Symptoms: weight gain due to fluid retention, headache, nausea, and, in severe cases, hyperhydration (water intoxication), accompanied by convulsions, confusion, or loss of consciousness, may occur if desmopressin is used at too high a dose or if excessive fluid intake occurs simultaneously or shortly after taking desmopressin.
Overdose may occur in children at an early age due to insufficient careful dose selection.
Treatment: depending on the severity of the overdose, you should reduce the dose of the drug, increase the time between taking the drug during the day, or stop taking the drug. If you suspect brain edema, you need to be immediately hospitalized in the intensive care unit. If seizures occur, immediate intensive care is required. Diuretics, such as furosemide, can be used to induce diuresis, while simultaneously monitoring the content of electrolytes in the blood plasma. The specific antidote of desmopressin is unknown.
48 months
Hypersensitivity, conditions accompanied by a reduced relative osmotic density of blood plasma, including psychogenic and habitual polydipsia, fluid retention of various etiologies, including in chronic heart failure, anuria.
hypersensitivity to desmopressin or any excipient of the drug,
habitual or psychogenic polydipsia (with a volume of urination of 40 ml / kg / day),
diagnosed or suspected chronic heart failure and other conditions requiring diuretic medication,
hyponatremia, including in the anamnesis,
moderate to severe renal insufficiency (creatinine Cl less than 50 ml / min),
inadequate ADH production syndrome,
polydipsia in chronic alcoholism,
age 65 years and older — when used for symptomatic therapy of nocturia,
children under 5 years of age.
With caution: chronic renal failure (creatinine Cl greater than 50 ml / min), bladder fibrosis, cystic fibrosis, coronary heart disease, arterial hypertension, impaired water-electrolyte balance, potential risk of increased intracranial pressure, risk of thrombosis, pregnancy, including preeclampsia, elderly age (65 years and older) when used for the treatment of diabetes insipidus.
Tricyclic antidepressants, SSRIs, chlorpromazine, chlorpropamide, carbamazepine, and other drugs that can cause ADH inappropriate secretion syndrome may increase the antidiuretic effect of desmopressin and increase the risk of fluid retention and hyponatremia.
Indomethacin and other NSAIDs, when combined with desmopressin, can induce fluid retention and hyponatremia.
Combination with loperamide can lead to a 3-fold increase in the concentration of desmopressin in the plasma and increase the risk of side effects (fluid retention, hyponatremia). There is a possibility that other drugs that reduce the tone and motility of the smooth muscles of the intestine may have a similar effect.
When used concomitantly with oxytocin, an increase in the antidiuretic effect and a decrease in uterine perfusion should be taken into account.
Clofibrate may enhance the antidiuretic effect of desmopressin. With the simultaneous use of the drug Antikva® Rapid with the above drugs for the prevention of hyponatremia, it is necessary to regularly determine the concentration of sodium in the blood plasma.
Taking glibenclamide and lithium preparations may reduce the antidiuretic effect of desmopressin.
Interaction with drugs metabolized in the liver is unlikely, since desmopressin does not significantly affect hepatic metabolism according to the results of the study of liver microsomes in vitro. Researches in vivo not conducted.
Gelatin
Mannitol
Citric acid, anhydrous
Nasal spray dosed
Nausea, vomiting,spastic abdominal pain, headache, difficulty urinating, excessive sweating, irritation of the nasal mucosa.
The use of the drug without concomitant restriction of fluid intake may lead to fluid retention and / or hyponatremia, which may be asymptomatic or accompanied by the following symptoms: headache, nausea and/or vomiting, weight gain, in severe cases — convulsions, which are combined with impaired consciousness up to prolonged loss of consciousness.
These symptoms are particularly common in children or the elderly, depending on their general condition. Frequency of side effects: very common (≥1/10), common (≥1/100 to <1/10), infrequent (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), frequency not established (currently, data on the prevalence of adverse reactions are not available, identified during post-registration use of desmopressin).
Use in adults
The table shows the adverse reactions and the frequency of their occurrence based on data obtained during a clinical study in patients with nocturia (n=1557) and with post-registration use of the drug but all indications for use (including in diabetes insipidus).
