Desmopressin oromucosal low strength
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Oral lyophilisate containing desmopressin acetate
Drugs List
Therapeutic Indications
Uses
Nocturia in females
Nocturia in males
Symptomatic treatment of nocturia due to idiopathic nocturnal polyuria in adults.
Dosage
Adults
Females: 25 micrograms daily, 1 hour before bedtime.
Males: 50 micrograms daily, 1 hour before bedtime.
Elderly
Females: 25 micrograms daily, 1 hour before bedtime.
Males: 50 micrograms daily, 1 hour before bedtime.
Contraindications
Children under 18 years
Cardiac impairment
Habitual polydipsia
Hypervolaemia
Hyponatraemia
Psychogenic polydipsia
Renal impairment - creatinine clearance below 50ml/minute
Syndrome of inappropriate ADH secretion
Precautions and Warnings
Disorder of fluid balance
Elderly
Bladder disorder
Bladder outflow obstruction
Chronic renal disorder
Cystic fibrosis
Electrolyte imbalance
Hypertension
Ischaemic heart disease
Pre-eclampsia
Pregnancy
Limit fluids for 1 hr before & 8 hrs after administration
Elderly: monitor serum sodium before therapy, in week 1 & at 1 month
Monitor fluid and electrolyte status
Pregnancy: Monitor blood pressure due to increased risk of pre-eclampsia
Suspend dose if vomiting/diarrhoea occurs until fluid/electrolytes normal
Discontinue immediately if hyponatraemia occurs
Advise patients to avoid excessive fluid intake
Pregnancy and Lactation
Pregnancy
Use desmopressin with caution in pregnancy.
Data on a limited number of exposed pregnancies indicate no adverse effects of desmopressin on pregnancy or on the health of the foetus/new-born child.
Monitor blood pressure in pregnant patients due to the increased risk of pre-eclampsia.
Animal studies do not indicate any direct or indirect harmful effects with pregnancy, embryonic/foetal development, parturition or postnatal development. Animal reproduction studies have shown no clinical relevant effects on parents and offspring. In vitro analysis of human cotyledon models have shown that there is no transplacental transport of desmopressin when administered at therapeutic concentration corresponding to the recommended dose.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Lactation
Desmopressin is considered safe for use in breastfeeding.
No adverse effects have been reported using this drug during breastfeeding.
Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 micrograms intranasally) indicated that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Counselling
Patients should be advised to hold the drug under the tongue and avoid swallowing until dissolved.
Side Effects
Abdominal discomfort
Constipation
Diarrhoea
Dizziness
Dry mouth
Fatigue
Headache
Hyponatraemia
Nausea
Peripheral oedema
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: October 2016
Reference Sources
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Desmopressin. Last revised: 07 September 2013
Last accessed: 19 October 2016
Summary of Product Characteristics: Noqdirna 25 microgram oral lyophilisate. Ferring Pharmaceuticals Ltd. Revised May 2016.
Summary of Product Characteristics: Noqdirna 50 microgram oral lyophilisate. Ferring Pharmaceuticals Ltd. Revised May 2016.
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