Universal reference book for medicines
Name of the drug: DESMOPRESSIN (DESMOPRESSIN)

Active substance: desmopressin

Type: Analogue of vasopressin.
Antidiuretic
Manufacturer: ACTAVIS GROUP PTC ehf.
(Iceland) manufactured by INPAC (Norway)
Composition, form of production and packaging
Tablets are
white, round, with a risk on one side and engraved "D1" - on the other.

1 tab.

desmopressin acetate 100 Ојg,

which corresponds to the content of desmopressin 89 Ојg

Excipients: lactose monohydrate - 120 mg, potato starch - 76.9 mg, povidone K30 - 2 mg, magnesium stearate - 1 mg.

28 pcs.
- polyethylene containers (1) - packs of cardboard.
30 pcs.
- polyethylene containers (1) - packs of cardboard.
90 pcs.
- polyethylene containers (1) - packs of cardboard.
Tablets are white, round, with a risk on one side and engraved "D2" on the other.

1 tab.

desmopressin acetate 200 Ојg,

which corresponds to desmopressin content of 178 Ојg

Excipients: lactose monohydrate - 120 mg, potato starch - 76.8 mg, povidone K30 - 2 mg, magnesium stearate - 1 mg.

28 pcs.
- polyethylene containers (1) - packs of cardboard.
30 pcs.
- polyethylene containers (1) - packs of cardboard.
90 pcs.
- polyethylene containers (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2011.

PHARMACHOLOGIC EFFECT

Desmopressin is an analogue of the natural hormone arginine-vasopressin with a pronounced antidiuretic effect.
Compared with vasopressin, it has a less pronounced effect on the smooth muscle of the vessels and internal organs, which is due to changes in the structure of the desmopressin molecule compared to the natural vasopressin molecule - deamination of 1-cysteine ​​and replacement of 8-L-arginine with D-arginine. Increases the permeability of the epithelium of the distal sections of the convoluted tubules for water and increases its reabsorption. The use of desmopressin in central diabetes insipidus leads to a decrease in the volume of urine output and a simultaneous increase in osmolality of urine and a decrease in osmolality of the blood plasma. This leads to a decrease in the frequency of urination and a decrease in nocturnal polyuria.
The maximum antidiuretic effect occurs when ingestion - after 4-7 hours Antidiuretic effect when administered orally at a dose of 0.1-0.2 mg - up to 8 hours, at a dose of 0.4 mg - up to 12 hours.

PHARMACOKINETICS

Absolute bioavailability for oral administration varies from 0.08% to 0.16%.
Simultaneous intake of food can reduce the degree of absorption by 40%. TC max - 2 h. Vd is 0.2-0.3 l / kg. Desmopressin does not penetrate the blood-brain barrier. Metabolised in the kidneys. It is excreted by the kidneys. T 1/2 with oral administration - 2-3 hours.
INDICATIONS

- central diabetes insipidus (diagnosis and treatment);

- primary nocturnal enuresis in children older than 5 years;

- nocturnal polyuria in adults as symptomatic therapy.

DOSING MODE

Inside.
The optimal dose is selected individually. The drug should be taken some time after eating, since eating can affect the absorption of the drug and its effectiveness.
Central diabetes insipidus: the initial dose for children and adults is 0.1 mg 1-3 times a day, then the dose is selected depending on the response - from 0.2 to 1.2 mg / day.
For the majority of patients, the optimal dose is 0.1-0.2 mg 1-3 times a day.
Primary nocturnal enuresis: the initial dose is 0.2 mg per night, if the dose is ineffective increase to 0.4 mg.
It is necessary to monitor compliance with the restriction of fluid intake in the evening. The recommended course of continuous treatment is 3 months. The decision to continue treatment should be made on the basis of clinical data, which will be observed after the drug is discontinued within 1 week.
Nocturnal polyuria in adults: the initial dose is 0.1 mg per night, with ineffectiveness after 1 week the dose is increased to 0.2 mg and further, with weekly increase.
If after 4 weeks of treatment and dose adjustment adequate clinical effect is not observed, continue taking the drug is not recommended


SIDE EFFECT

From the side of the central nervous system: headache, dizziness;

On the part of the digestive system: nausea, vomiting, dry mouth;

Other: hyperemia sclera, hot flashes, transient tachyarrhythmia, convulsions.

Taking desmopressin without a simultaneous restriction of fluid intake can lead to fluid retention in the body, accompanied by hyponatremia, weight gain, edema, and, in severe cases, seizures.

