Drugs Details

Drugs Info of DDAVP Nasal, DDAVP Rhinal Tube, Stimate
Drugs Details
  • Drugs Type  : Multum
  • Date : 15th Jan 2015 03:56 am
  • Brand Name : DDAVP Nasal, DDAVP Rhinal Tube, Stimate
  • Generic Name :  desmopressin (nasal) (Pronunciation: DEZ mo press in)
Descriptions

DDAVP® Nasal Spray (desmopressin acetate) 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 Nasal Spray (desmopressin acetate nasal spray) is provided as an aqueous solution for intranasal use.

Each mL contains:
Desmopressin acetate ..... 0.1 mg
Sodium Chloride ..... 7.5 mg
Citric acid monohydrate ..... 1.7 mg
Disodium phosphate dihydrate ..... 3.0 mg
Benzalkonium chloride solution (50%) ..... 0.2 mg

The DDAVP Nasal Spray compression pump delivers 0.1 mL (10 mcg) of DDAVP (desmopressin acetate) per spray.

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 DDAVP Nasal Spray »

What are the precautions when taking desmopressin acetate nasal spray (DDAVP Nasal Spray)?

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 DDAVP Nasal Spray »


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

Indications

Central Cranial Diabetes Insipidus: DDAVP Nasal Spray (desmopressin acetate nasal spray) is indicated as antidiuretic replacement therapy in the management of central cranial diabetes insipidus and for management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. It is ineffective for the treatment of nephrogenic diabetes insipidus.

The use of DDAVP Nasal Spray (desmopressin acetate nasal spray) in patients with an established diagnosis will result in a reduction in urinary output with increase in urine osmolality and a decrease in plasma osmolality. This will allow the resumption of a more normal life-style with a decrease in urinary frequency and nocturia.

There are reports of an occasional change in response with time, usually greater than 6 months. Some patients may show a decreased responsiveness, others a shortened duration of effect. There is no evidence this effect is due to the development of binding antibodies but may be due to a local inactivation of the peptide.

Patients are selected for therapy by establishing the diagnosis by means of the water deprivation test, the hypertonic saline infusion test, and/or the response to antidiuretic hormone. Continued response to intranasal DDAVP can be monitored by urine volume and osmolality.

DDAVP is also available as a solution for 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. 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

Central Cranial Diabetes Insipidus: DDAVP Nasal Spray (desmopressin acetate nasal spray) dosage must be determined for each individual patient and adjusted according to the diurnal pattern of response. Response should be estimated by two parameters: adequate duration of sleep and adequate, not excessive, water turnover. Patients with nasal congestion and blockage have often responded well to intranasal DDAVP. The usual dosage range in adults is 0.1 to 0.4 mL daily, either as a single dose or divided into two or three doses. Most adults require 0.2 mL daily in two divided doses. The morning and evening doses should be separately adjusted for an adequate diurnal rhythm of water turnover. For children aged 3 months to 12 years, the usual dosage range is 0.05 to 0.3 mL daily, either as a single dose or divided into two doses. About 1/4 to 1/3 of patients can be controlled by a single daily dose of DDAVP administered intranasally. Fluid restriction should be observed. (See WARNINGS, PRECAUTIONS, Pediatric Use and Geriatric Use.)

The nasal spray pump can only deliver doses of 0.1 mL (10 mcg) or multiples of 0.1 mL. If doses other than these are required, the rhinal tube delivery system may be used.

The spray pump must be primed prior to the first use. To prime pump, press down four times. The bottle will now deliver 10 mcg of drug per spray. Discard DDAVP Nasal Spray (desmopressin acetate nasal spray) after 50 sprays since the amount delivered thereafter per spray may be substantially less than 10 µg of drug.

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.)

How Supplied

DDAVP Nasal Spray (desmopressin acetate nasal spray) is available in a 5-mL bottle with spray pump delivering 50 sprays of 10 mcg (NDC 0075-2452-01). Desmopressin acetate is also available as DDAVP Rhinal Tube, a refrigerated product with 2.5 mL per bottle, packaged with two rhinal tube applicators per carton (NDC 0075-2450-01).

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP]. STORE BOTTLE IN UPRIGHT POSITION.

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, high dosages 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.

The following table lists the percentage of patients having adverse experiences without regard to relationship to study drug from the pooled pivotal study data for nocturnal enuresis.

