Drugs Details

Drugs Info of DDAVP
Drugs Details
  • Drugs Type  : Multum
  • Date : 15th Jan 2015 03:44 am
  • Brand Name : DDAVP
  • Generic Name : desmopressin (injection) (Pronunciation: DEZ mo press in)
Descriptions

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

DDAVP® (desmopressin acetate)  structural formula illustration

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 spreading to the arm or shoulder, nausea, sweating,...

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 »


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

Indications

Hemophilia A: DDAVP Injection (desmopressin acetate injection) 4 mcg/mL is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%.

DDAVP will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure.

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

DDAVP 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.

In certain clinical situations, it may be justified to try DDAVP in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored.

von Willebrand's Disease (Type I): DDAVP Injection (desmopressin acetate injection) 4 mcg/mL is indicated for patients with mild to moderate classic von Willebrand's disease (Type I) with factor VIII levels greater than 5%. DDAVP will often maintain hemostasis in patients with mild to moderate von Willebrand's disease during surgical procedures and postoperatively when administered 30 minutes prior to the scheduled procedure.

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

Those von Willebrand's disease patients who are least likely to respond are those with severe homozygous von Willebrand's disease with factor VIII coagulant activity and factor VIII von Willebrand factor antigen levels less than 1%. Other 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 during administration of DDAVP to ensure that adequate levels are being achieved.

DDAVP 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.)

Diabetes Insipidus: DDAVP Injection (desmopressin acetate injection) 4 mcg/mL is indicated as antidiuretic replacement therapy in the management of central (a href="/script/main/art.asp?articlekey=9250">cranial) diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. DDAVP is ineffective for the treatment of nephrogenic diabetes insipidus.

DDAVP is also available as an intranasal preparation. However, this means of delivery can be compromised by a variety of factors that can make nasal insufflation ineffective or inappropriate. These include poor intranasal absorption, nasal congestion and blockage, nasal discharge, atrophy of nasal mucosa, and severe atrophic rhinitis. Intranasal delivery may be inappropriate where there is an impaired level of consciousness. In addition, cranial surgical procedures, such as transsphenoidal hypophysectomy, create situations where an alternative route of administration is needed as in cases of nasal packing or recovery from surgery.

Dosage Administration

Hemophilia A and von Willebrand's Disease (Type I): DDAVP Injection (desmopressin acetate injection) 4 mcg/mL is administered as an intravenous infusion at a dose of 0.3 mcg DDAVP/kg body weight diluted in sterile physiological saline and infused slowly over 15 to 30 minutes. In adults and children weighing more than 10 kg, 50 mL of diluent is recommended; in children weighing 10 kg or less, 10 mL of diluent is recommended. Blood pressure and pulse should be monitored during infusion. If DDAVP Injection (desmopressin acetate injection) 4 mcg/mL is used preoperatively, it should be administered 30 minutes prior to the scheduled procedure.

The necessity for repeat administration of DDAVP or use of any blood products for hemostasis should be determined by laboratory response as well as the clinical condition of the patient. The tendency toward tachyphylaxis (lessening of response) with repeated administration given more frequently than every 48 hours should be considered in treating each patient.

Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

Diabetes Insipidus: This formulation is administered subcutaneously or by direct intravenous injection. DDAVP Injection (desmopressin acetate injection) 4 mcg/mL dosage must be determined for each patient and adjusted according to the pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover.

The usual dosage range in adults is 0.5 mL (2.0 mcg) to 1 mL (4.0 mcg) daily, administered intravenously or subcutaneously, usually in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For patients who have been controlled on intranasal DDAVP and who must be switched to the injection form, either because of poor intranasal absorption or because of the need for surgery, the comparable antidiuretic dose of the injection is about one-tenth the intranasal dose.

Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Geriatric Use: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY, Human Pharmacokinetics, CONTRAINDICATIONS, and PRECAUTIONS, Geriatric Use.)

Directions for use of One Point Cut (OPC) Ampules for DDAVP Injection (desmopressin acetate injection) :

  1. Use aseptic technique to clean ampule. Gently tap the top of the ampule to assist the flow of the solution from the upper portion of the ampule to the lower portion.
  2. Locate the blue dot on the upper portion of the ampule. Below this dot is a small score on the neck of the ampule. Hold the ampule with the blue dot facing away from you.
  3. Cover the vial with an appropriate wipe. Apply pressure to the top and bottom portions of the ampule to snap the ampule open away from you.

How Supplied

DDAVP Injection (desmopressin acetate injection) 4 mcg/mL is available as a sterile solution in cartons of ten 1 mL single-dose ampules (NDC 0075-2451-01) and in 10 mL multiple-dose vials (NDC 0075-2451-53), each containing 4.0 mcg DDAVP per mL.

Store refrigerated 2 to 8°C (36 to 46°F).

Keep out of the reach of children.

Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807 Rev. July 2007. FDA Rev date: 10/26/2007


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

Side Effects

Infrequently, DDAVP has produced transient headache, nausea, mild abdominal cramps and vulval pain. These symptoms disappeared with reduction in dosage. Occasionally, injection of DDAVP has produced local erythema, swelling or burning pain. Occasional facial flushing has been reported with the administration of DDAVP. DDAVP Injection (desmopressin acetate injection) has infrequently produced changes in blood pressure causing either a slight elevation or a transient fall and a compensatory increase in heart rate. Severe allergic reactions including anaphylaxis have been reported rarely with DDAVP Injection.

See WARNINGS for the possibility of water intoxication and hyponatremia.

Post Marketing: There have been rare reports of thrombotic events (acute cerebrovascular thrombosis, acute myocardial infarction) following DDAVP Injection in patients predisposed to thrombus formation, and rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutinin and imipramine.

Read the DDAVP Injection (desmopressin acetate injection) Side Effects Center for a complete guide to possible side effects

Interactions

Although the pressor activity of DDAVP is very low compared with the antidiuretic activity, use of doses as large as 0.3 mcg/kg of DDAVP 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, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine and carbamazepine) should be performed with caution.

DDAVP 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

  1. Very rare cases of hyponatremia have been reported from world-wide postmarketing experience in patients treated with DDAVP (desmopressin acetate). DDAVP 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.
  2. When DDAVP Injection (desmopressin acetate injection) is administered to patients who do not have need of antidiuretic hormone for its antidiuretic effect, in particular in pediatric and geriatric patients, fluid intake should be adjusted downward to decrease the potential occurrence of water intoxication and hyponatremia. (See PRECAUTIONS, Pediatric Use and Geriatric Use.) All patients receiving DDAVP therapy should be observed for the following signs of 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 which could lead to coma.
  3. DDAVP should not be used to treat patients with Type IIB von Willebrand's disease since platelet aggregation may be induced.
  4. DDAVP should be used with caution in patients with habitual or psychogenic polydipsia who may be more likely to drink excessive amounts of water, putting them at greater risk of hyponatremia.

Precautions

General: For injection use only.

DDAVP Injection (desmopressin acetate) 4 mcg/mL 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.

DDAVP (desmopressin acetate) 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 following DDAVP Injection (desmopressin acetate injection) 4 mcg/mL 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. Anaphylaxis has been reported rarely with intravenous and intranasal DDAVP, including isolated cases of fatal anaphylaxis with intravenous DDAVP. It is not known whether antibodies to DDAVP Injection 4 mcg/mL are produced after repeated injections.

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 DDAVP for hemostasis. If factor VIII coagulant activity is present at less than 5% of normal, DDAVP should not be relied on.

von Willebrand's Disease: Laboratory tests for assessing patient status include levels of factor VIII coagulant activity, factor VIII ristocetin cofactor activity, and factor VIII von Willebrand factor antigen. The skin bleeding time may be helpful in following these patients.

Diabetes Insipidus: Laboratory tests for monitoring the patient include urine volume and osmolality. In some cases, plasma osmolality may be required.

Carcinogenicity, Mutagenicity, Impairment of Fertility: Studies with DDAVP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy Category B: Fertility studies have not been done. Teratology studies in rats and rabbits at doses from 0.05 to 10 mcg/kg/day (approximately 0.1 times the maximum systemic human exposure in rats and up to 38 times the maximum systemic human exposure in rabbits based on surface area, mg/m2) revealed no harm to the fetus due to DDAVP. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

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 fifteen 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; however, the statistical power of this study is low. 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 DDAVP is administered to a nursing woman.

Pediatric Use: Use in infants and pediatric patients will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient and/or guardian. (See WARNINGS.) DDAVP Injection (desmopressin acetate injection) 4 mcg/mL should not be used in infants less than three months of age in the treatment of hemophilia A or von Willebrand's disease; safety and effectiveness in pediatric patients under 12 years of age with diabetes insipidus have not been established.

Geriatric Use: Clinical studies of DDAVP Injection (desmopressin acetate injection) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. DDAVP is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min). (See CLINICAL PHARMACOLOGY, Human Pharmacokinetics and CONTRAINDICATIONS )

Use of DDAVP injection (desmopressin acetate injection) in geriatric patients will require careful fluid intake restrictions to prevent possible hyponatremia and water intoxication. Fluid restriction should be discussed with the patient. (See WARNINGS.)


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 case 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 DDAVP Injection (desmopressin acetate injection) 4 mcg/mL.

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

ContrainDications

DDAVP Injection (desmopressin acetate injection) 4 mcg/mL is contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of DDAVP Injection 4 mcg/mL.

DDAVP is contraindicated in patients with moderate to severe renal impairment (defined as a creatinine clearance below 50ml/min).

DDAVP is contraindicated in patients with hyponatremia or a history of hyponatremia.


