Nativa - instructions for use, dose, side effects, contraindications

Active substance:	0,1 mg	0,2 mg
Desmopressin acetate	0,1 mg	0,2 mg
in terms of desmopressin	0.089 mg	0.178 mg
Excipients:
Lactose Monohydrate	10 mg	10 mg
Crospovidone XL	5 mg	5 mg
Magnesium stearate	2 mg	2 mg
Loudipresse	before 200 mg	before 200 mg
in terms of components:
Lactose Monohydrate	170.1 mg	170.0 mg
Crospovidone	6.4 mg	6.4 mg
Povidone	6.4 mg	6.4 mg

Description:

Dosage of 0.1 mg: white, round, flat tablet with a facet and a risk on one side.

Dosage of 0.2 mg: white, round, flat tablet with a facet and a risk on one side.

Pharmacotherapeutic group:diabetes insipid treatment medication

ATX: & nbsp

H.01.B.A.02 Desmopressin

Pharmacodynamics:

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 molecule vasopressin - deamination of L-cysteine and substitution of 8-L-arginine on the 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 a significantly enhanced antidiuretic ability lead to a 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 (BP).

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 oral administration occurs in 4-7 hours. Antidiuretic effect when ingested at a dose of 0.1-0.2 mg to 8 hours, at a dose of 0.4 mg to 12 hours.

Pharmacokinetics:

Suction

When administered, the maximum concentration in the plasma (C_m_Oh) is reached within 0.9 hours. Simultaneous intake of food can reduce the degree of absorption from the gastrointestinal tract (GIT) by 40%.

Distribution

Volume of distribution (V_d) is 0.2-0.3 l / kg. Absorption on intake - 5%. Desmopressin does not penetrate the blood-brain barrier.

Excretion

It is excreted by the kidneys. The half-life (T_1/2) at intake 1,5-2,5 hours.

Indications:

- Non-diabetes mellitus of the central genesis;

- primary nocturnal enuresis in children older than 5 years;

- nocturnal polyuria in adults (as symptomatic therapy).

Contraindications:

If you have any of the listed diseases, before taking the drug, be sure to consult a doctor:

- 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 under 4 years old (for treatment of diabetes insipidus) and 5 years (for treatment of primary nocturnal enuresis);

- syndrome of inadequate production of antidiuretic hormone;

- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.

Carefully:

Apply the drug for kidney failure, fibrosis of the bladder, with violations of water-electrolyte balance, the potential risk of increased intracranial pressure, during 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 Nativa therapy 3 days after the start of the dose and at 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.

Dosing and Administration:

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 a 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 a day.

Primary night 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 no more than 1 time per 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.

Side effects:

The following undesirable phenomena noted with the use of desmopressin are distributed according to the frequency of occurrence according to the following gradation: very often (≥ 1/10), often (≥ 1/100 to <1/10), infrequently (≥ 1/1000 to < 1/100), rarely (≥ 1/10000 to <1/1000), very rarely (<1/10000), frequency, unspecified (can not be calculated from available data).

Disturbances from the nervous system: often - headache, dizziness; frequency, unspecified - convulsions.

Disorders from the digestive system: often - nausea, vomiting, dry mouth.

Disorders from the cardiovascular system: infrequently - transient tachyarrhythmia.

Disturbances on the part of the organ of sight: infrequently - conjunctivitis.

Common violations: often - peripheral edema, weight gain.

Taking Nativa without restricting fluid intake can lead to fluid retention in the body and / or hyponatremia, which may be asymptomatic or accompanied by headache, nausea, vomiting, swelling, weight gain, and in severe cases - convulsions.

Overdose:

Overdose leads to an increase in the duration of desmopressin and an increased risk of fluid retention (headache, nausea, vomiting, peripheral edema, convulsions) and hyponatremia, in which the concentration of sodium ions in the blood plasma is below 135 mmol / l.

Treatment: with hyponatremia - discontinuation of use of the drug, removal 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 (cramps and loss of consciousness), the above therapy should be added furosemide.

Interaction:

With simultaneous application desmopressin strengthens the action of hypertensive drugs.

With simultaneous application buformin, tetracycline, lithium preparations, norepinephrine weaken the antidiuretic effect of desmopressin.

With the simultaneous use of desmopressin with non-steroidal anti-inflammatory drugs (NSAIDs), an increased risk of side effects may occur. With simultaneous application indomethacin strengthens, but does not increase the duration of action of desmopressin.

With the simultaneous use of tricyclic antidepressants, selective serotonin reuptake inhibitors, narcotic analgesics, NSAIDs, lamotrigine, chlorpromazine and carbamazepine, capable of causing a 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.

Special instructions:

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. In order to avoid the development of side effects, it is mandatory to minimize the intake of liquid 1 hour prior to use and within 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.

A high risk of side effects is for elderly patients with an initially low concentration of sodium in 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 the blood plasma, especially when used simultaneously with drugs that cause the syndrome of inadequate secretion, 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 tumor, the presence of polydipsia and decompensated diabetes mellitus, the diagnosis and treatment of these conditions and diseases should be carried out before starting treatment with Nativa.

When developing against the background of treatment of systemic infections, fever, gastroenteritis drug use should be discontinued.

Effect on the ability to drive transp. cf. and fur:

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.

Form release / dosage:

Tablets, 0.1 mg and 0.2 mg.

Packaging:

For 30 tablets in polymer bottles, ukuporennyh plastic caps (with a dehumidifier and with the control of the first autopsy).

For 1 bottle together with instructions for medical use in a cardboard bundle.

Storage conditions:

Store in a dark place at a temperature of no higher than 25 ° C.

The drug should be stored out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001402

Date of registration:28.12.2011 / 29.08.2014

Date of cancellation:2016-12-28

The owner of the registration certificate:NATIVA, LLC NATIVA, LLC Russia

Manufacturer: & nbsp

PHARMSTANDART-UFIM VITAMIN FACTORY, OJSC Russia

NATIVA, LLC Russia

Information update date: & nbsp15.01.2016

Illustrated instructions

Instructions

Nativa (Nativa)