Desmopressin

Generic name
Desmopressin
Brand name
ATC Code
H01BA02
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Desmopressin

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

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Treatment of slight to moderately severe bleeding and prevention of bleeding in more minor procedures in mild haemophilia A and Von Willebrand’s disease
  • Intravenous
    • 1 month up to 18 years
      [2] [19]
      • Desmopressine acetate 0.3 microg./kg/dose, once only.
        • Administer over 30 minutes depending on the pulse rate and blood pressure. Repeat after 12-24 hours if necessary.
        • Cave hyponatriemie (see warning section) Only to be administered to children under 3 years of age under clinical observation for 24 hours.
        • Treat in consultation with a haematologist
        • A desmopressin test should be performed prior to use in this indication to determine whether the patient with mild to moderate haemophilia has an adequate increase in factor VIII and does not experience excessive side effects. The factor VIII level should increase by about 3-4 times after administration of desmopressin (read more in warning section)
  • Nasal
    • 20 up to 40 kg
      [2]
      • Desmopressine acetate 150 microg./dose, once only.
        • Repeat after 12-24 hours if necessary.
        • Cave hyponatriemia (see warning section)
    • ≥ 40 kg
      [2]
      • Desmopressine acetate 300 microg./dose, once only.
        • Repeat after 12-24 hours if necessary.
        • Cave hyponatriemia (see warning section)
Nocturnal enuresis
  • Oral
    • 5 years up to 18 years
      [1] [3]
      • Desmopressin acetate
        Take 1-2 hours before going to bed 0.2         mg/day in 1 dose. Max: 0.4 mg/day.

      • The only place for this drug at ages under 12 years is for bridging short specific periods in which enuresis is a major issue, such as during school camps and sleepovers.In older children treatment should be discontinued for 1 week every 3 months  to assess if treatment is still indicated. 
        Cave hyponatriemia (see warning section)

  • Sublingual
    • 5 years up to 18 years
      [3] [4]
      • Desmopressine
        Take immediately before going to bed 120         microg./day in 1 dose. Max: 240 microg./day.

      • The only place for this drug at ages under 12 years is for bridging short specific periods in which enuresis is a major issue, such as during school camps and sleepovers. In older children treatment should be discontinued for 1 week every 3 months  to assess if treatment is still indicated. 
        Cave hyponatriemia (see warning section)
Diabetes insipidus
  • Oral
    • 1 year up to 12 years
      [3] [7]
      • Initial dose: Desmopressin acetate 25 - 50 microg./day in 1 - 2 doses.
      • Maintenance dose: Adjust the dose depending on the response to: 100 - 600 microg./day in 2 - 3 doses. Max: 1.200 microg./day.

      • Dose in consultation with endocrinologist/nephrologist.
        Cave hyponatriemia (see warning section)

    • 12 years up to 18 years
      [7]
      • Initial dose: Desmopressin acetate 50 - 100 microg./day in 1 - 2 doses.
      • Maintenance dose: Adjust the dose depending on the response to: 200 - 600 microg./day in 2 - 3 doses. Max: 1.200 microg./day.

      • Dose in consultation with endocrinologist/nephrologist.
        Cave hyponatriemie (see warning section)

  • Sublingual
    • 2 years up to 18 years
      [4] [7]
      • Initial dose: Desmopressin  60 - 180 microg./day in 1 - 3 doses.
      • Maintenance dose: Adjust the dose depending on the response to 180 - 360 microg./day in 1 - 3 doses. Max: 720 microg./day.

      • Dose in consultation with endocrinologist/nephrologist.
        Cave hyponatriemia (see warning section)

  • Nasal
    • 1 month up to 2 years
      [5]
      • Desmopressin actetate
        Give a test dose of 1 - 2.5         microg./dose, once only. then adjust based on the 24-hour urine production volume and the urine osmolality.

      • Dose in consultation with endocrinologist/nephrologist.
        Cave hyponatriemia (see warning section)

    • 2 years up to 18 years
      [5]
      • Desmopressin acetate
        Give a test dose of 5         microg./dose, once only. then adjust based on the 24-hour urine production volume and the urine osmolality.