On the part of the immune system: the frequency is not established — anaphylactic reactions.
From the side of metabolism and nutrition: often-hyponatremia, dehydration*, hypernatremia.*
Mental disorders: infrequently-insomnia, rarely-confusion.
From the nervous system: very often-headache, often-dizziness, infrequently-drowsiness, paresthesia, frequency is not established-convulsions, asthenia*, coma.
On the part of the visual organ: infrequently-decreased visual acuity.
On the part of the organ of hearing and labyrinth disorders: rarely-vertigo.
From the heart: infrequently-a feeling of palpitation.
From the side of the vessels: often-arterial hypertension, infrequently-orthostatic hypotension.
From the respiratory system, chest and mediastinal organs: infrequently-shortness of breath.
From the gastrointestinal tract: often-nausea, vomiting, abdominal pain, diarrhea, constipation, infrequently-dyspepsia, flatulence,bloating.
From the skin and subcutaneous tissues: infrequently-increased sweating, itching, skin rash, urticaria, rarely-allergic dermatitis.
From the musculoskeletal system and connective tissue: infrequently-muscle spasms, myalgia.
From the kidneys and urinary tract: often-a violation of the function of the bladder, a violation of urination.
General disorders and disorders at the injection site: often-peripheral edema, a feeling of fatigue, infrequently-a feeling of discomfort, chest pain, flu-like syndrome.
Laboratory and instrumental data: infrequently-weight gain, increased activity of liver enzymes, hypokalemia.
* Adverse reactions were observed only in patients with diabetes insipidus.
Use in children
The following adverse reactions and the frequency of their occurrence are indicated based on data obtained during a clinical trial (N=1923) and during post-registration use of the drug for the treatment of primary nocturnal enuresis in children.
On the part of the immune system: the frequency is not established — anaphylactic reactions.
From the side of metabolism and nutrition: the frequency is not established-hyponatremia.
Mental disorders: infrequently-emotional lability, aggression, rarely-anxiety, nightmares, sudden mood changes, frequency is not established-behavior changes, emotional disorders, depression, hallucinations, insomnia.
From the nervous system: often-headache, rarely-drowsiness, frequency is not established-attention disorder, psychomotor hyperactivity, convulsions.
From the side of the vessels: rarely-arterial hypertension.
From the respiratory system, chest and mediastinal organs: the frequency is not established — nasal bleeding.
From the gastrointestinal tract: infrequently-nausea, vomiting, diarrhea, pain in the stomach.
From the skin and subcutaneous tissues: the frequency is not established-allergic dermatitis, skin rash, increased sweating, urticaria.
From the kidneys and urinary tract: infrequently-violation of the function of the bladder, violation of urination.
General disorders and disorders at the injection site: infrequently-peripheral edema, fatigue, rarely-irritability.
Attention! Desmopressin may have an antidiuretic effect.
Taking the drug Antikva® Rapid, tablets dispersed in the oral cavity, without simultaneous restriction of fluid intake can lead to fluid retention in the body, accompanied by hyponatremia, manifested by headache, abdominal pain, nausea, vomiting, weight gain, dizziness, confusion, malaise and in severe cases, can lead to seizures, brain edema and coma. In particular, the highest risk of developing the above-mentioned complications is in children under the age of 1 year or elderly patients (over 65 years), depending on the general state of health.
In the treatment of nocturia in adults, hyponatremia often develops at the beginning of taking the drug or with an increase in the dose. Hyponatremia is reversible. When taking the drug Antikva® Rapid needs to control the water-electrolyte balance. During treatment, it is possible to develop arterial hypertension due to fluid retention. Patients with CHD may develop angina pectoris.
If any of the reported adverse reactions worsen, or the patient notices any other adverse reactions not listed in the description, the doctor should be informed.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Drops: diabetes insipidus, nocturnal urinary incontinence, in the study of the concentration capacity of the kidneys.
