Uropres (desmopressin) nasal spray 0.1 mg/ml. 2.5 ml. vial

Description

Uropres (desmopressin) nasal spray 0.1 mg/ml. 2.5 ml. vial

Composition

active substance: desmopressin;

1 ml of solution contains desmopressin acetate in terms of desmopressin 100% substance 0.1 mg;

Excipients: benzalkonium chloride, sodium chloride, glycine, betaine hydrochloride, water for injections.

Dosage form

Nasal spray.

Basic physical and chemical properties: transparent colorless liquid. When shaking, a layer of foam is formed, which disappears after 30 minutes.

Pharmacotherapeutic group

Hormone preparations for systemic use, excluding sex hormones and insulins. Hormones of the posterior pituitary gland. Vasopressin and its analogues. ATX code H01B A02.

Pharmacological properties

Desmopressin is a structural analogue of the natural hormone L-arginine-vasopressin. The drug increases the permeability of the epithelium of the distal parts of the convoluted tubules of the kidneys for water and increases its reabsorption. Reduces the amount of urine excreted, while increasing its osmolarity and reducing the osmolarity of blood plasma. This leads to a decrease in the frequency of urination and a decrease in nocturia. The antidiuretic effect after intranasal administration of 10-20 mcg of desmopressin lasts 8-12 hours.

Indication

As an antidiuretic: treatment of diabetes mellitus of central origin; in post-traumatic polyuria and polydipsia in the presence of transient insufficiency or absence of antidiuretic hormone after hypophysectomy, surgery in the pituitary gland or traumatic brain injury.

As a diagnostic tool: for a rapid test to determine the concentration capacity of the kidneys; for the differential diagnosis of diabetes mellitus.

Contraindication:

• hypersensitivity to desmopressin or to other components of the Uropres nasal spray;
• primary or psychogenic polydipsia, polydipsia in patients with alcoholism;
• severe forms of Willebrand’s disease (type IIb); reduction of factor VIII activity to 5% and the presence of antibodies to factor VIII;
• heart failure or other conditions requiring diuretics;
• moderate or severe renal insufficiency (creatinine clearance below 50 ml / min);
• hyponatremia;
• syndrome of antidiuretic hormone secretion.

Method of application and dosage

The drug Uropres nasal spray is administered intranasally. The nose should be cleaned before use.

1 spray dose contains 5 mcg of drug substance and corresponds to one press.

• Diabetes mellitus, post-traumatic polyuria and polydipsia of central origin.
  The dose should be selected individually, but the optimal dose for adults is 10-20 mcg (2-4 pressures) 1-2 times a day. For children over 1 year of age, the dose is 10 mcg (2 presses) 1-2 times a day. If symptoms of fluid retention and / or hyponatraemia occur, treatment should be discontinued and the dose adjusted.
• Rapid test to determine the concentration capacity of the kidneys and for the differential diagnosis of diabetes mellitus.
  To assess the concentration capacity of the kidneys, use the following dosages: for adults – 40 mcg (8 pressures), for children under 1 year – 10 mcg (2 pressures), for children over 1 year – 20 mcg (4 pressures).
  The rapid test should be used to differentiate between diabetes mellitus and polyuric syndrome of other genesis, as well as to determine the reduced concentration of the kidneys associated with urinary tract infection (cystitis, pyelonephritis). This test is also used for the early diagnosis of tubulointerstitial lesions, such as those caused by lithium, analgesics, chemotherapeutic agents, and immunosuppressants.
  The express test is best done in the morning. Fluid intake should be limited for the first 12 hours after administration. In children under 5 years of age and in patients with heart disease or hypertension, the amount of fluid consumed should be halved.
  Urine osmolality should be determined prior to testing. After administration of desmopressin, take 2 urine samples (preferably 2 and 4 hours). Urine obtained during the first hour should be collected separately and excreted. Osmolality is determined in both urine samples. To determine the concentration capacity of the kidneys, the highest achieved value of osmolality is compared with the value before the study or with the reference value corresponding to the patient’s age (for adults 800-1000 mOsm / kg). Low values, no increase or slight increase in the osmolality of urine indicate a violation of the concentration capacity of the kidneys. If the osmolality of the urine increases significantly and the volume of urine decreases significantly, this means that polyuria is associated with diabetes mellitus of central origin.

Children

Use in children under adult supervision to control the dose of the drug.

The test to determine the concentration capacity of the kidneys in children under 1 year of age should be performed exclusively in a hospital setting and followed by observation.

Overdose

Desmopressin overdose can lead to hyponatremia and seizures. Symptoms of overdose may occur when using too high a dose of the drug, excessive fluid intake during or immediately after the use of desmopressin, inadequate conditions of resorption of the drug during its intranasal administration. Overdose is manifested by the following symptoms: weight gain (water retention), headache, nausea, mild hypertension, tachycardia, “hot flashes”, in severe cases – hyperhydration and convulsions.

Overdose may occur in young children due to inadequate dose adjustment.

Treatment: in case of overdose, the dose should be reduced, the interval between doses should be increased or the drug should be discontinued. The presence of cerebral edema requires immediate hospitalization of the patient in the intensive care unit. Seizures in children also need immediate intensive care. In case of hyponatremia, desmopressin treatment should be stopped immediately and fluid intake should be limited until serum sodium returns to normal. There is no specific antidote. If there are indications for diuretic therapy, saluretics such as furosemide may be used.

Side effects:

• from the immune system: hypersensitivity reactions, including fever, bronchospasm, anaphylaxis;
• metabolism and nutrition: hyponatremia, dehydration;
• from the nervous system: dizziness, headache, drowsiness, cerebral edema, hyponatremic seizures, convulsions, confusion, loss of consciousness, coma;
• from the psyche: insomnia, affective lability, nightmares, nervousness, aggression, emotional disorders in children;
• from the cardiovascular system: hypertension, hot flashes; patients with coronary heart disease may have angina attacks;
• from the respiratory system: nasal congestion, rhinitis, nosebleeds, dry throat, upper respiratory tract infection, shortness of breath;
• from the gastrointestinal tract: nausea, vomiting, abdominal pain, diarrhea, gastroenteritis;
• from the skin and subcutaneous tissue: increased sweating, allergic reactions, including skin rash, itching, urticaria;
• from the musculoskeletal and connective tissue: muscle spasms;
• general disorders: increased fatigue, malaise, peripheral edema, chest pain, chills;
• laboratory and instrumental data: increase in body temperature, increase in body weight;
• pediatric population: Hyponatremia is a reversible condition, often seen in children due to changes in daily routine that affect water intake and / or sweating;
• other special patient groups: There may be an increased risk of hyponatraemia in young children and elderly patients whose serum sodium levels are below normal.