

Fenoprofen

Fentanyl

Fepradinol

Feprazone

Floctafenine

Flufenamic Acid

Fluoxetine

Flurbiprofen

Fluvoxamine

Gliclazide

Glimepiride

Glipizide

Gliquidone

Glyburide

Hydrochlorothiazide

Hydrocodone

Hydroflumethiazide

Hydromorphone

Ibuprofen

Imipramine

Indapamide

Indomethacin

Ketobemidone

Ketoprofen

Ketorolac

Lamotrigine

Levorphanol

Lofepramine

Lornoxicam

Loxoprofen

Lumiracoxib

Meclofenamate

Mefenamic Acid

Melitracen

Meloxicam

Meperidine

Meptazinol

Methadone

Methyclothiazide

Metolazone

Morniflumate

Morphine

Morphine Sulfate Liposome

Nabumetone

Nalbuphine

Naproxen

Nepafenac

Nicomorphine

Niflumic Acid

Nimesulide

Nimesulide Beta Cyclodextrin

Nortriptyline

Opipramol

Opium

Opium Alkaloids

Oxaprozin

Oxycodone

Oxymorphone

Oxyphenbutazone

Papaveretum

Parecoxib

Paregoric

Paroxetine

Pentazocine

Phenylbutazone

Piketoprofen

Piritramide

Piroxicam

Polythiazide

Pranoprofen

Proglumetacin

Propyphenazone

Proquazone

Protriptyline

Remifentanil

Rofecoxib

Salicylic Acid

Salsalate

Sertraline

Sodium Salicylate

Sufentanil

Sulindac

Tapentadol

Tenoxicam

Tianeptine

Tiaprofenic Acid

Tilidine

Tolazamide

Tolbutamide

Tolfenamic Acid

Tolmetin

Tolvaptan

Tramadol

Trichlormethiazide

Trimipramine

Valdecoxib

Vilazodone

Vortioxetine

Xipamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Relate drugs

How to use Stimate

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with Medication Guide or patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine should only be used in the nose.

Your doctor may limit the amount of fluid or water you drink. Follow the instructions carefully to prevent unwanted effects.

To use the nasal spray:

When used for the first time, the spray must be primed. Press the pump down 4 times. If the spray is not used for 1 week, prime the pump again by pressing once.

Gently blow your nose before using the spray. Tilt your head back slightly and insert the tip of the nose piece into your nostril.

Close the opposite nostril with a finger. Release one spray and breathe in gently at the same time.

Hold your breath for a few seconds then breathe out slowly through the mouth.

If a second dose is needed, spray the opposite nostril using the same steps.

Do not blow your nose or tip your head back after using the spray.

Wipe the tip of the bottle with a clean, dry tissue and replace the cap.

Throw away any unused medicine after 25 sprays (Stimate®) or 50 sprays (DDAVP® or desmopressin generic).

To use the DDAVP® Rhinal Tube nasal system:

The rhinal tube applicator is a soft, flexible plastic tube with numbers printed on the side. The numbers represent the dose.

Place the correct amount of medicine in the tube by inserting the tip of the container in the end of the tube that is marked with an arrow.

Put the end of the tube that is marked with an arrow into one nostril and put the other end into your mouth.

Hold your breath, tilt the head back, and blow with a short, strong puff until all the medicine is sprayed into the nose.

Do not let medicine run into your throat.

For young children, an adult must blow the medicine into the nose.

Wash the tube with water and shake it to remove all of the water.

Put the seal back on the container tip and replace the plastic cap.

To use the Noctiva™ nasal spray:

When used for the first time, the spray must be primed. Press the pump down 5 times. If the spray is not used for more than 3 days, prime the pump again by pressing 2 times.

Do not shake the bottle.

Gently blow your nose before using the spray. Tilt your head back slightly and insert the nasal applicator into your left or right nostril.

Close the opposite nostril with a finger. Release one spray and breathe in gently at the same time.

Wipe the nasal applicator with a clean, dry tissue and replace the cap.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For nasal dosage form (nasal spray):

For treatment of central diabetes insipidus:

DDAVP®:

Adults—10 micrograms (mcg) given into one nostril. Your doctor may increase your dose up to 40 mcg divided into 2 or 3 doses per day.

Children 4 years of age and older—At first, 10 mcg once a day into one nostril. Your doctor may increase the dose up to 30 mcg given once a day or divided into 2 doses (20 mcg in the morning and 10 mcg at nighttime).

Children younger than 4 years of age—Use is not recommended.

Desmopressin acetate:

Adults and children 13 years of age and older—0.1 to 0.4 milliliter (mL) given as a single dose or divided into 2 or 3 doses per day. The dose is given in one nostril or divided and given in both nostrils. Your doctor may adjust the dose as needed.

Children 3 months to 12 years of age—0.05 to 0.3 mL given as a single dose or divided into 2 doses per day. The dose is given in one nostril or divided and given in both nostrils. Your doctor may adjust the dose as needed.

Children younger than 3 months of age—Use and dose must be determined by your doctor.

For treatment of hemophilia A or won Willebrand disease:

Adults and children 13 years of age and older—One spray (0.1 milliliter) in each nostril as a single dose per day. Your doctor may adjust the dose as needed.

Children 11 months to 12 years of age—Use and dose must be determined by your doctor.

Children younger than 11 months of age—Use is not recommended.

For treatment of nocturnal polyuria:

Adults younger than 65 years of age who are not at increased risk for hyponatremia—One spray (1.66 micrograms [mcg]) in either left or right nostril 30 minutes before going to bed.

Older adults 65 years of age or older—At first, one spray (0.83 mcg) in either left or right nostril 30 minutes before going to bed. After 7 days, your doctor will increase your dose to 1.66 mcg as needed.

Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of Noctiva™, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

DDAVP® or desmopressin generic: Store at room temperature in an upright position.

DDAVP® Rhinal Tube System: Store in the refrigerator in an upright position. For travelers, the product is good for up to 3 weeks at room temperature.

Stimate®: Store at room temperature in an upright position. Throw the bottle away 6 months after it is used for the first time.

Noctiva™: Keep the unopened nasal spray bottle in the refrigerator in an upright position. You may store the opened bottle at room temperature. Throw away 60 days after opening.

Warnings

It is very important that your doctor check your or your child's progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.

Do not use Noctiva™ together with certain diuretics (eg, furosemide, torsemide, Demadex®, Lasix®) and systemic or inhaled glucocorticoids (eg, dexamethasone, fluticasone, methylprednisolone, prednisolone, prednisone, Cortef®, Medrol®).

This medicine lowers the amount of sodium in your blood. Check with your doctor right away if you have confusion, nausea, vomiting, muscle cramps or spasms, or unusual tiredness or weakness.

Desmopressin may rarely cause severe allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, swelling of the face, tongue, and throat, trouble breathing, or chest pain after you use this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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