Stimate

DRUG DESCRIPTION

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 Spraycontains 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;
  • ...

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 »


Stimate Consumer (continued)

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.

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.


Stimate Patient Information Including Side Effects

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.

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.

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  • Stimate
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