Composition, form of production and packaging
Tablets are white, flat, with a risk on one side.
desmopressin acetate 200 Ојg,
which corresponds to desmopressin content of 178 Ојg
Excipients: lactose monohydrate - 10 mg, crospovidone XL - 5 mg, magnesium stearate - 2 mg, lupus - up to 200 mg (lactose monohydrate - 170 mg, crospovidone - 6.4 mg, povidone - 6.4 mg).
30 pcs. - vials polymeric (1) - packs cardboard.
Tablets are white, flat, with a risk on one side.
desmopressin acetate 100 Ојg,
which corresponds to the content of desmopressin 89 Ојg
Excipients: lactose monohydrate - 10 mg, crospovidone XL - 5 mg, magnesium stearate - 2 mg, lupus - up to 200 mg (lactose monohydrate - 170.1 mg, crospovidone - 6.4 mg, povidone - 6.4 mg).
30 pcs. - vials polymeric (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2012.
Desmopressin is a structural analogue of the natural hormone arginine-vasopressin, with a pronounced antidiuretic effect. Desmopressin was obtained as a result of changes in the structure of the vasopressin molecule - deamination of L-cysteine вЂ‹вЂ‹and replacement of 8-L-arginine with 8-D-arginine. Desmopressin increases the permeability of the epithelium of the distal sections of the convoluted tubules of the nephron for water and increases its reabsorption. Structural changes in combination with significantly enhanced antidiuretic ability lead to less pronounced effect of desmopressin on the smooth muscles of blood vessels and internal organs compared with vasopressin, which leads to the absence of undesirable spastic side effects. In contrast, vasopressin acts longer and does not cause an increase in blood pressure. The use of desmopressin in diabetes insipidus of central origin leads to a decrease in the volume of excreted urine and a simultaneous increase in osmolarity of urine and a decrease in osmolarity of the blood plasma. This leads to a decrease in the frequency of urination and a decrease in nocturnal polyuria. The maximum antidiuretic effect with ingestion comes in 4-7 hours. Antidiuretic effect with oral administration at a dose of 0.1-0.2 mg - up to 8 hours, at a dose of 0.4 mg - up to 12 hours.
When administered C max in the plasma is achieved during 0.9 h. V d is 0.2-0.3 l / kg. Simultaneous intake of food can reduce the degree of absorption from the gastrointestinal tract by 40%.
Absorption on intake - 5%. Desmopressin does not penetrate the blood-brain barrier.
It is excreted by the kidneys. T 1/2 for oral administration - 1,5-2,5 h.
- diabetes insipidus of central genesis;
- primary nocturnal enuresis in children older than 5 years;
- nocturnal polyuria in adults (as symptomatic therapy).
Inside. Optimal dose of the drug is selected individually. The drug should be taken some time after eating, as eating can affect the absorption of the drug and its effectiveness.
Central diabetes insipidus : the recommended initial dose for children over 4 years and adults is 0.1 mg 1-3 times / day. In the subsequent 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 / day.
Primary nighttime enuresis: The recommended initial dose for children over 5 years and adults is 0.2 mg per night. In the absence of effect, the dose may 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, which will be observed after the drug is discontinued within 1 week. It is necessary to monitor compliance with the restriction of fluid intake in the evening.
Nocturnal polyuria in adults: the recommended initial dose is 0.1 mg per night. In the absence of effect within 7 days, the dose is increased to 0.2 mg and then to 0.4 mg with increasing dose at a frequency of not more than 1 time / week. Remember the danger of fluid retention in the body. If after 4 weeks of treatment and dose adjustments adequate clinical effect is not observed, continue to use the drug is not recommended.
The most common side effects are observed in cases where the treatment is performed without restricting fluid intake - fluid retention and / or hyponatremia occur, which may be asymptomatic or manifest with the following symptoms.
From the side of the central nervous system and peripheral nervous system: headache, dizziness; in severe cases, convulsions.
On the part of the digestive system : nausea, vomiting, dry mouth.
Other: peripheral edema, weight gain, transient tachyarrhythmia, reddening of the eyes.
It is known that with simultaneous use of desmopressin with oxybutynin or imipramine hyponatremic convulsions are possible.
- hypersensitivity to desmopressin or other components of the drug;
- habitual or psychogenic polydipsia;
- heart failure and other conditions requiring the appointment of diuretics;
- hyponatremia, including in the anamnesis (concentration of sodium ions in the blood plasma is lower than 135 mmol / l);
- renal insufficiency of moderate and severe degree (creatinine clearance below 50 ml / min);
- Children's age up to 4 years (for treatment of diabetes insipidus) and up to 5 years (for treatment of primary nocturnal enuresis); .