Solution for injection: diabetes insipidus (diagnosis and treatment), acute polyuria after pituitary surgery, hemophilia, Willebrand's disease.
diabetes insipidus of central origin,
polyuria / polydipsia after hypophysiectomy or turkish saddle surgery,
primary nocturnal enuresis in adults and children over 5 years of age,
nocturnal polyuria in adults, associated with nocturnal polyuria (increased urination at night, exceeding the capacity of the bladder and causing the need to get up at night more than once in order to empty the bladder) - as a symptomatic therapy.
In diabetes insipidus, it increases the reabsorption of water from the distal tubules of the kidneys, while increasing the relative osmotic density of urine. This helps to reduce the frequency of urination and eliminate the increased need for fluid.
Antikva drug® Rapid contains desmopressin-a structural analog of the natural hormone arginine-vasopressin, obtained as a result of changes in the structure of the vasopressin molecule. These structural changes lead, in combination with a significantly enhanced antidiuretic ability, to a less pronounced effect on the smooth muscles of blood vessels and internal organs compared to vasopressin, which leads to the absence of undesirable spastic side effects. Unlike vasopressin, it acts for a longer time and does not cause an increase in blood pressure. The drug increases the permeability of the epithelium of the distal convoluted tubules of the nephron to water and increases its reabsorption. Application of the drug Antikva® Rapid in central diabetes insipidus leads to a decrease in the volume of urine excreted and a simultaneous increase in the osmolarity of urine and a decrease in the osmolarity of blood plasma. This leads to a decrease in the frequency of urination and a decrease in nocturnal polyuria.
The bioavailability of desmopressin in sublingual form at doses of 200, 400 and 800 mcg is about 0.25%. Cmax desmopressin in blood plasma is reached within 0.5-2 hours after taking the drug and is directly proportional to the amount of the dose taken: after taking 200, 400 and 800 mcg Cmax it was 14, 30 and 65 pg / ml, respectively.
Desmopressin does not penetrate the BBB. Desmopressin is excreted by the kidneys, T1/2 is 2.8 hours.
June 2011
DDAVP
Ferring Pharmaceuticals Ltd.
Drayton Hall
Church Road
West Drayton
UB7 7PS
United Kingdom
In a place protected from light, at a temperature of 2-8 °C. Keep away from freezing.
Keep out of reach of children.
Shelf life of the drug Adiuretin®2 года.Do not use after the expiration date indicated on the package.
1 ml of nasal drops contains desmopressin acetate 0.1 mg (1 drop — 5 micrograms), in dropper bottles of 5 ml, in a box of 1 bottle.
DDAVP Melt 60 micrograms oral lyophilisate PL 03194/0091
DDAVP Melt 120 micrograms oral lyophilisate PL 03194/0092
DDAVP Melt 240 micrograms oral lyophilisate PL 03194/0093
Desmopressin
Care should be taken with patients who have reduced renal function and/or cardiovascular disease. In chronic renal disease the antidiuretic effect of DDAVP Melt would be less than normal.
Precautions to prevent fluid overload must be taken in:
- conditions characterised by fluid and/or electrolyte imbalance
- patients at risk for increased intracranial pressure.
None
Intranasally, for diabetes insipidus 1-3 drops 2-3 times a day. For nocturnal urinary incontinence - 2-10 drops at night. I / v and I / m, with diabetes insipidus — 1 ml (1 ampoule) for 8 hours, higher doses should be administered slowly, in the form of a drip infusion. Injections are also used when intranasal administration is not possible, or a more precise dosage is needed.
In the study of the concentration capacity of the kidneys: the recommended dose is 3 drops (about 15 mcg), for children older than 1 year-2-3 drops (about 10-15 mcg). Immediately after administration, the patient should: empty the bladder and limit the flow of fluid for the duration of the test and 4 hours after its completion (only 8 hours). During the next 4 hours after the use of the drug, urine samples of the patient are collected every hour to determine osmolarity. If the test results show a decrease in the concentration capacity of the kidneys — the test should be repeated.
In the development of acute central polyuria: intranasally, 2 drops. The start of the action should be expected in 30 minutes. Within 1 hour, the balance of fluid intake in the form of infusions and diuresis should normalize. If the balance does not normalize within 1 hour, it is recommended to switch to injection (more often intravenous).