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

Clinical Pharamacology

DDAVP Injection (desmopressin acetate injection) 4 mcg/mL contains as active substance, desmopressin acetate, a synthetic analogue of the natural hormone arginine vasopressin. One mL (4 mcg) of DDAVP (desmopressin acetate) solution has an antidiuretic activity of about 16 IU; 1 mcg of DDAVP is equivalent to 4 IU.

DDAVP 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 0.1 to 0.4 mcg/kg body weight, infused over a 10-minute period. Maximal dose response occurred at 0.3 to 0.4 mcg/kg. The response to DDAVP of factor VIII activity and plasminogen activator is dose-related, with maximal plasma levels of 300 to 400 percent of initial concentrations obtained after infusion of 0.4 mcg/kg body weight. The increase is rapid and evident within 30 minutes, reaching a maximum at a point ranging from 90 minutes to two hours. The factor VIII related antigen and ristocetin cofactor activity were also increased to a smaller degree, but still are dose-dependent.

  1. The biphasic half-lives of DDAVP were 7.8 and 75.5 minutes for the fast and slow phases, respectively, compared with 2.5 and 14.5 minutes for lysine vasopressin, another form of the hormone. As a result, DDAVP provides a prompt onset of antidiuretic action with a long duration after each administration.
  2. The change in structure of arginine vasopressin to DDAVP 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.
  3. 3. When administered by injection, DDAVP has an antidiuretic effect about ten times that of an equivalent dose administered intranasally.
  4. The bioavailability of the subcutaneous route of administration was determined qualitatively using urine output data. The exact fraction of drug absorbed by that route of administration has not been quantitatively determined.
  5. The percentage increase of factor VIII levels in patients with mild hemophilia A and von Willebrand's disease was not significantly different from that observed in normal healthy individuals when treated with 0.3 mcg/kg of DDAVP infused over 10 minutes.
  6. Plasminogen activator activity increases rapidly after DDAVP infusion, but there has been no clinically significant fibrinolysis in patients treated with DDAVP.
  7. The effect of repeated DDAVP administration when doses were given every 12 to 24 hours has generally shown a gradual diminution of the factor VIII activity increase noted with a single dose. The initial response is reproducible in any particular patient if there are 2 or 3 days between administrations.

Human Pharmacokinetics: DDAVP is mainly excreted in the urine. A pharmacokinetic study conducted in healthy volunteers and patients with mild, moderate, and severe renal impairment (n=24, 6 subjects in each group) receiving single dose desmopressin acetate (2mcg) injection demonstrated a difference in DDAVP terminal half-life. Terminal half-life significantly increased from 3 hours in normal healthy patients to 9 hours in patients with severe renal impairment. (See CONTRAINDICATIONS.)


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

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.


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 - INJECTION

 

(dess-mow-PRESS-in)

 

COMMON BRAND NAME(S): DDAVP

 

USES: Desmopressin is used to control the amount of urine your kidneys make. Normally, the amount of urine you make is controlled by a certain substance in the body called vasopressin. In people who have "water diabetes" (diabetes insipidus) or certain kinds of head injury or brain surgery, the body does not make enough vasopressin. Desmopressin is a man-made form of vasopressin and is used to replace a low level of vasopressin. This medication helps to control increased thirst and too much urination due to these conditions, and helps prevent dehydration.

Desmopressin is also used to control bleeding caused by surgery or injuries in people with certain bleeding problems (hemophilia A, type 1 von Willebrand's disease). It works by helping the body with normal blood clotting.

 

HOW TO USE: This medication is given by injection into a vein or under the skin by a health care professional.

When this medication is used to control increased thirst and too much urination, it is usually given twice a day or as directed by your doctor. If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. If you have any questions about using this medication properly, consult your doctor or pharmacist.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more details.

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 section.)

Dosage is based on your medical condition and response to treatment. Do not use more desmopressin or use it more often than prescribed.

Tell your doctor if your condition does not improve or if this medication stops working well.

Consumer Overview Side Effect

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.

 

Read the DDAVP Injection (desmopressin acetate injection) 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 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.

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 urine tests, blood tests, blood pressure, pulse) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store this medication in the refrigerator between 36-46 degrees F (2-8 degrees C). Do not freeze. 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

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.

Read the DDAVP Injection (desmopressin acetate injection) Side Effects Center for a complete guide to possible side effects

Learn More »

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.

Side Effects Centers
  • DDAVP Injection

Patient Detailed How Take

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

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, 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.

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

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

How is injectable desmopressin given (DDAVP Injection)?

Desmopressin is given as an injection under your skin or through a needle placed into a vein. In some cases, a healthcare provider will give you this injection. In other cases, you may be shown how to use your medicine at home.

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.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

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.

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. Do not miss any scheduled appointments.

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

Store this medicine in the refrigerator. Do not freeze.

Side Effects Centers
  • DDAVP Injection

Patient Detailed Avoid Taking

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

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 (DDAVP Injection)?

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 (DDAVP Injection)?

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

What other drugs will affect desmopressin (DDAVP Injection)?

Many drugs can interact with desmopressin. 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. 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.


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.

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