      • Dose in consultation with endocrinologist/nephrologist.
        Cave hyponatriemia (see warning section)

  • Intravenous
    • 1 month up to 18 years
      [6] [7]
      • Initial dose: Desmopressin acetate 0.005 - 0.01 microg./kg/day in 1 - 2 doses.
      • Maintenance dose: Adjust the dose depending on the response to 0.4 microg./day in 1 - 2 doses.
        • Only if nasal administration is not possible. 
        • Dose in consultation with endocrinologist/nephrologist.
        • Cave hyponatriemia (see warning section)
  • Subcutaneous
    • 1 month up to 18 years
      [6] [7]
      • Initial dose: Desmopressin acetate 0.005 microg./kg/day in 1 - 2 doses.
      • Maintenance dose: Adjust the dose depending on the response in steps of 50% to 0.4 microg./day in 1 - 2 doses.
        • Only if nasal administration is not possible. 
        • Dose in consultation with an endocrinologist/nephrologist
        • Cave hyponatriemia (see warning section)
Diagnosis of diabetes insipidus
  • Oral
    • 1 month up to 18 years
      [1]

      • Desmopressin acetate
        Dose in consultation with endocrinologist/nephrologist.

  • Intravenous
    • 1 month up to 1 year
      [8]
      • Desmopressin acetate 0.4 microg./dose, once only.
    • 1 year up to 18 years
      [8]
      • Desmopressin acetate 1 - 2 microg./dose, once only.
  • Nasal
    • 1 month up to 1 year
      [20]
      • 10 microg./dose, once only.
    • 1 year up to 18 years
      [5] [20]
      • 20 microg./dose, once only.
Renal function test
  • Nasal
    • ≥ 15 years
      [5]
      • 40 microg./dose, once only.
    • 1 year up to 15 years
      [5]
      • 20 microg./dose, once only.
    • 1 month up to 1 year
      [5]
      • 10 microg./dose, once only.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

In children, in combination with ample fluid intake, very severe hyponatremia may develop, resulting in headache, abdominal pain, nausea, vomiting, weight gain, dizziness, confusion, malaise, memory impairment, vertigo, falling and in severe cases, convulsions and coma.

Oral use:

Common (> 1%): headache

Uncommon (0.1-1%): affect lability, aggression, abdominal pain, nausea, vomiting, diarrhea,  peripheral edema, fatigue.

Rare (<0.1%): anxiety, nightmares, mood changes, drowsiness, hypertension, irritability.

Side effects of unknown frequency: anaphylactic reactions, hyponatremia, abnormal behavior, emotional disorders, depression, hallucinations, insomnia, attention deficit disorders, psychomotor hyperactivity, convulsions, nosebleeds, allergic dermatitis, rash, sweating, urticaria.

When used nasally, observed mainly in children and adolescents:

Very common (> 10%): increased body temperature.

Common (> 1%): sleep disorders, affect lability, nightmares, nervousness, aggression, upper respiratory tract infections

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In the treatment of enuresis nocturna and nycturia, fluid intake should be restricted as much as possible from 1 hour before administration at bedtime until the following morning, and in any case until at least 8 hours after administration. Treatment without concurrent restriction of fluid intake may result in fluid retention and/or hyponatremia with or without warning symptoms (headache, nausea/vomiting, weight gain and, in severe cases, convulsions and coma). Brain edema has been reported rarely in children and young adults treated with desmopressin acetate for enuresis nocturna.
All patients or, if appropriate, their caregiver, should be properly instructed to adhere to fluid restriction.