Inside, keep in the mouth until completely dissolved.
Tablets dispersed in the oral cavity should not be taken with wet hands, because the tablet may begin to dissolve.
Do not drink the tablet with liquid!
The optimal dose of the drug Antikva® Rapid is selected individually. The dosage ratios between oral tablets and tablets dispersed in the oral cavity are shown below.
| Tablets, mg | Tablets dispersed in the oral cavity, mcg |
| 0,1 | 60 |
| 0,2 | 120 |
Antikva drug® Rapid should be taken some time after a meal, because eating reduces the absorption of the drug and its effectiveness.
Diabetes insipidus of central origin and polyuria / polydipsia after hypophysiectomy or operations in the Turkish saddle area. At the beginning of treatment, the optimal dose of the drug is determined by the doctor individually, taking into account the indicators of osmolarity and urine volume. During therapy, it is necessary to monitor the duration of sleep and the water-electrolyte balance.
Recommended initial dose of Antikva® Rapid 60 mcg 3 times a day, then the dose is changed depending on the onset of the therapeutic effect. The recommended daily dose is in the range of 120-720 mcg. The optimal maintenance dose is 60-120 mcg 3 times a day.
If signs of fluid retention/hyponatremia appear, discontinue therapy and adjust the dose of the drug.
Primary nocturnal enuresis. The optimal therapeutic dose is determined individually and adjusted based on the patient's response to treatment. The recommended starting dose is 120 mcg per night. In the absence of an effect, the dose can be increased to 240 mcg.
During treatment, it is necessary to limit the intake of fluids in the evening. If signs of fluid retention/hyponatremia appear, discontinue therapy and adjust the dose of the drug.
The recommended course of continuous treatment is 3 months. The decision to continue treatment is made on the basis of clinical data that will be observed after discontinuation of the drug for 1 week.
Nicturia. The recommended starting dose is 60 mcg per night. In the absence of an effect for 1 week, increase to 120 mcg and subsequently to 240 mcg with an increase in the dose with a frequency of no more than 1 time per week. If there is no adequate clinical effect after 4 weeks of treatment and dose adjustment, it is not recommended to continue taking the drug. It is necessary to monitor compliance with the restriction of fluid intake.
Special patient groups
Old age. It is contraindicated to use the drug at the age of 65 years and older for the symptomatic treatment of nocturia. In patients aged 65 years and older, the drug should be used with caution for the treatment of diabetes insipidus. When prescribing desmopressin to elderly patients, it is necessary to monitor the sodium content in the blood plasma before starting treatment, 3 days after the start of treatment or when increasing the dose, as well as, if necessary, during the administration of the drug.
Inside. The optimal dose of the drug is selected individually.
The drug should be taken some time after a meal, as food intake can affect the absorption of the drug and its effectiveness.
Central diabetes insipidus: the recommended starting dose for children over 4 years of age and adults is 0.1 mg 1-3 times a day. Subsequently, the dose is selected depending on the response to treatment. Usually, the daily dose is from 0.2 to 1.2 mg. For most patients, the optimal maintenance dose is 0.1-0.2 mg 1-3 times a day.
Primary nocturnal enuresis: the recommended starting dose for children over 5 years of age and adults is 0.2 mg per night. In the absence of an effect, the dose can be increased to 0.4 mg. The recommended course of continuous treatment is 3 months. The decision to continue treatment should be made on the basis of clinical data that will be observed after discontinuation of the drug for 1 week. It is necessary to monitor compliance with the restriction of fluid intake in the evening.
Nocturnal polyuria in adults: the recommended starting dose is 0.1 mg per night. If there is no effect for 7 days, the dose is increased to 0.2 mg and subsequently to 0.4 mg (the frequency of increasing the dose is no more than 1 time per week). It should be remembered about the danger of fluid retention in the body. If there is no adequate clinical effect after 4 weeks of treatment and dose adjustment, it is not recommended to continue using the drug.
None.
19th January 2006