ADVERSE REACTION PLACEBO
(N=59)
DDAVP
20 mcg
(N=60)
DDAVP
40 mcg
(N=61)
  % % %
BODY AS A WHOLE
  Abdominal Pain 0 2 2
  Asthenia 0 0 2
  Chills 0 0 2
  Headache 0 2 5
NERVOUS SYSTEM
  Dizziness 0 0 3
RESPIRATORY SYSTEM
  Epistaxis 2 3 0
  Nostril Pain 0 2 0
  Rhinitis 2 8 3
DIGESTIVE SYSTEM
  Gastrointestinal Disorder 0 2 0
  Nausea 0 0 2
SPECIAL SENSES
  Conjunctivitis 0 2 0
  Edema Eyes 0 2 0
  Lachrymation Disorder 0 0 2

Post Marketing: There have been rare reports of hyponatremic convulsions associated with concomitant use with the following medications: oxybutinin and imipramine.

See WARNINGS for the possibility of water intoxication and hyponatremia.

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

Interactions

Although the pressor activity of DDAVP is very low compared to the antidiuretic activity, use of large doses of intranasal DDAVP with other pressor agents should only be done 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.


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

Warnings

  1. For intranasal use only.
  2. DDAVP Nasal Spray (desmopressin acetate nasal spray) should only be used in patients where orally administered formulations are not feasible.
  3. 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.
  4. When DDAVP Nasal Spray (desmopressin acetate 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 DDAVP 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 which could lead to coma.
  5. 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: Intranasal DDAVP at high dosage has infrequently produced a slight elevation of blood pressure, which disappeared with a reduction in dosage. The drug should be used with caution in patients with coronary artery insufficiency and/or hypertensive cardiovascular disease because of possible rise in blood pressure.

DDAVP 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.

Rare severe allergic reactions have been reported with DDAVP. Anaphylaxis has been reported rarely with intravenous and intranasal administration of DDAVP.

Central Cranial Diabetes Insipidus: Since DDAVP is used intranasally, changes in the nasal mucosa such as scarring, edema, or other disease may cause erratic, unreliable absorption in which case intranasal DDAVP should not be used. For such situations, DDAVP Injection should be considered.

Information for Patients: Ensure that in children administration is under adult supervision in order to control the dose intake. Patients should be informed that the DDAVP Nasal Spray (desmopressin acetate nasal spray) bottle accurately delivers 50 doses of 10 mcg each. Any solution remaining after 50 doses should be discarded since the amount delivered thereafter may be substantially less than 10 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.

Fluid intake should be adjusted downward based upon discussion with the physician.

Laboratory Tests: Laboratory tests for following the patient with central cranial diabetes insipidus or post-surgical or head trauma-related polyuria and polydipsia include urine volume and osmolality. In some cases plasma osmolality measurements may be required.

Carcinogenesis, Mutagenesis, 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 (desmopressin acetate). 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 a post-partum woman 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: Central Cranial Diabetes Insipidus: DDAVP Nasal Spray has been used in children with diabetes insipidus. Use in infants and children will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. (See WARNINGS.) The dose must be individually adjusted to the patient with attention in the very young to the danger of an extreme decrease in plasma osmolality with resulting convulsions. Dose should start at 0.05 mL or less.

Since the spray cannot deliver less than 0.1 mL (10 mcg), smaller doses should be administered using the rhinal tube delivery system. Do not use the nasal spray in pediatric patients requiring less than 0.1 mL (10 mcg) per dose.

Geriatric Use: Clinical studies of DDAVP Nasal Spray (desmopressin acetate nasal spray) 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 subjects. In general, dose selection for an elderly patient 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 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 Nasal Spray (desmopressin acetate nasal spray) in geriatric patients will require careful fluid intake restriction to prevent possible hyponatremia and water intoxication. (See WARNINGS).

There are reports of an occasional change in response with time, usually greater than 6 months. Some patients may show a decreased responsiveness, others a shortened duration of effect. There is no evidence this effect is due to the development of binding antibodies but may be due to a local inactivation of the peptide.


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 dose 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 Nasal Spray.

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

ContrainDications

DDAVP Nasal Spray (desmopressin acetate nasal spray) is contraindicated in individuals with known hypersensitivity to desmopressin acetate or to any of the components of DDAVP Nasal Spray (desmopressin acetate nasal spray) .

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 contains as active substance desmopressin acetate, a synthetic analogue of the natural hormone arginine vasopressin. One mL (0.1 mg) of intranasal DDAVP has an antidiuretic activity of about 400 IU; 10 mcg of desmopressin acetate is equivalent to 40 IU.

  1. The biphasic half-lives for intranasal DDAVP were 7.8 and 75.5 minutes for the fast and slow phases, compared with 2.5 and 14.5 minutes for lysine vasopressin, another form of the hormone used in this condition. As a result, intranasal 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. DDAVP administered intranasally has an antidiuretic effect about one-tenth that of an equivalent dose administered by injection.