For the indication haemophilia A / vWD, desmopressin should only be administered intravenously due to the high doses in small children weighing less than 20 kg. Especially in these young children, be aware not only of tachycardia and flushing but also of the occurrence of water intoxication (hyperhydration); for 12 hours after using desmopressin there is a strict fluid restriction of 100 ml. This is the reason why many haemophilia treatment centres do not administer desmopressin to children younger than 3 years and in children between 3 and 6 years of age only with caution and under strict observation with regard to fluid intake and excretion (Pabinger 2015). Due to the risk of severe side effects (convulsions, coma due to hyponatraemia), when administering desmopressin to young children weighing < 20 kg, it is recommended that the effect should be to clinically monitored with checks of the serum sodium up to 24 hours after administration. Especially in young children or on repeated administration, be aware that hyponatraemia can occur due to the antidiuretic effect of desmopressin.

In concomitant use of drugs that disrupt the release of ADH, such as tricyclic antidepressants, SSRIs, chlorpromazine, loperamide and carbamazepine there is an increased risk of water intoxication. Hyponatraemia can also occur with concomitant use of NSAIDs.

The effect on clotting after desmopressin is administered varies greatly between individuals; intra-individually, the response is constant. It is recommended that a test dose should be given to determine the effect of administration on the factor VIII plasma concentration, VWF:RCo and VWG:Ag, thrombocyte count and, if necessary, PFA100, as well as to document tolerance in the individual patient (desmopressin test). Desmopressin is not effective in severe haemophilia A, all forms of haemophilia B and Von Willebrand’s disease type 3.

Only carry out the renal concentration test in infants when strictly indicated and in the clinic.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

POSTERIOR PITUITARY LOBE HORMONES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Nederlandse Vereniging van Hemofiliebehandelaars (NVHB), Richtlijn Diagnostiek en behandeling van hemofilie en aanverwante stoornissen, 2009, ISBN: 978-90-8523-195-0, 171-175
  3. Ferring BV, SmPC Minrin tablet (RVG 12625) 12 maart 2014
  4. Ferring BV, SmPC Desmopressine Melt (RVG 116910) 16-02-2016
  5. Ferring BV, SmPC Minrin neusspray (RVG 18923) 26-11-2022, www.geneesmiddeleninformatiebank.nl
  6. Ferring BV, SmPC Minrin IV (RVG 08868) 05-09-2016, www.geneesmiddeleninformatiebank.nl
  7. Bruin de, C en Vries de, MC, Protocol diagnostiek en behandeling van centrale Diabetes Insipidus ZW NL , 23 okt 2017
  8. Ferring , SmPC Minirin-Amp (1-19335) , 03-2014
  9. Ferring GmbH, SmPC, Minirin 0,1/0,2 mg Tabletten (15542.00.00), 04/17
  10. Ferring GmbH, SmPC, Minirin 60/120/240 µg Lyophilisat zum Einnehmen (80334.00.00), 05/16
  11. Ferring GmbH, SmPC, Minirin parenteral 4 µg/ml Injektionslösung (6079556.00.00), 04/17
  12. Ferring GmbH, SmPC, Octostim Dosierspray 1,5 mg/ml Nasenspray (39761.00.00), 09/14
  13. INFECTOPHARM Arzneimittel und Consilium GmbH, SmPC, Niwinas 360 µg/ml Lösung zum Einnehmen (82949.00.00), 07/17
  14. Ferring GmbH, SmPC, Minirin 10 µg Nasenspray (3001921.00.00), 04/14
  15. Apogepha Arzneimittel GmbH, SmPC, Nocutil 0,1/0,2 mg Tabletten (63188.00.00), 02/14
  16. Ferring GmbH, SmPC, Minirin rhinyle 10 µg Nasentropfen (32188.00.00), 04/14
  17. Uptodate: UpToDate®, Pediatric Drug information: Desmopressin Lexicomp® Topic 9330 Version 228.0, accessed 01/19
  18. AVOXA, ABDA-Datenbank Wirkstoffdossier Desmopressin, Letzte Bearbeitung 04/2019, aufgerufen am 08.04.2019
  19. Pabinger, et al., Hämophiliebehandlung in Österreich, Wien Klin Wochenschr, 2015, 127 (Suppl 3), 115–S130
  20. Ferring GmbH, SmPC, Minirin 10 µg Nasenspray (3001921.00.00), 11/2019

Changes

Therapeutic Drug Monitoring


Overdose