- syndrome of inadequate production of antidiuretic hormone;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
With caution : renal failure, fibrosis of the bladder, violations of water and electrolyte balance, a potential risk of increased intracranial pressure, pregnancy . With extreme caution apply the drug in elderly patients (over 65 years) due to the high risk of side effects (fluid retention, hyponatremia). When prescribing therapy with Nativa drug, three days after the start of the dose and with each dose increase, the concentration of sodium in the blood plasma should be determined and the patient's condition monitored.
PREGNANCY AND LACTATION
According to known data, when using desmopressin in pregnant women with diabetes insipidus, there was no side effect on the course of pregnancy, on the state of health of the pregnant, fetus and newborn. However, the prospective benefit to the mother and the potential risk to the fetus should be correlated.
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 below 50 ml / min).
APPLICATION FOR CHILDREN
Contraindicated in children under 4 years (for treatment of diabetes insipidus) and up to 5 years (for treatment of primary nocturnal enuresis).
APPLICATION IN ELDERLY PATIENTS
With extreme caution apply the drug in elderly patients (over 65 years) due to the high risk of side effects (fluid retention, hyponatremia). When prescribing therapy with Nativa drug, three days after the start of the dose and with each dose increase, the concentration of sodium in the blood plasma should be determined and the patient's condition monitored.
Most often, hyponatremia occurs in elderly patients (over 65 years of age). It is necessary to control the treatment of children, adolescents, patients at risk of increased intracranial pressure. To avoid the development of side effects, it is mandatory to minimize the intake of liquid 1 h before and during 8 hours after taking the drug in patients with primary nocturnal enuresis.
The product of Nativa should not be used when there are other additional reasons for fluid retention and electrolyte disorders. High risk of side effects is for elderly patients with initially low concentration of sodium in blood plasma and polyuria from 2.8 to 3 liters.
Prevention of the development of hyponatremia consists in increasing the frequency of determination of sodium in blood plasma, especially when used with drugs that cause the syndrome of inadequate secretion of antidiuretic hormone (tricyclic antidepressants, selective serotonin reuptake inhibitors, narcotic analgesics, lamotrigine, chlorpromazine and carbamazepine) and NSAIDs. In the event of acute urinary incontinence, dysuria and / or nocturia, urinary tract infection, suspected bladder or prostate cancer, the presence of polydipsia and decompensated diabetes mellitus, the diagnosis and treatment of these conditions and diseases should be performed prior to initiation of treatment with Nativa.
When developing against the background of treatment of systemic infections, fever, gastroenteritis drug use should be discontinued.
Impact on the ability to drive vehicles and manage mechanisms
Currently, there is no data on the possible impact of Nativ's drug on the ability to drive a car and to control mechanisms. Nevertheless, the use of the drug may lead to the development of side effects such as dizziness, headache, which can adversely affect the ability to drive and carry out potentially dangerous activities that require increased concentration and speed of psychomotor reactions. It is recommended to use caution when driving a car or working with machinery.
Symptoms: increased duration of desmopressin and increased risk of fluid retention (headache, nausea, vomiting, peripheral edema, convulsions), hyponatremia, in which the concentration of sodium ions in the blood plasma is below 135 mmol / l.
Treatment: with hyponatremia - discontinuation of the drug, cancellation of the restriction on the intake of fluid, it is possible to perform an infusion of 0.9% or a hypertonic solution of sodium chloride. With severe fluid retention (convulsions and loss of consciousness), furosemide should be added to the above therapy.
With simultaneous use of desmopressin enhances the action of hypertensive drugs. With simultaneous application of buformin, tetracycline, lithium preparations, norepinephrine weaken the antidiuretic effect of desmopressin. With the simultaneous use of desmopressin with NSAIDs, an increased risk of side effects may occur.With simultaneous use of indomethacin increases, but does not increase the duration of action of desmopressin. With simultaneous use of tricyclic antidepressants, selective serotonin reuptake inhibitors, narcotic analgesics, NSAIDs, lamotrigine, 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. When using desmopressin with loperamide, a threefold increase in desmopressin concentration in plasma is possible, which significantly increases the risk of fluid retention and the occurrence of hyponatremia. Perhaps 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
According to doctor's prescription.
TERMS AND CONDITIONS OF STORAGE
Store in a dry place inaccessible to children and protected from light at a temperature of no higher than 25 В° C.
Shelf life - 2 years.