Desmopressin

Chemical formula: C₄₆H₆₄N₁₄O₁₂S₂  Molecular mass: 1,069.22 g/mol 

Interactions

Desmopressin interacts in the following cases:

Non-steroidal anti-inflammatory drugs (NSAIDs)

NSAIDs may induce water retention and/or hyponatraemia.

Substances known to induce SIADH

Substances which are known to induce SIADH e.g. tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine and carbamazepine, may cause an additive antidiuretic effect leading to an increased risk of water retention and/or hyponatraemia.

Dimethicone

Dimeticone

Glibenclamide, lithium

Glibenclamide and lithium may attenuate the antidiuretic effect of desmopressin.

Loperamide

Concomitant treatment with loperamide may result in a 3-fold increase of desmopressin plasma concentrations, which may lead to an increased risk of water retention and/or hyponatraemia. Although not investigated, other drugs slowing intestinal transport might have the same effect.

Cortisol deficiency

Decreased compound F level

Fluid imbalance, electrolyte imbalance

Precautions to prevent fluid overload must be taken in conditions characterised by fluid and/or electrolyte imbalance.

Cystic fibrosis

Care should be taken with patients who have cystic fibrosis.

Patients at risk for increased intracranial pressure

Precautions to prevent fluid overload must be taken in patients at risk for increased intracranial pressure.

Bladder dysfunction, urinary tract obstruction

at least one of
Bladder dysfunction
Urinary tract obstruction

Coronary heart disease, hypertension

Desmopressin should be used with caution in patients with coronary heart disease, hypertension and severe hypertension.

Pregnancy

There are no adequate and well-controlled studies in pregnant women. Published reports stress that, as opposed to preparations containing the natural hormone, desmopressin acetate in antidiuretic doses has no uterotonic action, but the physician will have to weigh the possible therapeutic advantage against potential danger in each case.

Reproduction studies performed in rats and rabbits have revealed no evidence of harm to the fetus due desmopressin acetate. Subcutaneous doses up to 4 times the human dose for Factor VIII stimulation on a mg/m² basis (or 12.5 times the human dose on a mg/kg basis) and doses up to 4 times the human dose for diabetes insipidus on a mg/m² basis (or 12.5 times the human dose on a mg/kg basis) were studied. There are several publications of management of diabetes insipidus in pregnant women with no harm to the fetus reported.

Data on a limited number (n=53) of exposed pregnancies in women with diabetes insipidus indicate rare cases of malformations in children treated during pregnancy. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.

Caution should be exercised when prescribing to pregnant women. Blood pressure monitoring is recommended due to the increased risk of pre-eclampsia.

Nursing mothers

There have been no controlled studies in nursing mothers. A single study on a post-partum woman demonstrated a marked change in plasma desmopressin acetate level following an intranasal dose of 10 mcg, but little drug was detectable in breast milk.

Results from analyses of milk from nursing mothers receiving high dose desmopressin (300 micrograms intranasally) indicate that the amounts of desmopressin that may be transferred to the child are considerably less than the amounts required to influence diuresis or haemostasis.

Effects on ability to drive and use machines

No studies on the effect of desmopressin on the ability to drive and use machines have been performed.

Desmopressin has no known effect on the ability to drive and use machines.

Adverse reactions


Oral / SC / IM / IV administration

Side-effects include headache, stomach pain and nausea. Isolated cases of allergic skin reactions and more severe general allergic reactions have been reported. Very rare cases of emotional disorders including aggression in children have been reported. Treatment with desmopressin without concomitant reduction of fluid intake may lead to water retention/hyponatraemia with accompanying symptoms of headache, nausea, vomiting, weight gain, decreased serum sodium and in serious cases, convulsions.

Nasal administration

The following undesirable effects of desmopressin were recorded from clinical studies and postmarketing experience. Adverse reactions are listed according to the following categories: Very common >1/10, Common >1/100 <1/10, Uncommon >1/1,000 <1/100, Rare >1/ 10,000 <1/1,000, Very rare <1/10,000, including isolated reports.

Nervous system disorder

Uncommon: headache

Rare: cerebral oedema

Very rare: emotional disturbance in case of nocturnal enuresis

Eye disorders

Common: conjunctivitis

Respiratory, thoracic and mediastinal disorders

Uncommon: nasal congestion, epistaxis, rhinitis

Gastrointestinal disorders

Uncommon: nausea, abdominal cramps, vomiting

General disorders and administration site conditions

Common: asthenia

Very rare: allergic and hypersensitivity reactions (e.g. pruritus, exanthema, fever, bronchospasms, anaphylaxis).

Metabolism disorders

Rare: hyponatraemia

Cardiovascular / Vascular disorders

Due to increased water reabsorption blood pressure may rise and in some cases hypertension may develop. In patients with coronary heart disease angina pectoris may occur.

These adverse effects, except for allergic reactions, may be prevented or disappear if the desmopressin dose is reduced.

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