DDAVP Injection

DRUG DESCRIPTION

DDAVP® Injection (desmopressin acetate) 4 mcg/mL 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 Injection (desmopressin acetate injection) 4 mcg/mL is provided as a sterile, aqueous solution
for injection. Each mL provides:

Desmopressin acetate 4.0 mcg

Sodium chloride          9.0 mg

Hydrochloric acid to adjust pH to 4.

The 10 mL vial contains chlorobutanol as a preservative (5.0
mg/mL).

What are the possible side effects of desmopressin (DDAVP)?

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 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 or heavy feeling, pain...

Read All Potential Side Effects and See Pictures of DDAVP Injection »

What are the precautions when taking desmopressin acetate injection (DDAVP Injection)?

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 or low 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...

Read All Potential Precautions of DDAVP Injection »

DDAVP Injection Consumer (continued)

SIDE EFFECTS: Headache, nausea, upset stomach, flushing of the face, or redness/pain/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, desmopressin may affect your blood pressure. It may cause an increase or decrease in your blood pressure. A temporary drop in your blood pressure may result in dizziness and a fast heartbeat. Ask your doctor for more details, especially if you have heart problems or high or low blood pressure. Tell your doctor promptly if changes in your blood pressure occur or if any of these symptoms occur.

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 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.

Seek immediate medical attention if any of these rare but serious side effects occur: chest pain, weakness on one side of the body, slurred speech, sudden vision changes.

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 or low 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, history of blood clots.

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

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Alcohol can also interfere with how well desmopressin works.

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.

DDAVP Injection Patient Information Including Side Effects

Brand Names: DDAVP

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

• What is desmopressin (DDAVP Injection)?


• What are the possible side effects of desmopressin (DDAVP Injection)?


• What is the most important information I should know about injectable desmopressin (DDAVP Injection)?


• What should I discuss with my healthcare provider before using injectable desmopressin (DDAVP Injection)?


• How is injectable desmopressin given (DDAVP Injection)?


• What happens if I miss a dose (DDAVP Injection)?


• What happens if I overdose (DDAVP Injection)?


• What should I avoid while using desmopressin (DDAVP Injection)?


• What other drugs will affect desmopressin (DDAVP Injection)?


• Where can I get more information?

What is desmopressin (DDAVP Injection)?

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 injection is used to treat hemophilia A or von Willebrand's disease Type I.

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

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

What are the possible side effects of desmopressin (DDAVP Injection)?

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 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 or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;


• sudden numbness or weakness, headache, confusion, or problems with vision, speech, or balance;


• vaginal pain; 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:

• headache;


• nausea, mild stomach pain;


• diarrhea;


• warmth, redness, or tingly feeling in your face; or


• pain, redness, or swelling where the medicine was injected.

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 injectable desmopressin (DDAVP Injection)?

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. 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, 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.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

To be sure desmopressin 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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