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

DDAVP® Nasal Spray
(desmopressin acetate)

A better way to deliver DDAVP

Delivering DDAVP more efficiently

Your doctor has prescribed DDAVP as antidiuretic hormone replacement therapy. Follow the dosage schedule that is specified. The convenient nasal spray pump provides an efficient, reliable way to administer your medication. It is important, however, to adhere completely to the following instructions so that you will always receive a consistent dose of your medication.

CAUTION: The nasal spray pump accurately delivers 50 doses of 10 micrograms each. Any solution remaining after 50 doses should be discarded since the amount delivered thereafter per actuation may be substantially less than 10 micrograms of drug. Do not transfer any remaining solution to another bottle. Please read the following instructions carefully before using the spray pump.

Ensure that in children administration is under adult supervision in order to control the dose intake.

If you accidentally deliver/administer too much of a dose, immediately telephone your doctor or a certified Regional Poison Center for advice. Possible signs of overdose may include confusion, drowsiness, continuing headache, problems with passing urine and rapid weight gain due to fluid retention.

Using your DDAVP Nasal Spray (desmopressin acetate nasal spray) Pump

  1. Remove protective cap.
  2. The spray pump must be primed prior to the first use. To prime pump, press down 4 times.
  3. Once primed, the spray pump delivers 10 micrograms of medication each time it is pressed. To ensure dosing accuracy, tilt bottle so that dip tube inside the bottle draws from the deepest portion of the medication.

     

    Using your DDAVP Nasal Spray Pump - illustration
    To administer a 10-microgram dose, place the spray nozzle in nostril and press the spray pump once. If a higher dose has been prescribed, spray half the dose in each nostril. The spray pump cannot be used for doses less than 10 micrograms or doses other than multiples of 10 micrograms.
  4. Replace the protective cap on bottle after use. The pump will stay primed for up to one week. If the product has not been used for a period of one week, re-prime the pump by pressing once.
  5. We have included a convenient check-off chart to assist you in keeping track of medication doses used. This will help assure that you receive 50 "full doses" of medication. Please note that the bottle has been filled with extra solution to accommodate the initial priming activity.

DDAVP Nasal Spray (desmopressin acetate nasal spray) 5
0-Dose Check-off

1 2 3 4 5
6 7 8 9 10
11 12 13 14 15
16 17 18 19 20
21 22 23 24 25
26 27 28 29 30
31 32 33 34 35
36 37 38 39 40
41 42 43 44 45
46 47 48 49 50
  1. Retain with medication or affix in convenient location.
  2. Starting with dose #1, check off after each administration.
  3. Discard medication after 50 doses.

Store at Controlled Room Temperature 20 to 25°C (68 to 77°F) [see USP]. STORE BOTTLE IN UPRIGHT POSITION.


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 SOLUTION - NASAL

 

(DES-moe-PRES-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 products applied in the nose are no longer indicated to control nighttime bedwetting in children because of the increased risk of developing a serious side effect (a low level of sodium in the blood).

 

HOW TO USE: Read the Patient Information Leaflet and instructions that come with your product. If you have any questions, consult your doctor or pharmacist.

Give this medication through the nose, usually 1 to 3 times a day as directed by your doctor. Use the marked tube that comes with your medication. Place your prescribed dose into the tube. Deliver the solution into your nose as directed. Wash the tube with water after use, and shake it until it is completely dry.

If a child is using this medication, 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. Do not use more desmopressin or use it more often than prescribed.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.

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

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 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 DDAVP Nasal Spray (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, bleeding/clotting problems.

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

 

MISSED DOSE: If you use 1 dose daily and miss a dose, use it as soon as you remember. If you do not remember until the next day, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

If you use more than 1 dose daily and 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 the US product in the refrigerator between 36-46 degrees F (2-8 degrees C). Do not freeze. When traveling, the US product may remain at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture for up to 3 weeks. Discard after 3 weeks out of the refrigerator.

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

What is desmopressin nasal (DDAVP Nasal Spray)?

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 (DDAVP Nasal Spray)?

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 DDAVP Nasal Spray (desmopressin acetate nasal spray) Side Effects Center for a complete guide to possible side effects

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What is the most important information I should know about desmopressin nasal (DDAVP Nasal Spray)?

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
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  • DDAVP Nasal Spray
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Patient Detailed How Take

What should I discuss with my healthcare provider before using desmopressin nasal (DDAVP Nasal Spray)?

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 (DDAVP Nasal Spray)?

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
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  • DDAVP Nasal Spray
  • DDAVP Rhinal Tube

Patient Detailed Avoid Taking

What happens if I miss a dose (DDAVP Nasal Spray)?

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 Nasal Spray)?

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 (DDAVP Nasal Spray)?

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 (DDAVP Nasal Spray)?

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.

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