CONTRAINDICATIONS

- chronic heart failure or other conditions requiring diuretic therapy;

- renal insufficiency of moderate and severe degree (creatinine clearance <50 ml / min);

- polydipsia (congenital or psychogenic);

- hyponatremia;

- syndrome of inadequate production of antidiuretic hormone;

- lactose intolerance / congenital intolerance to galactose, deficiency of lactase Lappa or glucose-galactose malabsorption;

hypersensitivity to the components of the drug.

With caution: with renal failure, fibrosis of the bladder, with violations of water-electrolyte balance, the potential risk of increased intracranial pressure, in pregnancy and in children under the age of 1 year.

Patients with diseases of the cardiovascular system, as well as patients with bronchial asthma, epilepsy and migraine in

anamnesis (if necessary, reduce the dose of Desmopressin).

With extreme caution: in elderly patients (over 65 years of age) due to a high risk of side effects (including fluid retention, hyponatremia).
If the decision to treat desmopressin is taken, the concentration of sodium in the blood plasma should be determined before the drug is prescribed, 3 days after the start of the dose and at each dose increase and the patient's condition is monitored.
PREGNANCY AND LACTATION

Care should be taken when applying the drug during pregnancy.
Studies have shown that the amount of desmopressin entering the body of a newborn with breast milk from a woman taking high doses of desmopressin is significantly less than that which can affect diuresis.
APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated in renal insufficiency of moderate and severe degree (creatinine clearance <50 ml / min).
With caution in the violation of kidney function.
APPLICATION FOR CHILDREN

Prescribe with caution to children under the age of 1 year.

APPLICATION IN ELDERLY PATIENTS

Prescribe cautiously to elderly patients.

SPECIAL INSTRUCTIONS

To avoid the development of side effects, it is mandatory to minimize the intake of liquid 1 h before and during 8 h after application of the drug in patients with primary nocturnal enuresis.
Treatment without restriction of fluid intake can lead to fluid retention in the body and hyponatremia with the development of such symptoms as: headache, nausea / vomiting, weight gain and in severe cases to seizures and coma. In the treatment of nocturnal enuresis, desmopressin in children and young people has been reported on the development of cerebral edema.
Desmopressin should not be used when there are other additional causes for fluid retention and electrolyte disorders.
The high risk of side effects in elderly patients and in patients with initially low concentrations of sodium in the blood plasma and polyuria from 2.8 to 3.0 liters.
Prevention of the development of hyponatremia consists in increasing the frequency of determining the concentration of sodium in the blood plasma, especially when used with drugs that cause the syndrome of inadequate secretion of antidiuretic hormone (including tricyclic antidepressants, selective inhibitors of serotonin, chlorpromazine and carbamazepine) and NSAIDs.

If there is acute urinary incontinence, dysuria and / or nocturia, urinary tract infection, suspected bladder or prostate tumor, the presence of polydipsia and decompensated diabetes mellitus, the diagnosis and treatment of these conditions and diseases should be performed prior to treatment with desmopressin.

OVERDOSE

Symptoms: fluid retention, plasma hypoosmolarity, hyponatremia, development of seizures and other neurological and psychic symptoms.

Treatment: withdrawal of the drug, restriction of fluid intake, in severe cases - slow intravenous infusion of concentrated saline solutions simultaneously with furosemide.

DRUG INTERACTION

When combined, indomethacin may increase, but not increase, the duration of action of desmopressin.

With the combined use of glybutide, tetracycline, lithium preparations, norepinephrine weaken the antidiuretic effect of desmopressin.

When combined, desmopressin increases the effect of hypertensive drugs.

With simultaneous use of tricyclic antidepressants, selective inhibitors of serotonin, chlorpromazine and carbamazepine, which can cause the syndrome of inadequate secretion of antidiuretic hormone, can enhance the antidiuretic effect of desmopressin and lead to an increased risk of fluid retention and hyponatremia.

With the simultaneous use of desmopressin with anti-inflammatory drugs (NSAIDs), an increased risk of side effects (fluid retention in the body, hyponatremia) is possible.

With the simultaneous use of desmopressin with loperamide, a threefold increase in desmopressin levels in plasma is possible, which significantly increases the risk of fluid retention and the occurrence of hyponatremia.
Presumably, other medications that slow down peristalsis can cause a similar effect.
With simultaneous use of desmopressin with dimethicone, a decrease in desmopressin absorption is possible.

TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

Store at a temperature not exceeding 30 В° C in a place inaccessible to children.
Shelf life - 2.5 years.
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